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Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00000767 |
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 virus expressing the env, gag, and pol genes of HIV-1 IIIB strain. To evaluate the potential of boosting with one of a variety of HIV-1 recombinant subunit, peptide, or pseudovirion vaccines, if available, to augment the immune responses of the vaccinees.
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 vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study.
Condition | Intervention | Phase |
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HIV Infections |
Biological: TBC-3B Vaccine Biological: Smallpox Vaccine |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Double-Blind, Safety Study |
Official Title: | 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) |
Estimated Enrollment: | 18 |
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 vaccine based solely on HIV-1 envelope proteins. Inclusion of conserved core and polymerase proteins along with envelope protein in a candidate vaccine may address some of the problems with antigenic variability. A prime-boost immunization approach using a novel priming immunogen expressing env, gag, and pol genes of the HIV-1 IIIB strain will be attempted in this study.
In Part I, vaccinia-immune volunteers are randomized to one of two regimens. Group A receives priming with TBC-3B on days 0 and 56, followed by boosting on day 224 (8 months) with one of the following: TBC-3B, an alternative immunogen such as pseudovirion particles or a recombinant HIV-1 subunit or peptide vaccine, or placebo. Group B receives priming with control vaccine (DryVax), followed by boosting with an appropriate placebo. At least 50 percent of subjects in Part I will be observed for a minimum of 8 weeks before subsequent volunteers are enrolled in Part II. PER 11/18/94 AMENDMENT, Part I boosting is given on day 392. PER 5/19/95 AMENDMENT, Part I boosting is given on day 756 if not available on day 392; if the appropriate product is not available then, the study will end on day 756. In Part II, vaccinia-naive volunteers are randomized to one of three regimens. Group C receives TBC-3B on day 0 and saline placebo on day 56. Group D receives TBC-3B on days 0 and 56. Both Group C and D receive boosting with TBC-3B or an alternative immunogen on day 224. Group E receives control vaccine (DryVax) on days 0 and 56, followed by appropriate placebo on day 224. Per 06/10/94 addendum, volunteers will be contacted once or twice per year for at least 5 years to check on health status.
NOTE: Part I (Part A) of the protocol has closed to accrual.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Subjects must have:
NOTE:
Exclusion Criteria
Co-existing Condition:
Subjects with the following symptoms or conditions are excluded:
Subjects with the following prior conditions are excluded:
Prior Medication:
Excluded:
Prior Treatment:
Excluded:
United States, Maryland | |
Johns Hopkins Univ / School of Hygiene & Public Health | |
Baltimore, Maryland, United States, 212051901 | |
United States, Missouri | |
St Louis Univ School of Medicine | |
St. Louis, Missouri, United States, 63104 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Tennessee | |
Vanderbilt Univ Hosp | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Study Chair: | Keefer M |
Study ID Numbers: | AVEG 014A/B |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000767 |
Health Authority: | United States: Federal Government |
Vaccines, Synthetic Vaccinia Virus Viral Vaccines Smallpox Vaccine |
HIV-1 AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Virus Diseases Smallpox Sexually Transmitted Diseases, Viral Poxviridae Infections Vaccinia HIV Infections |
Sexually Transmitted Diseases Acquired Immunodeficiency Syndrome DNA Virus Infections Retroviridae Infections Immunologic Deficiency Syndromes |
RNA Virus Infections Slow Virus Diseases Immune System Diseases Lentivirus Infections Infection |