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.
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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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent Biological: HIV-1 Peptide Immunogen, Multivalent |
Phase 1 |
Study Type: | Interventional |
Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Prevention |
Official Title: | 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. |
Estimated Enrollment: | 36 |
After the prescreening, volunteers will be randomized into Group I or Group II. Each group will contain 16 volunteers. At least 5 volunteers in each group must be women. At month 0 all volunteers will receive multivalent HIV-1 peptide immunogen or the placebo. Group I will receive the injection in the deltoid and Group II will receive it in the anterior thigh. At months 1, 2 and 8 all patients will receive microparticulate monovalent HIV-1 peptide or the placebo. Follow up will be conducted.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
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.
Exclusion Criteria
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.
United States, Alabama | |
Univ of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, New York | |
Univ of Rochester Med Ctr | |
Rochester, New York, United States, 14642 | |
United States, Washington | |
Univ of Washington / Pacific Med Ctr | |
Seattle, Washington, United States, 98144 |
Study Chair: | Mulligan M |
No publications provided
ClinicalTrials.gov Identifier: | NCT00000846 History of Changes |
Other Study ID Numbers: | AVEG 023 |
Study First Received: | November 2, 1999 |
Last Updated: | June 23, 2005 |
Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Vaccines, Synthetic HIV-1 AIDS Vaccines HIV Seronegativity HIV Preventive Vaccine |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on March 14, 2013