Plasmodium Malariae InfectionISAMIMANCT05650502
Impact of Seasonal Malaria Chemoprevention on Immunity Against Malaria Among Children in Northern Benin
An observational study of Plasmodium Malariae Infection and SMC, run by Université de Parakou at 1 site in Benin.
Trial summary
This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection. Read more about this study
- Who is it for?
- Ages 6 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Malariae Infection, SMC, Immune System Disease
- What is being tested?
- saisonal malaria chimoprevention
- How many people
- 440 participants
- Where
- 1 siteBenin
- Study dates
- 1 Jun 2021to 30 May 2022
- How long will I take part?
- 12 Months
- Phase
- Observational
- 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 6 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children who meet the inclusion and exclusion criteria, living in the communes of Cobly and Tchaourou located in northern Benin, whether or not they have received Saisonal malaria chimotreatment, will be recruited.
Who may be able to join
- Aged between 6 and 59 months
- Have been selected and accepted to receive SMC treatment (SP-AQ) in the intervention site and not in the control site
- Be able to take drugs
Who cannot join
- Child whose parents will no longer consent at some point in the study for one reason or another
- Children suffering from a chronic disease
- Intolerance to certain drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Seasonal Malaria Chemoprevention on the Acquisition and Maintenance of Immunity Against Malaria Among Children in Northern Benin
This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection.
This is a cross-sectional study on children aged 6 to 59 months with/without SMC in two villages in northern Benin. Sociodemographic and clinical data as well as repeated blood samples will be collected from 440 children (before, during and after treatment). Samples will be analyzed using a Luminex assay to investigate antibody responses to MSP (merozoite surface protein) , Glurp (Glutamate-Rich Protein) and a panel of PfEMP1. qPCR (quantitative polymerase chain reaction) will be used to detect the prevalence of malaria at this period and parasites infecting children will be characterize during the follow up.
Read the detailed description
Study location and population The study was conducted in parallel in two different sites, the health districts of Cobly and Tchaourou (two villages) located in northern Benin. These two districts have been chosen based on the Ministry of Health's programming for the implementation of SMC. The two sites were very similar in terms of malaria transmission characteristics and epidemiology, with the difference that SMC was implemented in Cobly but not in Tchaourou. Participants will be informed on the importance of SMC. A written informed consent was collected from parent or guardian of each child. Participation was entirely voluntary.
Study Design and procedures This is a case control study focuses on the follow-up over 12 months of children aged 6 to 59 months in northern Benin. The study was conducted in collaboration with National Malaria Control Program (NMCP). Demographic data generated by the NMCP had allow us for a random selection of children from random households. In both intervention and control sites, equal numbers of children were included. The study team visited each selected household to inform members. A monthly visit has been set up for monitoring. Children of consenting parents or guardians were recruited and parents/guardians were taken through a questionnaire administered by the researcher or an assistant (clinician). 1 ml of peripheral venous blood was collected into collection tubes and transferred to the Center for Expertise and Enhancing Research in Epidemiology and Public Health (CEEREPH) at the University of Parakou where a blood smear was prepared from each sample. Fifty microliters of blood have been transferred to Whatman 3MM filter paper and stored at room temperature for DNA extraction. The remaining whole blood have been centrifuged. The plasma and red blood cells were aliquoted. Samples was collected at 4 times during the 12 months follow-up period. The first samples were collected at the beginning of SMC implimentation (before children receive the first SMC dose), the second blood sample were collected at the day of the third dose of SMC, the third, at three month after the last dose of SMC and the fourth, six months after the last dose of SMC).
Malaria prevalence Thick and thin blood smears whave been prepared from all samples at all four times. Thick smears will be fixed in methanol. All slides were air dried and stained using Giemsa stain 3% for 45-60 min. Once dry, the stained thick and thin blood films were examined microscopically using a routine procedure. Parasite densities was recorded as the number of parasites/μl of blood assuming an average leukocyte count of 8,000/μl of blood. Dried blood spots were air dried and stored individually in small Ziploc bags with a desiccant. Plasmodium spp detection was performed using a real time polymerase chain reaction (qPCR).
Anti-PfEMP1 antibody response Plasmodium falciparum-encoded variant surface antigens (VSA) are expressed on the surface of infected erythrocytes (IE) and mediate binding to a range of endothelial cell receptors. The best characterized VSA are the var gene-encoded P. falciparum erythrocyte membrane protein 1 (PfEMP1) family in two exon units. Exon I codes for the extracellular and variable part of the protein as well as a transmembrane region and Exon II encodes the intracellular and relatively conserved acidic terminal segment (ATS). The most variable part of the protein contains a N-terminal segment followed by segments composed of three domain types; Duffy binding-like domains (DBL-domains): Cysteine-rich inter-domain regions (CIDRs) and C2. In this study, a panel of plasma antibody was quantified using microsphere bead-coupled proteins comprising 28 P. falciparum-derived antigens and tetanus toxoid, using the Luminex platform. The panel includes VAR2CSA (the VSA associated to placental malaria) and 25 HIS-tagged CIDR proteins representing all three main groups of PfEMP1, merozoite surface protein 1 (MSP1) and apical membrane antigen 1 (AMA1).
- Conditions
- Plasmodium Malariae Infection, SMC, Immune System Disease
- Being tested
- saisonal malaria chimoprevention
- Keywords
- Seasonal malaria chemoprevention, Malaria, Children, Anti PfEMP1
- Medical subject headings
- Immune System Diseases, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saisonal malaria chimopreventionDrug
Investigate the impact of saisonal malaria chimoprevention on children anti PfEMP1 construction and maintenance and their succeptibility to malaria infection
| Study group | Role | What they receive |
|---|---|---|
| ISC (ISAMIMA children group-Cobly) | This group included children from 6 to 59 months living in Cobly and receiving the SMC treatment. The treatment is administered for three consecutives days for 4 months (from july to october).
For children under 12 months: one dose of SP 250/12.5mg on day 1 AQ 75mg once daily for 3 days For children from 12 to 59 months: one dose of SP 500/25mg on day 1 AQ 150 mg once daily for 3 days A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April. Receives: Drug: saisonal malaria chimoprevention | |
| IST (ISAMIMA children group-Tchaourou) | This group included children from 6 to 59 months living inTchaourou and who did not receiving the SMC treatment.
A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April. Receives: Drug: saisonal malaria chimoprevention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficiency of Seasonal malaria chemoprevention
Malaria prevalence during the intervention
Measured: January 2023
Secondary outcomes (1)
Impact of Seasonal malaria chemoprevention
Hospital frequency rate of children
Measured: June 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start1 Jun 2021
- Primary completion30 Aug 2021
- Study completion30 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Malariae InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 440 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Université de Parakou
- Sponsor type
- University, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, University of Copenhagen, University of Ghana, Institut de Recherche Clinique du Benin, Hôpital Cochin
- Responsible party
- Principal investigator, Azizath Moussiliou, Université de Parakou
- Investigators
- Nicaise TIUKUE NDAM, Professor, Study chair, Institut régional de développement IRD (UMR261)Adrian LUTY, Professor, Study chair, Institut régional de développement IRD (UMR261)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05650502
- Sponsor's protocol ID
- University of Parakou
- Acronym
- ISAMIMA
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 28 Dec 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Protocol and the informed consent will be shared with other researchers
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Seasonal Malaria Chemoprevention on the Acquisition and Maintenance of Immunity Against Malaria Among Children in Northern Benin
- ClinicalTrials.gov ID
- NCT05650502
- Acronym / sponsor ID
- ISAMIMA / University of Parakou
- Conditions
- Plasmodium Malariae Infection, SMC, Immune System Disease
- Keywords
- Seasonal malaria chemoprevention, Malaria, Children, Anti PfEMP1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 440 participants (actual)
- Lead sponsor
- Université de ParakouUniversity, hospital or other
- Collaborators
- Institut de Recherche pour le Developpement, University of Copenhagen, University of Ghana, Institut de Recherche Clinique du Benin, Hôpital Cochin
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 May 2022 (actual)
- First posted
- 14 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the effects of SMC (Seasonal malaria chemoprevention) with Sulfadoxine-Pyrimethamine (SP) and Amodiaquine (AQ) on the evolution of anti-malarial immunity of children and their susceptibility to malarial infection.
This is a cross-sectional study on children aged 6 to 59 months with/without SMC in two villages in northern Benin. Sociodemographic and clinical data as well as repeated blood samples will be collected from 440 children (before, during and after treatment). Samples will be analyzed using a Luminex assay to investigate antibody responses to MSP (merozoite surface protein) , Glurp (Glutamate-Rich Protein) and a panel of PfEMP1. qPCR (quantitative polymerase chain reaction) will be used to detect the prevalence of malaria at this period and parasites infecting children will be characterize during the follow up.
Detailed description
Study location and population The study was conducted in parallel in two different sites, the health districts of Cobly and Tchaourou (two villages) located in northern Benin. These two districts have been chosen based on the Ministry of Health's programming for the implementation of SMC. The two sites were very similar in terms of malaria transmission characteristics and epidemiology, with the difference that SMC was implemented in Cobly but not in Tchaourou. Participants will be informed on the importance of SMC. A written informed consent was collected from parent or guardian of each child. Participation was entirely voluntary.
Study Design and procedures This is a case control study focuses on the follow-up over 12 months of children aged 6 to 59 months in northern Benin. The study was conducted in collaboration with National Malaria Control Program (NMCP). Demographic data generated by the NMCP had allow us for a random selection of children from random households. In both intervention and control sites, equal numbers of children were included. The study team visited each selected household to inform members. A monthly visit has been set up for monitoring. Children of consenting parents or guardians were recruited and parents/guardians were taken through a questionnaire administered by the researcher or an assistant (clinician). 1 ml of peripheral venous blood was collected into collection tubes and transferred to the Center for Expertise and Enhancing Research in Epidemiology and Public Health (CEEREPH) at the University of Parakou where a blood smear was prepared from each sample. Fifty microliters of blood have been transferred to Whatman 3MM filter paper and stored at room temperature for DNA extraction. The remaining whole blood have been centrifuged. The plasma and red blood cells were aliquoted. Samples was collected at 4 times during the 12 months follow-up period. The first samples were collected at the beginning of SMC implimentation (before children receive the first SMC dose), the second blood sample were collected at the day of the third dose of SMC, the third, at three month after the last dose of SMC and the fourth, six months after the last dose of SMC).
Malaria prevalence Thick and thin blood smears whave been prepared from all samples at all four times. Thick smears will be fixed in methanol. All slides were air dried and stained using Giemsa stain 3% for 45-60 min. Once dry, the stained thick and thin blood films were examined microscopically using a routine procedure. Parasite densities was recorded as the number of parasites/μl of blood assuming an average leukocyte count of 8,000/μl of blood. Dried blood spots were air dried and stored individually in small Ziploc bags with a desiccant. Plasmodium spp detection was performed using a real time polymerase chain reaction (qPCR).
Anti-PfEMP1 antibody response Plasmodium falciparum-encoded variant surface antigens (VSA) are expressed on the surface of infected erythrocytes (IE) and mediate binding to a range of endothelial cell receptors. The best characterized VSA are the var gene-encoded P. falciparum erythrocyte membrane protein 1 (PfEMP1) family in two exon units. Exon I codes for the extracellular and variable part of the protein as well as a transmembrane region and Exon II encodes the intracellular and relatively conserved acidic terminal segment (ATS). The most variable part of the protein contains a N-terminal segment followed by segments composed of three domain types; Duffy binding-like domains (DBL-domains): Cysteine-rich inter-domain regions (CIDRs) and C2. In this study, a panel of plasma antibody was quantified using microsphere bead-coupled proteins comprising 28 P. falciparum-derived antigens and tetanus toxoid, using the Luminex platform. The panel includes VAR2CSA (the VSA associated to placental malaria) and 25 HIS-tagged CIDR proteins representing all three main groups of PfEMP1, merozoite surface protein 1 (MSP1) and apical membrane antigen 1 (AMA1).
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ISC (ISAMIMA children group-Cobly) | – | Drug: saisonal malaria chimopreventionThis group included children from 6 to 59 months living in Cobly and receiving the SMC treatment. The treatment is administered for three consecutives days for 4 months (from july to october). For children under 12 months: one dose of SP 250/12.5mg on day 1 AQ 75mg once daily for 3 days For children from 12 to 59 months: one dose of SP 500/25mg on day 1 AQ 150 mg once daily for 3 days A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April. |
| IST (ISAMIMA children group-Tchaourou) | – | Drug: saisonal malaria chimopreventionThis group included children from 6 to 59 months living inTchaourou and who did not receiving the SMC treatment. A monthly visit was planned for monitoring during the follow up. Sample was collected in jun, september, january and April. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children who meet the inclusion and exclusion criteria, living in the communes of Cobly and Tchaourou located in northern Benin, whether or not they have received Saisonal malaria chimotreatment, will be recruited.
Key inclusion criteria (3 listed)
- Aged between 6 and 59 months
- Have been selected and accepted to receive SMC treatment (SP-AQ) in the intervention site and not in the control site
- Be able to take drugs
Key exclusion criteria (3 listed)
- Child whose parents will no longer consent at some point in the study for one reason or another
- Children suffering from a chronic disease
- Intolerance to certain drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| saisonal malaria chimopreventionInvestigate the impact of saisonal malaria chimoprevention on children anti PfEMP1 construction and maintenance and their succeptibility to malaria infection | Drug | ISC (ISAMIMA children group-Cobly), IST (ISAMIMA children group-Tchaourou) |
Primary outcome
Efficiency of Seasonal malaria chemoprevention
Time frame: January 2023
Malaria prevalence during the intervention
1 secondary outcome
Impact of Seasonal malaria chemoprevention
Time frame: June 2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2022.
- Individual participant dataSharing planned: No. Protocol and the informed consent will be shared with other researchers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicaise TIUKUE NDAM, Professor study chair
Institut régional de développement IRD (UMR261)
Adrian LUTY, Professor study chair
Institut régional de développement IRD (UMR261)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Plasmodium Malariae Infection and SMC, run by Université de Parakou at 1 site in Benin.
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 3 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 Dec 2022. 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 Benin. 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. 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?
Efficiency of Seasonal malaria chemoprevention (time frame: January 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2022.