A Phase I Randomized Trial to Evaluate the Safety and Immunogenicity of Vaccinia-HIV Envelope Recombinant Vaccine (HIVAC-1e) in Combination With Soluble Recombinant Envelope Vaccine (VaxSyn)

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

Keywords

ClinConnect Summary

Recent Phase I trials conducted at the AIDS Vaccine Units have shown that antibodies have persisted in most recipients for 6 months after boosting, and responses seem significantly higher and more persistent than responses achieved by just two doses of soluble protein vaccine alone or two doses of HIVAC-1e alone. This study tests in a previously recruited cohort of volunteers whether additional boosting with soluble recombinant gp160 results in increased immunogenicity of longer duration.

Twelve volunteers who have previously received two doses of HIVAC-1e (or DryVax) and two doses of gp16...

Gender

MALE

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Normal history and physical exam.
• • Negative ELISA for HIV.
• • Negative HIV p24 antigen test.
• • Normal urinalysis.
• Prior Medication: Required:
• • Two prior doses of HIVAC-1e (or DryVax) and two prior doses of gp160 vaccine.
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms and conditions are excluded:
• • Risk factors for HIV infection including active intravenous drug use and more than 2 sexual partners.
• • History of immunodeficiency or chronic illness.
• • Hypersensitivity to insects.
• • Medical or psychiatric condition that makes it unlikely the patient will comply with the protocol.
• Patients with the following prior conditions are excluded:
• • History of immunodeficiency or chronic illness.
• Prior Medication:
• Excluded:
• • Immunosuppressive medications.
• Prior Treatment:
• Excluded:
• • Blood or blood product transfusion within the past 6 months.
• Risk Behavior: Excluded:
• • Intravenous drug use.
• • More than 2 sexual partners.