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
2 other identifiers
interventional
25
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 hiv-infections
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Completion
Last participant's last visit for all outcomes
October 1, 1994
CompletedFirst Submitted
Initial submission to the registry
November 2, 1999
CompletedFirst Posted
Study publicly available on registry
August 31, 2001
CompletedNovember 4, 2021
October 1, 2021
November 2, 1999
October 28, 2021
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, 63104, United States
Univ. of Rochester AVEG
Rochester, New York, 14642, United States
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, 37232, United States
Related Publications (1)
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.
PMID: 9310283BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Belshe R
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Masking
- DOUBLE
- Purpose
- PREVENTION
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 1999
First Posted
August 31, 2001
Study Completion
October 1, 1994
Last Updated
November 4, 2021
Record last verified: 2021-10