title: Impact of anthelminthic treatment in pregnancy and childhood on immunisations, infections and eczema in childhood: a randomised controlled trial.
abstract: BACKGROUND
  Helminth infections may modulate immune responses to unrelated pathogens and allergens; these effects may commence prenatally. We addressed the hypothesis that anthelminthic treatment in pregnancy and early childhood would improve responses to immunisation and modulate disease incidence in early childhood with both beneficial and detrimental effects.
  
  
  RESULTS
  A randomised, double-blind, placebo-controlled trial was conducted in Entebbe, Uganda [ISRCTN32849447]. In three independent randomisations, 2507 pregnant women were allocated to receive single-dose albendazole or placebo, and praziquantel or placebo; 2016 of their offspring were randomised to receive quarterly single-dose albendazole or placebo from age 15 months to 5 years. Primary outcomes were post-immunisation recall responses to BCG and tetanus antigens, and incidence of malaria, diarrhoea, and pneumonia; incidence of eczema was an important secondary outcome. Analysis was by intention-to-treat. Of 2345 live births, 1622 (69%) children remained in follow-up at age 5 years. 68% of mothers at enrolment, and 11% of five-year-olds, had helminth infections. Maternal hookworm and Schistosoma mansoni were effectively treated by albendazole and praziquantel, respectively; and childhood hookworm and Ascaris by quarterly albendazole. Incidence rates of malaria, diarrhoea, pneumonia, and eczema were 34, 65, 10 and 5 per 100 py, respectively. Albendazole during pregnancy caused an increased rate of eczema in the children (HR 1.58 (95% CI 1.15-2.17), p = 0.005). Quarterly albendazole during childhood was associated with reduced incidence of clinical malaria (HR 0.85 (95% CI 0.73-0.98), p = 0.03). There were no consistent effects of the interventions on any other outcome.
  
  
  CONCLUSIONS
  Routine use of albendazole in pregnancy may not always be beneficial, even in tropical developing countries. By contrast, regular albendazole treatment in preschool children may have an additional benefit for malaria control where helminths and malaria are co-endemic. Given the low helminth prevalence in our children, the effect of albendazole on malaria is likely to be direct.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN32849447.
authors.affiliation: Medical Research Council/Uganda Virus Research Institute Uganda Research Unit on AIDS, Entebbe, Uganda.
authors.forename: Juliet
authors.initials: J
authors.lastname: Ndibazza
authors.forename: Harriet
authors.initials: H
authors.lastname: Mpairwe
authors.forename: Emily L
authors.initials: EL
authors.lastname: Webb
authors.forename: Patrice A
authors.initials: PA
authors.lastname: Mawa
authors.forename: Margaret
authors.initials: M
authors.lastname: Nampijja
authors.forename: Lawrence
authors.initials: L
authors.lastname: Muhangi
authors.forename: Macklyn
authors.initials: M
authors.lastname: Kihembo
authors.forename: Swaib A
authors.initials: SA
authors.lastname: Lule
authors.forename: Diana
authors.initials: D
authors.lastname: Rutebarika
authors.forename: Barbara
authors.initials: B
authors.lastname: Apule
authors.forename: Florence
authors.initials: F
authors.lastname: Akello
authors.forename: Hellen
authors.initials: H
authors.lastname: Akurut
authors.forename: Gloria
authors.initials: G
authors.lastname: Oduru
authors.forename: Peter
authors.initials: P
authors.lastname: Naniima
authors.forename: Dennison
authors.initials: D
authors.lastname: Kizito
authors.forename: Moses
authors.initials: M
authors.lastname: Kizza
authors.forename: Robert
authors.initials: R
authors.lastname: Kizindo
authors.forename: Robert
authors.initials: R
authors.lastname: Tweyongere
authors.forename: Katherine J
authors.initials: KJ
authors.lastname: Alcock
authors.forename: Moses
authors.initials: M
authors.lastname: Muwanga
authors.forename: Alison M
authors.initials: AM
authors.lastname: Elliott
mesh_terms: D000328:Adult; D015766:Albendazole / Q000627:therapeutic use*; D000871:Anthelmintics / Q000009:adverse effects*; D002675:Child, Preschool; D004311:Double-Blind Method; D004485:Eczema / Q000453:epidemiology / Q000276:immunology; D005260:Female; D006373:Helminthiasis / Q000188:drug therapy* / Q000453:epidemiology / Q000276:immunology; D006801:Humans; D015994:Incidence; D007223:Infant; D008297:Male; D011247:Pregnancy; D015597:Pregnancy Complications, Parasitic / Q000188:drug therapy* / Q000276:immunology; D016896:Treatment Outcome; D014454:Uganda; D014611:Vaccination
chemical_list: D000871:Anthelmintics; D015766:Albendazole