The first of a planned 80 participants was enrolled Tuesday in a trial to test the initial safety and immune-response-prompting potential for a vaccine candidate to protect against Zika virus infection, with hopes to yield results that will lead to further, larger scale testing beginning in January 2017, Dr. Anthony Fauci said today.
The Aug. 1 start puts the phase-1 clinical trial a month ahead of schedule, the National Institute of Allergy and Infectious Diseases director said. But, he added that a continued lack of dedicated funding for Zika research will slow necessary ground work for testing the candidate further in Zika-endemic countries. Planning and training at sites for those trials should be starting now, he said, in order for the next trial to begin immediately upon findings of safety and potential effectiveness from the current trial.
The vaccine candidate, developed earlier this year by NIAID scientists, is intended to protect girls and women of child-bearing age from the virus that can cause miscarriages and still births as well as neurological damage and birth defects among infants born to women infected during pregnancy.
With a second participant enrolled today, the initial study will ultimately take place at the National Institutes of Health in Bethesda, MD, Emory University in Atlanta, and the University of Maryland School of Medicine’s Institute for Global Health in Baltimore. Divided into four study groups of 20 each, all participants in the initial trial will receive the vaccine candidate at the same dosage, Fauci said. via a “needle-free” coil-spring injector that pushes the vaccine directly into an arm muscle. Forty of the participants will receive one additional dose eight or 12 weeks after the initial dose, and the remaining participants will receive two more doses at different intervals. After each administration, participants will be watched for reactions to the injection over the following half hour, and will then record their own temperatures and any other potential symptoms for the following seven days. Blood tests at follow up visits will measure immune system activity in response to the vaccine.
While the Congressional lag in providing emergency Zika funding will not impact the completion of this phase-1 trial, Fauci said, it will, if continued hinder preparation of clinics and personnel in the multiple sites of the next phase of testing the candidate.
Testing in areas of highly active infection, “as explosive” as the current spread in Puerto Rico, Fauci said, could speed findings and lead to results in as little as a year, although questions, in any case would remain about how fast the product could be approved for wide use. The start of the trial follows the confirmation Friday by the U.S. Centers for Disease Control and Prevention that “not unexpectedly,” as Fauci put it, mosquito-borne transmission has begun in the continental United States.
“We cannot afford,” he said, “to delay the work.”