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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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