A Phase I Double-Blind, Randomized, Dose Escalating, Placebo-Controlled, Study of Safety and Immunogenicity of WRAIR/NIH Live Recombinant MVA-CMDR (HIV-1 CM235 Env/ CM240 Gag/Pol) Administered by Intramuscular (IM) or Intradermal (ID) Route In HIV-Uninfected Adults

U.S. Army Medical Research and Development Command1 site in 1 country48 target enrollmentJuly 2005

ConditionsHIV Infections

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HIV Infections
Sponsor: U.S. Army Medical Research and Development Command
Enrollment: 48
Locations: 1
Primary Endpoint: Safety and Tolerability
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to determine the safety and the immune responses to the HIV vaccine candidate, MVA-CMDR. This vaccine was designed to induce immune responses to three HIV "passenger" genes encoded with the viral vector, MVA.

Registry

clinicaltrials.gov

Start Date

July 2005

End Date

December 2008

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

U.S. Army Medical Research and Development Command

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•A participant must meet all of the following criteria:
•Low risk for HIV infection
•18 to 40 years at the time of enrollment and vaccinia naive
•Good health
•Availability for 12 months of participation.
•Successful completion of the Test of Understanding
•Able and willing to give informed consent.
•HEMATOCRIT: WOMEN: 35 %-45 %; MEN 36 % - 49 %
•White cell count: 3,000 - 11,000 cells/mm3
•Platelets: 125,000 - 450,000 per mm3

Exclusion Criteria

•A volunteer will be excluded if one or more of the following conditions apply.
•A woman who:
•Is pregnant.
•Is breast-feeding.
•Anyone who:
•Is U.S. military personnel.
•Acknowledges engaging in highest-risk behavior within six months of study entry
•Has active tuberculosis or other systemic infectious process by review of systems and physical examination.
•Has history of or known cardiac disease including any of the following: prior myocardial infarction (heart attack), angina pectoris, congestive heart failure, conduction disturbances, repolarization (ST segment or T wave) abnormalities, serious cardiac arrhythmias (ventricular tachycardia or ventricular fibrillation), cardiomyopathy, pericarditis, stroke or transient ischemic attack, chest pain or shortness of breath with activity (e.g. climbing stairs), valvular heart disease including mitral valve prolapse, or other heart conditions under the care of a doctor.
•Has ECG on Screening Visit 2 with clinical significant findings, or features that would interfere with the assessment of myo/pericarditis (as determined by the contract ECG Lab) including any of the following: conduction disturbance (atrioventricular or intraventricular condition, left or right bundle branch block, AB block of any degree or QTc prolongation), repolarization (ST segment or T wave) abnormality, significant atrial or ventricular arrhythmia, frequent atrial or ventricular ectopy (e.g. frequent premature atrial contractions, 2 premature ventricular contractions in a row), ST elevation consistent with ischemia, or evidence of past or evolving myocardial infarction