MONDAY, SEPTEMBER 26, 2016

NYVAC-HIV vaccine applied in HVTN 092 and HVTN 096 clinical trials

NYVAC-HIV vaccine applied in HVTN 092 and HVTN 096 clinical trials | Courtesy of medicalexpo.com
A recent announcement from the National Institute of Allergy and Infectious Diseases (NIAID), which is a branch of the National Institutes of Health, states that NIAID officials just learned that an investigational HIV vaccine named NYVAC-HIV was contaminated with bacterium and used in two clinical trials.

A total of 15 trial subjects in the HIV Vaccine Trials Network (HVTN) 092 clinical trial received the vaccine. An additional 79 trial subjects involved in the HVTN 096 clinical trial also received the vaccine.

The bacterium, named Mycoplasma hyorhinis, does not cause illnesses in humans, but it does cause disease in pigs.

Both of the contaminated trials ended in 2013. The participants have not reported any unusual side effects since the study ended, but in light of the new evidence, the participants have been contacted. NIAID officials have asked these participants to return to their clinic sites; health professionals must conduct physical examinations and blood tests to determine that the patients are truly safe.

Eurovacc, a not-for-profit organization based in Switzerland, supplied the NYVAC-HIV vaccine to the clinical trial. IDT Biologika, a company based in Germany, manufactured the investigational vaccine for both of the clinical trials.

In 2011, the vaccine passed all of the necessary sterility testing that was available at the time. Now, using a more sensitive DNA-based testing method, a new batch of the vaccine has been discovered to have contaminants. In light of this, the researchers tested earlier vaccine batches with the new DNA testing method. All of these tests show that M. hyorhinis has contaminated all of the vaccines.

Organizations in this story

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