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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480454
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : February 9, 2010
Medical Research Council
Information provided by:
University of Oxford

Brief Summary:
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 or disease Intervention/treatment Phase
TB Biological: MVA 85A Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 214 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : October 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Dose selection, safety and immunogenicity of MVA85A vaccines in 4 month old healthy Gambian infants [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   2 Months to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480454

Banjul, Gambia
Sponsors and Collaborators
University of Oxford
Medical Research Council
Principal Investigator: Helen McShane University of Oxford

Responsible Party: Dr Helen McShane, University of Oxford Identifier: NCT00480454     History of Changes
Other Study ID Numbers: TB012
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: February 9, 2010
Last Verified: February 2010

Keywords provided by University of Oxford:

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs