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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 Uganda Research Unit on Aids
Information provided by (Responsible Party):
University of Oxford

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.


Condition or disease Intervention/treatment Phase
Tuberculosis Biological: MVA85A Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2014
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
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.
Biological: MVA85A
Single dose of 1x10^8pfu MVA85A intramuscular vaccination
Other Names:
  • Modified Vaccinia Ankara 85A
  • AERAS-485

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.
Biological: MVA85A
Single dose of 1x10^8pfu MVA85A intramuscular vaccination
Other Names:
  • Modified Vaccinia Ankara 85A
  • AERAS-485




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02178748


Locations
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Uganda
MRC/UVRI Uganda Research Unit on AIDS
Entebbe, Uganda
Sponsors and Collaborators
University of Oxford
MRC/UVRI Uganda Research Unit on Aids
Investigators
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Study Director: Helen McShane University of Oxford
Principal Investigator: Alison Elliot MRC/UVRI Uganda Research Unit on Aids
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02178748    
Other Study ID Numbers: TB036
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: January 30, 2015
Last Verified: January 2015
Keywords provided by University of Oxford:
Tuberculosis
Phase II
MVA85A
Schistosoma mansoni
Additional relevant MeSH terms:
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Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections