AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 8, Number 8, 1992 Mary Ann Liebert, Inc., Publishers
Phase I/II Studies of the Toxicity and Immunogenicity of Recombinant gpl60 and p24 Vaccines in HIV-Infected Individuals
Downloaded by East Carolina University from www.liebertpub.com at 01/14/19. For personal use only.
KATHRYN M. ZUNICH, H. CLIFFORD LANE, RICHARD T. DAVEY, JUDITH FALLOON, MICHAEL POLIS, JOSEPH A. KOVACS, and HENRY MASUR
ACTIVE
immunization of patients with HIV infection using recombinant HIV viral proteins may alter the immune response and the natural history of the disease. We are currently completing phase I/II studies to evaluate the toxicity and immunogenicity of recombinant gpl60 envelope and p24 core proteins in HIV-infected individuals in two separate clinical trials. In the completed evaluation of gpl60, ten HIV-seropositive patients with greater than 500 CD4 cells/mm' were enrolled. Five patients received 160 pg and five patients received 1280 pg at months 0,1,2,3 and 6, with clinical and toxicity monitoring performed monthly for 12 months. All ten patients completed the 12 months of follow up. No significant clinical or laboratory toxicities were noted; minor local reactions such as tenderness and induration were observed. Immunologie studies showed the development of gpl60-specific blastogenesis responses. There were no significant changes in CD4 counts over the 12 month period for either of the dosage groups and when "responders" were compared to "nonresponders." In the ongoing clinical trial
Laboratory of Immunoregulation. National
utilizing p24, twenty patients have been enrolled, five in each of the following dosage groups: 40 pg, 160 pg, 640 pg, and 1280 pg, at months 0, 1, 2, 3 and 6. Thus far, there have been minor local reactions and limited systemic reactions such as headache, fever, and myalgias. Preliminary immunologie studies have shown the development of p24-specific blastogenesis. Overall, the use of recombinant gpl60 and p24 proteins in early HIV infection appears to be safe; it remains to be seen whether this approach in treating HIV infection will prove to be efficacious.
Institute of Allergy and Infectious Diseases. NIH,
1335
Address
reprint requests to: Kathryn M. Zunich Laboratory of Immunoregulation National Institute of Allergy and Infectious Diseases NIH, Bldg 10, Rm I1B13 Bethesda, MD 20892
Bldg. 10,
Rm. 1 IB 13, Bethesda. MD 20892.
Phase I/II Studies of the Toxicity and Immunogenicity of Recombinant gpl60 and p24 Vaccines in HIV-Infected Individuals
Downloaded by East Carolina University from www.liebertpub.com at 01/14/19. For personal use only.
KATHRYN M. ZUNICH, H. CLIFFORD LANE, RICHARD T. DAVEY, JUDITH FALLOON, MICHAEL POLIS, JOSEPH A. KOVACS, and HENRY MASUR
ACTIVE
immunization of patients with HIV infection using recombinant HIV viral proteins may alter the immune response and the natural history of the disease. We are currently completing phase I/II studies to evaluate the toxicity and immunogenicity of recombinant gpl60 envelope and p24 core proteins in HIV-infected individuals in two separate clinical trials. In the completed evaluation of gpl60, ten HIV-seropositive patients with greater than 500 CD4 cells/mm' were enrolled. Five patients received 160 pg and five patients received 1280 pg at months 0,1,2,3 and 6, with clinical and toxicity monitoring performed monthly for 12 months. All ten patients completed the 12 months of follow up. No significant clinical or laboratory toxicities were noted; minor local reactions such as tenderness and induration were observed. Immunologie studies showed the development of gpl60-specific blastogenesis responses. There were no significant changes in CD4 counts over the 12 month period for either of the dosage groups and when "responders" were compared to "nonresponders." In the ongoing clinical trial
Laboratory of Immunoregulation. National
utilizing p24, twenty patients have been enrolled, five in each of the following dosage groups: 40 pg, 160 pg, 640 pg, and 1280 pg, at months 0, 1, 2, 3 and 6. Thus far, there have been minor local reactions and limited systemic reactions such as headache, fever, and myalgias. Preliminary immunologie studies have shown the development of p24-specific blastogenesis. Overall, the use of recombinant gpl60 and p24 proteins in early HIV infection appears to be safe; it remains to be seen whether this approach in treating HIV infection will prove to be efficacious.
Institute of Allergy and Infectious Diseases. NIH,
1335
Address
reprint requests to: Kathryn M. Zunich Laboratory of Immunoregulation National Institute of Allergy and Infectious Diseases NIH, Bldg 10, Rm I1B13 Bethesda, MD 20892
Bldg. 10,
Rm. 1 IB 13, Bethesda. MD 20892.
