NIH starts Phase l trial of rZIKV/D4Δ30-713 for Zika virus infection

NIH starts Phase l trial of rZIKV/D4Δ30-713 for Zika virus infection

The US National Institutes of Health (NIH) has started a Phase l clinical trial of rZIKV/D4Δ30-713 vaccine for the prevention of Zika virus infection.

The randomised trial is designed to investigate the safety, reactogenicity, and immunogenicity of a single dose of the live attenuated Zika vaccine rZIKV/D4Δ30-713 in adults with no history of previous flavivirus infection such as Zika, dengue, or yellow fever.

It is expected to enrol 28 healthy, non-pregnant adults aged 18 to 50 at two sites in the US, including Johns Hopkins Bloomberg School of Public Health Center for Immunization Research in Baltimore, Maryland, and the Vaccine Testing Center at the Larner College of Medicine at the University of Vermont in Burlington.

During the trial, the subjects will be randomly assigned to receive a single subcutaneous dose of rZIKV/D4Δ30-713 or a placebo.

Of the total subjects, 20 will receive rZIKV/D4Δ30-713, while the remaining eight will receive placebo.

“During the trial, the subjects will be randomly assigned to receive a single subcutaneous dose of rZIKV/D4Δ30-713 or a placebo.”
Following the vaccination, the subjects will receive a diary card to record their temperature at home at certain intervals.

For the next six months, the subjects will visit the clinic periodically for physical examinations and to provide blood and other samples.

NIH unit National Institute of Allergy and Infectious Diseases (NIAID) will sponsor the trial.

NIAID director Anthony Fauci said: “Zika virus infection remains a significant threat to pregnant women and their developing fetuses, and we can expect to see periodic outbreaks and cases in areas where Aedes aegypti mosquitoes thrive.”

In addition, NIAID Laboratory of Viral Diseases PhD holder Dr. Stephen Whitehead has led the efforts to develop the investigational rZIKV/D4Δ30-713 vaccine that could help prevent the infection of Zika virus.

Zika virus is primarily caused by the bite of an infected mosquito or can be transmitted through sex.

There are currently no licensed vaccines available for Zika virus infection.

19 AUGUST 2018

https://www.drugdevelopment-technology.com/

August 22, 2018 / Pharma News