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2001 MAY 9 - (NewsRx.com & NewsRx.net) --
A Phase I, placebo-controlled study to examine the safety, tolerability, and immunogenicity of an experimental HIV vaccine consisting of plasmid DNA.
The manufacturer of the experimental vaccine is Merck & Co., Inc.
Vaccination will take place at Day 0 and at Weeks 4, 8, and 26. Patients will be followed for 104 weeks.
Initially, 16 volunteers will be randomized to receive either the HIV-1 gag DNA vaccine at a 1-mg dose or placebo. These volunteers will be observed for adverse events for two weeks after the Week 4 vaccination. If there are no significant adverse effects, Stage 2 will begin.
In Stage 2, 16 patients will receive vaccine at a 5-mg dose or placebo. These 16 patients will be observed for two weeks after the Week 4 injection. If it is determined that the ...
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