A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Hepatitis B Vaccine (Recombinant)

gp160 Vaccine (MicroGeneSys)

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 - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria Subjects must have: Normal history and physical exam. Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). T4 count >= 800 cells/mm3. Normal chest x-ray and urinalysis. Negative surface antibody and core antibody for hepatitis B. Negative hepatitis B surface antigen. Negative HIV p24 antigen test. Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Positive PPD. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or use of immunosuppressive medications. Prior hepatitis B vaccination. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Medication: Excluded: Prior hepatitis B vaccine. Prior Treatment: Excluded: Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: Any history of IV drug use. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Sites / Locations

JHU AVEG
Vanderbilt Univ. Hosp. AVEG

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00000745

First Posted

November 2, 1999

Last Updated

October 27, 2021

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Protein Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00000745

Brief Title

A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

Official Title

A Phase I Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Safety and Immunogenicity of HIV-1 Recombinant Envelope Glycoprotein gp160

Study Type

Interventional

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Completed

Study Start Date

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Primary Completion Date

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Study Completion Date

May 1991 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators

Protein Sciences Corporation

4. Oversight

5. Study Description

Brief Summary

To determine the reactivity and safety of HIV-1 recombinant envelope glycoprotein gp160. To determine the immunogenicity of gp160. Although recent advances have been made in antiviral therapy against AIDS, there is currently no cure. It is likely that ultimate control of the disease will depend 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. It is likely that ultimate control of the disease will depend on the development of safe and effective vaccines against HIV. Healthy volunteers are injected on days 0, 30, and 180 with one of four preparations: gp160 vaccine (40 mcg), gp160 vaccine (80 mcg), hepatitis B vaccine, and placebo. The hepatitis B vaccine group will serve as an additional control for immunological evaluations. An optional fourth injection may be given 15-21 months following the initial inoculation.

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

72 (false)

8. Arms, Groups, and Interventions

Intervention Type

Biological

Intervention Name(s)

Hepatitis B Vaccine (Recombinant)

Intervention Type

Biological

Intervention Name(s)

gp160 Vaccine (MicroGeneSys)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Subjects must have: Normal history and physical exam. Negative for HIV infection by ELISA and Western blot (i.e., no reactivity at gp160, gp120, gp41, or p24). T4 count >= 800 cells/mm3. Normal chest x-ray and urinalysis. Negative surface antibody and core antibody for hepatitis B. Negative hepatitis B surface antigen. Negative HIV p24 antigen test. Normal skin reactivity by Merieux test. Exclusion Criteria Co-existing Condition: Subjects with the following symptoms or conditions are excluded: Positive PPD. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease). Subjects with the following prior conditions are excluded: History of immunodeficiency, chronic illness, or use of immunosuppressive medications. Prior hepatitis B vaccination. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. Prior Medication: Excluded: Prior hepatitis B vaccine. Prior Treatment: Excluded: Prior blood transfusions or cryoprecipitates within the past 6 months. Identifiable high-risk behavior for HIV infection (as determined by prescreening questions designed to identify risk factors for HIV infection), including: Any history of IV drug use. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months. More than two sexual partners, or sexual contact with a high-risk partner, in the past 6 months.

Overall Study Officials: