NCT00231452

Age of Exposure and Immunity to Malaria in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 349 (actual)
• Sponsor: Hospital Clinic of Barcelona · Academic / Other
• Sex: All
• Age: 1 Week
• Healthy volunteers: Accepted

Summary

The overall objective is to evaluate the effect of exposure to Plasmodium (P.) falciparum erythrocytic stage antigens during different periods of infancy on the development of naturally acquired immunity (NAI). 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.

Conditions

• Malaria

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2005-09-01
• Primary completion: 2009-03-01
• Completion: 2009-03-01
• First posted: 2005-10-04
• Last updated: 2011-10-28

Locations

1 site across 1 country: Mozambique