Molecular Basis of Erythrocyte Invasion by Plasmodium Vivax Into Duffy-Negative Erythrocytes in Mali

  • STATUS
    Recruiting
  • End date
    Apr 30, 2023
  • participants needed
    900
  • sponsor
    National Institute of Allergy and Infectious Diseases (NIAID)
Updated on 25 July 2022
anemia
Accepts healthy volunteers

Summary

Background

Malaria is caused by parasites carried by some mosquitos. When the mosquitos bite people, the parasites can infect them. One of these parasites is Plasmodium vivax (P. vivax). Some children have P. vivax in their blood. They did not have malaria symptoms, but some also had a blood problem called anemia. This can make people feel tired or weak. This could have been caused by P. vivax. Researchers want to know how P. vivax infects these children, and if it affects their health.

Objective

To collect blood, stool, and urine monthly from children to look for infections with P. vivax, worms, and other parasites.

Eligibility

Children between 6 months and 10 years old

Design

For screening, the study will be explained to the participant s parents or guardians, who will provide consent.

Participants will have a visit once a month for about 3 months, from November to January, and then for about 6 months from June to November 2018. Visits include:

Questions about their health

Medical history

Physical exam

Blood draw by pricking the finger tip

Urine and stool collection. They may collect these at home and bring them back.

If participants have P. vivax in their blood, them may need to come back to the clinic within 3 days. They will have blood taken from their arm using a needle.

If participants feel ill during the study, they can go to the clinic for an exam and blood tests.

If participants develop malaria while on the study, they will be treated.

Participants samples will be stored for future research studies.

...

Description

Plasmodium vivax was thought not to be a problem in Duffy blood group negative Africans. However, recent research has found that P. vivax infection occurs not only in areas where Duffy-positive and -negative people live side-by-side, but also in areas where populations are predominantly Duffy-negative, such as Bandiagara, Mali. In this region, our research group recently observed 25 P. vivax infections in children, all of whom were Duffy-negative. Furthermore, some preliminary data suggest that, despite having extremely low parasitemia and no malarial symptoms (no fever, muscle aches, or chills), the children of Bandiagara with P. vivax may have a drop in hemoglobin.

The present study involves two substudies to detect P. vivax infections in children and adults of two predominantly Duffy-negative Malian populations where P. vivax infections have previously been identified. The cohort study will be conducted in the Bandiagara region. We will conduct physical exams and collect blood, urine, and stool samples at baseline and monthly (urine samples will be collected only at baseline) for about 10 months. Our goal is to detect and characterize P. vivax infections, focusing on molecularly characterizing how P. vivax invades erythrocytes in Duffy-negative individuals. Specifically, we want to identify the parasite ligands involved in this invasion. We will use RNA sequencing (RNAseq) of P. vivax in blood samples of infected subjects to define the level of expression of parasite invasion ligands. From the parasite DNA found in blood samples, we will determine whether there is gene expansion of the parasite ligand Duffy binding protein (PvDBP) (the number of copies of PvDBP in each genome), and identify the sequence of PvDBP to determine whether it can bind an erythrocyte receptor other than the Duffy blood group antigen (i.e., Duffy-negative erythrocytes). An additional focus will be whether P. vivax leads to anemia in the Duffy-negative children.

In addition, we will conduct a cross-sectional study to investigate the prevalence of P. vivax in the general population in Yirimadio, a periurban setting of Bamako, which is the sole place in Mali besides Bandiagara where P. vivax infections have been reported in Duffy-negative individuals. This will be achieved by undertaking a cross-sectional survey. Subjects will provide blood for blood smear and filter paper analyses to identify the presence of P. vivax infection at 3 different time points.

Details
Condition Malaria
Clinical Study IdentifierNCT03304691
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last Modified on25 July 2022

Eligibility

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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