Safety, Immunogenicity, and Impact of MVA85A, on the Immunogenicity of the EPI Vaccines - Full Text View

Sponsors and Collaborators:	University of Oxford Medical Research Council
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00480454

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 I

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
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.

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 ]

Estimated Enrollment:	471
Study Start Date:	October 2006
Estimated Study Completion Date:	July 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Stage 1 would require 12 per group low dose and 12 per group high dose (total 72)	Biological: MVA 85A intradermal vaccine
2: Active Comparator Stage 2 would require 48 per group (total 144)	Biological: MVA 85A intradermal vaccine
3: Active Comparator Stage 3 would require 85 per group (total will depend on the number of groups needed. If two groups 170, if three 255)	Biological: MVA 85A intradermal vaccine

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

Contacts

Contact: Helen McShane	01865 857417	helen.mcshane@ndm.ox.ac.uk
Contact: Ian Poulton	01865 857401	ian.poulton@ndm.ox.ac.uk

Locations

Gambia
MRC	Recruiting
Banjul, Gambia
Principal Investigator: Martin Ota

Sponsors and Collaborators

University of Oxford

Medical Research Council

Investigators

Principal Investigator:

Helen McShane

University of Oxford

More Information

Publications:

McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. Epub 2004 Oct 24. Erratum in: Nat Med. 2004 Dec;10(12):1397.

Goonetilleke NP, McShane H, Hannan CM, Anderson RJ, Brookes RH, Hill AV. Enhanced immunogenicity and protective efficacy against Mycobacterium tuberculosis of bacille Calmette-Guerin vaccine using mucosal administration and boosting with a recombinant modified vaccinia virus Ankara. J Immunol. 2003 Aug 1;171(3):1602-9.

Bejon P, Peshu N, Gilbert SC, Lowe BS, Molyneux CS, Forsdyke J, Lang T, Hill AV, Marsh K. Safety profile of the viral vectors of attenuated fowlpox strain FP9 and modified vaccinia virus Ankara recombinant for either of 2 preerythrocytic malaria antigens, ME-TRAP or the circumsporozoite protein, in children and adults in Kenya. Clin Infect Dis. 2006 Apr 15;42(8):1102-10. Epub 2006 Mar 14.

Huygen K, Content J, Denis O, Montgomery DL, Yawman AM, Deck RR, DeWitt CM, Orme IM, Baldwin S, D'Souza C, Drowart A, Lozes E, Vandenbussche P, Van Vooren JP, Liu MA, Ulmer JB. Immunogenicity and protective efficacy of a tuberculosis DNA vaccine. Nat Med. 1996 Aug;2(8):893-8.

Responsible Party:	University of Oxford ( Dr Helen McShane )
Study ID Numbers:	TB012
Study First Received:	May 30, 2007
Last Updated:	April 2, 2008
ClinicalTrials.gov Identifier:	NCT00480454 History of Changes
Health Authority:	United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:

TB
Tuberculosis
Infants
EPI

Study placed in the following topic categories:

Tuberculosis
Healthy

ClinicalTrials.gov processed this record on May 07, 2009