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Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route

Primary Purpose

Tuberculosis

Status

Completed

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

MVA 85A

About this trial

This is an interventional prevention trial for Tuberculosis focused on measuring Vaccine, MVA 85A

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy adult aged 18 - 55 years (both male and female)
Resident in or near Oxford for the duration of the study period
Confirmation of prior vaccination with BCG not less than 3 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation)
Normal medical history and physical examination
Willingness to allow the Investigators to discuss the individual's medical history with their GP
Willingness to use continuous effective barrier contraception for three months after receiving the vaccination (males and females)
Willingness to use effective contraception for the duration of the study period (females only)
Agreement to refrain from blood donation during the course of the study
Give written informed consent
Agreement to allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials
Able and willing (in the Investigator's opinion) to comply with all the study requirements

Exclusion Criteria:

Clinical, radiological, or laboratory evidence of current active TB infection
Laboratory evidence at screening of latent TB infection as indicated by a positive ELISPOT test (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola
Previous vaccination with candidate vaccine MVA85A or another recombinant MVA vaccine
Clinically significant history of skin disorder, allergy, immunodeficiency (including human immunodeficiency virus [HIV]), cancer (except basal cell carcinoma [BCC] or carcinoma in situ [CIS]), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse
History of serious psychiatric condition
Concurrent oral or systemic steroid medication or the use of other immunosuppressive agents
History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine
Any clinically significant abnormality of screening blood or urine tests
Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV antibodies
Female currently lactating, confirmed pregnancy or intention to become pregnant during study period
Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study period
Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date
Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk or may influence the result of the study or may affect the volunteer's ability to participate in the study

Sites / Locations

Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A

Group B

Arm Description

Intramuscular immunisation

Intradermal immunisation

Outcomes

Primary Outcome Measures

Safety

Safety data in both groups, as assessed by the frequency, incidence, and nature of adverse events (AEs) and serious adverse events (SAEs) during the study. Safety is measured throughout the 6 months follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84 and 168 and. Blood for safety testing is taken at Days 7 and 28.

Secondary Outcome Measures

Immunogenicity

Immunogenicity data in both groups. This will be obtained from exploratory immunological laboratory investigations on blood samples taken at screening, and throughout follow up. Immunogenicity is measured throughout the 6 months follow up period, but specifically on the following days: 2, 7, 14, 28, 56, 84 and 168.

Full Information

NCT ID

NCT01181856

First Posted

August 11, 2010

Last Updated

March 25, 2011

Sponsor

University of Oxford

1. Study Identification

Unique Protocol Identification Number

NCT01181856

Brief Title

Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route

Official Title

Safety and Immunogenicity of Candidate Tuberculosis (TB) Vaccine MVA85A Administered by the Intramuscular Route and the Intradermal Route: a Phase I Randomised Active Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

March 2011

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University of Oxford

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This is a phase I study that will compare the safety and immunogenicity of candidate tuberculosis (TB) vaccine MVA85A administered by the intramuscular route and the intradermal route in healthy adult individuals who have been previously vaccinated with Bacillus Calmette-Guerin (BCG).

Detailed Description

We postulate that the intramuscular route is not inferior to the intradermal route of administration of MVA85A in BCG vaccinated adults when evaluated for safety and immunogenicity. If MVA85A can be given safely by intramuscular route and it is at least equally immunogenic and efficacious in a prime-boost strategy, then it would probably be the preferred route in subsequent phase II and III trials. There are several reasons for this: Reduced pain associated with injection. Reduced local reaction at the injection site. More straightforward procedure; less technically demanding; less time consuming. Easier production and storage of vaccine. Larger volume of vaccine can be given. Trials of MVA85A to date have established 1 x 10^8 pfu as the optimal dose for intradermal injection in adults. We therefore intend to administer this same dose intramuscularly in order to directly compare the two routes for both safety and immunogenicity. These results will guide future trials in which the intramuscular route, if safe, could be further evaluated at either higher or lower dose depending on immunogenicity at 1 x 10^8 pfu dosage.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tuberculosis

Keywords

Vaccine, MVA 85A

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Intramuscular immunisation

Arm Title

Group B

Arm Type

Experimental

Arm Description

Intradermal immunisation

Intervention Type

Biological

Intervention Name(s)

MVA 85A

Intervention Description

Single injection of 1 x 108 pfu MVA85A

Primary Outcome Measure Information:

Title

Safety

Description

Time Frame

6 months following vaccination

Secondary Outcome Measure Information:

Title

Immunogenicity

Description

Time Frame

6 months following vaccination

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy adult aged 18 - 55 years (both male and female) Resident in or near Oxford for the duration of the study period Confirmation of prior vaccination with BCG not less than 3 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation) Normal medical history and physical examination Willingness to allow the Investigators to discuss the individual's medical history with their GP Willingness to use continuous effective barrier contraception for three months after receiving the vaccination (males and females) Willingness to use effective contraception for the duration of the study period (females only) Agreement to refrain from blood donation during the course of the study Give written informed consent Agreement to allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials Able and willing (in the Investigator's opinion) to comply with all the study requirements Exclusion Criteria: Clinical, radiological, or laboratory evidence of current active TB infection Laboratory evidence at screening of latent TB infection as indicated by a positive ELISPOT test (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide poola Previous vaccination with candidate vaccine MVA85A or another recombinant MVA vaccine Clinically significant history of skin disorder, allergy, immunodeficiency (including human immunodeficiency virus [HIV]), cancer (except basal cell carcinoma [BCC] or carcinoma in situ [CIS]), cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse History of serious psychiatric condition Concurrent oral or systemic steroid medication or the use of other immunosuppressive agents History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine Any clinically significant abnormality of screening blood or urine tests Positive hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) or HIV antibodies Female currently lactating, confirmed pregnancy or intention to become pregnant during study period Use of an investigational medicinal product or non-registered drug, live vaccine, or medical device other than the study vaccine for 30 days prior to dosing with the study vaccine, or planned use during the study period Administration of immunoglobulins and/or any blood products within the three months preceding the planned trial vaccination date Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the volunteer at risk or may influence the result of the study or may affect the volunteer's ability to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Helen McShane

Organizational Affiliation

University of Oxford

Official's Role

Principal Investigator

Facility Information:

Facility Name

Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital

City

Oxford

ZIP/Postal Code

OX3 7LJ

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

23266342

Citation

Meyer J, Harris SA, Satti I, Poulton ID, Poyntz HC, Tanner R, Rowland R, Griffiths KL, Fletcher HA, McShane H. Comparing the safety and immunogenicity of a candidate TB vaccine MVA85A administered by intramuscular and intradermal delivery. Vaccine. 2013 Feb 4;31(7):1026-33. doi: 10.1016/j.vaccine.2012.12.042. Epub 2012 Dec 21.

Results Reference

derived

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Safety of Tuberculosis Vaccine, MVA85A, Administered by the Intramuscular Route and the Intradermal Route

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