At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 581 enrolled
Drug / intervention
IMVAMUNE (MVA-BN)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Open-label, Controlled Phase II Study to Evaluate Safety and Immunogenicity of MVA-BN® (IMVAMUNE) Smallpox Vaccine in 18-55 Year Old Naive and Previously Vaccinated HIV Infected Subjects With CD4 Counts >200 - 750/µl.
In Brief
A Phase 2 clinical trial evaluating IMVAMUNE (MVA-BN) for HIV Infections. Completed, enrolled 581 participants across 36 sites in 2 countries.
Detailed Summary
The purpose of this study is to gather information on the safety and immunogenicity of an investigational smallpox vaccine in HIV infected populations. Subjects will receive two vaccinations
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHIV Infections
CountriesPuerto Rico, United States
CollaboratorsNational Institutes of Health (NIH)
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 2006
Enrollment StartJun 2006
Primary CompletionMar 2009
Study CompletionOct 2009
TodayJul 2026
First PostedApr 21, 2006
Enrollment StartJun 1, 2006
Primary CompletionMar 1, 2009
Study CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 20.2 years ago
Interventions
IMVAMUNE (MVA-BN)biological
2 immunizations, four weeks apart: 1 x 10E8 TCID50, subcutaneous