Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
349 participants
INTERVENTIONAL
2005-09-30
2009-03-31
Brief Summary
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Hypothesis: Exposure to P. falciparum prior to 5 months of age does not result in the development of NAI, while exposure to P. falciparum after 5 months of age leads to the development of NAI. The risks of clinical malaria and anaemia during the second year of life will be compared between cohorts, as well as their correlations with the type and quality of immune responses (antibodies to several P. falciparum antigens, cytokines), oxidative stress markers and host genetic factors. These results should shed light on the determinants of the development of anti-P. falciparum responses early in life and the potential constraints to early life immunisation.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
QUADRUPLE
Study Groups
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Late exposure group
Participants received monthly Sulfadoxine-Pyrimethamine (SP) plus Artesunate (AS) from 2.5-4.5 months of age and monthly placebo from 5.5-9.5 months of age.
Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
Early exposure group
Participants received monthly placebo from 2.5-4.5 months of age and monthly SP+AS from 5.5-9.5 months of age.
Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
Control group
Participants received monthly placebo from 2.5 to 9.5 months of age.
Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
Interventions
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Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Monthly chemoprophylaxis with SP (Fansidar® 500/25 mg) plus Artesunate (AS, Arsumax® 50 mg) or placebo (provided by Roche and Sanofi-Aventis) was administered according to the following age-based dosing schedule: ½ tablet of SP or placebo and ½ tablet of AS or placebo on the first day and ½ tablet of AS or placebo on the second and third days.
Eligibility Criteria
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Inclusion Criteria
* Permanent residents of the Manhiça area and expecting to be living in the area with their infant for at least 2 years.
* Healthy infants, weighing \>= 2 kg and having an alive mother.
Exclusion Criteria
* Women not willing to get tested for HIV infection at the VCT center;
* Test positive for HIV;
* Not willing to provide informed consent;
* Cannot understand either Portuguese or Changana (consent forms are written in these languages).
* Any obvious congenital malformation;
* Any signs of cerebral asphyxia;
* Any obvious neonatal infection;
* Same gender Twins;
* Low birth weight (\<2 kg).
1 Week
ALL
Yes
Sponsors
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European Commission
OTHER
Hospital Clinic of Barcelona
OTHER
Principal Investigators
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Pedro Alonso, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Barcelona Center for International Health Research, Hospital Clinic/University of Barcelona
Carlota Dobaño, PhD
Role: PRINCIPAL_INVESTIGATOR
Barcelona Center for International Health Research, Hospital Clinic/University of Barcelona
Locations
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Centro de Investigaçao em Saude da Manhiça
Manhiça, Maputo Province, Mozambique
Countries
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References
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Dobano C, Nhabomba AJ, Manaca MN, Berthoud T, Aguilar R, Quinto L, Barbosa A, Rodriguez MH, Jimenez A, Groves PL, Santano R, Bassat Q, Aponte JJ, Guinovart C, Doolan DL, Alonso PL. A Balanced Proinflammatory and Regulatory Cytokine Signature in Young African Children Is Associated With Lower Risk of Clinical Malaria. Clin Infect Dis. 2019 Aug 16;69(5):820-828. doi: 10.1093/cid/ciy934.
Nhabomba AJ, Guinovart C, Jimenez A, Manaca MN, Quinto L, Cistero P, Aguilar R, Barbosa A, Rodriguez MH, Bassat Q, Aponte JJ, Mayor A, Chitnis CE, Alonso PL, Dobano C. Impact of age of first exposure to Plasmodium falciparum on antibody responses to malaria in children: a randomized, controlled trial in Mozambique. Malar J. 2014 Mar 27;13:121. doi: 10.1186/1475-2875-13-121.
Guinovart C, Dobano C, Bassat Q, Nhabomba A, Quinto L, Manaca MN, Aguilar R, Rodriguez MH, Barbosa A, Aponte JJ, Mayor AG, Renom M, Moraleda C, Roberts DJ, Schwarzer E, Le Souef PN, Schofield L, Chitnis CE, Doolan DL, Alonso PL. The role of age and exposure to Plasmodium falciparum in the rate of acquisition of naturally acquired immunity: a randomized controlled trial. PLoS One. 2012;7(3):e32362. doi: 10.1371/journal.pone.0032362. Epub 2012 Mar 7.
Related Links
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CISM webpage
Barcelona Center for International Health Research
Other Identifiers
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AgeMal
Identifier Type: -
Identifier Source: org_study_id