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.
MN rgp120/HIV-1
+ TBC-3B Vaccine
Blood-Borne Infections+14
+ Urogenital Diseases
+ Genital Diseases
Prevention Study
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 administered by all 3 methods; however, the second priming dose administered at 2 months intradermally and subcutaneously will be 2 logs higher in order to achieve boosting of immune responses, particularly to gag and pol components of TBC-3B. After volunteers are recruited, screened and enrolled in the study, they will be randomized to group C, D, or E. Each group will enroll 10 patients and 2 controls. The placebo control for TBC-3B will be standard vaccinia vaccination administered at doses no higher than that administered by scarification; the placebo control for MN rgp120 will be alum. Group C will receive undiluted TBC-3B by scarification, at months 0 and 2. Group D will receive diluted TBC-3B intradermally at month 0 and undiluted TBC-3B at month 2. Group E will receive diluted TBC-3B subcutaneously at month 0 and undiluted TBC-3B at month 2. At months 8 and 12 all groups will receive MN rgp 120/HIV-1 in alum intramuscularly.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 60 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
St. Louis Univ. School of Medicine AVEG
St Louis, United StatesVanderbilt Univ. Hosp. AVEG
Nashville, United StatesUW - Seattle AVEG
Seattle, United States