A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects
Completed · Phase 1
Conditions studied: HIV Infections
In brief
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.
Key facts
- Study ID
- NCT00002428
- Run by
- United Biomedical
- Last updated by the study team
- 2005-06-24
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Univ of California at San Francisco Gen Hosp — San Francisco, California, United States
Full record on ClinicalTrials.gov
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