Heterologous Effects of BCG in Healthy UK Adults

NCT02380508 | Completed

• 1 other identifier: TB038
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

TB038 is a clinical study to assess the non-specific effects of BCG vaccination and gain a better understanding of how the body's immune system reacts to BCG and in turn potentially prevents infection from other bacteria.

Conditions

Tuberculosis

Keywords

BCG study

Outcome Measures

Primary Outcomes (1)

• Growth inhibition assays

  Determine the heterologous effects of BCG vaccination in healthy UK adults using in-vitro Growth Inhibition Assays as a surrogate marker to assess the individuals' capacity to control growth of S. aureus, K. pneumonia, Group B streptococci and E.coli.

  Up to Day 84

Secondary Outcomes (1)

• Immune response markers

  Up to Day 84

Other Outcomes (2)

• Background levels of S. aureus, K. pneumonia, Group B streptococci and E.coli carriage.

  Up to Day 14

• Confounding effects of BCG on bacterial growth.

  Up tp Day 14

Study Arms (2)

Group 1

EXPERIMENTAL

32 BCG-naïve subjects receiving BCG SSI or BCG Sii at standard dose (2-8x10\^5 cfu) via Intradermal route.

Drug: BCG SSI; Drug: BCG Sii

Group 2

EXPERIMENTAL

8-16 control volunteers receiving no vaccination.

Other: No vaccination

Interventions

BCG SSI DRUG

Intradermal injection

Also known as: Bacille Calmette-Guérin Statens Serum Institute (BCG SSI)

Group 1

No vaccination OTHER

Group 2

BCG Sii DRUG

intradermal injection

Also known as: Bacille Calmette-Guérin Serum Institute of India

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Volunteers must meet all of the following criteria to enter the study:
• Healthy adult aged 18-45 years
• BCG naïve
• Resident in or near Oxford (for CCTVM and John Warin Ward) or Birmingham (for NIHR WTCRF) for the duration of the study period
• No relevant findings in medical history or on physical examination
• Allow the Investigators to discuss the volunteer's medical history with their GP
• Use effective contraception for the duration of the study period (females only)
• Agreement to refrain from blood donation during the duration of the study and for a period of 3 months after their last visit
• Give written informed consent
• Allow the Investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials or studies
• Able and willing (in the Investigator's opinion) to comply with all the study requirements

You may not qualify if:

• Volunteers must meet none of the following criteria to enter the study:
• Laboratory evidence at screening of latent M. tb infection as indicated by a positive IGRA response
• Clinical, radiological, or laboratory evidence of current active TB disease
• Previous vaccination with BCG, or any candidate TB vaccine
• Within the last year had close household contact with an individual with smear positive pulmonary tuberculosis
• Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or 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 concurrent use of other immunosuppressive agents
• Concurrent use of long term antibiotic therapy
• History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the BCG vaccine
• Any abnormality of screening blood or urine tests that is deemed to be clinically significant or that may compromise the safety of the volunteer in the study
• Positive HBsAg, HCV or HIV antibodies
• Female confirmed pregnant or intention to become pregnant during study period, or currently lactating
• Current involvement in another study or trial that involves regular blood tests or an investigational medicinal product
• Use of an investigational medicinal product or non-registered drug, live vaccine, or investigational medical device for four weeks prior to dosing with the study vaccine

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (3)

Centre for Clinical Vaccinology and Tropical Medicine , University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

Oxford University Hospitals- John Warin Ward, University of Oxford

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Location

NIHR Wellcome Trust Clinical Research Facility, University of Birmingham

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Related Publications (1)

• Wilkie M, Tanner R, Wright D, Lopez Ramon R, Beglov J, Riste M, Marshall JL, Harris SA, Bettencourt PJG, Hamidi A, van Diemen PM, Moss P, Satti I, Wyllie D, McShane H. Functional in-vitro evaluation of the non-specific effects of BCG vaccination in a randomised controlled clinical study. Sci Rep. 2022 May 12;12(1):7808. doi: 10.1038/s41598-022-11748-x.

  PMID: 35552463 DERIVED

Related Links

• Jenner Institute Clinical Trials

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Helen McShane

  University of Oxford

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: March 5, 2015
• Study Start: February 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-10

Locations

GB (3)