A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Completed · Phase 1
Conditions studied: HIV Infections, HIV Seronegativity
In brief
To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus (HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
Key facts
- Study ID
- NCT00002204
- Run by
- Chiron Corporation
- People needed
- 40
- 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:
- Good health as determined by medical history, physical examination, and clinical judgment.
- Negative serology for HIV infection as determined by licensed HIV ELISA test performed within 6 weeks prior to first immunization.
- In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be established (required for selected Part B volunteers only).
You may not qualify if…
- Co-existing Condition:
- Volunteers with the following symptoms or conditions are excluded:
- Significant acute systemic infection.
- Occupational or other responsibilities that would prevent completion of participation in the study.
- Any condition that might interfere with the evaluation of the study objectives.
- Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, autoimmune disease, or any serious chronic illness.
- Evidence of psychiatric or medical history or substance abuse that would adversely affect the volunteer's ability to participate in the trial.
- History of anaphylaxis or other serious adverse reactions to vaccines or vaccine components.
- Immunosuppressive medications.
- Live, attenuated vaccine within 60 days of study entry.
- NOTE:
- Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are not exclusionary but should be given at least 4 weeks before or after HIV immunizations to avoid potential confusion of adverse reactions.
- Experimental agents within 30 days of study entry.
- HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.
- Engaging in high-risk behavior within 6 months of study entry, i.e.:
- injection drug use, sexual intercourse without a condom with 4 or more partners or with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted disease.
Where it is running
- Creighton Univ Med Ctr / Ped Infect Disease Div — Omaha, Nebraska, United States
Full record on ClinicalTrials.gov
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