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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Seventy healthy volunteers are randomized to one of four groups. Groups A and D receive one initial immunization with HIVAC-1e followed by two boosts with subunit gp120 and Env 2-3, respectively, at months 8 and 12. Group B receives two immunizations with HIVAC-1e at months 0 and 8 followed by a single boost with subunit gp120 at month 12. Group C receives t...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• 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.