Condition category
Infections and Infestations
Date applied
02/05/2013
Date assigned
26/07/2013
Last edited
26/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Infection with the blood fluke Schistosoma mansoni that causes schistosomiasis (also called bilharzia) is still a problem in communities along the lake shores and rivers in Uganda. Infection with S. mansoni has a very great effect on the body immunity. We think that when children are infected with S. mansoni they may respond poorly to the childhood immunizations such as measles booster immunization. We want to find out if the children among the fishing communities have good body defences against measles. We also want to find out how S. mansoni infection among children under five years and its treatment may affect the body’s defeneces against measles. With the results, we may be able to develop better ways of fighting bilharzia, measles and possibly other diseases.

Who can participate?
Children aged 3-5 years old on the Entebbe peninsula of Lake Victoria and adjacent islands of Wakiso district (Uganda).

What does the study involve?
All S. mansoni infected participants will be treated with single dose of praziquantel and children will be given measles booster immunization . S. mansoni infected children will be randomly allocated to one of the three groups (A,B and C) to receive praziquantel treatment at different times. The children will either receive praziquantel treatment two weeks before measles booster immunization (group A) or receive praziquantel and measles booster immunization on the same day (group B) or receive praziquantel one week after immunization (group C). Uninfected children who will participate in the study will only receive measles booster immunization.

What are the possible benefits and risks of participating?
Participating children will be tested for worm infections, in particular bilharzia, and are expected to benefit from the treatment for the worm infections. Participating children will get measles booster immunization. Praziquantel treatment may have some side effects like itching, rashes, dizziness and diarrhea, especially in individuals with heavy infections, but these effects are limited and the team will provide treatment for these side effects.

Where is the study run from?
The study is based at the Uganda Virus Research Institute and is conducted in collaboration with the Vector Control Division of the Ugandan Ministry of Health.

When is the study starting and for how long is it expected to run?
The study started in March 2013 and is expected to run for three years.

Who is funding the study?
European Foundations Initiative for African Research into NTDs (EFINTD)- The Fondazione Cariplo (Italy), Fundação Calouste Gulbenkian (Portugal), Fondation Mérieux (France), Nuffield Foundation (UK) and the Volkswagen Stiftung (Germany).

Who is the main contact?
Dr Robert Tweyongyere; tmrobert966@gmail.com
Dr Swaibu Lule; swaiblule@gmail.com or swaiblule@yahoo.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Robert Tweyongyere

ORCID ID

Contact details

Uganda Virus Research Institute
P. O. Box 49
Entebbe
Kampala
256
Uganda

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HS1307

Study information

Scientific title

Immune Modulation and Childhood Immunization (IMoChI) Study: Immune modulation in Schistosoma mansoni infection and effects on immune responses to childhood measles immunization

Acronym

IMoChI

Study hypothesis

Considering that Schistosoma mansoni infection is associated with induction of strong Th2 and immune modulation profiles that could influence immune responses to non-schistosome antigens, this study aims to explore and elucidate the effect of S. mansoni infection and its treatment on the efficacy of childhood measles immunization. We will examine the hypothesis that S. mansoni infection skews measles specific immune responses towards type two responses away from the more protective type one responses. If such an effect exists it may be correlated to the magnitude of schistosome-specific type two and regulatory responses. If this is the case, concurrent de-worming and immunization may actually worsen the situation, increasing the bias to type two rather than type one responses to measles vaccination, since praziquantel treatment results in significant boost of type two immune responses. Alternatively, the removal of the immune-suppressive effects of active worm infection may result an immediate benefit for the response to measles immunization.

Thus the study will generally address the hypothesis that vaccine immunogenicity is impaired in S mansoni infected communities compared to uninfected communities in Uganda and will seek to understand the mechanisms by which S. mansoni infection exerts such effects with the following specific objectives:
1. To determine the effects of S. mansoni infection on antibody and cellular responses to measles booster immunization in children aged three to five years
2. To determine the effects of praziquantel treatment of S. mansoni infection on antibody and cellular responses to measles booster immunization in children aged three to five years
3. To correlate immune responses to measles immunization to schistosome-specific immune responses.

Ethics approval

The Uganda Virus research institute, Entebbe, 20 November 2012
The Uganda National Council for Science and Technology, Kampala 11 January 2013

Study design

Randomized intervention study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Helminth infections and effects on childhood immunization

Intervention

All S. mansoni infected participants will be treated with single dose of praziquantel at the recommended dosage of 40mg per Kg body weight and children will be given measles booster immunization (in accordance to the Uganda Ministry of Health). S. mansoni infected children will be randomly assigned into three groups (A,B and C) to receive praziquantel treatment at different time points with respect to measles booster immunization as follows:
The children will either receive praziquantel treatment two weeks before measles booster immunization (group A) or receive praziquantel and measles booster immunization on same day (group B) or receive praziquantel one week after immunization (group C). Uninfected children who will participate in the study will only receive measles booster immunization.

Intervention type

Drug

Phase

Not Applicable

Drug names

praziquantel

Primary outcome measures

Immune responses to Measles: Antibody responses and Cytokine responses will be measured at baseline, one week after measles booster immunization and 24 weeks after measles booster immunization.

Secondary outcome measures

S. mansoni infection intensity and response to praziquantel treatment will be measured at baseline and at 24 weeks after measles booster immunization.

Overall trial start date

28/02/2013

Overall trial end date

28/02/2016

Reason abandoned

Eligibility

Participant inclusion criteria

Children of age 3-5 years residing on the Entebbe Peninsula in Lake Victoria and adjacent islands of Wakiso district

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

225 children with S. mansoni and 50 children without S mansoni infection.

Participant exclusion criteria

1. Children whose parents or guardian do not consent to join the study
2. Cildren who do not meet the inclusion criteria

Recruitment start date

28/02/2013

Recruitment end date

28/02/2016

Locations

Countries of recruitment

Uganda

Trial participating centre

Uganda Virus Research Institute
Kampala
256
Uganda

Sponsor information

Organisation

The Uganda Virus Research Institute (Uganda)

Sponsor details

Plot 51-59
Nakiwogo Road
P. O. Box 49
Entebbe
Kampala
256
Uganda

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

European Foundations Initiative for African Research into NTDs“EFINTD”- The Fondazione Cariplo (Italy)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fundação Calouste Gulbenkian (Portugal)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Fondation Mérieux (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Nuffield Foundation (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

foundation

Location

United Kingdom

Funder name

The Volkswagen Stiftung (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes