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23 May 2013
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| [ Print-friendly version ] |
| The effect of worm infections during pregnancy on immunisations and infections in infants |
| ISRCTN | ISRCTN32849447 |
| DOI | 10.1186/ISRCTN32849447 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | The effect of worm infections during pregnancy on immunisations and infections in infants |
| Scientific title | The impact of helminths on the response to immunisation and on the incidence of infection and disease in childhood in Uganda |
| Acronym | N/A |
| Serial number at source | 064693 |
| Study hypothesis |
That helminth infection in pregnancy and in early childhood affects the immune response to childhood vaccines and susceptibility to disease in childhood.
Please note that as of 04/02/2009 this record has been updated to include a public title and a new scientific title. All other additions can be found under the relevant section. The initial scientific title at the time of registration was: The impact of helminths on the response to immunisation and on susceptibility to infectious diseases in childhood in Uganda. This was changed after a renewal of funding in 2006. |
| Lay summary | Not provided at time of registration |
| Ethics approval |
Added as of 04/02/2009:
1. Science and Ethics Committee of the Uganda Virus Research Institute in 2001 2. Uganda National Council for Science and Technology in 2001 3. London School of Hygiene & Tropical Medicine in 2001 (ref: 790) |
| Study design | Randomised controlled trial |
| Countries of recruitment | Uganda |
| Disease/condition/study domain | Helminthiasis |
| Participants - inclusion criteria |
1. Pregnant women (aged 14 to 47 years) in the second or third trimester
2. Resident in the study area 3. Planning to deliver at Entebbe Hospital 4. Willing to know Human Immunodeficiency Virus (HIV) status |
| Participants - exclusion criteria |
1. Anaemia (more than or equal to 8 g/dl), bloody diarrhoea
2. Clinical evidence of severe liver disease 3. History of adverse reaction to anthelminthics 4. Already enrolled in previous pregnancy 5. Abnormal pregnancy (e.g. bleeding) |
| Anticipated start date | 01/04/2003 |
| Anticipated end date | 30/04/2011 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 2500 |
| Interventions |
1. Randomised, double-blind, placebo controlled trial of albendazole versus placebo and praziquantel versus placebo during pregnancy (all mothers treated with both six weeks after delivery)
2. Randomised, double blind placebo controlled trial of three-monthly albendazole versus placebo from age 15 months (all infants treated annually for helminths identified on analysis of a stool sample) Added as of 04/02/2009: Follow-up to age 5 was planned at the outset; a recent protocol amendment will allow follow up to age 10 if funding is available. Added as of 21/03/2012: Funding has been awarded to allow follow-up to 2016, this will allow the assessment of outcomes between ages 5 and 12 years. Additional outcome measures have been added for this age group. |
| Primary outcome measure(s) |
Current primary outcome measure(s)
1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases 3. Primary outcomes at age nine years 3.1. Reported wheeze in last 12 months 3.2. SPT positivity to any allergen 3.3. Allergen-specific IgE to any allergen Previous primary outcome measure(s) 1. Immune responses in infants: 1.1. To selected childhood vaccines 1.2. To selected infectious diseases 1.3. To selected helminths 2. Incidence of childhood diseases |
| Secondary outcome measure(s) |
Current secondary outcome measure(s)
1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events 3. Secondary outcomes at age nine years 3.1. Reported eczema in last 12 months 3.2. Visible flexural eczema 3.3. Forced expiratory volume in one second (FEV1) Previous secondary outcome measure(s) 1. Measures of: 1.1. Anaemia 1.2. Growth 1.3. Development 2. Incidence of allergic disease events |
| Sources of funding |
Current source of funding
The Wellcome Trust (UK) (grant refs: 079110 and 095778) Previous source of funding The Wellcome Trust (UK) (grant ref: 064693) |
| Trial website | |
| Publications |
Results in:
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16371154 2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17555783 3. 2007 design review in http://www.ncbi.nlm.nih.gov/pubmed/17327245 4. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19296834 5. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20067426 6. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21176950 7. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21888656 8. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21255083 9. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21810307 10. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22728750 11. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23236367 |
| Contact name | Dr Alison Elliott |
| Address | Uganda Virus Research Institute |
| City/town | Entebbe |
| Zip/Postcode | - |
| Country | Uganda |
| Tel | +256 (0)41 320272 |
| Fax | +256 (0)41 321137 |
| alison.tom@infocom.co.ug | |
| Sponsor | London School of Hygiene and Tropical Medicine (UK) |
| Address |
Research Grants and Contracts Office
Keppel Street |
| City/town | London |
| Zip/Postcode | WC1E 7HT |
| Country | United Kingdom |
| Tel | +44 (0)20 7827 2678 |
| Fax | +44 (0)20 7927 5636 |
| Penny.Ireland@lshtm.ac.uk | |
| Sponsor website: | http://www.lshtm.ac.uk |
| Date applied | 22/07/2005 |
| Last edited | 25/02/2013 |
| Date ISRCTN assigned | 22/07/2005 |
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