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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02178748
• Date of registration: 03/06/2014
• Prospective Registration: No
• Primary sponsor: University of Oxford
• Public title: Trial to Investigate the Effect of Schistosoma Mansoni Infection on the Response to Vaccination With MVA85A in BCG-vaccinated African Adolescents TB036
• Scientific 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
• Date of first enrolment: June 2014
• Target sample size: 36
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02178748
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Uganda

Contacts

• Name: Alison Elliot
• Affiliation: MRC/UVRI Uganda Research Unit on Aids

• Name: Helen McShane
• Affiliation: University of Oxford

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Tuberculosis

Intervention(s)

Biological: MVA85A

Primary Outcome(s)

T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. [Time Frame: 8 weeks]

Secondary Outcome(s)

Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response. [Time Frame: 8 weeks]

Secondary ID(s)

TB036

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

MRC/UVRI Uganda Research Unit on Aids