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)

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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 patients previously enrolled on VEU 009). ORIGINAL DESIGN: To evaluate the clinical and immunologic safety of MN rgp120/HIV-1 vaccine (MN rgp120 vaccine) given alone or concurrently with the IIIB rgp120/HIV-1 vaccine (IIIB rgp120 vaccine) in healthy HIV-1 seronegative adult subjects. To compare the immune response to MN rgp120 vaccine given at 100, 300, or 600 mcg. To determine the immune response to 300 mcg MN rgp120 vaccine and 300 mcg IIIB rgp120 vaccine given concurrently. 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 two vaccines are derived from distinct HIV-1 strains, they may elicit some immunologic responses that differ. Unlike IIIB rgp120 vaccine, the MN rgp120 vaccine has not yet been evaluated in humans, although it is expected that the MN type will result in similar safety and immunogenicity as the IIIB type.

Key facts

Study ID

NCT00001021

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

57

Last updated by the study team

2005-06-24

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• St Louis Univ School of Medicine — St Louis, Missouri, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Vanderbilt Univ Hosp — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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