Safety of an Oral HIV Vaccine in HIV Uninfected Volunteers
Status unconfirmed · Phase 1
Conditions studied: HIV Infections
In brief
This study will test the safety of and immune response to an oral HIV vaccine in healthy volunteers. The vaccine in this study uses a weakened bacterium called Salmonella typhi to deliver an HIV gene into the body through the mouth. The body then produces an HIV protein from the gene; this protein stimulates an anti-HIV immune response. The vaccine contains only one of the many substances that HIV needs to make more copies of itself, so the vaccine itself cannot cause HIV or AIDS.
Key facts
- Study ID
- NCT00062530
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 38
- Last updated by the study team
- 2008-09-26
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- HIV uninfected
- Low risk sexual behavior
- Negative for Hepatitis B surface antigen
- Negative for Hepatitis C viral sequences and antibody
- Availability for follow-up for planned duration of the study (12 months)
- Acceptable methods of contraception
You may not qualify if…
- Receipt of HIV vaccines or placebo in a previous HIV vaccine trial
- History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications
- History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure
- Medical or psychiatric condition or occupational responsibilities which preclude compliance with the protocol
- History of suicide attempts, recent suicidal ideation, or psychosis
- High risk behavior for HIV infection as determined by screening questionnaire
- History of injection drug use within 12 months of study entry
- Live attenuated vaccines within 60 days of study entry. Medically indicated killed or subunit 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 of study entry
- Receipt of blood products or immunoglobulin within 6 months of study entry
- Active syphilis
- Active tuberculosis
- History of anaphylaxis or serious adverse reactions to vaccines
- History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension)
- Pregnant or breastfeeding
Where it is running
- Institute of Human Virology — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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