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MalariaNCT00231452

Age of Exposure and Immunity to Malaria in Infants

A study testing Sulfadoxine-pyrimethamine (SP) + Artesunate (AS) in people with Malaria, run by Hospital Clinic of Barcelona at 1 site in Mozambique.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 1 weekHealthy volunteers can take part
Conditions the study is for
Malaria
What is being tested?
Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
349 participants
Where
1 siteMozambique
Study dates
Sep 2005to Mar 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 1 week
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

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

Who cannot join

  • 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).
  • Any obvious congenital malformation;
Show all 10Show fewer
  • Any signs of cerebral asphyxia;
  • Any obvious neonatal infection;
  • Same gender Twins;
  • Low birth weight (<2 kg).

Trial locations and contacts

1 site in 1 country.

Mozambique1 site

  • Centro de Investigaçao em Saude da Manhiça

    Manhiça, Maputo Province, 1929

Other trials in Mozambique

About this study

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
Being tested
Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Keywords
natural acquired immunity,, clinical malaria,, P. falciparum,, age,, exposure,, neonatal immunology,, infants
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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.

Study groups in NCT00231452
Study groupRoleWhat they receive
Late exposure groupExperimentalParticipants 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.
Receives: Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Early exposure groupExperimentalParticipants received monthly placebo from 2.5-4.5 months of age and monthly SP+AS from 5.5-9.5 months of age.
Receives: Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)
Control groupPlacebo comparatorParticipants received monthly placebo from 2.5 to 9.5 months of age.
Receives: Drug: Sulfadoxine-pyrimethamine (SP) + Artesunate (AS)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: from 12 to 24 months of age

Secondary outcomes (4)

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

    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.

    Measured: 12 to 24 months of age

  2. Oxidative stress markers

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

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

  3. Humoral and cellular immune responses

    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

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

  4. Host genetics

    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.

    Measured: 2.5 months of age

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2005 (estimated)
  2. Study startSep 2005
  3. Primary completionMar 2009
  4. Study completionMar 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
349 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00231452
Sponsor's protocol ID
AgeMal
Status last verified
Oct 2011
First submitted
30 Sep 2005
Last updated
28 Oct 2011
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 30380038

  • 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.

    PubMed 24674654

  • 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.

    PubMed 22412865

Questions about this trial

What is this clinical trial studying?

A study testing Sulfadoxine-pyrimethamine (SP) + Artesunate (AS) in people with Malaria, run by Hospital Clinic of Barcelona at 1 site in Mozambique.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mozambique. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

(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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00231452, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2011.

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