Effect of S. mansoni infection on immune responses to measles immunization
| ISRCTN | ISRCTN87107592 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87107592 |
| Secondary identifying numbers | HS1307 |
- Submission date
- 02/05/2013
- Registration date
- 26/07/2013
- Last edited
- 17/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
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 bodys 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
Contact information
Scientific
Uganda Virus Research Institute
P. O. Box 49, Entebbe
Kampala
256
Uganda
Study information
| Study design | Randomized intervention study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Immune Modulation and Childhood Immunization (IMoChI) Study: Immune modulation in Schistosoma mansoni infection and effects on immune responses to childhood measles immunization |
| Study acronym | IMoChI |
| Study objectives | 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(s) | The Uganda Virus research institute, Entebbe, 20 November 2012 The Uganda National Council for Science and Technology, Kampala 11 January 2013 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | praziquantel |
| Primary outcome measure | 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 study start date | 28/02/2013 |
| Completion date | 28/02/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 3 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 225 children with S. mansoni and 50 children without S mansoni infection. |
| Total final enrolment | 254 |
| Key inclusion criteria | Children of age 3-5 years residing on the Entebbe Peninsula in Lake Victoria and adjacent islands of Wakiso district |
| Key exclusion criteria | 1. Children whose parents or guardian do not consent to join the study 2. Cildren who do not meet the inclusion criteria |
| Date of first enrolment | 28/02/2013 |
| Date of final enrolment | 28/02/2016 |
Locations
Countries of recruitment
- Uganda
Study participating centre
256
Uganda
Sponsor information
Research organisation
Plot 51-59, Nakiwogo Road
P. O. Box 49, Entebbe
Kampala
256
Uganda
"ROR" |
https://ror.org/04509n826 |
|---|
Funders
Funder type
Charity
No information available
No information available
No information available
Private sector organisation / Trusts, charities, foundations (both public and private)
- Location
- United Kingdom
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 14/02/2019 | Yes | No |
Editorial Notes
17/12/2020: Total final enrolment added.
21/03/2019: Publication reference added.
