(Laboratory at Makerere University Walter Reed Project, where Sabin's Phase 2
Sudan ebolavirus vaccine clinical trial begins this month.)
WASHINGTON, July 15, 2024 (GLOBE NEWSWIRE) -- Sabin Vaccine Institute launched a
Phase 2 clinical trial for its vaccine against Sudan ebolavirus, with healthy
volunteers receiving the single-dose vaccine at Makerere University Walter Reed
Project (MUWRP) in Uganda. There are currently no approved vaccines for this
strain of ebolavirus, which saw an outbreak end just last year. Ebolavirus
disease kills on average half the people infected, according to the World Health
Organization.
Sudan ebolavirus is a filovirus, in the same family as Marburg virus disease and
Zaire ebolavirus, which killed 11,325 in one outbreak in West Africa from
2014-16. Ebolavirus disease spreads between people via direct contact with the
blood or other bodily fluids of infected people and is highly virulent, causing
hemorrhagic fever.
Based on the same cAd3 platform as its Marburg vaccine candidate, Sabin's
single-dose investigational Sudan ebolavirus vaccine was found to be promising
in Phase 1 clinical (https://www.nih.gov/news-events/news-releases/marburg-
vaccine-shows-promising-results-first-human-study) and non-clinical studies,
with results showing it to be safe, while eliciting rapid and robust immune
responses that lasted up to 12 months.
This is Sabin's second Phase 2 clinical trial partnership with MUWRP, based in
Uganda's capital, Kampala. A Phase 2 trial for a Marburg vaccine is already
underway, having recently completed enrollment
(https://www.sabin.org/resources/sabin-vaccine-institute-begins-phase-2-
clinical-trial-for-marburg-vaccine-in-uganda/). Initial results from the Marburg
trial are expected later this year.
Dr. Betty Mwesigwa, deputy executive director of MUWRP, is once again the
principal investigator (PI) for the Sabin-sponsored trial for the Sudan
ebolavirus vaccine. In the coming weeks, participants will also be enrolled at
the Kenya Medical Research Institute in Siaya, Kenya, with Dr. Videlis Nduba
serving as PI for that site. In all, 125 volunteers will participate in the
trial across the two countries.
"We are delighted to advance a vaccine candidate that can thwart a deadly and
devastating disease, especially one that caused a fairly recent outbreak and for
which no approved treatments exist," says Amy Finan, Sabin's Chief Executive
Officer. "Sabin's vaccine candidate is backed by strong safety and
immunogenicity data, and we hope this trial will yield further evidence to move
the vaccine closer to licensure."
The most recent outbreak of Sudan ebolavirus occurred in the fall of 2022 in
Uganda, after six suspicious deaths in the Mubende district. That outbreak
ultimately resulted in 55 deaths. Sabin's vaccine was the first to arrive
(https://www.who.int/news/item/09-12-2022-ebola-trial-candidate-vaccines-arrive-
in-uganda-in-record-79-days-after-outbreak-declared/) in Uganda during that
outbreak after the World Health Organization included it as one of three
vaccines for possible use in an outbreak trial. The outbreak ended on January
11 (https://www.afro.who.int/countries/uganda/news/uganda-declares-end-ebola-
disease-outbreak), prior to vaccine being deployed for use.
"Makerere University Walter Reed Project is pleased to partner with the Sabin
Vaccine Institute once again," says Dr. Mwesigwa. "Uganda has the most
experience with Sudan ebolavirus outbreaks so we understand the importance of
testing and researching an effective Sudan ebolavirus vaccine that could be used
in the event of an outbreak."
The Phase 2 clinical trial
(https://classic.clinicaltrials.gov/ct2/show/NCT05817422?term=sabin+vaccine&cond
=Marburg+Virus+Disease&draw=2&rank=1) will evaluate safety and immunogenicity
for the vaccine among a larger group of individuals than in previous trials.
This is a randomized, placebo-controlled, double-blind study, meaning that
neither the participants nor the researchers will know whether trial
participants receive a vaccine dose or a placebo dose until after the trial is
over, an approach used to help reduce experimental bias.
Participants in the clinical trial will be monitored for a full year and will
include both younger (18-50 years) and older age groups (51-70 years). Interim
results are expected next year. In addition to the current trial in Uganda and
Kenya, Sabin plans to conduct a similar Phase 2 clinical trial for Sudan
ebolavirus vaccine in the U.S.
The Sudan ebolavirus vaccine trials are supported by the Biomedical Advanced
Research and Development Authority (BARDA), part of the Administration for
Strategic Preparedness and Response within the U.S. Department of Health and
Human Services, under multi-year contracts between the organizations.
To date, Sabin has received around $216 million in contract awards from BARDA
for furthering vaccine research and development against Sudan ebolavirus and
Marburg virus diseases. BARDA and Sabin began working together in September
2019 (https://www.sabin.org/our-impact/programs/vaccine-research-and-
development/) to develop the two monovalent vaccine candidates.
This project has been supported 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 (BARDA), under contract numbers 75A50119C00055 and 75A50123C00010.
About the Sabin Vaccine Institute
The Sabin Vaccine Institute is a leading advocate for expanding vaccine access
and uptake globally, advancing vaccine research and development, and amplifying
vaccine knowledge and innovation. Unlocking the potential of vaccines through
partnership, Sabin has built a robust ecosystem of funders, innovators,
implementers, practitioners, policy makers and public stakeholders to advance
its vision of a future free from preventable diseases. As a non-profit with
three decades of experience, Sabin is committed to finding solutions that last
and extending the full benefits of vaccines to all people, regardless of who
they are or where they live. At Sabin, we believe in the power of vaccines to
change the world. For more information, visit www.sabin.org and follow us on
X, @SabinVaccine.
About Sabin's Vaccine R&D Using the cAd3 Platform
In August 2019, Sabin announced exclusive agreements with GSK for Sabin to
advance the development of the prophylactic candidate vaccines against the
deadly Zaire ebolavirus, Sudan ebolavirus and Marburg virus. The three candidate
vaccines were initially developed collaboratively by the U.S. National
Institutes of Health and Okairos, which was acquired by GSK in 2013. The
candidate vaccines, based on GSK's proprietary cAd3 platform, were further
developed by GSK, including the Phase 2 development for the Zaire ebolavirus
vaccine. Under the agreements between GSK and Sabin, Sabin exclusively licensed
the technology for all three candidate vaccines and acquired certain patent
rights specific to these vaccines.
About the Makerere University Walter Reed Project
MUWRP is a non-profit biomedical research organization with a mission to
mitigate disease threats through quality research, health care and disease
surveillance. The project's scope includes, among others; clinical research in
infectious and non-infectious diseases such as HIV, Ebola, Marburg, COVID-19,
Influenza and Influenza-like illnesses, and neglected tropical diseases such as
Schistosomiasis, among others. A major part of the clinical research are
clinical trials, where the MUWRP has conducted more than 12 phase 1 and 2
vaccine clinical trials including the first Ebola vaccine trial in Africa.
Media Contact:
Monika Guttman
Media Relations Specialist
Sabin Vaccine Institute
+1 (202) 662-1841
press@sabin.org (mailto:press@sabin.org)
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/7ea30f47-768e-4cd0-b0a3-
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