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Completed

NCT Number: NCT00231452

Age of Exposure and Immunity to Malaria in Infants

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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

Up to 1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro de Investigaçao em Saude da Manhiça

Manhiça, Maputo Province, 1929, Mozambique

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for pregnant women:

  • Healthy HIV-negative pregnant females less than 50 years of age who attend the voluntary counseling and testing (VCT) center at the Maragra or Manhiça antenatal clinic,
  • Permanent residents of the Manhiça area and expecting to be living in the area with their infant for at least 2 years.

Inclusion criteria

for newborn infants:

  • Healthy infants, weighing >= 2 kg and having an alive mother.

Exclusion criteria

Exclusion criteria

for pregnant women:

  • Plan to leave the area in less than 2 years from the start of the study;
  • 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).

Exclusion criteria

for newborn infants:

  • Any obvious congenital malformation;
  • Any signs of cerebral asphyxia;
  • Any obvious neonatal infection;
  • Same gender Twins;
  • Low birth weight (<2 kg).

Treatment and study plan

Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)

Drug

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.

Primary outcomes

  1. (Clinical) Time to first or only episode of clinical malaria in the second year of life detected by passive case detection

    Time frame: from 12 to 24 months of age

    Global comparison between the 3 groups of the time to first or only episode of clinical malaria (according to the primary case definition) in the second year of follow up detected by passive case detection in the According-To-Protocol cohort. In addition, pairwise comparisons of the 3 groups are also presented.

Secondary outcomes

  1. (Clinical) Time to first or only episode of malaria (using other case definitions), anaemia and other clinical endpoints.

    Time frame: 12 to 24 months of age

    Global comparison between the 3 study groups of the time to first or only episode of clinical malaria (according to the secondary case definitions) in the second year of follow up detected by passive case detection. Other endpoints include multiple episodes of malaria, time to first or only episode of anaemia, total hospital visits and prevalence of parasitaemia and anaemia at different time points. In addition, pairwise comparisons of the 3 groups are also presented.

  2. Oxidative stress markers

    Time frame: multiple time points during the first two years of life (2.5, 5.5, 10.5, 15 and 24 months of age)

    Quantification of the antioxidant/pro-oxidant status over the first two years of life in relation to age of first exposure to infection.

  3. Humoral and cellular immune responses

    Time frame: multiple time points during the first two years of life (2.5, 5.5, 10.5, 15 and 24 months of age)

    Quantification of antibody and cytokine responses to P. falciparum protein antigens and toxins over the first two years of life in relation to age of first exposure to infection

  4. Host genetics

    Time frame: 2.5 months of age

    Analysis of haematological genetic factors, polymorphisms in genes involved in inflammatory or immunological responses to malaria and polymorphisms in genes involved in the Th1/Th2 immunological pathway.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Collaborators

  • European Commission

Registry information

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 4, 2005
Registry last updated
Oct 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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