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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

Primary Purpose

HIV Infections

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gp160 Vaccine (Immuno-AG)
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • St. Louis Univ. School of Medicine AVEG
  • Univ. of Rochester AVEG
  • Vanderbilt Univ. Hosp. AVEG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 2, 1999
Last Updated
October 28, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immuno-US
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1. Study Identification

Unique Protocol Identification Number
NCT00001056
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1994 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immuno-US

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV Infections
Keywords
Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
gp160 Vaccine (Immuno-AG)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belshe R
Official's Role
Study Chair
Facility Information:
Facility Name
St. Louis Univ. School of Medicine AVEG
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Univ. of Rochester AVEG
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Vanderbilt Univ. Hosp. AVEG
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
9310283
Citation
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.
Results Reference
background

Learn more about this trial

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

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