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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001056
• Other study ID #: AVEG 004A
• Secondary ID: 10544
• Status: Completed
• Phase: Phase 1
• Est. completion date: October 1994

Study information

• Verified date: October 2021
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 1994
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Vaccinia

Intervention

Biological:
• gp160 Vaccine (Immuno-AG)

Locations

Country	Name	City	State
United States	Vanderbilt Univ. Hosp. AVEG	Nashville	Tennessee
United States	Univ. of Rochester AVEG	Rochester	New York
United States	St. Louis Univ. School of Medicine AVEG	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immuno-US

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation