Researchers from the National Institute of Allergy and Infectious Diseases and GlaxoSmithKline will soon launch phase I clinical trials of experimental Ebola vaccines.
When the experimental medication ZMApp was sent to Africa to treat two Americans infected with the Ebola virus it had never been tested on humans up to that point. In an effort to further test a possible treatment, the National Institutes of Health (NIH) has announced it will initiate human trials for a new vaccine.
The trials will be a combined effort by the National Institute of Allergy and Infectious Diseases (NIAID) and GlaxoSmithKline (GSK) at the NIH facility in Maryland.
As part of the partnership, researchers will work with an experimental vaccine developed by the Public Health Agency of Canada that was licensed to NewLink
Genetics Corp, as well as a vaccine candidate developed by the NIAID and GSK.
A statement from the NIH said it has also teamed with Wellcome Trust and Britain’s Medical Research Council and Department for International Development to test the GSK vaccine in volunteers in the United Kingdom and Gambia.
Gambia has not yet reported any cases of Ebola but the US Centers for Disease Control and Prevention has reported discussions with the government of Nigeria, which has reported a few cases, about testing the vaccine on healthy patients there.
With the World Health Organization estimating that more than 1400 people have been killed by the latest Ebola outbreak, researchers are scrambling to develop a safe and effective treatment for the virus.
“There is an urgent need for a protective Ebola vaccine, and it is important to establish that a vaccine is safe and spurs the immune system to react in a way necessary to protect against infection,” noted Anthony Fauci, MD, the head of the NIAID.
Fauci added that while current prevention methods are effective in most cases, there is a need for a more definitive medical option. “A vaccine will ultimately be an important tool in the prevention effort,” he said. “The launch of Phase 1 Ebola vaccine studies is the first step in a long process.”
CDC Director Thomas R. Frieden, MD, MPH, also said in the NIH statement linked above that the need for the vaccine is clear as the outbreak continues. “Tried and true public health interventions, strong supportive medical care and the rapid testing of Ebola vaccines and antiviral treatments can help to reduce suffering now and in the future,” he said.
The plan for the Phase 1 trial was developed by Susan Sullivan, PhD, who serves as the chief of the Biodefense Research Section of the NIAID’s Vaccine Research Center (VRC). The statement said she worked with other researchers at the VRC as well as the US Army Medical Research Institute of Infectious Diseases and the European biotechnology company Okairos, which was acquired by GSK in 2013.
According to the statement, the vaccine is based on chimp adenovirus type 3, which is a cold virus for the animals. As the carrier for genetic materials from two “Ebola virus specifies,” Zaire Ebola and Sudan Ebola it has been termed a “bivalent vaccine.” It is the Zaire strain of the virus that has wreaked havoc in West Africa.
Fauci said as human testing begins the vaccine “performed extremely well in protecting nonhuman primates from Ebola infection.”
The trial is expected to include 20 people between the ages of 18- and 50-years-old. Of that group 10 will receive an intramuscular injection of the vaccine while the other will receive a higher dose of the vaccine.
This marks the fourth round of Phase 1 testing of Ebola vaccines for the NIAID since 2003. John Mascola, MD, the director of the NIAID’s Vaccine Research Center said the previous three should prove helpful to this round.
“The knowledge gained from each of these trials has contributed to the development of the candidate vaccine we are now studying, as well as our improved understanding of human immune responses to investigational Ebola vaccines,” Mascola said.