Status:
COMPLETED
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers. One approach to improve the immunogenicity of an HIV-1...
Detailed Description
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 wit...
Eligibility Criteria
Inclusion Criteria
Volunteers must have:
- Normal history and physical exam.
- HIV negativity.
- Absolute CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
- Lower risk sexual behavior.
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.
- 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.
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.
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-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:
- Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations.
- Experimental agents within 30 days prior to study entry.
- Prior HIV vaccines.
Prior Treatment:
Excluded:
- Blood products or immunoglobulin within the past 6 months.
Identifiable high-risk behavior for HIV infection, including:
- History of injection drug use within past 12 months.
- Higher risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 1998
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00000832
End Date
January 1 1998
Last Update
November 4 2021
Active Locations (4)
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1
UAB AVEG
Birmingham, Alabama, United States, 35294
2
St. Louis Univ. School of Medicine AVEG
St Louis, Missouri, United States, 63104
3
Univ. of Rochester AVEG
Rochester, New York, United States, 14642
4
JHU AVEG
Pittsburgh, Pennsylvania, United States