Status:
COMPLETED
A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA)
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To evaluate the safety of HIV-1 gp120 C4-V3 hybrid polyvalent peptide immunogen (C4-V3 peptides) formulated in mineral oil containing mannose mono-oleate (IFA) in HIV-1 uninfected volunteers. To evalu...
Detailed Description
The test immunogen (C4-V3 peptides) is constructed from 4 sequences of the HIV-1 V3 gp120 loop shared by approximately 80% of North American HIV-1 strains. Because of the critical role that this regio...
Eligibility Criteria
Inclusion Criteria
Volunteers must have:
- Negative ELISA for HIV within 8 weeks of immunization.
- Normal history and physical examination.
- Normal chest x-ray within 4 weeks prior to initial immunization.
- Low-risk sexual behavior as defined by AVEG.
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions are excluded:
- Medical or psychiatric condition that precludes compliance with the protocol, including recent suicidal ideation or present psychosis.
- Occupational responsibilities which preclude compliance with the protocol.
- Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible).
- Active tuberculosis (volunteers with a positive purified protein derivative and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible).
- Positivity for hepatitis B surface antigen.
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, or autoimmune disease. NOTE: Individuals with a history of cancer are excluded unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
- History of suicide attempts or past psychosis.
- 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).
- History of lung disease.
Prior Medication:
Excluded:
- Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
- Experimental agents within 30 days prior to study.
- HIV-1 vaccines or placebo, received in a previous HIV vaccine trial.
- Immunosuppressive medications.
Prior Treatment:
Excluded:
- Receipt of blood products or immunoglobulin in the past 6 months.
Risk Behavior: Excluded:
- Alcohol intake greater than or equal to the equivalent of 1 oz of 100 proof per day (4 oz. glass of wine or 12 oz. of beer per day).
- Identifiable higher-risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection; specific exclusions include a history of injection drug use within the last 12 months prior to enrollment and higher- or immediate-risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Groups C and D).
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 1999
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00000886
End Date
April 1 1999
Last Update
October 29 2021
Active Locations (3)
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1
Univ. of Rochester AVEG
Rochester, New York, United States
2
Vanderbilt Univ. Hosp. AVEG
Nashville, Tennessee, United States, 37232
3
UW - Seattle AVEG
Seattle, Washington, United States, 98144