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Safety, Immunogenicity, and Impact of MVA85A, on the Immunogenicity of the EPI Vaccines

This study has been completed.
Sponsor:
Collaborator:
Medical Research Council
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00480454
First received: May 30, 2007
Last updated: February 8, 2010
Last verified: February 2010
History of Changes
  Purpose

This study is preliminary to proving that this vaccine could protect against tuberculosis in humans. Although there is no proven data to show that infants will benefit directly from participation in this study by being protected against TB, MVA85A protection of mice, guinea pigs and monkeys against tuberculosis is encouraging. It is hoped that the information gained from this study will contribute to the development of a safe and effective TB vaccine for HIV negative and positive individuals. Participants in this study will benefit by having information about their general health status, and the rigorous follow up visit that could enhance early detection and management of medical conditions that might arise in the course of the study.


Condition Intervention Phase
TB
 Biological: MVA 85A
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: An Open Randomized Dose Selection Study Evaluating the Safety, Immunogenicity, and Impact of a TB Vaccine, MVA85A, on the Immunogenicity of EPI Vaccines Administered Simultaneously to Healthy Infants Previously Vaccinated With BCG.

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Dose selection, safety and immunogenicity of MVA85A vaccines in 4 month old healthy Gambian infants [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Impact of MVA85A on the immunogenicity of EPI vaccines (DTwPHib, Hep B) and vice versa when administered simultaneously to children who have had BCG vaccine within the first two weeks of life. [ Time Frame: One year ] [ Designated as safety issue: No ]

Enrollment: 214
Study Start Date: October 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Stage 1 would require 12 per group low dose and 12 per group high dose (total 72)
 Biological: MVA 85A
intradermal vaccine
Other Names:
  • TB vaccine
  • modified vaccinia virus Ankara
Active Comparator: 2
Stage 2 would require 48 per group (total 144)
 Biological: MVA 85A
intradermal vaccine
Other Names:
  • TB vaccine
  • modified vaccinia virus Ankara

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   2 Months to 3 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy infants aged 2 - 3 months
  • Recorded BCG vaccination within first two weeks of life with typical BCG scar on the left arm
  • Receiving standard EPI immunizations according to national immunization programme (DTwPHib at 2/3/4 months, OPV at birth, 1, 2 and 3 months, Hep B at birth, 2 & 4 months)
  • Written informed consent by parent / guardian

Exclusion Criteria:

  • Any clinically significant abnormal finding on screening from biochemistry or haematology
  • Any AIDS defining illness
  • Prior receipt of a recombinant MVA or Fowlpox vaccine, or other experimental vaccine
  • Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 2 weeks preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within 6 months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ≥ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Presence of any underlying disease that compromises the diagnosis and evaluation of response to the vaccine
  • History of > 2 hospitalisations for invasive bacterial infections (pneumonia, meningitis)
  • Any other on-going chronic illness requiring hospital specialist supervision
  • Administration of immunoglobulins and/or any blood products within one month preceding the planned administration of the vaccine candidate
  • Any history of anaphylaxis in reaction to vaccination
  • Research Physician's assessment of lack of willingness by parents to participate and comply with all requirements of the protocol, or identification of any factor felt to significantly increase the infant's risk of suffering an adverse outcome
  • Likelihood of travel away from the study area
  • Untreated malaria infection
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480454

Locations
Gambia
MRC
Banjul, Gambia
Sponsors and Collaborators
University of Oxford
Medical Research Council
Investigators
Principal Investigator: Helen McShane University of Oxford
  More Information

Publications:

Responsible Party: Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier: NCT00480454     History of Changes
Other Study ID Numbers: TB012
Study First Received: May 30, 2007
Last Updated: February 8, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
TB
Tuberculosis
Infants
EPI

ClinicalTrials.gov processed this record on May 16, 2013