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

January 29, 2015 updated by: University of Oxford

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
      • Entebbe, Uganda
        • MRC/UVRI Uganda Research Unit on AIDS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • AERAS-485
  • Modified Vaccinia Ankara 85A
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:
  • AERAS-485
  • Modified Vaccinia Ankara 85A

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Collaborators

MRC/UVRI and LSHTM Uganda Research Unit

Investigators

  • Principal Investigator: Alison Elliot, MRC/UVRI and LSHTM Uganda Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

January 30, 2015

Last Update Submitted That Met QC Criteria

January 29, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB036

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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