The effect of worm infections during pregnancy on immunisations and infections in infants

ISRCTN	ISRCTN32849447
DOI	https://doi.org/10.1186/ISRCTN32849447
Secondary identifying numbers	064693

Submission date: 22/07/2005
Registration date: 22/07/2005
Last edited: 06/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Alison Elliott
Scientific

Uganda Virus Research Institute
Entebbe
-
Uganda

Phone	+256 (0)41 320272
Email	alison.tom@infocom.co.ug

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	The impact of helminths on the response to immunisation and on the incidence of infection and disease in childhood in Uganda
Study objectives	That helminth infection in pregnancy and in early childhood affects the immune response to childhood vaccines and susceptibility to disease in childhood.
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Helminthiasis
Intervention	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)
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Albendazole, praziquantel
Primary outcome measure	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 measures	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
Overall study start date	01/04/2003
Completion date	30/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	2500
Key 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
Key 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)
Date of first enrolment	01/04/2003
Date of final enrolment	30/04/2011

Locations

Countries of recruitment

Uganda

Study participating centre

Uganda Virus Research Institute

Entebbe
-
Uganda

Sponsor information

London School of Hygiene and Tropical Medicine (UK)
University/education

Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
England
United Kingdom

Phone	+44 (0)20 7827 2678
Email	Penny.Ireland@lshtm.ac.uk
Website	http://www.lshtm.ac.uk
"ROR"	https://ror.org/00a0jsq62

Funders

Funder type

Charity

Wellcome Trust (grant refs: 079110 and 095778)
Private sector organisation / International organizations

Location: United Kingdom

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	21/12/2005		Yes	No
Other publications	design review	01/09/2007		Yes	No
Results article	results	01/09/2007		Yes	No
Results article	results	18/03/2009		Yes	No
Results article	results	15/02/2010		Yes	No
Results article	results	01/01/2011		Yes	No
Results article	results	01/05/2011		Yes	No
Results article	results	02/09/2011		Yes	No
Results article	results	01/10/2011		Yes	No
Results article	results	01/07/2012		Yes	No
Results article	results	01/07/2012		Yes	No
Results article	results	01/07/2013		Yes	No
Results article	results	06/08/2014		Yes	No
Results article	results	08/02/2017		Yes	No
Results article	results	17/05/2019	06/08/2020	Yes	No

Editorial Notes

06/08/2020: Publication reference added.
09/02/2017: Publication reference added.

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.

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. 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.