Important note: Information in this article was accurate in March 2002. The state of the art may have changed since the publication date. IAVI Report - March / April 2002
Emily Bass
On April 4, 2002, UK researchers immunized the first volunteer in a Phase IIa trial of an HIV-DNA vaccine and a second vaccine based on MVA (MVA.HIV) a weakened version of vaccinia virus. The study, headed by Jonathan Weber of London’s Imperial College of Science, Technology and Medicine, is taking place there and at Oxford University, and will enroll 120 volunteers. It is sponsored by IAVI and the UK Medical Research Council.
Both vaccines contain most of the HIV-gag gene derived from subtype A, the most common subtype in Kenya, fused to a string of 25 partially overlapping CTL epitopes from gag, pol, nef and env.
They were developed by Oxford researchers Tomas Hanke and Andrew McMichael in partnership with scientists at the University of Nairobi. Data from a small Phase I prime-boost trial, presented at the recent Keystone Symposium (see Keystone Vaccine Conference article), showed cellular immune responses against HIV in all vaccinated participants.
The new expanded, double-blinded trial is being called a Phase IIa study by the Oxford team. Sometimes referred to as a Phase I/II, such intermediate-size trials typically enroll a larger number of volunteers than Phase I safety studies and gather information on optimal vaccine dosing and immunization schedule, but do not enroll people at high risk for HIV infection. Participants in the UK trial will receive one of two DNA doses or a placebo, followed by MVA.HIV or placebo. They will also be randomized into two further groups to test different intervals between prime and boost.
The DNA and MVA.HIV vaccines first entered human studies in August 2000 and have been tested in 26 healthy, HIV-negative volunteers in the UK. Clinical trials are also underway in Kenya through the Kenyan AIDS Vaccine Initiative (KAVI) and the University of Nairobi. The Kenyan team has completed a Phase I HIV-DNA study and enrolled 12/18 individuals in an MVA.HIV trial. Upon completion of the latter, KAVI will launch the first of a series of prime-boost trials. •
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©2002. The IAVI Report.
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