A Phase I Multicenter Clinical Trial to Evaluate the Safety and Immunogenicity of Vaccinia Derived HIV-1 Recombinant Envelope Glycoprotein (gp160) of Human Immunodeficiency Virus: Evaluation of a 200-mcg Dose

NCT ID: NCT00001056

Last Updated: 2021-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 1994-10-31

Brief Summary

To determine the safety of and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) at a dose of 200 mcg in human volunteers; to evaluate duration of antibody response and its relationship to the dose and frequency of inoculation.

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Detailed Description

Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure for AIDS. It is likely that the ultimate control of the disease depends on the development of safe and effective vaccines against HIV.

Healthy, adult volunteers without identifiable high-risk behavior for HIV-1 infection are randomly assigned to receive three injections of either 200 mcg gp160 vaccine or a placebo. At each participating site, four volunteers receive vaccine and two volunteers receive placebo. Primary immunization and two booster immunizations at day 30 and day 180 are done in an outpatient setting. Volunteers are closely monitored for the first 2 weeks postimmunization (primary and boosters), and extensively followed for 2 years. Volunteers may be offered an additional booster of the same preparation at 12 months.

Conditions

HIV Infections

Keywords

Vaccines, Synthetic; Vaccinia Virus; Viral Vaccines; HIV-1; HIV Envelope Protein gp160; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine

Study Design

• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Interventions

gp160 Vaccine (Immuno-AG)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Patients must be:

• Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study.
• Available for 2 years of follow-up.

Exclusion Criteria

Co-existing Condition:

Patients with the following conditions or symptoms are excluded:

• History of positive PPD (tuberculin test) and abnormal chest x-ray.
• Positive syphilis serology (e.g., RPR).
• Positive for circulating hepatitis B surface antigen.

Patients with the following are excluded:

• They or their sexual partners have identifiable high-risk behavior for HIV infection.
• History of immunodeficiency or chronic illness.
• Evidence of psychological or psychiatric problems that may lead to noncompliance.

Prior Medication:

Excluded:

• Immunosuppressive medications.

Prior Treatment:

Excluded:

• Blood transfusions or cryoprecipitates within the past 6 months.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Immuno-US

INDUSTRY

Sponsor Role: collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Belshe R

Role: STUDY_CHAIR

Locations

St. Louis Univ. School of Medicine AVEG

St Louis, Missouri, United States

Univ. of Rochester AVEG

Rochester, New York, United States

Vanderbilt Univ. Hosp. AVEG

Nashville, Tennessee, United States

Countries

United States

References

Keefer MC, Wolff M, Gorse GJ, Graham BS, Corey L, Clements-Mann ML, Verani-Ketter N, Erb S, Smith CM, Belshe RB, Wagner LJ, McElrath MJ, Schwartz DH, Fast P. Safety profile of phase I and II preventive HIV type 1 envelope vaccination: experience of the NIAID AIDS Vaccine Evaluation Group. AIDS Res Hum Retroviruses. 1997 Sep 20;13(14):1163-77. doi: 10.1089/aid.1997.13.1163.

Reference Type: BACKGROUND

PMID: 9310283 (View on PubMed)

Other Identifiers

10544

Identifier Type: REGISTRY

Identifier Source: secondary_id

AVEG 004A

Identifier Type: -

Identifier Source: org_study_id