A Phase I Trial To Evaluate the Safety and Immunogenicity of the UBI HIV-1MN PND Peptide Immunogen, Given by IM Injection, in Combination With the UBI Microparticulate Monovalent HIV-1 MN Branched Peptide Given Orally, in HIV-1 Uninfected Volunteers.

Completed · Phase 1

Conditions studied: HIV Infections

In brief

To evaluate safety and immunogenicity of 2 different HIV-1 peptide candidate vaccines, the UBI HIV-1 MN PND peptide immunogen and the UBI microparticulate monovalent HIV-1 MN branched peptide when administered sequentially by 2 different routes of immunization, parental priming followed by oral boosting.

Key facts

Study ID

NCT00000846

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

36

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 or be:
• Healthy.
• Negative ELISA for HIV.
• Negative for Hepatitis B surface antigen.
• Normal urine dipstick.
• Normal history and physical exam.
• Availability for follow-up for planned duration of the study (60 weeks).
• Risk Behavior: Required:
• Lower or intermediate risk sexual behavior as defined by AVEG.

You may not qualify if…

• Co-existing Condition:
• Patients with any of the following symptoms or conditions are excluded:
• Medical or psychiatric condition or occupational responsibilities which preclude subject compliance with the protocol.
• Active syphilis. NOTE: If the serology is documented to be a false positive or due to a remote (> 6 months) treated infection, the volunteer is eligible.
• Active tuberculosis. NOTE: Volunteers with a positive PPD and a normal chest X-ray showing no evidence of TB and not requiring INH therapy are eligible.
• Patients with any of the following prior conditions are excluded:
• History of immunodeficiency, chronic illness, malignancy or autoimmune disease.
• History of anaphylaxis or other serious adverse reactions to vaccines.
• History of inflammatory gastrointestinal disease, celiac disease or intestinal malignancy.
• History of acute gastroenteritis within the past month or gastrointestinal surgery within the past 12 months.
• Prior Medication:
• Excluded:
• History of use of immunosuppressive medication.
• 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.
• Use of experimental agents within 30 days prior to study.
• Receipt of blood products or immunoglobulin in the past 6 months.
• Prior receipt of HIV vaccines or a placebo recipient in an HIV vaccine trial.
• Risk Behavior:
• Excluded:
• Subjects with identifiable higher risk behavior for HIV infection as determined by screening questionnaire designed to identify risk factors for HIV infection.
• History of injection drug use within the last 12 months to enrollment.
• Higher risk sexual behavior as defined by AVEG.

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Univ of Washington / Pacific Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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