NIAID Launches Three New AIDS Vaccine Trials

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vaccine into a controlled-release formula. Thus, a single dose could be used instead of booster
shots. Moreover, tests in small animals show that delivering HIV peptides in microparticles
increases antibody production. The microparticles alone will be used as a control in the boosting
phase of the protocol.
No serious safety problems have been reported with the injectable or oral UBI vaccine in
other AVEG trials in which these vaccines are being tested separately.
AVEG 023 will enroll 32 men and women at low or intermediate risk for HIV-1 infection.
By random assignment, half will receive their first immunization in the upper arm and the other
half in the front of the thigh to see if the latter location induces better genital antibody responses
after oral boosting. Each group will enroll at least five women. Twelve in each group of 16 will
receive active vaccine and four an inactive look-alike or placebo. All 32 volunteers will be
boosted with the oral UBI vaccine or placebo one, two and eight months later. Neither the
investigators nor the patients will know who is getting vaccine or placebo.
The 14-month trial also will determine if a faster immunization schedule (zero, one and
two months) stimulates optimal immune responses, or if a rest period followed by a fourth
immunization (month eight) is needed. The results of AVEG 023 will be compared with those of
a similar ongoing UBI-sponsored trial that requires booster shots at one and six months only.
The study is being conducted at three AVEG sites; the University of Alabama at
Birmingham (UAB), the University of Rochester Medical Center and the University of
Washington. Mark Mulligan, M.D., of UAB chairs the study.