Status:
COMPLETED
A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Recombinant Vaccinia-HIV-1 IIIB Env/Gag/Pol Vaccine (TBC-3B)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To evaluate, in healthy HIV-1 seronegative vaccinia-immune and vaccinia-naive volunteers, the safety and immunogenicity of an HIV-1 candidate vaccine (TBC-3B) consisting of a live recombinant vaccinia...
Detailed Description
Antigenic drift, defined as the genetic variation of the HIV-1 envelope gene that results in antigenic variation during natural infection, may confound attempts to achieve protective immunity using a ...
Eligibility Criteria
Inclusion Criteria
Subjects must have:
- Negative ELISA and Western blot for HIV-1 within 6 weeks prior to immunization.
- Normal history and physical exam.
- History of smallpox vaccination at least 5 years prior to study entry (Part I) OR no prior smallpox vaccination (Part II).
- Absolute CD4 count >= 400 cells/mm3.
- Normal urinalysis.
NOTE:
- No more than 10 percent of volunteers in both Parts I and II may be over 50 years of age.
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
- Positive hepatitis B surface antigen.
- Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.
- Occupational responsibilities that preclude compliance.
- Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (> 6 months) treated infection are eligible.
- Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible.
- Eczema.
- Household contact with persons meeting any of the following criteria:
- pregnancy, less than 12 months of age, eczema, immunodeficiency disease, or use of immunosuppressive medications.
Subjects with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- Eczema within the past year.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Steven-Johnson syndrome, bronchospasm, or hypotension).
- Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance.
- History of cancer unless there has been surgical excision that is considered to have achieved cure.
Prior Medication:
Excluded:
- Prior HIV vaccines.
- Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
- Experimental agents within the past 30 days.
Prior Treatment:
Excluded:
- Receipt of blood products or immunoglobulins within the past 6 months. It is STRONGLY RECOMMENDED that any activity that might expose subject to HIV (unprotected sex or needle sharing) be avoided.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
End Date :
July 1 1996
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00000767
End Date
July 1 1996
Last Update
October 28 2021
Active Locations (5)
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1
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104
2
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
3
JHU AVEG
Pittsburgh, Pennsylvania, United States
4
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232