Back to resultsA 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 Accelerated Schedules
Primary Purpose
HIV Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
gp160 Vaccine (Immuno-AG)
Sponsored by
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring Vaccines, Synthetic, Vaccinia Virus, Viral Vaccines, HIV-1, Drug Evaluation, HIV Envelope Protein gp160, Drug Administration Schedule, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Eligibility Criteria
Inclusion Criteria Patients must be: Normal, healthy, HIV-negative adults who fully comprehend the purpose and details of the study. Available for 1 year of follow-up. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: They or their sexual partners have identifiable high-risk behavior for HIV infection. Positive syphilis serology (e.g., VDRL). Positive for circulating hepatitis B antigen. Patients with the following prior conditions are excluded: History of positive PPD (tuberculin test). History of immunodeficiency or chronic illness. Evidence of depression or under treatment for psychiatric problems during the past year. Prior Medication: Excluded: Immunosuppressive medications. Prior Treatment: Excluded: Blood transfusions or cryoprecipitates within the past 6 months. Risk Behavior: Excluded: High-risk behavior for HIV infection. History of intravenous drug use. More than one sexual partner in the last 6 months. Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in the past 6 months.
Sites / Locations
- St. Louis Univ. School of Medicine AVEG
- JHU AVEG
- Vanderbilt Univ. Hosp. AVEG
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000957
First Posted
November 2, 1999
Last Updated
October 27, 2021
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators
Immuno-US
1. Study Identification
Unique Protocol Identification Number
NCT00000957
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 Accelerated Schedules
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 Accelerated Schedules
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
August 1993 (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 evaluate the safety and immune response to vaccinia-derived HIV-1 recombinant envelope glycoprotein (gp160) using an accelerated dosage schedule; 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 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 ultimate control of the disease depends on the development of safe and effective vaccines against HIV.
Thirty healthy adult volunteers without identifiable high-risk behavior for HIV-1 are randomly assigned to receive vaccination with gp160 (50 mcg) according to one of the following schedules: Group 1 receives vaccine on days 0, 28, 56, and 140 and placebo on days 84 and 112; Group 2 receives vaccine on days 0, 28, 56, 84, and 112 and placebo on day 140. Subjects are followed for 1 year after the last injection. Per 05/13/94 amendment, 10 subjects at the St. Louis University site receive an additional boost 18-24 months after the last injection.
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, Drug Evaluation, HIV Envelope Protein gp160, Drug Administration Schedule, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Masking
Double
Enrollment
30 (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 1 year of follow-up.
Exclusion Criteria
Co-existing Condition:
Patients with the following conditions or symptoms are excluded:
They or their sexual partners have identifiable high-risk behavior for HIV infection.
Positive syphilis serology (e.g., VDRL).
Positive for circulating hepatitis B antigen.
Patients with the following prior conditions are excluded:
History of positive PPD (tuberculin test).
History of immunodeficiency or chronic illness.
Evidence of depression or under treatment for psychiatric problems during the past year.
Prior Medication:
Excluded:
Immunosuppressive medications.
Prior Treatment:
Excluded:
Blood transfusions or cryoprecipitates within the past 6 months.
Risk Behavior: Excluded:
High-risk behavior for HIV infection.
History of intravenous drug use.
More than one sexual partner in the last 6 months.
Syphilis, gonorrhea, or any other sexually transmitted diseases (including chlamydia or pelvic inflammatory disease) in 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
JHU AVEG
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
19104
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
PubMed Identifier
7955519
Citation
Gorse GJ, Schwartz DH, Graham BS, Matthews TJ, Stablein DM, Frey SE, Belshe RB, Clements ML, Wright PF, Eibl M, et al. HIV-1 recombinant gp160 vaccine given in accelerated dose schedules. NIAID AIDS Vaccine Clinical Trials Network. Clin Exp Immunol. 1994 Nov;98(2):178-84. doi: 10.1111/j.1365-2249.1994.tb06122.x.
Results Reference
background
PubMed Identifier
8578800
Citation
Gorse GJ, Patel GB, Newman FK, Mandava M, Belshe RB. Recombinant gp160 vaccination schedule and MHC HLA type as factors influencing cellular responses to HIV-1 envelope glycoprotein. NIAID AIDS Vaccine Clinical Trials Network. Vaccine. 1995 Sep;13(13):1170-9. doi: 10.1016/0264-410x(95)00020-2.
Results Reference
background
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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 Accelerated Schedules
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