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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Page 1 of 1 (3 locations)

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