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)

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

Keywords

ClinConnect Summary

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 region plays in generating anti-HIV sequences, it is hypothesized that the test immunogen (C4-V3 peptides) will be capable of inducing a broad range of cross-reactive neutralizing antibodies in the majority of recipients.

Twenty-eight volunteers are randomized to receive two 0.5 ml injections of C4-43 peptides in IFA or placebo (IFA alone) administered intramuscularly at 0, 1, 6, and 12 months. At ...

Gender

ALL

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).