OUTLINE OF PROTOCOL 003B

Subjects: Healthy, HIV-1 uninfected adult volunteers without identifiable high-risk behavior for HIV-1 infection.

Schema:

Product Description: VaxSyn: Baculovirus/insect cell-derived HIV-1 LAI rgp160 in alum [MicroGeneSys]

Time Period: First volunteer entered on 10/30/90 and the last was enrolled on 03/13/91; follow-up of 24 months.

Clinical Sites: Johns Hopkins University, Saint Louis University, University of Rochester, University of Washington, Vanderbilt University

Study Chair: Raphael Dolin, University of Rochester

INCLUSION CRITERIA

• Age: >18 and <50
• Sex: Male or Female
• Normal history and physical examination
• Normal complete blood count and differential defined as:
  • Hematocrit >35% for women; >39% for men
  • White count >4000 cells/mm³ with normal differential
  • Total lymphocyte count >1500 cells/mm³
  • T4 cells >800 cells/mm³
  • Platelets in the normal range
• Normal chest x-ray
• Normal urinalysis
• Normal ALT and creatinine
• Negative ELISA and Western blot test for HIV
• Negative HIV p24 antigen test
• Negative surface antibody and core antibody for Hep B
• Negative for Hep B surface antigen
• For females, negative pregnancy test at time of entry and assurance that adequate birth control measures are employed for the next 12 months
• Normal skin reactivity by Merieux multiskin test kit
• Availability for one year of follow-up

EXCLUSION CRITERIA

• Subjects with identifiable high-risk behavior for HIV infection as determined by prescreening questions designed to identify risk factors for HIV infection
• Previous receipt of blood transfusions or cryoprecipitates within the past 6 months
• History of immunodeficiency, chronic illness, or use of immunosuppressive medications
• Positive PPD
• Positive syphilis serology (e.g., VDRL)
• Hepatitis B vaccination

STUDY GOALS

To evaluate the safety and immune response to 640 µg of the rgp160 candidate vaccine using a similar schedule to that evaluated in Protocols 003 and 003A. The duration of antibody response and its relationship to dose and frequency of inoculation will be evaluated.

REFERENCES

Keefer MC, Graham BS, Belshe RB, Schwartz D, Corey L, Bolognesi DP, Stablein DM, Montefiori DC, McElrath MJ, Clements ML, Gorse GJ, Wright PF, Matthews TJ, Smith GE, Lawrence D, Dolin R, AIDS Vaccine Clinical Trials Network. Studies of high doses of a human immunodeficiency virus type 1 recombinant glycoprotein 160 candidate vaccine in HIV type 1-seronegative humans. AIDS Res Hum Retroviruses. 1994;10:1713-1723.