U.S. health officials have begun enrolling volunteers for critical next-stage testing of an experimental vaccine to protect against Zika, the mosquito-borne virus that can cause devastating birth defects in pregnant women.
The first volunteer was vaccinated Wednesday at Baylor College of Medicine in Houston, as the National Institutes of Health gears up for a two-part study that aims to enroll at least 2,400 people in Texas, Florida, Puerto Rico and five at-risk countries: Brazil, Mexico, Panama, Costa Rica and Peru.
Zika has caused an epidemic of birth defects – including babies with abnormally small heads and brains – in parts of Latin America and the Caribbean, and continues to spread to a creeping list of other countries. For the U.S. the risk has largely been to travelers, although mosquitoes spread the virus in parts of southern Florida and Texas last year, where health officials remain on guard.
But while Zika largely disappeared from the headlines over the winter, mosquito season is fast approaching – and the risk persists internationally.
“It is imperative that public health research continue to work to contain the spread of the virus,” Dr. Anthony Fauci, director of NIH’s National Institute of Allergy and Infectious Diseases, said Friday in announcing the $100 million study.
First-stage safety testing of a so-called DNA vaccine against Zika signaled no side effect concerns, Fauci said – allowing the NIH-created shots to progress to the next stage of testing that will help tell if they really work.
It’s a two-part study. First, researchers will evaluate 90 healthy adults given different doses to determine the best one. Those volunteers will be tested at Baylor, the University of Miami and University of Puerto Rico.
Once the correct dose is picked, the larger part of the study could begin as early as June at those sites and additional ones in the at-risk countries – giving 2,400 volunteers either the experimental vaccine or dummy shots. Pregnant women can’t receive the experimental shots but women of child-bearing age can enroll. All the volunteers will be tracked for nearly two years to see if the vaccine really protects against Zika infection.