AIDSWEEKLY Plus, Monday, 17 February 1997
Daniel J. DeNoon, Senior Editor
CD4 counts and anti-HIV immune responses failed to improve in recipients of a therapeutic vaccine administered in combination with zidovudine (AZT).
The vaccine, p24-VLP, contains the HIV p24 protein expressed by a genetically engineered yeast in the form of a virus-like particle.
It theoretically has the potential to react with a broad range of HIV strains because the p17 and p24 proteins on which it is modeled come from HIV's interior. Across multiple HIV strains, these core proteins do not change as much as the gp120 and gp160 HIV surface proteins used in many first- generation HIV vaccines
Clinical trials of the vaccine have been underway since 1994.
A.D. Kelleher of St. Vincent's Hospital, Sydney, Australia, reported early results from a study of p24-VLP in combination with AZT at the 4th Conference on Retroviruses and Opportunistic Infections, held January 22-26 in Washington, D.C.
The trial enrolled 61 asymptomatic, HIV infected patients who were randomized to three treatment arms: Arm A received AZT 200 mg TID plus adjuvant alone; Arm B received AZT 200 mg TID plus p24-VLP 500 (micro)g/month in alum IMI adjuvant; and Arm C received placebo capsules plus p24-VLP 500 (micro)g/month in alum IMI adjuvant.
No serious adverse events occurred. CD4 count changes did not differ significantly between treatment arms.
At baseline, nine percent of the patients were anergic and 54 percent had reduced DTH responses; there was no significant difference between treatment arms in DTH responses after one year of treatment.
"p24-VLP either alone or in combination with AZT does not appear to significantly alter CD4(+) cell count or DTH responses over one year," Kelleher and colleagues wrote in their presentation abstract.
Three hundred patients with advanced HIV infection, including AIDS, were enrolled in a Phase II study of p24-VLP added to current medications.
The first data from this trial were not promising: according to a 1996 report, the vaccine failed to boost key antibodies in people with HIV infection.
"Immunization with p24-VLP did not increase anti-p24 antibody levels and had no effect on CD4 cell counts or virus load," wrote Jan Veenstra of the Municipal Health Service, Amsterdam, Netherlands, and colleagues (J Infect Dis, 1996;174:862-6).
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