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)

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00000767

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

18

Expected to finish

1996-07-01

Last updated by the study team

2021-10-28

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• St. Louis Univ. School of Medicine AVEG — St Louis, Missouri, United States
• Univ. of Rochester AVEG — Rochester, New York, United States
• JHU AVEG — Pittsburgh, Pennsylvania, United States
• Vanderbilt Univ. Hosp. AVEG — Nashville, Tennessee, United States
• UW - Seattle AVEG — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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