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Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents (TB036)

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ClinicalTrials.gov Identifier: NCT02178748
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : January 30, 2015
Sponsor:
Collaborator:
MRC/UVRI and LSHTM Uganda Research Unit
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date  ICMJE June 3, 2014
First Posted Date  ICMJE July 1, 2014
Last Update Posted Date January 30, 2015
Study Start Date  ICMJE June 2014
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2014)
T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. [ Time Frame: 8 weeks ]
To compare T cell immunogenicity in adolescents with and without S. mansoni infection.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2014)
Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response. [ Time Frame: 8 weeks ]
Effects of S. mansoni infection on other aspects of the immune response following MVA85A immunisation.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 27, 2014)
Actively and passively collected data on adverse events. [ Time Frame: 8 weeks ]
To assess the safety of MVA85A vaccination in BCG-vaccinated African adolescents aged 12-17 years.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents
Official Title  ICMJE A Phase II Open Label Trial to Investigate the Effect of Schistosoma Mansoni (Sm) Infection on the Immunogenicity of a Candidate TB Vaccine, MVA85A, in BCG-vaccinated African Adolescents
Brief Summary

Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority.

Over a billion people worldwide are infected with one or more helminths. Helminths are parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that helminth infection may affect a person's response to a vaccine. In this trial the investigators hope to investigate whether Schistosoma mansoni infection affects adolescents' responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group for an effective TB vaccine.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Tuberculosis
Intervention  ICMJE Biological: MVA85A
Single dose of 1x10^8pfu MVA85A intramuscular vaccination
Other Names:
  • Modified Vaccinia Ankara 85A
  • AERAS-485
Study Arms  ICMJE
  • Experimental: Group 1
    Group 1 (Schistosoma mansoni uninfected): 12-24 BCG-vaccinated volunteers with no helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0.
    Intervention: Biological: MVA85A
  • Experimental: Group 2
    Group 2 (Schistosoma mansoni infected): 12-24 BCG-vaccinated volunteers with helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0.
    Intervention: Biological: MVA85A
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 29, 2015)
36
Original Estimated Enrollment  ICMJE
 (submitted: June 27, 2014)
90
Actual Study Completion Date  ICMJE January 2015
Actual Primary Completion Date January 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria

Participants must meet all of the following criteria to enter the trial:

  • Healthy adolescents aged 12-17 years (both male and female)
  • Resident in the study area for the duration of the study period
  • Confirmation of prior vaccination with BCG not less than 6 months prior to projected study vaccination date (by visible BCG scar on examination or written documentation)
  • No relevant findings in medical history or on physical examination
  • Written informed consent by parent or guardian
  • Written informed assent by subject
  • Refrain from blood donation during the trial
  • Agree to avoid pregnancy for the duration of the trial (female only)
  • Able and willing (in the Investigator's opinion) to comply with all the study requirements
  • Stool sample negative for S. mansoni (group 1) or positive for S. mansoni infection (group 2), based on the results of the Kato Katz stool analysis
  • Willing to delay treatment for schistosomiasis for at least one month (group 2)

Exclusion Criteria

Participants may not enter the trial if ANY of the following apply:

  • Clinical, radiological, or laboratory evidence of current active TB disease
  • Laboratory evidence at screening of latent M. tb infection as indicated by a positive ELISPOT response to ESAT6 or CFP10 antigens
  • Previous treatment for active or latent tuberculosis infection
  • Shared a residence within one year prior to day 0 with an individual on anti-tuberculosis treatment or with culture or smear-positive pulmonary tuberculosis
  • Received a TST within 90 days prior to day 0
  • Clinically significant history of skin disorder, allergy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness, drug or alcohol abuse
  • History of serious psychiatric condition or disorder
  • Concurrent oral or systemic steroid medication or the concurrent use of other immunosuppressive agents within 2 months prior to enrolment
  • History of anaphylaxis to vaccination or any allergy likely to be exacerbated by any component of the study vaccine, including eggs
  • 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
  • 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
  • Female currently lactating, confirmed pregnancy or intention to become pregnant during the trial period
  • Screening blood sample positive for malaria or Mansonella perstans by microscopy
  • Schistosoma mansoni infection intensity greater than 2000 eggs per gram of stool
  • Any of the three screening stool samples positive for any helminths on Kato Katz examinations or for S. mansoni or Strongyloides stercoralis by PCR (group 1); or any of the three screening stool samples positive for helminths other than S. mansoni on Kato Katz examinations or for Strongyloides stercoralis by PCR (group 2)
  • Screening urine sample positive for S. mansoni infection (group 1)
  • Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may either put the subject at risk or may influence the result of the trial or may affect the subject's ability to participate in the trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Uganda
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02178748
Other Study ID Numbers  ICMJE TB036
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Oxford
Study Sponsor  ICMJE University of Oxford
Collaborators  ICMJE MRC/UVRI and LSHTM Uganda Research Unit
Investigators  ICMJE
Study Director: Helen McShane University of Oxford
Principal Investigator: Alison Elliot MRC/UVRI and LSHTM Uganda Research Unit
PRS Account University of Oxford
Verification Date January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP