A Phase I, Multicenter, Randomized Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV Envelope Vaccine (HIVAC-1e) in Combination With a Panel of Subunit Recombinant HIV Envelope Vaccines

Completed · Phase 1

Conditions studied: HIV Infections

In brief

Primary: To determine in healthy volunteers whether priming with a vaccinia HIV-1 gp160 envelope gene recombinant vaccine (HIVAC-1e) followed by boosting with one of two subunit recombinant HIV-1 envelope vaccines (Env 2-3 and gp120) provides enhanced immunogenicity compared to vaccination with the gp120 subunit vaccine alone. (Per 10/01/92 amendment, boosts with VaxSyn (gp160) were eliminated.) To evaluate the immunogenicity of one versus two priming doses of HIVAC-1e prior to a boost with gp120. To compare the relative immunogenicity of the three subunit vaccines when administered as boosters. Secondary: To examine the safety of administering the individual subunit vaccines in combination with HIVAC-1e and the safety of administering the gp120 subunit vaccine alone. In a previous study of candidate HIV vaccines, the evidence suggested that administration of a booster vaccination with a different vaccine preparation may produce a better immune response than administration of HIVAC-1e vaccine alone.

Key facts

Study ID

NCT00000746

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

56

Expected to finish

1994-07-01

Last updated by the study team

2021-11-04

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects must have:
• Normal history and physical exam.
• Negative HIV screening by ELISA, Western blot, and p24 antigen (PBMC HIV culture or HIV-specific PCR can be substituted for Western blot and p24 antigen).
• History of smallpox vaccination more than 5 years prior to enrollment.
• Normal urinalysis.
• Absolute CD4 count = or > 500 cells/mm3.
• Prior Medication: Required:
• Vaccinia (smallpox) vaccination more than 5 years prior to study enrollment. Identifiable high-risk behavior for HIV infection as determined by screening questionnaire/interview.

You may not qualify if…

• Co-existing Condition:
• Subjects with the following symptoms or conditions are excluded:
• Household contacts who are pregnant, < 12 months of age, have eczema, or have immunodeficiency disease or who use immunosuppressive medications.
• Hepatitis B surface antigenemia.
• Medical or psychiatric condition or occupational responsibilities that preclude compliance.
• Subjects with the following prior conditions are excluded:
• History of immunodeficiency or chronic illness.
• Eczema within the past year.
• Prior Medication:
• Excluded:
• Prior experimental HIV vaccine.
• Immunoglobulin administration or use of experimental agent within the past 2 months.
• History of immunosuppressive medications.
• Prior Treatment:
• Excluded:
• Blood or blood product transfusion within the previous 6 months.

Where it is running

• JHU AVEG — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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