A Study of MVA85A in Healthy Children and Infants

This study has been completed.
Sponsor:
Collaborator:
University of Cape Town
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00679159
First received: April 2, 2008
Last updated: February 8, 2010
Last verified: February 2010
  Purpose

This study is designed to evaluate the safety of the TB vaccine MVA85A in healthy children and infants in South Africa. A single vaccination with MVA85A has been shown to be safe and highly immunogenic in a wide range of subjects in previous clinical trials. In this trial,we will vaccinate 24 children with 5 x 10^7pfu of MVA85A and three groups of 36 infants with 2.5 x 10^7, 5 x 10^7 or 1 x 10^8 pfu.

Participants will be identified from the general population living in Worcester, Western Cape, South Africa


Condition Intervention Phase
Tuberculosis
Biological: MVA85A
Biological: Prevenar
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Children and Infants After BCG Vaccination at Birth

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Safety of MVA85A. Both local and systemic adverse events will be monitored, including a daily diary card for the first week. Blood will be taken at day 7 and day 28 for biochemistry and haematology. [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Immunogenicity of MVA85A [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
24 children (5 x 10^7pfu)
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis
Other Name: Modified vaccinia virus Ankara
Experimental: 2
36 infants (2.5 x 10^7pfu)
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis
Other Name: Modified vaccinia virus Ankara
Experimental: 3
36 infants (5 x 10^7 pfu)
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis
Other Name: Modified vaccinia virus Ankara
Experimental: 4
36 infants (1 x 10^8pfu)
Biological: MVA85A
Modified vaccinia virus Ankara expressing antigen 85A from M. tuberculosis
Other Name: Modified vaccinia virus Ankara
Placebo Comparator: 5
36 infants (Prevenar vaccine)
Biological: Prevenar
Streptococcus pneumoniae vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 11 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Eligible subjects will be children or infants aged 6 months - 11 years.
  • Subject's parent/guardian is willing and able to give written informed consent for participation in the study.
  • Subject is BCG vaccinated within the first 4 weeks of life
  • In addition, informed assent will be obtained from all children aged 7 years or older unless they are adjudged incapable of understanding the basic concepts covered in the informed assent form, and an attempt will be made to obtain informed assent from children aged younger than 7 years if they are judged capable of understanding the basic concepts covered in the informed assent form
  • Subject is in good health
  • Subject has clinically acceptable laboratory results from screening visit
  • CXR normal with no evidence of active or past TB
  • Subject's parent/legal guardian is willing to allow child to undergo an HIV test
  • Parent/guardian and subject able (in the Investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

  • Subject is Mantoux (>10 mm) and/or ELISPOT (> 50 spots/million PBMC) positive for M tb (PPD, ESAT 6 and/or CFP10)
  • Subject is HIV antibody positive
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patient/subject at risk because of participation in the study, or may influence the result of the study, or the patient/subject's ability to participate in the study.
  • Patient/subjects/healthy volunteers who have participated in another research study involving an investigational product in the past 12 weeks
  • Patient/subjects previously enrolled into this study.
  • Received a live vaccine (e.g. measles) in the previous 4 weeks or due to receive a live vaccine in the 4 weeks following enrolment
  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: NCT00679159

Locations
South Africa
University Cape Town
Worcester, Western Cape, South Africa
Sponsors and Collaborators
University of Oxford
University of Cape Town
Investigators
Principal Investigator: Helen McShane University of Oxford
Principal Investigator: Gregory Hussey University of Cape Town
  More Information

No publications provided by University of Oxford

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Helen McShane, University of Oxford
ClinicalTrials.gov Identifier: NCT00679159     History of Changes
Other Study ID Numbers: TB014, MCC: 20070156
Study First Received: April 2, 2008
Last Updated: February 8, 2010
Health Authority: South Africa: Medicines Control Council

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on October 19, 2014