A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
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Purpose
To evaluate the safety and immunogenicity of a combination of microparticulate monovalent HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in intermediate or higher risk HIV-negative volunteers.
| Condition | Intervention | Phase |
|---|---|---|
|
HIV Infections |
Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent Biological: rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects |
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28, and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3 consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0, followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are followed for 1 year.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria
Volunteers must have:
- Normal history and physical exam.
- HIV negativity.
- CD4 count >= 400 cells/mm3.
- Intermediate or high risk sexual behavior or a history of injection drug use within 12 months prior to study entry.
- Normal urine dipstick with esterase and nitrite.
Exclusion Criteria
Co-existing Condition:
Volunteers with the following symptoms or conditions are excluded:
- Active tuberculosis.
- Occupational or other responsibilities that would prevent completion of study.
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
- Psychiatric, medical, or substance abuse problems within the past 6 months that would affect ability to participate in study.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of inflammatory gastrointestinal disease, celiac disease, or intestinal malignancy.
- Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
Prior Medication:
Excluded:
- Live or attenuated vaccine within the past 60 days.
- Illicit or experimental agents within the past 30 days. Intermediate or high risk sexual behavior. Injection drug use within the past 12 months.
Contacts and Locations More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00002428 History of Changes |
| Other Study ID Numbers: | 091, UBI V106 |
| Study First Received: | November 2, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by NIH AIDS Clinical Trials Information Service:
|
Vaccines, Synthetic HIV-1 HIV Envelope Protein gp120 AIDS Vaccines HIV Seronegativity |
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 May 23, 2013