A Zika virus vaccine was injected into 75 healthy adults on Monday at the start of human trials of the vaccine developed by the Army, Defense Department officials. This vaccination happenned in th Walter Army Institute of Reasearch's Clinical Trial Center in Silver Spring, Maryland.
Zika is spread mostly by the bite of an infected Aedes species mosquito. These mosquitoes bite during the day and night. According to WHO, people with Zika virus disease can have symptoms including mild fever, skin rash, conjunctivitis, muscle and joint pain, malaise or headache.
Army-Developed Zika Vaccine Testing
The Phase 1 trial will test the safety and immunogenicity. It is the ability of the Zika purified inactivated virus (ZPIV) vaccine to trigger an immune response in the body.
“The Army has moved efficiently from recognizing Zika virus as a threat, producing ZPIV for use in animals and demonstrating its effectiveness in mice and monkeys, producing ZPIV for human testing, and now initiating clinical trials to establish its safety and build the case for subsequent efficacy trials,” Army Col. (Dr.) Nelson Michael, director of WRAIR’s Military HIV Research Program, or MHRP, and Zika program co-lead, said in a statement. “All of this,” he added, “was done in 10 months.”
Officials of WRAIR said that this study is part of the Defense Department response to the ongoing Zika outbreak in North America, South America and Southeast Asia. As of Nov. 2, according to the Centers for Disease Control and Prevention, 149 cases of Zika infection were confirmed in the military health system, including four pregnant service members and one pregnant family member.
"Asymptomatic Zika infections can lead to severe birth defects and neurological complications. A safe and effective Zika vaccine that prevents infection in those at risk is a global public health priority," said Maj. Leyi Lin, principal investigator of the study.
NIH Trial Using ZPIV Vaccine
WRAIR's ZPIV candidate will also be part of the NIH trial that began in August. The study will test ZPIV in a group of people who first receive the DNA vaccine and then are boosted with the ZPIV vaccine. Three additional Phase 1 trials using ZPIV are scheduled to begin this year:
- St. Louis University researchers, through the NIAID-funded Vaccine and Treatment Evaluation Units network, will examine the optimal dose of the vaccine to be used in larger studies.
- Beth Israel Deaconess Medical Center and Harvard Medical School researchers will evaluate the safety and immune response from a compressed vaccine schedule.
- The clinical research center CAIMED, part of Ponce Health Sciences University in Puerto Rico, will examine the vaccine's safety and immunogenicity in participants who have already been naturally exposed to Zika or dengue viruses
The WRAIR trial that began recently is sponsored by NIAID and funded by the Departments of the Army and Defense.