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

Phase 2

Completed

• Conditions: Tuberculosis
• Interventions: Biological: MVA85A

• Registration Number: NCT02178748
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Status Verified: 2015-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-01-29
• Last Update Posted: 2015-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1	MVA85A	Group 1 (Schistosoma mansoni uninfected): 12-24 BCG-vaccinated volunteers with no helminth infection. Single dose of 1x10\^8pfu MVA85A intramuscular vaccination at D0.
Group 2	MVA85A	Group 2 (Schistosoma mansoni infected): 12-24 BCG-vaccinated volunteers with helminth infection. Single dose of 1x10\^8pfu MVA85A intramuscular vaccination at D0.

Primary Outcome Measures

Name	Time	Method
T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response.	8 weeks	To compare T cell immunogenicity in adolescents with and without S. mansoni infection.

Secondary Outcome Measures

Name	Time	Method
Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response.	8 weeks	Effects of S. mansoni infection on other aspects of the immune response following MVA85A immunisation.

Trial Locations

Locations (1)

MRC/UVRI Uganda Research Unit on AIDS; 🇺🇬 Entebbe, Uganda