cAD3-Marburg Vaccine

Marburg Outbreak Terminated in Tanzania

Karen McClorey Hackett — Fri, 02 Jun 2023 18:32:20 +0000

Reviewer:

The United Republic of Tanzania today declared the end of the Marburg Virus Disease (MVD) outbreak after two months. This was the country’s first MVD outbreak of the disease.

As of June 2, 2023, nine cases and six related fatalities were recorded in the outbreak declared on March 21, 2023.

The last confirmed case tested negative for the second test of MVD was on April 19, 2023, setting off the 42-day mandatory countdown to declare the end of the outbreak.

“With the investments being made to prepare for and tackle health emergencies in the region, we are responding even faster and more effectively to save lives, livelihoods and safeguard health,” said Dr. Matshidiso Moeti, WHO Regional Director for Africa, in a press release.

“Thanks to these efforts, Tanzania has been able to end this outbreak and limit the potentially devastating impacts of a highly infectious disease,” Dr Moeti said.

Marburg is highly virulent and causes hemorrhagic fever, with many patients developing severe symptoms within seven days. Illness begins abruptly, with high fever, severe headache, and severe malaise.

MVD is in the same family as the virus that causes Ebola virus disease.

The virus is transmitted to people from fruit bats and spreads among humans through direct contact with the bodily fluids of infected people, surfaces, and materials.

The WHO encourages countries to maintain most response activities for three months after the outbreak ends. This ensures that if the disease re-emerges, health authorities can detect it immediately, prevent it from spreading again, and ultimately save lives.

Additionally, the WHO advises against other international travel and/or trade measures in the United Republic of Tanzania.

Previous MVD outbreaks and sporadic cases in Africa have been reported in Angola, the Democratic Republic of the Congo, Ghana, Kenya, Equatorial Guinea, South Africa, and Uganda.

The WHO published on February 13, 2023, the Marburg virus vaccine development landscape. As of June 2, 2023, no vaccines or antiviral treatments have been approved to treat the virus.

Sub Title:

United Republic of Tanzania ends 2023 marburg virus outbreak

References:

WHO - Marburg virus disease - the United Republic of Tanzania

ECDC Communicable Disease Threats Report

Marburg Virus Disease outbreak in Tanzania declared over

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WHO June 2, 2023 - MVD outbreak

Africa's Marburg Disease Outbreaks Explained

Karen McClorey Hackett — Mon, 08 May 2023 15:18:58 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) today announced how two African countries have been responding to separate outbreaks of Marburg virus disease (MVD) in 2023.

Initially detected in 1967, MVD is a viral hemorrhagic fever, and infections are often fatal.

In March 2023, the WHO assessed the public health risk posed by the MVD outbreaks in Equatorial Guinea and the United Republic of Tanzania as very high at the national level, high at the sub-regional level, moderate at the regional, and low at the global level.

Additionally, the U.S. CDC recently issued travel advisories for these MVD outbreaks.

In Equatorial Guinea, from February 13 to May 1, 2023, 17 laboratory-confirmed MVD cases and 23 probable cases have been reported. The last confirmed case was reported on April 20. Among the laboratory-confirmed cases, there were 12 deaths (Case Fatality Ratio (CFR) 75%).

For one confirmed case, the outcome is unknown. Among the confirmed cases, four have recovered. However, all of the probable cases are dead.

The most affected district is Bata in Litoral province, with 11 laboratory-confirmed MVD cases reported.

And in the United Republic of Tanzania, between March 16 to April 30, 2023, a cumulative total of nine cases, including eight laboratory-confirmed cases and one probable case, have been reported.

The last confirmed case was reported on April 11, 2023. A total of six deaths (CFR 66.7%) have been reported, including one probable case and five among confirmed cases.

Among the confirmed cases, three have recovered. All cases have been reported from Bukoba district, Kagera region.

The WHO says health authorities in both countries have shown strong political commitment.

In recent weeks they have further strengthened critical response functions, such as disease surveillance, including at points of entry; laboratory activities; clinical case management; infection prevention and control; risk communication and community engagement; and operations support and logistics with the backing of WHO and partners.

As of May 8, 2023, no MVD cases have been reported in the U.S., no MVD vaccines are available, and other Marburg outbreak news is posted at Vax-Before-Travel.

Sub Title:

Marburg disease vaccines are not authorized in May 2023

References:

MVD - Equatorial Guinea and the United Republic of Tanzania

U.S. CDC Marburg virus disease May 2023

ECDC Factsheet about Marburg virus disease

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ECDC Marburg disease outbreaks May 2023

Equatorial Guinea's Marburg Disease Fatalities Increase

Donald Hackett — Sat, 15 Apr 2023 17:47:47 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) today announced Equatorial Guinea (EG) continues facing an outbreak of Marburg Virus Disease (MVD) for the first time.

And as of April 15, 2023, the country's capacity to manage the outbreak must be strengthened.

In addition to the nine confirmed cases reported in the WHO's Disease Outbreak News of March 22, 2023, six more individuals tested positive for MVD, with one more affected EG province.

And the presence of cases and/or clusters across multiple districts without clear epidemiologic links may indicate undetected virus transmission.

The presence of confirmed cases in the capital city of Bata increases the risk of disease spread, as it is the most populated city with an international airport and port.

Furthermore, surveillance at the entry points of the international Bata airport or international seaport is not optimal.

Bata has also reported the highest number of confirmed cases and confirmed deaths.

Frequent population movements and porous land borders are also reported in EG districts bordering Cameroon and Gabon.

The surveillance at land entry points is suboptimal, and countless uncontrolled paths or trails along the border with Cameroon and Gabon.

Considering the above-described situation, WHO continues to assess the risk posed by this MVD outbreak as very high at the national level, high at the sub-regional level, moderate at the regional level, and low at the global level.

The U.S. CDC has issued travel alerts regarding MVD outbreaks in Africa to notify international travelers of their health risks. Other Marburg disease outbreak news is posted at Vax-Before-Travel.

Unfortunately, no Marburg vaccines are available as of April 15, 2023.

Sub Title:

Marburg virus disease vaccine candidates continue research

References:

WHO Marburg virus disease - April 15, 2023

U.S. CDC travel alerts

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WHO Marburg Disease alert April 15, 2023

Fatal Marburg Disease Outbreak Confirmed in Tanzania

Karen McClorey Hackett — Tue, 21 Mar 2023 20:38:46 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The World Health Organization (WHO) today announced the Republic of Tanzania had confirmed its first-ever cases of Marburg Virus Disease (MVD) following reports of cases and deaths in the country’s north-west Kagera region.

Five of the eight cases, including a health worker, have died, and the remaining three are receiving treatment.

A total of 161 contacts have been identified and are being monitored as of March 21, 2023.

According to Tanzania health officials on YouTube, Tanzania’s National Public Health Laboratory analyzed samples to determine the cause of illness.

“The efforts by Tanzania’s health authorities to establish the cause of the disease clearly indicate the determination to respond to the outbreak effectively. We are working with the government to rapidly scale up control measures to halt the spread of the virus and end the outbreak as soon as possible,” said Dr. Matshidiso Moeti, WHO Regional Director for Africa, in a related press release.

WHO is supporting the Ministry of Health in deploying an emergency team to Kagera for further epidemiological investigations.

The emergency team will focus on active case finding in the community and local healthcare facilities to identify more contacts and provide them with appropriate care.

Previously, MVD cases were reported in Angola, DR Congo, Equatorial Guinea, Cameroon, Germany (1967), Ghana, Guinea, Kenya, Serbia, South Africa, and Uganda.

Equatorial Guinea confirmed an outbreak on February 13, 2023, its first-ever outbreak of MVD. The index case died in early January 2023. As of February 27, 2023, the cumulative number of MVD cases reported was 11, all fatal, and 48 close contacts were under follow-up.

MVD is highly virulent and causes hemorrhagic fever, with a fatality ratio of up to 88%, says the WHO.

Illness caused by the Marburg virus begins abruptly, with high fever, severe headache, and severe malaise. Many patients develop severe hemorrhagic symptoms within seven days.

The virus is transmitted to people from fruit bats and spreads among humans through direct contact with the bodily fluids of infected people, surfaces, and materials.

It is in the same family as the virus that causes Ebola virus disease.

Currently, no MVD vaccines or antiviral treatments are approved to treat the virus.

Tanzania is an East African country formed as a sovereign state in 1964 through the union of Tanganyika and Zanzibar, says Britannica.

To notify international travelers of potential health risks, the U.S. CDC issued a Watch - Level 1, Practice Usual Precaution regarding active MVD outbreaks in Africa on February 16, 2023.

Sub Title:

Tanzania confirms its first Marburg disease outbreak

References:

Tanzania confirms first-ever outbreak of Marburg Virus Disease

Marburg outbreaks March 2023

Marburg vaccine candidates March 2023

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U.S. CDC Africa Marburg Virus Outbreak March 21, 2023

$30 Million Funding Advances Marburg and Sudan Virus Vaccines

Karen McClorey Hackett — Thu, 02 Mar 2023 18:03:12 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

IAVI announced today that the U.S. Biomedical Advanced Research and Development Authority (BARDA) funded additional development and testing of single-dose vaccine candidates against the filoviruses Marburg virus (MARV) and Sudan ebolavirus (SUDV).

BARDA's US$30 million award to the nonprofit IAVI on March 2, 2023, expands the agency's existing support of SUDV vaccine candidate (rVSVΔG-SUDV-GP) development.

The new BARDA funding empowers IAVI and partners to advance the rVSVΔG-SUDV-GP development plan to include a Phase I clinical trial in the United States in 2023.

This funding is in addition to the initial award of $17 million in 2022 to advance IAVI's MARV vaccine candidate (rVSVΔG-MARV-GP) into human clinical trials.

These plans are enhanced following recent preclinical data demonstrating that a single dose of the vaccine was 100% efficacious at preventing Marburg virus disease (MVD) in nonhuman primates.

The Defense Threat Reduction Agency of the U.S. Department of Defense funded the nonclinical development of rVSVΔG-MARV-GP.

"Ongoing intermittent viral hemorrhagic fever outbreaks, including the recent SUDV and current MARV outbreaks, demonstrate the importance of developing and stockpiling vaccines against known threats so they are ready for rapid evaluation in clinical trials," said Swati Gupta, vice president and head of emerging infectious diseases and epidemiology at IAVI, in a press release on March 2, 2023.

"The funding from BARDA will enable us to continue critical development and testing of IAVI's filovirus vaccine candidates to facilitate better preparedness."

"It is essential that we efficiently accelerate our vaccine development efforts for known infectious disease threats now and apply our lessons learned from the past, such that we are truly better prepared when outbreaks continue to occur in the future."

Previously, Filoviruses have caused severe hemorrhagic fever outbreaks in Central and Western Africa during 2022 and 2023.

IAVI's filovirus vaccine candidates are based on the same recombinant vesicular stomatitis virus (rVSV) vector used in ERVEBO®, a highly efficacious Ebola Zaire (ZEBOV) vaccine previously deployed by several African countries during Ebola virus outbreaks.

MARV is associated with sporadic African outbreaks and has a case fatality rate of up to 88%.

For example, Equatorial Guinea confirmed its first MARV outbreak in 2023, while Ghana and Guinea confirmed outbreaks in 2022 and 2021, respectively.

And in response to Uganda's SUDV outbreak in late 2022, the World Health Organization (WHO) vaccine prioritization working group assembled to rapidly evaluate the suitability of three candidate Ebola vaccines for inclusion in a planned ring vaccination trial in Uganda.

The WHO group ranked IAVI's rVSVΔG-SUDV-GP candidate the highest based on the proven safety and efficacy of ERVEBO®.

Vaccines against SUDV and MARV remain critical unmet needs because immunity against ZEBOV, SUDV, and MARV is not cross-protective.

This project is funded in whole or in part with federal funds from the Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract number 75A50121C00077.

IAVI is a nonprofit scientific research organization that addresses urgent, unmet global health challenges, including HIV, tuberculosis, and emerging infectious diseases. Read more at iavi.org.

Sub Title:

Marburg and Sudan vaccine candidates gain funding

References:

U.S. BARDA Expand Partnership to Advance IAVI's Filovirus Vaccine Candidates

IAVI and the BARDA partner to advance filovirus vaccine candidates

BARDA

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IAVI’s Brooklyn-based Vaccine Design & Development Lab 2023

Marburg Virus Disease Outbreak Confirmed in Equatorial Guinea

Donald Hackett — Mon, 13 Feb 2023 21:16:30 +0000

Reviewer:

Holly Lutmer PharmD

Robert Carlson, MD

Equatorial Guinea confirmed its first-ever Marburg virus disease (MVD) outbreak today. This highly infectious virus causes hemorrhagic fever, with a fatality ratio of up to 88%.

MVD is in the same virus family that causes Ebola virus disease.

Preliminary tests carried out following the deaths of at least nine people in the country's western Kie Ntem Province turned out positive for MVD, wrote the World Health Organization (WHO) on February 13, 2023.

So far, nine deaths and 16 suspected cases with symptoms including fever, fatigue, blood-stained vomit, and diarrhea have been reported.

Advance teams have been deployed in the affected districts to trace contacts, isolate and provide medical care to people showing disease symptoms.

Efforts are also underway to rapidly mount an emergency response, with WHO deploying health emergency experts in epidemiology, case management, infection prevention, laboratory, and risk communication to support the national response efforts and secure community collaboration in outbreak control.

The WHO is also facilitating the shipment of laboratory glove tents for sample testing and one viral hemorrhagic fever kit that includes personal protective equipment that 500 health workers can use.

"Thanks to the rapid and decisive action by the Equatorial Guinean authorities in confirming the disease, emergency response can get to full steam quickly so that we save lives and halt the virus as soon as possible," commented Dr. Matshidiso Moeti, WHO Regional Director for Africa, in a related press release.

The virus is transmitted to people from fruit bats and spreads among humans through direct contact with the bodily fluids of infected people, surfaces, and materials.

As of February 13, 2023, no vaccines or antiviral treatments have been U.S. FDA-approved to treat this severe virus.

However, several vaccine candidates are being evaluated, such as the Sabin Vaccine Institute's ChAd3-MARV and the National Institute of Allergy and Infectious Diseases phase 1 study.

Additionally, the U.S. CDC recommends several vaccinations before visiting Equatorial Guinea.

Sub Title:

Equatorial Guinea reported viral hemorrhagic fever fatalities in 2023

References:

WHO: Equatorial Guinea confirms first-ever MVD outbreak

Marburg vaccine candidates 2023

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WHO Equatorial Guinea Feb. 2023

First-in-Human Marburg Vaccine Study Shows Promise

Donald Hackett — Mon, 30 Jan 2023 21:15:50 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

The peer-review journal Lancet recently published a study that found a vaccine candidate targeting the Marburg virus (MARV) was safe and induced an immune response in a small, first-in-human clinical trial.

The vaccine known as cAd3-Marburg vaccine, developed by researchers at the U.S. National Institute of Allergy and Infectious Diseases (NIAID), could become an essential tool if approved to respond to future Marburg virus outbreaks.

This vaccine uses a modified chimpanzee adenovirus called cAd3, which can no longer replicate or infect cells.

Instead, it displays a glycoprotein found on the surface of MARV to induce immune responses against the virus.

The cAd3 vaccine platform demonstrated a good safety profile in prior clinical trials when used in Ebola virus and investigational Sudan virus vaccines.

This study enrolled 40 healthy adult volunteers at the Walter Reed Army Institute of Research Clinical Trials Center in Silver Spring, Maryland. They received a single dose of either a low dose of the vaccine (1x1010 particle units) or a higher dose (1x1011 particle units).

For safety, the volunteers were enrolled in a dose-escalation plan. First, three participants received the lower dose.

Then, when they did not exhibit severe adverse reactions after the first seven days, the trial enrolled the remaining 17 volunteers.

The same procedure was also used for the higher-dose group.

Volunteers were monitored for adverse reactions to the investigational vaccine and evaluated at regular intervals for 48 weeks to track their immune responses.

The trial’s safety results were encouraging, as there were no serious adverse events, and the experimental vaccine was well-tolerated.

One higher-dose group participant developed a fever following vaccination, which resolved by the following day.

In addition, the investigational vaccine appeared to induce strong, long-lasting immunity to the MARV glycoprotein: 95% of participants in the trial exhibited a robust antibody response after vaccination, and 70% maintained that response for more than 48 weeks.

There are plans to conduct clinical trials for the cAd3-Marburg vaccine in Ghana, Kenya, Uganda, and the U.S.

MARV, a filovirus in the same family as the Ebola virus, causes a rapidly progressive febrile illness that leads to shock and death in many infected individuals, says the U.S. CDC.

Marburg virus was first recognized in 1967 when hemorrhagic fever outbreaks co-occurred in laboratories in Germany and Serbia.

MVD is caused by the MARV, a genetically unique zoonotic RNA virus of the filovirus family.

In areas of Africa where a vaccine for Marburg is most needed, a single-dose vaccine that could protect recipients over a long period would be a crucial part of quelling outbreaks.

As of January 30, 2023, no vaccines or specific therapies are U.S. Food and Drug Administration approved for MARV disease.

The NIAID conducts and supports research throughout the U.S. and worldwide to study the causes of infectious and immune-mediated diseases and to develop better means of preventing, diagnosing, and treating these illnesses. News releases, fact sheets, and other NIAID-related materials are available on the NIAID website.

Sub Title:

cAd3-Marburg vaccine candidate at Walter Reed Army Institute of Research Clinical Trials Center

References:

Safety, tolerability, and immunogenicity of the chimpanzee adenovirus type 3-vectored Marburg virus (cAd3-Marburg) vaccine

Marburg vaccine candidates 2023

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U.S. CDC Marburg virus disease outbreaks 2023