Janssen Ad26.Mos4.HIV Vaccine

HIV Vaccine Candidate Fails in South Africa Study

Don Hackett — Mon, 03 Feb 2020 17:57:50 +0000

Reviewer:

The Human Immunodeficiency (HIV) vaccine efficacy study known as HVTN702, has been discontinued.

According to reporting by the journal Science published on February 3, 2020, an independent monitoring board informed leaders of the South Africa phase 2b/3 clinical study that it was “futile” to continue.

National Institute of Allergy & Infectious Diseases (NIAID) Director Anthony S. Fauci, M.D., said in a statement 'the development of an (HIV) vaccine is essential to “end the global pandemic” and they had hoped this asset would work. Regrettably, it does not.'

This study was a ‘prime and boost’ strategy.

This HVTN702 study evaluated the preventive vaccine efficacy, safety, and tolerability of ALVAC-HIV (vCP2438) + Bivalent Subtype C gp120/MF59 in HIV-seronegative adults over 24 months and potentially up to 36 months from enrollment.

The ‘prime’ was a canarypox virus that carries genes for HIV’s surface protein and 2 of its other structural proteins.

The ‘boost’ contained a recombinant version of the surface protein mixed with an immune system booster, or adjuvant, called alum.

Various HIV scientists had doubted this study would succeed because the vaccines used in the prime-boost scheme had only produced lackluster results in a previous efficacy study in Thailand. In that study, the vaccine candidate’s efficacy was reported to be just 31 percent.

This article says ‘no one knows which immune responses can prevent an HIV infection—the so-called correlates of immunity—but many researchers have focused on creating a vaccine that can trigger antibodies capable of “neutralizing” the ability of the virus to infect cells in lab studies.’

Mitchell Warren, who heads a nonprofit HIV prevention advocacy group, says this latest vaccine failure won’t slow the vaccine field.

“There are other products in efficacy trials and there’s a slightly larger pipeline in phase I trials than we’ve had in a long time,” says Warren.

Similar to smallpox and polio vaccines, a preventive HIV vaccine could help save millions of lives.

Human immunodeficiency virus type 1 (HIV-1) is a retrovirus that, if left untreated, can progress to acquired immunodeficiency syndrome (AIDS), a condition in which the immune system is severely compromised, leading to life-threatening conditions.

In the USA, data shows that around 80 percent of the infected population are aware of the status, but less than half of those who have been diagnosed have HIV under control, says the CDC.

The NIAID said the vaccine approach used in the HVTN 702 trial is different from that being tested in other HIV vaccine studies, including the Imbokodo study and the Mosaico study.

Jannsen Vaccines produced an HIV vaccine candidate that deploys a prime-boost scheme with a preparation that contains a “mosaic” of HIV genes from different subtypes of the virus that researchers stitched into a harmless adenovirus.

The purpose of this phase 3 study is to evaluate the vaccine efficacy of a heterologous vaccine regimen utilizing Ad26.Mos4.HIV and aluminum phosphate-adjuvanted Clade C gp140 and Mosaic gp140 for the prevention of HIV-1 infection in HIV-1 seronegative cis-gender men and transgender individuals having sex with cisgender men and/or transgender individuals.

In earlier tests, this Jannsen vaccine also did not trigger neutralizing antibodies but produced high levels of binding antibodies and other immune responses. A booster shot consists of a mosaic version of HIV’s surface protein mixed with the alum adjuvant.

The Janssen Vaccines & Prevention B.V. study was last updated on December 24, 2019.

HIV vaccine candidate news published by Precision Vaccinations.

Sub Title:

Janssen prime and boost HIV vaccine strategy remains active phase 3 study

References:

Another HIV vaccine strategy fails in large-scale study

Pivotal Phase 2b/3 ALVAC/Bivalent gp120/MF59 HIV Vaccine Prevention Safety and Efficacy Study in South Africa (HVTN702)

Ad26.Mos4.HIV HIV Vaccine

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HIV-Associated Immune Amnesia Could Explain Why HIV-Positive People Have Shorter Lives

Don Hackett — Thu, 02 Jan 2020 22:36:19 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

A new study led by the Oregon Health & Science University School of Medicine and Oregon National Primate Research Center found Human Immunodeficiency (HIV) patients lose immunity to smallpox, even though they were vaccinated against the disease as children.

Called HIV-associated immune amnesia, this finding published on January 2, 2020, could explain why people living with HIV still tend to have shorter lives on average than their HIV-negative counterparts, despite being on antiretroviral therapy.

This new study was published in the Journal of Infectious Diseases and follows other research recently published in the journals Science and Science Immunology that found the immune systems of children who contracted measles similarly "forgot" their immunity against other illnesses, such as influenza.

The previous study was published on October 31, 2019, found measles infections in children can eliminate the immune system’s memory to fight off other illnesses.

That was the first study to show definitive evidence that a measles virus infection can destroy important immune cells that ‘remember’ previous encounters with specific bacteria.

Led by Mark K. Slifka, Ph.D., a professor of molecular microbiology and immunology at the Oregon Health & Science University School of Medicine and Oregon National Primate Research Center, this new study compared T-cell and antibody responses of a total of 100 HIV-positive and HIV-negative women who were vaccinated against smallpox in their youth.

The research team chose smallpox because its last known U.S. case was in 1949, meaning study subjects haven't recently been exposed to its virus, which would have triggered new T-cell and antibody responses.

They found the immune systems of HIV-positive women who were on antiretroviral therapy had a limited response when their blood was exposed to the vaccina virus, which is used in the smallpox vaccine.

Normally, those vaccinated against smallpox have CD4 T cells that remember the virus and respond in large numbers when they're exposed again. Previous research has shown smallpox virus-specific CD4 T cells are maintained for up to 75 years after vaccination.

This finding happened despite the fact that antiretroviral therapy works by boosting CD4 T cell counts in HIV-positive patients. This indicates that while antiretroviral therapy may boost total T cell counts overall, it can't recover virus-specific T cells generated from prior childhood vaccinations.

Dr. Slifka and his colleagues plan to evaluate whether the same phenomenon occurs in HIV-infected men and if people living with HIV also lose immune memory to other diseases.

Recent HIV vaccine new

Researchers who contributed to this study are affiliated with OHSU, SUNY Downstate, Georgetown University, Cornell University, University of Southern California and John Hopkins University.

This research was supported by the National Institutes of Health Public Health Service (grant U19 AI109948) and the Oregon National Primate Research Center (grant 8P51 OD011092).

HIV vaccine news published by Precision Vaccinations.

Sub Title:

Immune amnesia could explain how people forget their immunity against illnesses

References:

Loss of Pre-Existing Immunological Memory among HIV Infected Women Despite Immune Reconstitution with Antiretroviral Therapy

HIV patients lose smallpox immunity despite childhood vaccine, AIDS drugs

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HIV Preventive Vaccine Launches Large Phase 2b Efficacy Study

Don Hackett — Fri, 31 May 2019 18:20:01 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

John Paul Sanchez, PharmD

J&J Janssen Vaccines announced the full enrollment for a Phase 2b efficacy study evaluating a preventive vaccine candidate against Human Immunodeficiency Virus (HIV-1) infections.

This is important news since this is 1 of only 5 experimental HIV-1 vaccine concepts that have progressed to human efficacy trials in 35 years.

The Imbokodo study is evaluating an Ad26.Mos4.HIV regimen in 2,600 women in Malawi, Mozambique, the Republic of South Africa, Zambia and Zimbabwe.

Women in these African countries experience very high rates of HIV infection.

Imbokodo, also known as HVTN 705/HPX2008, is the first efficacy study conducted in relation to Janssen’s investigational HIV-1 preventive vaccine Ad26.Mos4.HIV, which contains molecules capable of inducing an immune response that has been created using genes from a wide variety of viral subtypes responsible for the HIV pandemic.

Early-stage clinical data from Phase 1/2a studies conducted to date, Approach and Traverse, suggest that mosaic-based vaccine regimens are well tolerated and induce robust immune responses to different HIV-1 strains.

“The search for a vaccine began the moment HIV was first identified over 35 years ago, but there have been many challenges along the way due to the unique properties of this virus, including its global genetic diversity,” said Johan Van Hoof, M.D., Global Therapeutic Area Head IDV, Vaccines, and Managing Director, Janssen Vaccines & Prevention B.V., Janssen Pharmaceutica NV.

Although significant progress has been made in the fight against HIV, more than 35 million people are living with the virus globally.

HIV weakens a person’s immune system by destroying important cells that fight disease and infection. No effective cure exists for HIV. But with proper medical care, HIV can be controlled.

In 2017, 1.8 million people were newly infected with HIV and nearly 1 million people died of AIDS, according to the Joint United Nations Programme on HIV/AIDS.

The Imbokodo study is supported by a public-private partnership led by Janssen Vaccines & Prevention B.V., the Bill & Melinda Gates Foundation, the National Institutes of Health and the HIV Vaccine Trials Network (HVTN).

Initial results from the Imbokodo study are anticipated by 2021.

Additional Phase 3 studies will be needed for licensure of the mosaic-based vaccine regimen against Human Immuno Virus-1.

Janssen will disclose further details regarding these studies as plans are finalized.

For more information about the Imbokodo study and the Phase 2b Clinical Trial can be found here.

Visit Johnson&Johnson/HIV to learn more about the breadth of HIV science being pursued by the Janssen Pharmaceutical Companies of Johnson & Johnson and its partners across prevention, treatment and cure research.

Sub Title:

Imbokodo study is evaluating Ad26.Mos4.HIV and aluminum-phosphate adjuvanted Clade C gp 140 vaccine efficacy for the prevention of HIV

References:

Johnson & Johnson Announces Full Enrollment in Proof-of-Concept Efficacy Study of Janssen’s Investigational HIV Preventive

A Study to Assess the Efficacy of a Heterologous Prime/Boost Vaccine Regimen of Ad26.Mos4.HIV and Aluminum Phosphate-Adjuvanted

A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic

Global HIV & AIDS statistics — 2018 fact sheet

HIV Basics

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HIV Vaccine Candidate Imbokodo Advances into Phase 2 Study

Don Hackett — Mon, 09 Jul 2018 12:47:06 +0000

Reviewer:

Robert Carlson, MD

Danielle Reiter, RN

With 37 million people living with HIV/AIDS, and an estimated 1.8 million new cases each year, a preventative vaccine is urgently needed to curb this worldwide pandemic.

“The main challenges facing the development of an HIV vaccine are scientific”, said Linda-Gail Bekker, Ph.D., and colleagues in a new report on the development of an HIV vaccine.

“And these challenges are unprecedented in the history of vaccinology,” said Professor Bekker.

This new research published in The Lancet HIV found that an experimental HIV-1 vaccine regimen to be well-tolerated and generated comparable and robust immune responses against HIV in healthy adults and rhesus monkeys.

This is 1 of only 5 experimental HIV-1 vaccine concepts that have progressed to efficacy trials in humans over 35 years.

Based on the results from the APPROACH phase 1/2a clinical trial that involved 393 healthy adults from 12 clinics, a phase 2b trial has been initiated with 2,600 women at risk for acquiring HIV.

The experimental regimens tested in this study are based on ‘mosaic’ vaccines that take pieces of different HIV viruses and combine them to elicit immune responses against a wide variety of HIV strains.

“This study demonstrates that the mosaic Ad26 prime, Ad26 plus gp140 boost HIV vaccine candidate induced robust immune responses in humans and monkeys with comparable magnitude, kinetics, phenotype, and durability and also provided 67% protection against viral challenge in monkeys”, says Professor Dan Barouch, Director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center and Professor of Medicine at Harvard Medical School, who led the study, said in a press release.

Professor Barouch said, “These results should be interpreted cautiously. The challenges in the development of an HIV vaccine are unprecedented, and the ability to induce HIV-specific immune responses does not necessarily indicate that a vaccine will protect humans from HIV infection.”

“We eagerly await the results of the phase 2b efficacy trial called HVTN705, or ‘Imbokodo’, which will determine whether or not this vaccine will protect humans against acquiring HIV,” said Barouch.

This study was funded by Janssen Vaccines & Prevention BV, US National Institutes of Health, Ragon Institute of MGH, MIT and Harvard, Henry M Jackson Foundation for the Advancement of Military Medicine, US Department of Defense, and International AIDS Vaccine Initiative. No conflicts have been reported.

Sub Title:

HVTN705 study is a Mosaic HIV vaccine candidate with the potential to protect people against a variety of HIV strains

References:

Subtype C ALVAC-HIV and bivalent subtype C gp120/MF59 HIV-1 vaccine in low-risk, HIV-uninfected, South African adults: a phase 1

Evaluation of a mosaic HIV-1 vaccine in a multicentre, randomised, double-blind, placebo-controlled, phase 1/2a clinical trial

A step forward for HIV vaccines

RV144 Trial

3BNC117 and 10-1074 in HIV Uninfected Adults

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