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Age of Exposure and Immunity to Malaria in Infants

NCT00231452 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 349

Last updated 2011-10-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Pedro Alonso, MD, PhD · Barcelona Center for International Health Research, Hospital Clinic/University of Barcelona

  • Carlota Dobaño, PhD · Barcelona Center for International Health Research, Hospital Clinic/University of Barcelona

Study Design

Allocation
RANDOMIZED
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
1 Week
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • Mozambique

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00231452 on ClinicalTrials.gov