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 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. 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 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, 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 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 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
SpecialistSabin Vaccine Institute +1 (202) 662-1841
press@sabin.org
A photo accompanying this announcement is available at
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