A Study of MVA85A in Healthy Children and Infants - Full Text View

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:

MedlinePlus related topics: Tuberculosis

Drug Information available for: Heptavalent pneumococcal conjugate vaccine Pneumococcal Vaccines

U.S. FDA Resources

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

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):

Scriba TJ, Tameris M, Mansoor N, Smit E, van der Merwe L, Mauff K, Hughes EJ, Moyo S, Brittain N, Lawrie A, Mulenga H, de Kock M, Gelderbloem S, Veldsman A, Hatherill M, Geldenhuys H, Hill AV, Hussey GD, Mahomed H, Hanekom WA, McShane H. Dose-finding study of the novel tuberculosis vaccine, MVA85A, in healthy BCG-vaccinated infants. J Infect Dis. 2011 Jun;203(12):1832-43.

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 May 21, 2013