A Multicenter, Randomized, Placebo-Controlled, Double-Blind Trial to Evaluate the Safety and Immunogenicity of the Therion Recombinant Vaccinia-HIV-1 IIIB ENV/GAG/POL Vaccine (TCB-3B) and MN RGP 120/HIV-1 In Alum.

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

Keywords

ClinConnect Summary

In prior trials evaluating alternative methods of vaccine administration, scarification has been found to be an imprecise method of administration and allows only 1.0 - 2.5 microliters of immunogen to be given. Since it is not feasible to produce vaccine at concentrations higher than 10 to the 10th pfu/ml, this method limits the maximum deliverable dose. Intradermal and subcutaneous injection routes allow larger volumes of vaccinia to be given, i.e.: up to 200 microliters intradermally and up to 100 ml subcutaneously. In the present study, the initial priming dose will be the same administe...

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• Patients must have:
• • Negative FDA-approved ELISA for HIV within 8 weeks of immunization.
• • Normal history and physical examination.
• • Negativity for Hepatitis B surface antigen.
• • Availability for follow-up for planned duration of the study (18 months).
• • Exclusion Criteria
• Co-existing Condition:
• Patients with the following symptoms or conditions are excluded:
• • Medical or psychiatric condition or occupational responsibilities that preclude subject compliance with the protocol. Specifically excluded are people with a history of suicide attempts, recent suicidal ideation or who have past or present psychosis.
• • Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (\> 6 months) treated infection, the volunteer is eligible.
• • Active tuberculosis. NOTE: Patients with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.
• * Household contacts with, or occupational exposure to, people with any of the following:
• • Pregnancy. \<12 months of age. Eczema or Immunodeficiency disease. Use of immunosuppressive medications.
• Patients with the following prior conditions are excluded:
• • History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
• • History of cancer, unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
• • Any history of anaphylaxis or history of other serious adverse reactions to vaccines.
• • History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
• • Eczema within the past year.
• • History of smallpox vaccination.
• • Envelope bands on HIV-1 Western blot within 8 weeks of immunization.
• Prior Medication: Excluded:
• • Use of immunosuppressive.
• • Live attenuated vaccines within 60 days of study.
• • NOTE: Medically indicated subunit or killed vaccines (e.g. influenza, pneumococcal) do not exclude, but should be given at least 2 weeks prior to HIV immunizations.
• • Experimental agents within 30 days prior to study.
• • Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
• • Receipt of blood products or immunoglobulin within past 6 months.
• Risk Behavior: Excluded:
• • History of injection drug use within the last 12 months prior to enrollment.
• • Higher or intermediate risk sexual behavior as defined by the AVEG.
• • Lower risk sexual behavior as defined by AIDS Vaccine Evaluation Group (AVEG) procedures.