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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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: gp160 Vaccine (Immuno-AG) |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Prevention |
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 |
Enrollment: | 30 |
Study Completion Date: | August 1993 |
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.
![](https://webarchive.library.unt.edu/web/20130315212148im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
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.
![](https://webarchive.library.unt.edu/web/20130315212148im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
United States, Missouri | |
St. Louis Univ. School of Medicine AVEG | |
St. Louis, Missouri, United States, 63104 | |
United States, Pennsylvania | |
JHU AVEG | |
Pittsburgh, Pennsylvania, United States, 19104 | |
United States, Tennessee | |
Vanderbilt Univ. Hosp. AVEG | |
Nashville, Tennessee, United States, 37232 |
Study Chair: | Belshe R |
![](https://webarchive.library.unt.edu/web/20130315212148im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Publications:
Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000957 History of Changes |
Other Study ID Numbers: | AVEG 004B, 10545 |
Study First Received: | November 2, 1999 |
Last Updated: | April 26, 2012 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic Vaccinia Virus Viral Vaccines HIV-1 Drug Evaluation |
HIV Envelope Protein gp160 Drug Administration Schedule AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Additional relevant MeSH terms:
Acquired Immunodeficiency Syndrome HIV Infections Immunologic Deficiency Syndromes Vaccinia Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Slow Virus Diseases Immune System Diseases Poxviridae Infections DNA Virus Infections |
Krestin Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs Interferon Inducers Radiation-Protective Agents Protective Agents |
ClinicalTrials.gov processed this record on March 14, 2013