Status:

COMPLETED

A Phase I Multicenter Study of the Safety and Immunogenicity of MN rgp120/HIV-1 Vaccine Given Either Alone or in Combination With IIIB rgp120/HIV-1 Vaccine in Healthy Adult Subjects (NOTE: Original Study Extended ONLY for Patients Previously Enrolled on VEU 009)

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Genentech, Inc.

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

Brief Summary

AMENDED 10/1/93: To evaluate the influence of prior immunization with an rgp120 vaccine on immune response to a subsequent immunization with a different strain of rgp120 (VEU 009X extension - in patie...

Detailed Description

Recent studies suggest that immunity to the HIV-1 rgp120 protein may prevent primary infection. MN rgp120 vaccine and IIIB rgp120 vaccine are both prepared by recombinant DNA technology. Because the t...

Eligibility Criteria

Inclusion Criteria

Patients must have:

  • Documented HIV seronegativity.
  • Negative HIV-1 culture.
  • Normal history and physical exam.
  • No high-risk behavior for HIV infection.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

  • Clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease.
  • Serologic evidence of current Hepatitis B or C infection.
  • Positive PPD (unless subject has a clear chest x-ray with no suggestion of active or old pulmonary tuberculosis and is not eligible for tuberculosis prophylaxis.
  • Positive HBsAb (unless positive result is caused by hepatitis vaccination OR infection occurred more than 2 years ago and subjects are HBsAg, HBeAg, and HBcAb negative with no elevation of liver enzymes within the past 2 years).
  • Positive VDRL.
  • Febrile illness within 1 week prior to study entry.

Concurrent Medication:

Excluded:

  • Concomitant corticosteroids or other known immunosuppressive drugs.
  • Any experimental agent.
  • Any anti-tuberculosis medication (e.g., isoniazid).

Patients with the following prior conditions are excluded:

  • History of clinically significant cardiac, pulmonary, neoplastic, hepatic, renal, neurologic, or autoimmune disease.
  • Recent (within past 2 years) evidence of Hepatitis B infection.
  • Past serologic evidence of Hepatitis C infection.
  • Prior history of receiving HIV vaccine.

Prior Medication:

Excluded:

  • Other immunization within 4 weeks prior to study entry.

Identifiable high-risk behavior for HIV infection.

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

57 Patients enrolled

Trial Details

Trial ID

NCT00001021

Last Update

June 24 2005

Active Locations (3)

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Page 1 of 1 (3 locations)

1

St Louis Univ School of Medicine

St Louis, Missouri, United States, 63104

2

Univ of Rochester Med Ctr

Rochester, New York, United States, 14642

3

Vanderbilt Univ Hosp

Nashville, Tennessee, United States, 37232