HIV

HIV Vaccine Research Rekindles in 2024

Karen McClorey Hackett — Thu, 01 Feb 2024 22:32:28 +0000

Reviewer:

Following the announcement in December 2023 that the PrEPVacc study team was discontinuing vaccinations following a review that determined a minimal chance the vaccine candidates being tested could stop human immunodeficiency virus (HIV) acquisition, many were disappointed.

With an estimated 1.3 million people worldwide becoming infected with HIV annually, there is a tremendous unmet need for a preventive vaccine.

However, recent news indicates other HIV vaccine candidates are moving forward to address this market need in 2024.

Uvax Bio, LLC, a spin-off vaccine company from the highly regarded Scripps Research, is utilizing rational and computational biology to design and deliver novel 1c-SApNP® protein-based vaccines.

With great anticipation, Uvax announced on January 30, 2024, that the first participant was dosed in a Phase 1 clinical trial in Australia evaluating the Company's HIV-1 vaccine candidates, UVAX-1107 and UVAX-1197.

The two antigens differ insofar as UVAX-1197 retains the virus' wild-type glycan shield, while UVAX-1107 has a portion of the glycan shield removed through glycan trimming (GT).

GT is an enzymatic removal of glycans to allow better access to the conserved neutralizing epitopes on HIV-1 Env.

The UFO trimer, 1c-SApNP platform, and glycan trimming strategy were developed by Dr. Jiang Zhu, Associate Professor, Department of Integrative Structural and Computational Biology at Scripps Research.

The study's first-in-human clinical trial primary endpoints will measure the safety and immunogenicity of UVAX-1107 and UVAX-1197 after the primary and boosting dose series are evaluated in parallel arms.

The study will also determine whether either vaccine or combination produces the optimal immunological response.

In the January 30th press release, Uvax Bio stated that it expects to report topline data from the Phase 1 trial in the fourth quarter of 2024.

Ji Li, Ph.D., Uvax Bio CEO, commented, "UVAX-1107 and UVAX-1197 represent an advancement in HIV vaccine technology with industry-recognized innovations in our antigen design and delivery. I am proud of the Uvax Bio team for bringing our promising HIV-1 vaccine candidates into human testing, a significant milestone for the Company."

In a preclinical toxicology study, UVAX-1107 and UVAX-1197 combined with adjuvant were shown to be safe with no serious adverse events, consistent with previously approved protein-based vaccines.

Additionally, a second preclinical immunogenicity study demonstrated immunization with UVAX-1107 and UVAX-1197, which elicited robust neutralizing antibody responses against the vaccine-matched virus in 99% of the animals.

Furthermore, preliminary screening assays demonstrated appreciable neutralization in serum when tested against a panel of primary HIV-1 isolates.

The HIV Vaccine Trials Network says there are many types of vaccines. Still, all generally work by teaching the immune system to recognize and fight back against a disease-causing microorganism.

Some vaccines are designed to help the immune system prevent an infection and are called preventive vaccines. Others are therapeutic vaccines designed to help people who already have a disease to clear the infection.

As of February 2, 2024, there are no HIV vaccines approved by the U.S. FDA.

Note: The article was updated on 2/2/24 to reflect accurate dates.

Sub Title:

HIV vaccine candidates are conducting clinical research in 2024

References:

First Participant in Phase 1 Clinical Trial Evaluating Two Vaccines to Prevent HIV-1 Infection

HVTN 2024

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HIV Vaccine Development Disrupted in Africa

Karen McClorey Hackett — Mon, 11 Dec 2023 18:17:06 +0000

Reviewer:

Robert Carlson, MD

According to a recent announcement, a much anticipated human immunodeficiency virus (HIV) vaccine clinical trial that began in December 2020 has been discontinued in Africa because there is little or no chance of the trial demonstrating vaccine efficacy in preventing HIV acquisition.

On December 6, 2023, the PrEPVacc clinical trial leadership announced they decided to stop vaccinations based on the recommendation of its independent data monitoring committee (IDMC).

The PrEPVacc HIV prevention study of experimental vaccine regimens combined with a new form of oral pre-exposure prophylaxis (PrEP) was operating in East and Southern Africa among 1,500 volunteer participants.

However, the IDMC also recommended that the study's oral PrEP component (TAF/FTC, Descovy ©) continue to completion.

Results from this study are being analyzed and will be shared with participants, study teams, and the public in the second half of 2024.

This is unfortunate news, as there are no approved HIV vaccines as of December 11, 2023.

PrEPVacc's Trial Director, Dr. Eugene Ruzagira, who announced the news, commented in a press release, "Vaccinations to PrEPVacc trial participants have been stopped because an analysis of the data collected so far by our IDMC has led them to conclude that there is little or no chance of demonstrating that the vaccines we are testing are reducing the risk of acquiring HIV."

"The scientific hurdles are high, but I have equally high hopes that an HIV vaccine will be developed one day. Every day, important research like PrEPVacc is moving us forward worldwide."

"As we move towards a new era of HIV prevention studies and vaccine efficacy trials, the lessons of Good Participatory Practice have never been more important to apply."

PrEPVacc was three trials in one.

It was testing two different combinations of HIV vaccines to find out if either can prevent HIV infection in populations at risk of acquiring HIV.

Participants received injections of either one regimen combining a DNA vaccine with a protein-based vaccine (AIDSVAX), a regimen combining DNA, MVA, and a protein-based vaccine (CN54gp140), or a placebo.

Participants received four injections in each regimen or of the placebo.

At the same time as participants receive vaccinations, PrEPVacc is also testing a new oral PrEP drug formulation to see if it is as good as the drugs already approved for PrEP (TDF/FTC, Truvada©).

Participants received study PrEP as either Descovy © or Truvada © up to two weeks after the third vaccine injection. After that, the study teams either provide non-study PrEP in a clinic or refer the participants to access non-study PrEP at the local service providers.

The PrEPVacc study is funded by the European & Developing Countries Clinical Trials Partnership supported by the European Union.

Sub Title:

PrEPVacc clinical trial discontinues vaccinations

Reference:

Experimental HIV vaccine regimens likely to be ineffective in preventing HIV acquisition, PrEPVacc study reports

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PrEPVacc vaccine study volunteer

HIV Vaccine Research Accelerates with Government Funding

Karen McClorey Hackett — Wed, 26 Apr 2023 14:39:03 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

While millions of people worldwide await the launch of an HIV vaccine, the U.S. government recently took action by committing to fund early-stage vaccine candidates.

On April 26, 2023, Uvax Bio, LLC announced that its HIV vaccine candidates had shown significantly improved immune response compared with current vaccine strategies.

According to results from preclinical studies described in a paper published in Nature Communications titled, “Single-component multilayered self-assembling protein nanoparticles presenting glycan-trimmed uncleaved prefusion optimized envelope trimers as HIV-1 vaccine candidates.”

Based on these results, the U.S. National Institutes of Health (NIH) has agreed to sponsor a Phase 1 clinical trial expected to launch in the first quarter of 2024.

And last week, Scripps Research announced this HIV vaccine candidate showed a significantly improved ability to neutralize the virus in preclinical tests.

The new and unique HIV vaccine design uses tiny protein “nanoparticles” to display multiple copies of HIV’s surface protein Env, thus presenting itself to the immune system much as real HIV particles would without causing HIV infection.

The key innovation that explains its effects involves flexible sugar molecules called glycans, which normally cover Env on the real virus but are shortened in the new design.

“With this design, we appear to have solved a big piece of the HIV vaccine puzzle,” says the paper’s senior author Jiang Zhu, Ph.D., an associate professor in the Department of Integrative Structural and Computational Biology at Scripps Research, in a press release.

And Uvax Bio confirmed it is conducting two definitive preclinical studies in preparation for submitting a U.S. FDA Investigational New Drug application.

As of April 26, 2023, the U.S. FDA had not approved an HIV vaccine.

The Joint United Nations Programme on HIV/AIDS estimates that 38.4 million people worldwide live with HIV, and 1.5 million people became newly infected with HIV in 2021 alone.

The development of HIV vaccines represents the best solution for eradicating the HIV pandemic, says the Vaccine Research Institute.

Other sexually transmitted disease vaccine news, such as herpes and HPV, are posted by Precision Vaccinations.

Sub Title:

HIV vaccine candidates April 2023

References:

Single-component multilayered self-assembling protein nanoparticles presenting glycan-trimmed uncleaved prefusion optimized enve

Uvax Bio Announces Publication of Results from Preclinical Studies of HIV Vaccine Candidates

Trim the sugar: New HIV vaccine design improves immune response

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mRNA Vaccines Targets HIV

Karen McClorey Hackett — Wed, 12 Apr 2023 19:02:08 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Moderna Inc. recently announced it is advancing three Phase I clinical trials of Human immunodeficiency virus (HIV) vaccines with partners (mRNA-1644/IAVI G002; mRNA-1644/IAVI G003; mRNA-1574/NIAID) to expand on proof-of-concept data.

And these trials will evaluate the potential of Moderna's mRNA technology to successfully deliver immunogens and will be conducted in parallel to accelerate the advancement of immunogens into vaccine candidates.

The trials are the beginning of an iterative research process with the expectation for multiple Phase 1 trials to converge on a potentially protective vaccine that merits advancement to Phase 2.

These trials aim to determine whether this approach is safe and immunogenic, meaning that the immunogens elicit the correct type of broadly neutralizing HIV-1 antibodies (bnAbs).

A study published in February 2022 stated bNAbs targeting the HIV-1 envelope glycoprotein are promising molecules for therapeutic or prophylactic interventions.

Beyond neutralization, bNAbs exert Fc-dependent functions, including antibody-dependent cellular cytotoxicity and activation of the complement.

HIV, the cause of AIDS, is a sexually transmitted disease that has devastating health effects globally, resulting in approximately 650,000 related fatalities annually.

The U.S. Centers for Disease Control and Prevention recently identified a correlation between HIV and Mpox infections.

As of April 12, 2023, the U.S. Food and Drug Administration has not approved any HIV vaccine candidates for use in the United States.

Sub Title:

HIV vaccine candidates continue clinical trials in April 2023

References:

Moderna Inc. April 11, 2023

Broadly neutralizing anti-HIV-1 antibodies tether viral particles at the surface of infected cells

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Hep B Vaccination Protects People with HIV

Donald Hackett — Mon, 31 Oct 2022 18:27:35 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Recent peer-reviewed research out of Cincinnati showed that an entire course of a hepatitis B vaccine provides substantial protection for people living with HIV.

The University of Cincinnati (UC) research published on October 20, 2022, shows that three doses of a hepatitis B vaccine protect people with HIV who had not been vaccinated against or exposed to the hepatitis B virus (HBV).

This phase 3 study's findings are essential since little is known about its protective effects on people with HIV. In the U.S., about 10% of U.S. adults with HIV also have HBV.

"Hepatitis B is highly ranked among liver-disease-related causes of death among people living with HIV," says Kenneth Sherman, MD, Ph.D., at the UC College of Medicine and study chair and senior author of the research, in a related press release.

"This finding may change routine vaccine practices among persons living with HIV."

"While this will not cure those who already have hepatitis B, it will keep others from getting the disease," commented Dr. Sherman.

HBV is spread primarily through sexual contact and sharing of contaminated needles. It causes chronic hepatitis B infection and can lead to progressive liver disease.

People living with HIV, including those taking antiretroviral therapy, are at greater risk of liver-related illness and death when co-infected with HBV, according to the U.S. CDC.

People living with HIV are less likely to produce a protective immunological response to HBV vaccination.

HBV, spread primarily through sexual contact and sharing contaminated needles, causes hepatitis B liver infections.

Therefore, people living with HIV are at greater risk of liver-related illness and death when co-infected with HBV.

"The difference in HEPLISAV-B from other vaccines is that it contains a product called CPG, which is a type of immune booster that could improve response to the vaccine by the body's immune cells," says Sherman.

"In the pivotal clinical trials that led to that vaccine's licensure, it was shown that the vaccine with just two doses rather than the usual three-dose series required for prior vaccines achieved equivalent or greater levels of response.

However, persons with HIV do not have high rates of response to the older vaccine preparations.

So that is why it was suspected that a three-dose regimen with the new vaccine might lead to better overall response rates."

The analysis included 68 adults living with HIV at 38 sites in the United States, South Africa, and Thailand. None of the people in the study group had received HBV vaccination previously or had evidence of being exposed to HBV; all were on antiretroviral therapy.

The levels of antibodies produced were higher than what has been observed following older vaccine preparations.

"Higher antibody levels often translate to better vaccine durability," according to Sherman.

The HEPLISAV-B vaccine, made by Dynavax Technologies Corp., was approved in 2017 by the U.S. FDA as a two-dose vaccine regimen for adults.

The CDC's Advisory Committee on Immunization Practices recommends HepB vaccination among all adults aged 19–59 years and adults > 60 years with risk factors for hepatitis B or without identified risk factors but seeking protection. (July 2022)

The National Institute of Allergy and Infectious Diseases, part of the U.S. NIH, sponsors the ongoing Phase 3 ACTG A5379 clinical study.

Precision Vaccinations publishes other hepatitis and HIV vaccine news.

PrecisionVaccinations publishes fact-checked, research-based vaccine news manually curated for mobile readers.

Sub Title:

High HBsAb seroprotection achieved after HepB-CpG vaccination

References:

NIH - hepatitis B vaccine regimen protects people with HIV

Data showing success of hepatitis B vaccine among people living with HIV

CDC - Hepatitis B Vaccination of Adults

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Severe Monkeypox Impacts People with HIV

Donald Hackett — Thu, 27 Oct 2022 15:17:00 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

During previous monkeypox outbreaks, severe disease manifestations and poor outcomes have been reported among persons with HIV infection, particularly those with AIDS.

A U.S. CDC Morbidity and Mortality Weekly Report (MMWR) issued on October 26, 2022, summarizes findings from CDC clinical consultations provided for 57 adult patients who were hospitalized with severe manifestations of monkeypox from August 10–October 10, 2022.

This MMWR highlights 47 (82%) monkeypox patients who had HIV infection, four (9%) of whom were receiving antiretroviral therapy (ART) before monkeypox diagnosis.

Most patients were male (95%), and 68% were non-Hispanic Black (Black).

Overall, 17 (30%) patients received intensive care unit (ICU)–level care, and 12 (21%) died.

As of this report published on October 26, 2022, monkeypox was a cause of death or contributing factor in five of these deaths; six deaths remain under investigation to determine whether monkeypox was a causal or contributing factor; and in one death, monkeypox was not a cause or contributing factor.

The CDC stated healthcare providers should be aware that severe morbidity and mortality associated with monkeypox have been observed during the current outbreak in the United States, particularly among highly immunocompromised persons.

Providers should test all sexually active patients with suspected monkeypox for HIV at the time of monkeypox testing unless a patient is already known to have HIV infection.

And providers should consider early commencement and extended duration of monkeypox-directed therapy in highly immunocompromised patients with suspected or laboratory-diagnosed monkeypox.

The CDC also highlighted three Representative Case Descriptions.

Engaging all persons with HIV in sustained care remains a critical public health priority.

Furthermore, the CDC encourages using the two-dose JYNNEOS® (MVA-BN, IMVANEX®) vaccine.

About 1,012,283 JYNNEOS vaccine doses had been administered in the 57 U.S. Jurisdictions reporting data to the CDC as of October 25, 2022.

Additional monkeypox outbreak news, vaccines, and research are posted at Monkeypox Today.

Note: As of October 27, 2022, the U.S. FDA has not approved an HIV prevention vaccine. However, several vaccine candidates are conducting studies in 2022.

PrecisionVaccinations publishes fact-checked, research-based vaccine information manually curated for mobile readers.

Sub Title:

HIV is a risk factor for monkeypox virus infection

Reference:

U.S. CDC MMWR - Severe Monkeypox in Hospitalized Patients

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Will Gene Editing Cure HIV

Donald Hackett — Mon, 17 Oct 2022 21:01:46 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Recent announcements indicate innovative technologies may provide new clinical solutions for the 36.9 million people living with HIV/AIDS worldwide.

The current standard of care for these people of all ages is a combination of antiretroviral therapies, which may control the disease, but are not curative, as they cannot target integrated HIV-1 genomes, says HIV.gov.

Recently, a potential cure for human immunodeficiency virus type 1 (HIV-1) created with CRISPR-based editing of HIV proviral DNA was announced.

The participant was dosed in July 2022, with initial findings indicating EBT-101 has been well tolerated to date, announced San Francisco-based Excision BioTherapeutics, Inc.

"Dosing the first participant with EBT-101 is a landmark event that solidifies Excision's position as a pioneer in gene editing," said Daniel Dornbusch, Chief Executive Officer of Excision, in a related press release on October 15, 2022.

"It is the first time a CRISPR-based therapy targeting an infectious disease has been administered to a patient."

"In addition, it is expected to enable the first-ever clinical assessment of a multiplexed, in vivo gene editing approach."

EBT-101 is a unique, clinical-stage in vivo CRISPR-based therapeutic designed to cure HIV infections after a single intravenous infusion.

EBT-101 employs an adeno-associated virus (AAV) to deliver CRISPR-Cas9 and dual guide RNAs, enabling a multiplex editing approach simultaneously targeting three distinct sites within the HIV genome.

This allows for the excision of large portions of the HIV genome, thereby minimizing potential viral escape.

The participant continues to be monitored for safety and is expected to qualify for analytical treatment interruption (ATI) of their background antiretroviral therapy (ART) to evaluate a potential cure.

Rachel M. Presti, M.D., Ph.D., Associate Professor of Medicine at Washington University School of Medicine in St. Louis, MO, and Principal Investigator of the Phase 1/2 trial, added, "Using gene editing to target the HIV DNA reservoirs in human cells is a novel investigational approach, designed to cure HIV."

"We are well-positioned to collect key data in this first-in-human study to determine whether we can duplicate the success of this approach in animal models."

All participants in the study will be assessed for eligibility for an ATI of their background ART at Week 12.

Following the initial 48-week follow-up period, all participants will be enrolled in a long-term follow-up protocol.

For more information, see NCT05144386 (Phase 1/2 trial) and NCT05143307 (long-term follow-up protocol).

And on October 12, 2022, the journal International Journal of Infectious Diseases published a very positive systematic review and meta-analysis regarding COVID-19 vaccination and people living with HIV (PLWH).

Twenty-two studies with 6,522 subjects met the study's inclusion criteria.

This review concluded COVID-19 vaccines show favorable immunogenicity and efficacy in PLWH.

And a second vaccine dose is associated with consistently improved seroconversion, although it is slightly lower in PLWH compared with healthy individuals.

Additional strategies, such as a booster vaccination with mRNA COVID-19 vaccines, might improve seroprotection for these patients.

As of October 17, 2022, the U.S. FDA has not approved an HIV vaccine. Other breaking news is posted at PrecisionVaccinations.com/HIV.

PrecisionVaccinations publishes fact-checked, research-based vaccine news manually curated for mobile readership.

Sub Title:

CRISPR Cas9 therapy targeting people living with HIV

References:

Guidelines for the Use of Antiviral Agents For HIV

First Participant in EBT-101 Phase 1/2 Trial Dosed

Systematic review and meta-analysis HIV and COVID-19 vaccines

HIV vaccines 2022

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HIV Vaccine Roadmap Becomes Clearer

Donald Hackett — Fri, 09 Sep 2022 16:49:12 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

Over the years, numerous scientists have stated to 'successfully produce a Human Immunodeficiency Virus (HIV-1) vaccine, innovative technologies could be required.'

HIV-1 is the most common virus type, has unprecedented genetic variability, and the ability to quickly establish a lifelong infection are just some of the obstacles researchers face in trying to understand how to induce protective immunity against the virus, confirms the International AIDS Vaccine Initiative.

"Finding an HIV (prevention) vaccine has proven a daunting scientific challenge," stated Anthony S. Fauci, M.D. NIAID director, on March 14, 2022.

Most importantly, 'HIV vaccine candidates can not cause HIV infection.'

Since nobody with HIV has ever developed an immune response that cleared the infection, scientists do not yet know what constitutes an effective immune response to the virus, wrote the U.S. NIAID.

However, a new, pre-human study published by the peer-review journal Science Translational Medicines on September 7, 2022, offers a clinical path for accelerating HIV vaccine development.

The extensive research team noted that HIV vaccine candidates tend to focus on empowering the human body to produce antibodies that bind to certain parts of the virus.

The challenge with this approach is that HIV changes its spike protein so quickly.

That means a successful HIV vaccine must target multiple neutralizing antibodies (nAbs) that cover a broad spectrum of proteins.

These researchers wrote, 'A successful HIV-1 vaccine will require induction of a polyclonal neutralizing antibody (nAb) response, yet vaccine-mediated induction of such a response in primates remains a challenge.

We found a stabilized HIV-1 CH505 envelope (Env) trimer formulated with a Toll-like receptor 7/8 agonist-induced potent HIV-1 polyclonal nAbs correlated with protection from homologous simian-human immunodeficiency virus (SHIV) infection.

Structural analyses of vaccine-induced nAbs demonstrated targeting of the Env CD4 binding site or the N156 glycan and the third variable loop base.

CH505 viral isolated mutated the V1 to escape the infection- and vaccine-induced antibodies were isolated.

In summary, these results define the specificities of a vaccine-induced nAb response and the protective titers of HIV-1 vaccine-induced nAbs required to protect nonhuman primates from low-dose mucosal challenge by SHIVs bearing a primary transmitted/founder Env.'

Regarding a therapeutic HIV vaccine to treat active virus infections, Research Priorities for an HIV Cure: International AIDS Society Global Scientific Strategy was published in Nature Medicine in December 2021.

This strategy identified a series of questions to draw nearer to an HIV cure that must be safe, affordable, and applicable at scale to everyone with HIV.

This research work was supported by the National Institutes of Health Division of AIDS for the Center for HIV/AIDS Vaccine Immunology-Immunogen Discovery, the National Institutes of Health Division of AIDS grant for the Duke Consortia for HIV/AIDS Vaccine Development, and the National Institutes of Health Division of AIDS grant. These researchers disclosed no significant industry-related conflicts of interest.

Additional HIV vaccine development news is posted at PrecisionVaccinations.com/HIV.

PrecisionVaccinations publishes fact-checked, research-based HIV vaccine news curated for mobile readership.

Sub Title:

HIV vaccine candidates included mRNA technology

References:

IAVI HIV vaccines

NIH HIV vaccine studies

Stabilized HIV-1 envelope immunization induces neutralizing antibodies to the CD4bs and protects macaques against mucosal infect

NIAID HIV vaccine overview

Research priorities for an HIV cure: International AIDS Society Global Scientific Strategy 2021

HIV vaccine candidates

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Monday, September 19, 2022 - 23:15

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by Lorri Lang

First HIV, Monkeypox, SARS-CoV-2 Coinfection Confirmed

Karen McClorey Hackett — Sun, 21 Aug 2022 15:01:30 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

A new Letter presented the clinical features and diagnostic procedure of the first documented case of co-infection with monkeypox virus, SARS-CoV-2, and HIV-1 in an Italian 36-year-old male.

Published on August 19, 2022, by the peer-review Journal of Infection, this case highlights how monkeypox disease and COVID-19 symptoms may overlap and corroborates how in case of co-infection, anamnestic collection and sexual habits are crucial to perform the correct diagnosis.

In fact, the patient tested positive for HIV-1 with a viral load of 234,000 copies/mL, and given his preserved CD4 count, which was unaltered with 812 cells/μL, it could be assumed that the infection was relatively recent.

However, as this is the only reported case of monkeypox virus, SARS-CoV-2 coronavirus, and HIV co-infection, there is still not enough evidence supporting that this combination may aggravate a patient's condition.

Given the current SARS-CoV-2 pandemic and the daily increase of monkeypox cases, healthcare systems must be aware of this eventuality, promoting appropriate diagnostic tests in high-risk subjects, which are essential to containment as there is no widely available treatment or prevention, wrote Santi Nolasco, MD, Department of Clinical and Experimental Medicine, University of Catania and colleagues.

To note, the monkeypox oropharyngeal swab was still positive after twenty days, suggesting that these individuals may still be contagious for MPXV several days after clinical remission.

Consequently, physicians should encourage appropriate precautions.

And clinicians should be aware of the possibility of SARS-CoV-2 and MPXV co-infection, particularly in subjects with a recent history of travel to monkeypox-outbreak areas.

If monkeypox is suspected, an oropharyngeal swab should be performed even without cutaneous manifestations as the skin may be spared, but the oral or rectal mucosa may be involved.

These study authors have no industry conflicts of interest to declare, and this study had no outside funding.

The full Research Letter is posted at this link.

In a previous report published on June 2, 2022, four cases in Italy detected MPX DNA in semen, feces, and saliva.

The good news is there are MPXV and COVID-19 vaccines approved by the U.S. FDA.

Unfortunately, HIV vaccine candidates remain unauthorized as of August 21, 2022.

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.

Sub Title:

Monkeypox, SARS-CoV-2, HIV infections can occur simultaneously

References:

Journal of Infection

HIV Vaccine Candidates

Monkeypox vaccines

EuroSurveillance Report

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HIV, monkeypox, COVID-19 vaccines, jynneos, aids,

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by Mabel Amber

COVID-19 Breakthrough Infection 28% Greater in People with HIV

Karen McClorey Hackett — Thu, 09 Jun 2022 18:18:54 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

According to findings from a new study led by researchers at the Johns Hopkins Bloomberg School of Public Health, people with HIV have a higher rate of breakthrough COVID-19 infections after vaccination than those without HIV.

In the study published in the peer-review JAMA Network Open on June 7, 2022, the researchers analyzed anonymized health records among nearly 114,000 people fully vaccinated with either two doses of mRNA vaccines or one dose of the viral vector vaccine in late 2021.

When comparing vaccine recipients with and without HIV, the researchers found that the chance of a positive SARS-CoV-2 test result or a COVID-19 diagnosis within nine months after full vaccination, though low, was 28% higher among people with HIV.

While the risk of breakthrough infection was 3.8% for the non-HIV group and 4.4% for the HIV group.

“These findings should alert all people with HIV to their greater risk of COVID-19 breakthrough and can inform official recommendations about COVID-19 vaccination for people with HIV,” says senior study author Keri Althoff, Ph.D., associate professor in the Bloomberg School’s Department of Epidemiology, in a related press release issued on June 7, 2022.

Currently, the U.S. Centers for Disease Control and Prevention (CDC) recommends that people who are “moderately or severely immunocompromised”—a category that includes people with HIV who are untreated or have low CD4 T-cell counts (<200 cells per microliter)—receive an extra dose of vaccine as part of their primary vaccination series, followed by a booster dose.

In total, the CDC suggests people with HIV get four doses of an mRNA vaccine.

Moreover, the study found an increased risk of a breakthrough infection with increasing immune suppression, measured via decreasing CD4 counts.

Those with CD4 counts that signal moderate immune suppression in people with HIV—in the 200-350 cells/mm3 range—had a statistically significant increase in the risk of breakthrough compared to people without HIV.

That suggests that people with HIV and moderate immune suppression may need to be included in the CDC’s guidelines for additional vaccine doses in the primary vaccination series.

“Policymakers who establish the guidelines should consider the benefits and risks of an additional dose of vaccine in the primary series not only for those with severe or untreated HIV but also include those with moderate immune suppression or even all persons with HIV,” says the study first author Sally Coburn Ph.D., a post-doctoral fellow in the Bloomberg School’s Department of Epidemiology.

Althoff and colleagues are following up with a study to determine whether vaccinated people with HIV have higher breakthrough infection rates and higher hospitalization rates after breakthrough infection.

For their study, Althoff and her colleagues pooled individual-level data from four health systems in the U.S. to create a study population named the Corona-Infectious-Virus Epidemiology Team (CIVET) cohort.

The CIVET cohort contains de-identified records from private health insurers, the Veterans Affairs health care system, and an academic-affiliated health system.

The researchers’ observations of differential breakthrough risk by vaccine type are consistent with studies showing lower effectiveness for Ad26.COV2.S relative to mRNA vaccines.

And among mRNA vaccines, more breakthroughs among those with BNT162 vs. mRNA-1273 primary series.

‘We also saw a steep increase in the rate of breakthrough infections in December 2021 related to the SARS-CoV-2 Omicron variant circulation.’

The study was funded under the North American AIDS Cohort Collaboration on Research and Design (NA-ACCORD, U01AI069918) from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health. No industry conflicts of interest were disclosed.

Note: HIV vaccine development news is posted at PrecisionVaccinations.com/HIV.

PrecisionVaccinations publishes fact-checked, research-based vaccine news curated for mobile readership.

Sub Title:

People with HIV may benefit from an additional COVID-19 vaccine dose

References:

Analysis of Postvaccination Breakthrough COVID-19 Infections Among Adults With HIV in the United States

Risk of breakthrough Covid-19 infection after vaccination is higher among people with HIV

HIV Vaccines 2022

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health, vaccines, vaccinations, hiv, hiv and covid, hiv vaccines, hiv covid vaccines, covid-19 breakthrough, breakthrough infections

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Tuesday, June 14, 2022 - 10:00

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by Tobi Berger

HIV Vaccine Acceptance Depends on Behavioral and Clinical Success

Karen McClorey Hackett — Mon, 30 May 2022 17:47:10 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The first human trials of mRNA-based vaccines targeted against HIV began earlier this year. And these phase 1 studies are making encouraging progress with patient recruitment.

However, epidemiologists and virologists have recently voiced ‘cautious optimism’ about these vaccine candidates' success.

It is also essential to engage behavioral scientists early in vaccine development. Scientists must think about how to place biological solutions within prevailing social norms, stated an article written by Devi Leena Bose on May 16, 2022.

Published by the journal Nature, this insightful article is excerpted below.

‘For an HIV vaccine to be acceptable, experts need to strategize from users’ behavior-resistance point of view.

Gagandeep Kang, a professor at the Wellcome Trust Research Laboratory in Christian Medical College Vellore, says bodily integrity matters the most to people while making health-related choices.

“In a way, vaccines breach that integrity.”

“An HIV vaccine will struggle with this whenever it comes in the future,” she says.

In his book Change: How to Make Big Things Happen, Damon Centola suggests that, while information and disease spread through ‘simple contagions,’ behavior change often takes place in ‘complex contagions,’ meaning it requires multiple sources of reinforcement.

So, for example, if an idea needs to overcome more resistance, its acceptance will likely be a complex contagion.

Based on Centola’s work, the journey of an HIV vaccine needs to be understood through this prism of complex contagions where intervention needs to cross some critical barriers:

• Credibility barrier: People may be skeptical about the effectiveness and safety of a vaccine.

• Legitimacy barrier: Vaccines must be introduced alongside efforts to reduce situations that fuel fear of embarrassment or social sanctions.

• Coordination barrier: For the intervention to be successful, more people must adopt it simultaneously.

• Excitement: Social acceptance from peers is critical to boosting enthusiasm for new products and practices.

• Digital realities: Information and misinformation now spread at lightning speed, and the reach of a hashtag is not something to be undervalued.

An accessible, affordable life-saving solution can falter on these barriers if people’s resistance to change is not accounted for. This is where behavioral science plays an essential and complementary role in vaccine science.

It can help design strategies calibrated to users’ needs and specific communities where resistance is higher,’ concluded Bose’s article.

"Finding an HIV vaccine has proven a daunting scientific challenge," commented Anthony S. Fauci, M.D. NIAID director, on March 14, 2022.

"With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection."

Currently, two HIV vaccine candidates are active.

mRNA-1574 - Produced by Moderna Inc., is participating in the HVTN 302 study to examine the safety and immune responses of experimental vaccines that encode for different but highly related stabilized proteins.
mRNA-1644 (eOD-GT8 60mer) - Was developed by scientific teams at IAVI and Scripps Research and delivered via Moderna's mRNA platform.

Note: HIV vaccines can not cause HIV infection says the U.S. FDA.

PrecisionVaccinations publishes fact-checked, research-based news curated for mobile readership.

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HIV vaccines can not cause HIV infection

References:

Preparing society for a HIV vaccine

Cautious optimism for trials of mRNA-based HIV vaccine

HIV Vaccines 2022

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Do HIV and COVID-19 Vaccines Mix?

Karen McClorey Hackett — Thu, 12 May 2022 20:47:52 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Vaccine research organizations recently announced a new program in Kenya, Rwanda, and the Democratic Republic of Congo to evaluate the safety and immunogenicity of homologous and heterologous COVID-19 vaccine booster regimens in people living with Human immunodeficiency virus (HIV).

The Coalition for Epidemic Preparedness Innovations (CEPI) and the Kenya-based Victoria Biomedical Research Institute (VIBRI) confirmed on May 11, 2022, that about $12.5 million in funding would be deployed to assess this “mix and match” booster approach in HIV populations.

This vital research is needed since 38 million people globally live with HIV, and two-thirds of them are in sub-Saharan Africa.

Data on the effectiveness of COVID-19 vaccines in people living with HIV are limited, and many outstanding questions remain, such as:

Are people living with HIV a risk population for SARS-CoV-2 infection and COVID-19?
Do people living with HIV have reduced immune responses to COVID-19 vaccination, allowing post-vaccination breakthrough infections to occur?
Should this population be offered mix-and-match vaccine regimens to boost their immune responses?

Dr. Melanie Saville, Executive Director of Vaccine R&D, CEPI, commented in a related media release, “To effectively expand access to COVID-19 vaccines around the world, we urgently need to boost clinical research into how well these vaccines work in vulnerable populations, especially in people living with HIV.”

“For example, people living with HIV could have reduced immune responses to COVID-19 vaccination, increasing the chances of breakthrough infections.”

“This study will help to gather the data needed to fill this gap in our understanding and inform how governments and COVAX can optimize their vaccination strategies going forwards to better protect this large vulnerable population of people who are potentially immunocompromised.”

Participants in this Phase 2B study who have already received homologous COVID-19 vaccination with either Moderna or Pfizer mRNA vaccines or the vaccines produced by Janssen, Sinovac, or Sinopharm will receive a booster of either the Janssen or Novavax vaccines five to seven months after completion of the primary vaccination series.

Each study participant aged 12 to 64 years living with or without HIV infection will be followed over an 18-month period. After booster vaccination, investigators will assess the safety and immune response at months 6, 12, and 18.

CEPI is an innovative partnership between public, private, philanthropic, and civil organizations

This is the latest program to be funded in response to a CEPI Call for Proposals launched in January 2021, which aims to address current gaps in our clinical knowledge of vaccine performance both now and in the long term.

Regarding HIV vaccine development, the U.S. National Institute of Allergy and Infectious Diseases (NIAID) recently launched a Phase 1 clinical trial evaluating three experimental HIV vaccines "Finding an HIV vaccine has proven a daunting scientific challenge," commented Anthony S. Fauci, M.D. NIAID director, on March 14, 2022.

"With the success of safe and highly effective COVID-19 vaccines, we have an exciting opportunity to learn whether mRNA technology can achieve similar results against HIV infection."

More information about the HVTN 302 study is available on ClinicalTrials.gov using the identifier NCT05217641.

Additional HIV vaccine development news is posted at PrecisionVaccinations.com/HIV.

PrecisionVaccinations publishes fact-checked research-based vaccine news.

Sub Title:

CEPI awarded $12.5 million in funding to assess “mix and match” COVID-19 boosters in HIV populations

References:

CEPI funds project led by Victoria Biomedical Research Institute (Kenya) to assess mix-and-match COVID-19 vaccine boosters in ad

Mapping HIV prevalence in sub-Saharan Africa between 2000 and 2017

NIH launches clinical trial of three mRNA HIV vaccines

HIV Vaccines 2022

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$24 Million in Grants Will Help End the HIV Epidemic

Karen McClorey Hackett — Mon, 28 Mar 2022 20:43:25 +0000

Reviewer:

Robert Carlson, MD

Gilead Sciences, Inc. today announced $24 million in new grants that will help reduce health disparities, improve access to quality healthcare, advance medical education and support local communities most impacted by the HIV epidemic and COVID-19 pandemic.

Gilead confirmed the Zeroing In: Ending the HIV Epidemic program will support 116 organizations in 41 countries.

The funding recipients will focus on advancing at least one of three focus areas: Comprehensive HIV Innovation, Digital Health Innovation, and Community Outreach and Education.

Comprehensive HIV Innovation Programs: This includes at-home testing efforts that help close the gaps in HIV testing and prevention, supportive service programs, and comprehensive HIV prevention programs inclusive of biomedical prevention options.
Digital Health Innovations: Strategies will address the health literacy divide in accessing digital health services, support digital access in rural areas for better outcomes for people living with HIV, or support digital health education for those with language barriers, aging populations, indigenous, migrant and stigmatized populations.
Community Outreach and Education: Community-driven programs will provide resources for HIV community outreach workers, address the lack of culturally appropriate service options, break down barriers between communities and service providers, and reduce stigma and improve education around HIV.

“While the HIV community has made tremendous progress toward ending the HIV epidemic, the COVID-19 pandemic created barriers and amplified health inequities in the most marginalized communities,” commented Alex Kalomparis, SVP, Public Affairs, Gilead Sciences, in a press release issued on March 28, 2022.

“We are working with organizations that will reach under-resourced communities and support them to find innovative, effective solutions. Zeroing In programs aim to increase access to HIV care and services and build on Gilead’s efforts to help end the epidemic for everyone, everywhere.”

To build on progress in local communities, Zeroing In organizations will prioritize populations most affected by the HIV epidemic. This includes projects from local organizations collaborating to end the HIV epidemic in their respective cities, states, countries, or regions.

Zeroing In builds on previous Gilead funding and grant programs while supporting organizations to increase the overall health and wellness of communities most impacted by HIV and COVID-19.

For more information on Gilead’s Zeroing In: Ending the HIV Epidemic grant program, please visit Zeroing In. A complete list of funded organizations can be found here.

Gilead Sciences, Inc. is a biopharmaceutical company with headquarters in Foster City, California, that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people.

PrecisionVaccinations publishes fact-checked research-based news.

Note: This news article edited Gilead’s press release for clarity and was manually curated for mobile readers.

Sub Title:

Gilead Zeroing In: Ending the HIV Epidemic Program will support over 100 organizations in 41 countries

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Gilead Sciences Announces $24 Million in Grants to Help End the HIV Epidemic for Everyone, Everywhere

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A Triumph for Injectable PrEP

Don Hackett — Tue, 02 Feb 2021 21:52:40 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A presentation on the HPTN 084 study delivered on January 27, 2021, confirmed the results announced when the trial was stopped early in November 2020 but added new details.

This presentation focused on women randomly allocated to receive injectable PrEP (every eight weeks) or oral PrEP (every day).

The study used a 'double-dummy' design, meaning that half the participants got active injectable cabotegravir and inactive placebo pills; the other half got inactive placebo injections and active tenofovir/emtricitabine pills.

Whereas there were 36 infections in women assigned the active PrEP pills, there were only four in women given the active injections. Two of the four had not had any injections at the time of infection, one had been injected four months previously, and one woman did acquire HIV despite following the injection schedule.

In the absence of these prevention options in the study communities, HIV incidence is approximately 3.5% a year.

The study’s oral PrEP arm was 1.9%, and in the injectable PrEP arm, it was 0.2%.

The researchers believe that lower adherence to the pills likely explains these results.

At week 4, only 60% of women in the oral PrEP arm had blood levels of tenofovir consistent with daily dosing, which declined to 34% by week 57.

In contrast, women attended 93% of their injection visits, a figure that only declined slightly over time.

In terms of side effects, there were more injection site reactions in women receiving the active injections (32%) than in those receiving placebo injections (9%). Still, these were mostly minor and did not lead to anyone withdrawing from the study.

Delany-Moretlwe signaled two essential simplifications to how injectable cabotegravir is likely to be implemented.

In the study, women took cabotegravir pills (or placebo pills) for five weeks before starting the injections. The rationale was to ensure that cabotegravir is well-tolerated since the injectable cannot be removed from the body if it causes problems.

However, the evidence from this and other studies is that such side effects are rare, so the oral ‘lead in’ may not be necessary.

The other suggested simplification concerns the ‘long tail’.

This refers to the persistence of low levels of cabotegravir in the body for many months after a person’s last injection. The individual will be vulnerable to HIV unless they start or continue another method of HIV prevention, such as oral PrEP.

The ‘long tail’ means a long period during which, if they caught HIV, they could develop drug resistance. Drug resistance only arises in situations like this when there is some drug in the body but not enough to entirely suppress an infection.

To deal with this concern, study participants who stopped receiving injectable cabotegravir were offered a year-long course of oral PrEP. There are questions about how practicable this will be in real-world settings.

"Injections offer a real alternative and fit in with women’s already existing sexual and reproductive health practices.”

Delany-Moretlwe argued that healthcare providers' vital thing to do would be to understand why the person is discontinuing. If they want to stop because they no longer feel at risk of HIV infection, they may not acquire HIV or develop drug resistance. If the injections are not right for them, the provider should explore alternative HIV prevention options.

However, there was some pushback from conference delegates on this point. Stopping will not always be a conscious choice, and many people will simply be lost to follow-up. An increasing prevalence of strains of HIV that are resistant to cabotegravir would be a risk to HIV treatment programs that are now based on dolutegravir (a drug from the same class).

Nonetheless, the general mood is of excitement about the increasing range of HIV prevention options, including oral tenofovir/emtricitabine, the dapivirine vaginal ring (recommended in World Health Organization guidelines), and injectable cabotegravir.

The injection will be submitted for approval by the US Food and Drug Administration in 2021 and then to other regulatory agencies.

Delany-Moretlwe S et al. Long-acting injectable cabotegravir is safe and effective in preventing HIV infection in cisgender women: interim results from HPTN 084. HIV Research for Prevention (HIVR4P) virtual conference, abstract HY01.02, 2021.

PrecisionVaccinations publishes research-based news.

Sub Title:

Women taking long-acting injections of cabotegravir had 89% fewer HIV infections

References:

A triumph for injectable PrEP, but a sobering result for oral PrEP

HPTN at HIV R4P 2021

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FDA Approves the First Long-acting Regimen for HIV Treatment

Don Hackett — Fri, 22 Jan 2021 19:51:12 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

The U.S. Food and Drug Administration (FDA) announced the approval of Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults.

This is the first FDA-approved injectable, complete regimen for HIV-infected adults administered once a month.

This approval replaces a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

The FDA also approved Vocabria (cabotegravir, tablet formulation) on January 21, 2021, which should be taken in combination with oral rilpivirine (Edurant) for one month before starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation.

The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare.

“Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen,” said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA’s Center for Drug Evaluation and Research, in a press release.

“Having this treatment available for some patients provides an alternative for managing this chronic condition.”

The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed.

The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.

Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter).

Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA.

Lynn Baxter, Head of North America, ViiV Healthcare, added, “Today’s FDA approval of Cabenuva represents a shift in the way HIV is treated, offering people living with HIV a completely new approach to care.”

“Cabenuva reduces the treatment dosing days from 365 days to 12 days per year.”

“At ViiV Healthcare, we are dedicated to ensuring no one living with HIV is left behind, and adding this first-of-its-kind regimen to our industry-leading portfolio of innovative medicines reinforces our mission.”

The FDA is an agency within the U.S. Department of Health and Human Services that protect public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.

PrecisionVaccinations publishes research-based news.

Sub Title:

First Extended-Release, Injectable Drug Regimen for Adults Living with HIV Approved by the US FDA

References:

FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV

ViiV Healthcare announces FDA approval of Cabenuva, the first and only complete long-acting regimen for HIV treatment

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