Human Immunity to MSP-1 in Western Kenya

NCT ID: NCT00138372

Last Updated: 2022-01-20

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 475 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2013-04-30

Brief 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. 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.

Conditions

Plasmodium Falciparum Malaria

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult Repeat Cross-Sectional study (ARCS)

This group will be enrolled from the sub-location of Kanyawegi, Kisumu District, Nyanza Province.

No interventions assigned to this group

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.

No interventions assigned to this group

Normal volunteers

will be recruited from the CWRU/UHCMC area as well as general local community.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Permanent residency in the study area for ARCS study and within 50 km of Chulaimbo Rural Health Training Center for PIC study.

2. Healthy by medical examination.

3. Understood and signed written informed consent and is willing to participate in the study.

4. 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.

5. Study participant willing to attend scheduled follow up visits at clinic and willing to have field assistant make home visits during follow-up.

Exclusion Criteria

1. Hemoglobin <5 g/dl for children, <10 g/dl for adults.

2. Received a blood transfusion within the past 6 months for adults or ever for children.

3. Presence or signs of severe complicated falciparum malaria (WHO, 1989).

4. Women who are self-reported to be pregnant.

5. Unwilling or unable to continue participation.

• Minimum Eligible Age: 1 Month
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

James Kazura

Distinguished University Professor School of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James W Kazura, M.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Kenya Medical Research Institute

Kisumu, , Kenya

Countries

Kenya

Other Identifiers

04-110

Identifier Type: -

Identifier Source: org_study_id