NCT00376090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Timeline
Completed

Started Jul 2005

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

3.4 years

First QC Date

September 13, 2006

Last Update Submit

October 13, 2017

Conditions

HIV Infections

Keywords

MVA vectorImmunogenicityHIV vaccineHIV preventative vaccine

Outcome Measures

Primary Outcomes (1)

  • Safety and Tolerability

    Evaluate the safety and tolerability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) administered by IM or ID injection to HIV uninfected adults

    Study Day 0 through 8 months post-vaccination

Secondary Outcomes (1)

  • Immunogenicity

    Study Day 0 through Study Day 280

Study Arms (8)

Group I Vaccine

EXPERIMENTAL
Biological: MVA-CMDR

Group I Placebo

PLACEBO COMPARATOR
Biological: Placebo

Group II Vaccine

EXPERIMENTAL
Biological: MVA-CMDR

Group II Placebo

PLACEBO COMPARATOR
Biological: Placebo

Group III Vaccine

EXPERIMENTAL
Biological: MVA-CMDR

Group III Placebo

PLACEBO COMPARATOR
Biological: Placebo

Group IV Vaccine

EXPERIMENTAL
Biological: MVA-CMDR

Group IV Placebo

PLACEBO COMPARATOR
Biological: Placebo

Interventions

MVA-CMDRBIOLOGICAL

10\^7 PFU IM, 1.0 mL

Group I Vaccine
PlaceboBIOLOGICAL

1.0 mL IM

Group I PlaceboGroup III Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • A participant must meet all of the following criteria:
  • Low risk for HIV infection
  • 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
  • Normal cardiac enzyme level at second Screening Visit
  • Urinalysis (UA) for protein and blood: negative or trace.
  • Normal liver function tests to include ALT/AST, alkaline phosphatase, GGT (\< 1.25x institutional upper limits of normal) and CPK (\< 480) and creatinine (\< 1.25 mg/dL)
  • Negative serology for HIV infection
  • Any female volunteer must have a negative serum or urine pregnancy test at the screening visit as well as immediately prior to each vaccine/placebo vaccination, as well as verbal assurance that adequate birth control measures have been followed for 60 days prior to the first vaccine/placebo vaccination and will continue to be followed for at least 3months after the final vaccine/placebo vaccination. This means using any of the following methods: Birth control drugs that prevent pregnancy given by pills, shots or placed under the skin, Male or female condoms with or without a cream or gel that kills sperm, diaphragm or cervical cap with a cream or gel that kills sperm, or Abstinence

You may not qualify if:

  • 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
  • Has history of seizure disorder, immunodeficiency, chronic illness, autoimmune disease, diabetes mellitus active malignancy or use of immunosuppressive medications.
  • Has evidence of psychiatric, medical and/or substance abuse problems during the past six months that the investigator believes would adversely affect the volunteer's ability to participate in the trial.
  • Has occupational or other responsibilities that would prevent completion of participation in the study.
  • Has received any live attenuated vaccine within 60 days of study entry.
  • Has used experimental therapeutic agents within 30 days of study entry.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

US Military HIV Research Program

Rockville, Maryland, 20850, United States

Location

Related Publications (1)

  • Currier JR, Ngauy V, de Souza MS, Ratto-Kim S, Cox JH, Polonis VR, Earl P, Moss B, Peel S, Slike B, Sriplienchan S, Thongcharoen P, Paris RM, Robb ML, Kim J, Michael NL, Marovich MA. Phase I safety and immunogenicity evaluation of MVA-CMDR, a multigenic, recombinant modified vaccinia Ankara-HIV-1 vaccine candidate. PLoS One. 2010 Nov 15;5(11):e13983. doi: 10.1371/journal.pone.0013983.

    PMID: 21085591DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Mary Marovich, MD, DTM&H

    US Military HIV Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2006

First Posted

September 14, 2006

Study Start

July 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations

US(1)