Safety of and Immune Response to a Modified Vaccinia Ankara (MVA) HIV Vaccine in HIV Uninfected Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier:
NCT00376090
First received: September 13, 2006
Last updated: September 2, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
HIV Infections
Biological: MVA-CMDR
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by U.S. Army Medical Research and Materiel Command:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Study Day 0 through 8 months post-vaccination ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Immunogenicity [ Time Frame: Study Day 0 through Study Day 280 ] [ Designated as safety issue: No ]
    Evaluate the ability of MVA-CMDR (HIV-1 CM235 Env/CM240 Gag/Pol) to induce HIV antigen specific cellular and humoral immune responses


Enrollment: 48
Study Start Date: July 2005
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group I Vaccine Biological: MVA-CMDR
10^7 PFU IM, 1.0 mL
Placebo Comparator: Group I Placebo Biological: Placebo
1.0 mL IM
Experimental: Group II Vaccine Biological: MVA-CMDR
10^6 PFU ID, 0.1 mL
Placebo Comparator: Group II Placebo Biological: Placebo
0.1 mL ID
Experimental: Group III Vaccine Biological: MVA-CMDR
10^8 PFU IM, 1.0 mL
Placebo Comparator: Group III Placebo Biological: Placebo
1.0 mL IM
Experimental: Group IV Vaccine Biological: MVA-CMDR
10^7 PFD ID, 0.1 mL
Placebo Comparator: Group IV Placebo Biological: Placebo
0.1 mL ID

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  • 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

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
  • 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.
  • Has received blood products or immunoglobulins in the past three months.
  • Has history of anaphylaxis or other serious adverse reactions to vaccines.
  • Has previously received an HIV vaccine or an MVA or vaccinia vaccine.
  • Has chronic or active Hepatitis B or Hepatitis C virus infection or active syphilis (positive RPR and FTA).
  • Has had an immediate type hypersensitivity reaction to eggs, egg products or neomycin/streptomycin (used to prepare MVA vaccine).
  • Is a study site employee.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00376090

Locations
United States, Maryland
US Military HIV Research Program
Rockville, Maryland, United States, 20850
Sponsors and Collaborators
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Mary Marovich, MD, DTM&H US Military HIV Research Program
  More Information

No publications provided by U.S. Army Medical Research and Materiel Command

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: U.S. Army Medical Research and Materiel Command
ClinicalTrials.gov Identifier: NCT00376090     History of Changes
Other Study ID Numbers: RV 158, A-12403, WRAIR 1143
Study First Received: September 13, 2006
Last Updated: September 2, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by U.S. Army Medical Research and Materiel Command:
MVA vector
Immunogenicity
HIV vaccine
HIV preventative vaccine

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 28, 2014