16,000 In Largest HIV-Vaccine Trial

Tuesday, July 17, 2001
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Source: The Nation (Thailand)

The Nation (Thailand) via NewsEdge Corporation -- The country's largest phase III trial of a possible HIV vaccine, involving 16,000 non-infected volunteer subjects, will commence next year, the Public Health Ministry said.

It is the first time that a live-vector-based vaccine will be tested in the final stage of large-scale trial, said Dr Supachai Roek-ngarm of the Communicable Disease Control Department.

Volunteers will get seven shots of the vaccine, ALVAC-HIV (vCP1521).

Researchers will boost two of the seven ALVAC shots with AIDSVAX (rGP120 B/E).

They hope that this prime-boost model of the vaccine trial will stimulate the humoral anti-bodies and the cell-mediated immunity vital in preventing HIV infection.

The vaccine will be consid-ered successful if the test group shows a decline in HIV incidence by half.

The vaccine will be administered over six months, but the volunteers will be monitored for three years.

ALVAC is genetically made by inserting part of the HIV gene into the canary-pox virus.

The vaccine is safe as canary pox, which affect birds, is harmless in humans, as is the HIV gene, which cannot multiply.

The 16,000 volunteers, aged between 20 and 30, will be chosen from residents of eight districts: Sattahip, Sri Racha, Pan Thong and Bang Lamung in Chon Buri; and Muang Rayong, Bang Khai, Ban Chang and Klaeng in Rayong.

Supachai said the HIV-infection rate in these two provinces was still high, making them suitable places for the vaccine trial.

The trial is a collaboration between the health ministry, the US Army's Office of the Surgeon General and Mahidol University.

The university, Siriraj Hospital and Chiang Mai University's Research Institute in Health Sciences, had earlier conducted separate phase I and II trials to test the vaccine's safety and efficacy in boosting immunity.

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