The first steps are being taken towards creating a Zika vaccine. Scientists are about to begin tests, on humans, of a vaccine called the NIAID Zika virus investigational DNA vaccine. They hope that this vaccine will generate an immune system response that will guard against Zika.
The experimental Zika vaccine was developed at the National Institute of Allergy and Infectious Diseases earlier this year. The NIAID says tests on animals have been very encouraging. Now, 80 human volunteers will participate in a clinical trial. “A safe and effective vaccine to prevent Zika virus infection and the devastating birth defects it causes is a public health imperative,” says NIAID Director Anthony S. Fauci, M.D. “Although it will take some time before a vaccine against Zika is commercially available, the launch of this study is an important step forward.”
Volunteers in this Zika vaccine trial will be divided randomly into four study groups of 20 people each. All participants will receive a vaccination in their arm on their first visit. Half of the participants will receive one additional vaccination eight weeks or 12 weeks later. The remaining participants will receive two additional vaccinations: one group of 20 participants will receive a second vaccine at week four and a third at week eight; the other group of 20 participants will receive a second vaccine at week four and a third at week 20. All participants will receive the same dose at each vaccination.
Participants will receive a diary card to use at home to record their temperature and any symptoms for seven days following each vaccination. They’ll also return for follow-up visits within a 44-week time period after the first vaccination so investigators can monitor their health to determine if the vaccine is safe. The study team will review patient data daily and weekly to monitor safety.