Marburg vaccine shows promising results in first-in-human study

Date:
January 30, 2023
Source:
NIH/National Institute of Allergy and Infectious Diseases
Summary:
A new article shows that an experimental vaccine against Marburg
virus (MARV) was safe and induced an immune response in a small,
first-in-human clinical trial. The vaccine could someday be an
important tool to respond to Marburg virus outbreaks.


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FULL STORY ==========================================================================
A newly published paper in The Lancetshows that an experimental vaccine
against Marburg virus (MARV) was safe and induced an immune response
in a small, first- in-human clinical trial. The vaccine, developed by researchers at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, could someday be an important tool to respond to Marburg virus outbreaks.


==========================================================================
This first-in-human, Phase 1 study tested an experimental MARV vaccine candidate, known as cAd3-Marburg, which was developed at NIAID's Vaccine Research Center (VRC). This vaccine uses a modified chimpanzee adenovirus called cAd3, which can no longer replicate or infect cells, and 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 investigational Ebola
virus and Sudan virus vaccines developed by the VRC.

MARV, a filovirus in the same family as Ebola virus, causes a rapidly progressive febrile illness that leads to shock and death in a large
proportion of infected individuals. Many scientists think that MARV
disease outbreaks in humans begin by when the virus makes the jump
from its primary animal host, which is likely to be certain chronically infected bats in sub-Saharan Africa.

The symptoms of MARV disease are akin to those seen with Ebola virus
disease and can include fever, headache, chills, rash, abdominal pain, vomiting, and diarrhea. As the disease progresses, patients may suffer
from multiple organ dysfunction, delirium, and significant bleeding from
the gastrointestinal tract or other sites that may result in death. No
approved vaccines or specific therapies are available for MARV disease,
aside from supportive care. While some experimental vaccines have
previously been tested, none have proven to be both highly effective
and to provide durable protection. In areas of Africa where a vaccine
for Marburg is most needed, a single-dose vaccine that could protect
recipients over a long period of time would be a crucial part of quelling outbreaks.

In this study, 40 healthy adult volunteers were enrolled 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. Three participants
received the lower dose. Then, when they did not exhibit severe adverse reactions after the first seven days, the trial proceeded to enroll 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: There were no serious adverse events, and the experimental vaccine was well-tolerated. One participant
in the higher dose group developed a fever following vaccination, but it 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.

Plans are in place to conduct further trials of the cAd3-Marburg
vaccine in Ghana, Kenya, Uganda, and the United States. If additional
data supports the promising results seen in the Phase 1 trial, the
cAd3-Marburg virus vaccine could someday be used in emergency responses
to MARV outbreaks.

* RELATED_TOPICS
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# Virology # Bird_Flu_Research # Microbes_and_More #
Veterinary_Medicine
* RELATED_TERMS
o Flu_vaccine o H5N1 o Pandemic o Natural_killer_cell o HIV
o Epstein-Barr_virus o MMR_vaccine o Avian_flu

========================================================================== Story Source: Materials provided by NIH/National_Institute_of_Allergy_and_Infectious Diseases. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Melinda J Hamer, Katherine V Houser, Amelia R Hofstetter, Ana
M Ortega-
Villa, Christine Lee, Anne Preston, Brooke Augustine, Charla
Andrews, Galina V Yamshchikov, Somia Hickman, Steven Schech,
Jack N Hutter, Paul T Scott, Paige E Waterman, Mihret F Amare,
Victoria Kioko, Casey Storme, Kayvon Modjarrad, Melanie D McCauley,
Merlin L Robb, Martin R Gaudinski, Ingelise J Gordon, LaSonji
A Holman, Alicia T Widge, Larisa Strom, Myra Happe, Josephine
H Cox, Sandra Vazquez, Daphne A Stanley, Tamar Murray, Caitlyn
N M Dulan, Ruth Hunegnaw, Sandeep R Narpala, Phillip A Swanson,
Manjula Basappa, Jagada Thillainathan, Marcelino Padilla, Britta
Flach, Sarah O'Connell, Olga Trofymenko, Patricia Morgan, Emily E
Coates, Jason G Gall, Adrian B McDermott, Richard A Koup, John R
Mascola, Aure'lie Ploquin, Nancy J Sullivan, Julie A Ake, Julie E
Ledgerwood, Rebecca Lampley, Brenda Larkin, Pamela Costner, Hope
Wilson, Mike Read. Safety, tolerability, and immunogenicity of the
chimpanzee adenovirus type 3- vectored Marburg virus (cAd3-Marburg)
vaccine in healthy adults in the USA: a first-in-human, phase 1,
open-label, dose-escalation trial. The Lancet, 2023; 401 (10373):
294 DOI: 10.1016/S0140-6736(22)02400-X ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2023/01/230130130531.htm

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