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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Purpose
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.
| 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 a 200-mcg Dose |
| Enrollment: | 25 |
| Study Completion Date: | October 1994 |
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.
Eligibility| 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 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.
Contacts and Locations| United States, Missouri | |
| St. Louis Univ. School of Medicine AVEG | |
| St. Louis, Missouri, United States, 63104 | |
| United States, New York | |
| Univ. of Rochester AVEG | |
| Rochester, New York, United States, 14642 | |
| United States, Tennessee | |
| Vanderbilt Univ. Hosp. AVEG | |
| Nashville, Tennessee, United States, 37232 | |
| Study Chair: | Belshe R |
More Information
Publications:
| Responsible Party: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001056 History of Changes |
| Other Study ID Numbers: | AVEG 004A, 10544 |
| 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 |
HIV Envelope Protein gp160 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 June 17, 2013