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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.

On 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 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 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
12. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23816281
13. 2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25100338
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
  Email 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
  Email Penny.Ireland@lshtm.ac.uk
  Sponsor website: http://www.lshtm.ac.uk
Date applied 22/07/2005
Last edited 23/09/2014
Date ISRCTN assigned 22/07/2005
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