Status:
COMPLETED
A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults
Lead Sponsor:
Crucell Holland BV
Collaborating Sponsors:
US Military HIV Research Program
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.
Detailed Description
This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 23 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2015
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT02218125
Start Date
September 23 2014
End Date
November 30 2015
Last Update
November 27 2018
Active Locations (1)
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1
Boston, Massachusetts, United States