IAVI Report - September / November 2000
David Gold

Efforts to advance two IAVI-sponsored candidate HIV vaccines received a major boost with the announcement that clinical trials of one vaccine have begun, and a second one has received regulatory approval to start.

On 21 September, Wayne Koff, IAVI's Vice President for Research and Development, announced that an HIV vaccine using a modified vaccinia Ankara (MVA) vector was approved for Phase I testing by the Medicines Control Agency in the United Kingdom. The vaccine is based on subtype A strains of HIV, the most common strain in Kenya and in many other parts of Africa. It encodes a consensus clade A gag sequence along with epitopes shared between subtypes A and B, and "mini-genes" encoding these epitopes as 20-mer peptides. The MVA vaccine was designed by Oxford University's Thomas Hanke and manufactured by Impfstoffwerke Dessau-Tornau (IDT), a German pharmaceutical company. It is the second component of a prime-boost vaccination strategy.

A few weeks earlier, the first component - an HIV DNA vaccine - entered Phase I testing in Oxford, in a trial that will involve a total of 18 volunteers. Oxford researcher Andrew McMichael told the IAVI Report that, as of 30 October, about 50% of the needed volunteers had been immunized. The researchers will randomize participants to either the DNA or the MVA vaccines. They then plan to seek approval for testing both vaccines in combination.

Like the MVA vaccine, the DNA component is also made from HIV subtype A strains. Evan Harris, a member of the British Parliament, led off the trial on 31 August when he became the first person to be injected with the vaccine. Pending approvals from the appropriate Kenyan authorities, it is hoped that the DNA vaccine will enter human trials in Nairobi early in 2001.

The vaccine candidates are being moved into clinical studies by the research teams of Andrew McMichael at Oxford University and J.J. Bwayo at the University of Nairobi. Both vaccines are designed to generate HIV-specific cellular immune responses, which researchers increasingly believe can provide some protection against HIV infection or disease progression. Koff made the announcement of the MVA vaccine approval in Bonn, Germany, noting that "two IAVI-sponsored vaccine candidates have now moved from concept to clinic in less than two years, near record time for these type of products." He added that the HIV MVA vaccine is the first of its kind to be approved for human testing.

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