A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
Key facts
- Study ID
- NCT02218125
- Run by
- Crucell Holland BV
- People needed
- 25
- Starts
- 2014-09-23
- Expected to finish
- 2015-11-30
- Last updated by the study team
- 2018-11-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Healthy adults (determined by medical history, physical examination, and clinical judgment)
- HIV uninfected
- Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
- Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
You may not qualify if…
- Confirmed HIV-1/-2 infection
- Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
- Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
- A woman who is breastfeeding
- Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
- Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
Where it is running
- Study site — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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