Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alison Elliott

ORCID ID

Contact details

Uganda Virus Research Institute
Entebbe
-
Uganda
+256 (0)41 320272
alison.tom@infocom.co.ug

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

064693

Study information

Scientific title

The impact of helminths on the response to immunisation and on the incidence of infection and disease in childhood in Uganda

Acronym

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.

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

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

Condition

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)

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.

Intervention type

Drug

Phase

Not Applicable

Drug names

Albendazole, praziquantel

Primary outcome measures

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 trial start date

01/04/2003

Overall trial end date

30/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

2500

Participant 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)

Recruitment start date

01/04/2003

Recruitment end date

30/04/2011

Locations

Countries of recruitment

Uganda

Trial participating centre

Uganda Virus Research Institute
Entebbe
-
Uganda

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine (UK)

Sponsor details

Research Grants and Contracts Office
Keppel Street
London
WC1E 7HT
United Kingdom
+44 (0)20 7827 2678
Penny.Ireland@lshtm.ac.uk

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Charity

Funder name

Current source of funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant refs: 079110 and 095778)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Previous source of funding

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

The Wellcome Trust (UK) (grant ref: 064693)

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

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

Publication citations

  1. Results

    Elliott AM, Namujju PB, Mawa PA, Quigley MA, Nampijja M, Nkurunziza PM, Belisle JT, Muwanga M, Whitworth JA, , A randomised controlled trial of the effects of albendazole in pregnancy on maternal responses to mycobacterial antigens and infant responses to Bacille Calmette-Guérin (BCG) immunisation [ISRCTN32849447]., BMC Infect. Dis., 2005, 5, 115, doi: 10.1186/1471-2334-5-115.

  2. Results

    Muhangi L, Woodburn P, Omara M, Omoding N, Kizito D, Mpairwe H, Nabulime J, Ameke C, Morison LA, Elliott AM, Associations between mild-to-moderate anaemia in pregnancy and helminth, malaria and HIV infection in Entebbe, Uganda., Trans. R. Soc. Trop. Med. Hyg., 2007, 101, 9, 899-907, doi: 10.1016/j.trstmh.2007.03.017.

  3. Design review

    Elliott AM, Kizza M, Quigley MA, Ndibazza J, Nampijja M, Muhangi L, Morison L, Namujju PB, Muwanga M, Kabatereine N, Whitworth JA, The impact of helminths on the response to immunization and on the incidence of infection and disease in childhood in Uganda: design of a randomized, double-blind, placebo-controlled, factorial trial of deworming interventions delivered in pregnancy and early childhood [ISRCTN32849447]., Clin Trials, 2007, 4, 1, 42-57, doi: 10.1177/1740774506075248.

  4. Results

    Ndibazza J, Muhangi L, Akishule D, Kiggundu M, Ameke C, Oweka J, Kizindo R, Duong T, Kleinschmidt I, Muwanga M, Elliott AM, Effects of deworming during pregnancy on maternal and perinatal outcomes in Entebbe, Uganda: a randomized controlled trial., Clin. Infect. Dis., 2010, 50, 4, 531-540, doi: 10.1086/649924.

  5. Results

    Webb EL, Mawa PA, Ndibazza J, Kizito D, Namatovu A, Kyosiimire-Lugemwa J, Nanteza B, Nampijja M, Muhangi L, Woodburn PW, Akurut H, Mpairwe H, Akello M, Lyadda N, Bukusuba J, Kihembo M, Kizza M, Kizindo R, Nabulime J, Ameke C, Namujju PB, Tweyongyere R, Muwanga M, Whitworth JA, Elliott AM, Effect of single-dose anthelmintic treatment during pregnancy on an infant's response to immunisation and on susceptibility to infectious diseases in infancy: a randomised, double-blind, placebo-controlled trial., Lancet, 2011, 377, 9759, 52-62, doi: 10.1016/S0140-6736(10)61457-2.

  6. Results

    Tweyongyere R, Mawa PA, Kihembo M, Jones FM, Webb EL, Cose S, Dunne DW, Vennervald BJ, Elliott AM, Effect of praziquantel treatment of Schistosoma mansoni during pregnancy on immune responses to schistosome antigens among the offspring: results of a randomised, placebo-controlled trial., BMC Infect. Dis., 2011, 11, 234, doi: 10.1186/1471-2334-11-234.

  7. Results

    Elliott AM, Ndibazza J, Mpairwe H, Muhangi L, Webb EL, Kizito D, Mawa P, Tweyongyere R, Muwanga M, , Treatment with anthelminthics during pregnancy: what gains and what risks for the mother and child?, Parasitology, 2011, 138, 12, 1499-1507, doi: 10.1017/S0031182011001053.

  8. Results

    Webb EL, Kyosiimire-Lugemwa J, Kizito D, Nkurunziza P, Lule S, Muhangi L, Muwanga M, Kaleebu P, Elliott AM, The effect of anthelmintic treatment during pregnancy on HIV plasma viral load: results from a randomized, double-blind, placebo-controlled trial in Uganda., J. Acquir. Immune Defic. Syndr., 2012, 60, 3, 307-313, doi: 10.1097/QAI.0b013e3182511e42.

  9. Results

    Ndibazza J, Mpairwe H, Webb EL, Mawa PA, Nampijja M, Muhangi L, Kihembo M, Lule SA, Rutebarika D, Apule B, Akello F, Akurut H, Oduru G, Naniima P, Kizito D, Kizza M, Kizindo R, Tweyongere R, Alcock KJ, Muwanga M, Elliott AM, Impact of anthelminthic treatment in pregnancy and childhood on immunisations, infections and eczema in childhood: a randomised controlled trial., PLoS ONE, 2012, 7, 12, e50325, doi: 10.1371/journal.pone.0050325.

  10. Results

    Kizito D, Tweyongyere R, Namatovu A, Webb EL, Muhangi L, Lule SA, Bukenya H, Cose S, Elliott AM, Factors affecting the infant antibody response to measles immunisation in Entebbe-Uganda., BMC Public Health, 2013, 13, 619, doi: 10.1186/1471-2458-13-619.

  11. Results

    Millard JD, Muhangi L, Sewankambo M, Ndibazza J, Elliott AM, Webb EL, Assessing the external validity of a randomized controlled trial of anthelminthics in mothers and their children in Entebbe, Uganda., Trials, 2014, 15, 310, doi: 10.1186/1745-6215-15-310.

  12. Tweyongyere R, Mawa PA, Emojong NO, Mpairwe H, Jones FM, Duong T, Dunne DW, Vennervald BJ, Katunguka-Rwakishaya E, Elliott AM, Effect of praziquantel treatment of Schistosoma mansoni during pregnancy on intensity of infection and antibody responses to schistosome antigens: results of a randomised, placebo-controlled trial., BMC Infect. Dis., 2009, 9, 32, doi: 10.1186/1471-2334-9-32.

  13. Mpairwe H, Webb EL, Muhangi L, Ndibazza J, Akishule D, Nampijja M, Ngom-wegi S, Tumusime J, Jones FM, Fitzsimmons C, Dunne DW, Muwanga M, Rodrigues LC, Elliott AM, Anthelminthic treatment during pregnancy is associated with increased risk of infantile eczema: randomised-controlled trial results., Pediatr Allergy Immunol, 2011, 22, 3, 305-312, doi: 10.1111/j.1399-3038.2010.01122.x.

Editorial Notes