The first volunteer for the Phase I prime-boost AIDS vaccine trial, which will have a duration of two years, has been enrolled by the Tuberculosis Research Centre (TRC) here.
“The first volunteer was enrolled on April 1, 2009” said V.D. Ramanathan, Senior Deputy Director, TRC, who is one of the principal investigators. “The volunteer got the first of the four doses.”
The Modified Vaccinia Ankara (MVA) cleared Phase I trials at the TRC recently. Although it showed good immune response in all the volunteers who received it, the level of immune responses was modest and the persistence of the responses was not very encouraging.
Hence the decision to conduct a Phase II trial using MVA was dropped. Instead, a prime-boost vaccine trial strategy using MVA as a boost was considered. ADVAX, a DNA vaccine, will be the prime.
Using the MVA as a boost is based on the premise that it would be possible to boost the level of immune responses produced by ADVAX.
The trial will be conducted simultaneously at the National AIDS Research Institute and the TRC.
Thirty-two volunteers will be recruited — 16 each at NARI and the TRC. The 16 volunteers at each centre will be split into two arms of eight each.
One will get only MVA while the other will get ADVAX and MVA (prime-boost). Two volunteers in each will get a placebo.
Patricia Fast, Executive Director (Medical Affairs) of the International AIDS Vaccine Initiative, New York, had told The Hindu last year that ADVAX was tested in the U.S., and was found to be safe.
The trial has been registered at the Clinical Trials Registry – India. On the Net, it is at http://www.ctri.in:8080/Clinicaltrials/ViewTrial.jsp?trialno=468