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Phase I Clinical Trial Of Plasmid DNA-Based Vaccine Is Enrolling Patients.(Brief Article)

Vaccine Weekly

| May 09, 2001 | COPYRIGHT 2001 NewsRX. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan.  All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)Copyright

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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