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)

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Aug 30, 2001

Keywords

ClinConnect Summary

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-im...

Gender

ALL

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.