Plasmodium Falciparum MalariaNCT00138372
Human Immunity to MSP-1 in Western Kenya
An observational study of Plasmodium Falciparum Malaria, run by Case Western Reserve University at 1 site in Kenya.
Trial summary
This is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300 healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of age. Read more about this study
- Who is it for?
- Ages 1 month and olderHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- Type of treatment
- Vaccines
- How many people
- 475 participants
- Where
- 1 siteKenya
- Study dates
- Jul 2004to Apr 2013
- 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 1 month and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Study population will consist of 125 healthy male and female adults older than 18 years from a rural area of Western Kenya AND 300 healthy male and female infants from Western Kenya enrolled at 1 month of age and followed until the age of 3 years. Normal volunteers will be recruited from the CWRU/UHCMC area as well as general local community.
Who may be able to join
- Permanent residency in the study area for ARCS study and within 50 km of Chulaimbo Rural Health Training Center for PIC study.
- Healthy by medical examination.
- Understood and signed written informed consent and is willing to participate in the study.
- ARCs study participants must be older than 18 years of age, and PIC study participants will be enrolled at 1 month and followed until 3 years of age.
- Study participant willing to attend scheduled follow up visits at clinic and willing to have field assistant make home visits during follow-up.
Who cannot join
- Hemoglobin <5 g/dl for children, <10 g/dl for adults.
- Received a blood transfusion within the past 6 months for adults or ever for children.
- Presence or signs of severe complicated falciparum malaria (WHO, 1989).
- Women who are self-reported to be pregnant.
- Unwilling or unable to continue participation.
Trial locations and contacts
1 site in 1 country.
About this study
This is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300 healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of age. Twenty healthy adults (US residents) who have no self-reported history of Malaria exposure, infection or travel to malaria endemic areas of the world will serve as Malaria Naive Negative Controls. The proposed study represents a continuation of molecular and immunologic studies done in human populations describing mechanisms of protection against malaria infection and disease. Human investigation of those experiencing natural exposure to malaria infections are justified since they will eventually be the target population for testing malaria vaccine safety and efficacy.
Read the detailed description
This study will include two major populations: (1) the Adult Repeat Cross Sectional study (ARCS) will involve 125 healthy Kenya-residents male and female aged 18 years and above; and (2) the Pediatric Infant Cohort (PIC) will include 300 healthy male and female infants who are residents of Kenya. In addition, 20 healthy adult US residents, who have no self-reported history of malaria exposure, infection or travel to malaria endemic areas of the world, will serve as Malaria Naive Negative Controls (MNNC). The adult (ARCS) study will consist of 6 venous blood donations to be completed in one year. The primary outcome of the ACRS is to determine the stability of Immune responses to MSP-1 who are clinically protected against P. falciparum infections and the secondary outcome is to measure the level and stability of MSP-1 specific IIA activity, MSP-1 specific T-cell memory phenotypes and immune functions and lastly, to determine the MSP-1 genotypes. The PIC study is both home and clinic-based. The overall duration of this study will be three years. The subjects will be recruited during their routine immunizations visit. The data and sample collections consist of monthly home-visits interspersed by clinic-visits every 6 months until the child reaches 3 years old. The primary outcome of the PIC study is to evaluate the development of humoral and cellular immunity to MSP-1 in healthy children in relation to their history of P. falciparum infections, number of episodes of uncomplicated acute malarial infections in the first 3 years of life and secondary outcome is to measure the acquisition of MSP-1 specific IIA activity, shifts in T-cell memory phenotypes and amalaira-specific immunity and their association with the history of exposure to P. falciparum MSP-1 alleleic variants. For the MNNS study, the primary objective is to optimize molecular and immunologic assays to be used in Kenya and to determine background level responses in healthy adult and the secondary outcomes aims to measure the level of MSP-1 specific IIA-activity, T-cell memory phenotypes and any non-specific immunity to malaria antigens and to provide negative control DNA for P. falciparum detection and genotyping studies. The result of these studies will provide insight into how the frequency and intensity of prior malaria infection and antigenic polymorphism influence the generation and maintenance of T-cell memory and AB responses to merozoite surface proteins in humans.
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- malaria, immunity, MSP-1, Kenya, infants
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Adult Repeat Cross-Sectional study (ARCS) | This group will be enrolled from the sub-location of Kanyawegi, Kisumu District, Nyanza Province. | |
| Prospective Infant Cohort study (PIC) | will be a clinic-based study recruiting infants attending Chulaimbo Rural Health Training Center (CRHTC), Maseno Division, Kisumu District, Nyanza Province for routine immunizations. | |
| Normal volunteers | will be recruited from the CWRU/UHCMC area as well as general local community. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startJul 2004
- Primary completionSep 2008
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Kazura, Case Western Reserve University
- Investigators
- James W Kazura, M.D., Principal investigator, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138372
- Sponsor's protocol ID
- 04-110
- Status last verified
- Jan 2022
- First submitted
- 26 Aug 2005
- Last updated
- 20 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Immunity to MSP-1 in Western Kenya
- ClinicalTrials.gov ID
- NCT00138372
- Acronym / sponsor ID
- 04-110
- Conditions
- Plasmodium Falciparum Malaria
- Keywords
- malaria, immunity, MSP-1, Kenya, infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Jul 2004
- Primary completion
- Sep 2008 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 30 Aug 2005 (estimated)
- 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 is a study of 125 healthy male and female Kenyan adults aged 18 years and above, and 300 healthy male and female Kenyan infants enrolled at 1 month of age and followed to 3 years of age. Twenty healthy adults (US residents) who have no self-reported history of Malaria exposure, infection or travel to malaria endemic areas of the world will serve as Malaria Naive Negative Controls. The proposed study represents a continuation of molecular and immunologic studies done in human populations describing mechanisms of protection against malaria infection and disease. Human investigation of those experiencing natural exposure to malaria infections are justified since they will eventually be the target population for testing malaria vaccine safety and efficacy.
Detailed description
This study will include two major populations: (1) the Adult Repeat Cross Sectional study (ARCS) will involve 125 healthy Kenya-residents male and female aged 18 years and above; and (2) the Pediatric Infant Cohort (PIC) will include 300 healthy male and female infants who are residents of Kenya. In addition, 20 healthy adult US residents, who have no self-reported history of malaria exposure, infection or travel to malaria endemic areas of the world, will serve as Malaria Naive Negative Controls (MNNC). The adult (ARCS) study will consist of 6 venous blood donations to be completed in one year. The primary outcome of the ACRS is to determine the stability of Immune responses to MSP-1 who are clinically protected against P. falciparum infections and the secondary outcome is to measure the level and stability of MSP-1 specific IIA activity, MSP-1 specific T-cell memory phenotypes and immune functions and lastly, to determine the MSP-1 genotypes. The PIC study is both home and clinic-based. The overall duration of this study will be three years. The subjects will be recruited during their routine immunizations visit. The data and sample collections consist of monthly home-visits interspersed by clinic-visits every 6 months until the child reaches 3 years old. The primary outcome of the PIC study is to evaluate the development of humoral and cellular immunity to MSP-1 in healthy children in relation to their history of P. falciparum infections, number of episodes of uncomplicated acute malarial infections in the first 3 years of life and secondary outcome is to measure the acquisition of MSP-1 specific IIA activity, shifts in T-cell memory phenotypes and amalaira-specific immunity and their association with the history of exposure to P. falciparum MSP-1 alleleic variants. For the MNNS study, the primary objective is to optimize molecular and immunologic assays to be used in Kenya and to determine background level responses in healthy adult and the secondary outcomes aims to measure the level of MSP-1 specific IIA-activity, T-cell memory phenotypes and any non-specific immunity to malaria antigens and to provide negative control DNA for P. falciparum detection and genotyping studies. The result of these studies will provide insight into how the frequency and intensity of prior malaria infection and antigenic polymorphism influence the generation and maintenance of T-cell memory and AB responses to merozoite surface proteins in humans.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Adult Repeat Cross-Sectional study (ARCS) | – | –This group will be enrolled from the sub-location of Kanyawegi, Kisumu District, Nyanza Province. |
| Prospective Infant Cohort study (PIC) | – | –will be a clinic-based study recruiting infants attending Chulaimbo Rural Health Training Center (CRHTC), Maseno Division, Kisumu District, Nyanza Province for routine immunizations. |
| Normal volunteers | – | –will be recruited from the CWRU/UHCMC area as well as general local community. |
Who may qualify
- Ages
- 1 month and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population will consist of 125 healthy male and female adults older than 18 years from a rural area of Western Kenya AND 300 healthy male and female infants from Western Kenya enrolled at 1 month of age and followed until the age of 3 years. Normal volunteers will be recruited from the CWRU/UHCMC area as well as general local community.
Key inclusion criteria (5 listed)
- Permanent residency in the study area for ARCS study and within 50 km of Chulaimbo Rural Health Training Center for PIC study.
- Healthy by medical examination.
- Understood and signed written informed consent and is willing to participate in the study.
- ARCs study participants must be older than 18 years of age, and PIC study participants will be enrolled at 1 month and followed until 3 years of age.
- Study participant willing to attend scheduled follow up visits at clinic and willing to have field assistant make home visits during follow-up.
Key exclusion criteria (5 listed)
- Hemoglobin <5 g/dl for children, <10 g/dl for adults.
- Received a blood transfusion within the past 6 months for adults or ever for children.
- Presence or signs of severe complicated falciparum malaria (WHO, 1989).
- Women who are self-reported to be pregnant.
- Unwilling or unable to continue participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 20 Jan 2022.
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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.
James W Kazura, M.D. principal investigator
Case Western Reserve University
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 Falciparum Malaria, run by Case Western Reserve University at 1 site in Kenya.
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 5 inclusion and 5 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 20 Jan 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 Kenya. 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.
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 20 Jan 2022.