Status:
COMPLETED
A Phase I Safety and Immunogenicity Study of HIV p17/p24:Ty-VLP in HIV-1 Seronegative Subjects
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
HIV Infections
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
To evaluate the safety and immunogenicity of HIV p17/p24:Ty-VLP (virus-like particles) vaccine in uninfected volunteers. Specifically, to determine whether the vaccine formulated with and without alum...
Detailed Description
Induction of CD8+ CTL activity is considered a critical property for a candidate vaccine. Additionally, since the majority of HIV-1 infections occur after inoculation of a mucosal surface, it is desir...
Eligibility Criteria
Inclusion Criteria
Concurrent Medication: Required:
- Omeprazole given concurrently in patients receiving the oral vaccine dose.
Volunteers must have:
- HIV-1 negativity.
- Normal history and physical exam.
- Lower risk for HIV infection.
- CD4 count >= 400 cells/mm3.
- Normal urine dipstick with esterase and nitrite.
NOTE:
- No more than 10 percent of volunteers may be over age 50.
Exclusion Criteria
Co-existing Condition:
Volunteers with the following conditions are excluded:
- Positive for hepatitis B surface antigen.
- Medical or psychiatric condition (including recent suicidal ideation or present psychosis) that precludes compliance.
- Occupational responsibilities that preclude compliance.
- Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (> 6 months) infection, subject is eligible).
- Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible).
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, malignancy, autoimmune disease, or use of immunosuppressive medications.
- History of cancer unless surgically excised with reasonable assurance of cure.
- History of suicide attempts or past psychosis.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of serious allergic reaction requiring hospitalization or emergent medical care.
Prior Medication:
Excluded:
- Prior HIV-1 vaccines or placebo in an HIV vaccine trial.
- Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations.
- Experimental agents within the past 30 days.
Prior Treatment: Excluded:
- Blood products or immunoglobulin within the past 6 months.
Higher risk behavior for HIV infection as determined by screening questionnaire, including:
- History of injection drug use within the past year.
- Higher or intermediate risk sexual behavior.
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 1996
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00001053
End Date
March 1 1996
Last Update
November 4 2021
Active Locations (1)
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1
Univ. of Rochester AVEG
Rochester, New York, United States, 14642