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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000631

Enrollment

Registered

2001-08-31

Start date

Unknown

Completion date

1992-12-31

Last updated

2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections

Keywords

Vaccines, Synthetic, Vaccinia Virus, Viral Envelope Proteins, Viral Vaccines, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

Brief summary

Primary: To determine whether additional boosting with soluble recombinant gp160 vaccine (VaxSyn) after priming with a vaccinia-HIV envelope recombinant (HIVAC-1e) provides a significant advantage in the degree and duration of immunogenicity. Secondary: To learn more about the safety of the combination use of the two HIV envelope vaccines in the study (VaxSyn and HIVAC-1e). 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.

Detailed description

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 gp160 receive an additional boost of gp160 at 12-20 months after the last boost and an additional dose of HIVAC-1e at least 9 months after the final gp160 boost.

Interventions

BIOLOGICALHIVAC-1e

BIOLOGICALgp160 Vaccine (MicroGeneSys)

Study design

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026