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

NCT03304691 | Completed

• 2 other identifiers: 99991716517-I-N165
• Study Type: observational
• Target: 667
• Locations: 1 country
• Sites: 2

Brief 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. ...

Conditions

Malaria

Keywords

Malaria; Parasitemia; Anemia; Ligand; Anopheles gambiae; Natural History

Outcome Measures

Primary Outcomes (1)

• Identify the P. vivax ligands for infection of Duffy blood group negative Africans by RNA sequencing (RNAseq) of blood from P. vivax cases.

  Identify the P. vivax ligands for infection of Duffy blood group negative Africans by RNA sequencing (RNAseq) of blood from P. vivax cases.

  Monthly surveillance visits throughout length of the study

Secondary Outcomes (5)

• Determine the prevalence of P. vivax in Yirimadio in Duffy negative population

  Beginning, peak, and end of transmission season

• Identify the vector populations in and around the study area that may transmit malaria, including during the dry season, as well as the infection rates in these populations.

  Monthly surveillance visits throughout length of the study

• Study the association between P. vivax parasitemia and anemia in Duffy-negative Africans.

  Monthly surveillance visits throughout length of the study

• Determine by stool examinations the presence of hypnozoites in the liver that fail to cause blood infections.

  Monthly surveillance visits throughout length of the study

• Determine the number of clones of P. vivax circulating in the community by DNA sequencing of polymorphic parasite proteins.

  Monthly surveillance visits throughout length of the study

Study Arms (2)

Bandiagara, Mali

Children of both sexes between 6 months and 10 years of age.

Yirimadio, Bamako, Mali

Children and adults of both sexes 6 months and older.

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be selected to enroll based on community permission and sensitization strategies for both the Bandiagara and Yirimadio sites.

You may qualify if:

• Is greater than or equal to 6 months and less than or equal to 10 years of age
• Residing in Bandiagara for at least 6 months prior to screening
• Will be available to attend visits during this study
• Agrees to provide urine and stool samples during this study
• Agrees to allow storage of samples for future research.
• Aged greater than or equal to 6 months;
• Residing in Yirimadio for at least 6 months prior to screening.
• EXCLUISION CRITERIA:
• \) Has any underlying conditions that, in the judgement of the clinical investigators, could increase the risk to the subject.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (2)

Yirimadio Community Health Center

Bamako, Mali

Location

Bandiagara Malaria Program (BMP) Clinic

Bandiagara, Mali

Location

Related Publications (3)

• Gunalan K, Niangaly A, Thera MA, Doumbo OK, Miller LH. Plasmodium vivax Infections of Duffy-Negative Erythrocytes: Historically Undetected or a Recent Adaptation? Trends Parasitol. 2018 May;34(5):420-429. doi: 10.1016/j.pt.2018.02.006. Epub 2018 Mar 9.

  PMID: 29530446 BACKGROUND

• Gunalan K, Sa JM, Moraes Barros RR, Anzick SL, Caleon RL, Mershon JP, Kanakabandi K, Paneru M, Virtaneva K, Martens C, Barnwell JW, Ribeiro JM, Miller LH. Transcriptome profiling of Plasmodium vivax in Saimiri monkeys identifies potential ligands for invasion. Proc Natl Acad Sci U S A. 2019 Apr 2;116(14):7053-7061. doi: 10.1073/pnas.1818485116. Epub 2019 Mar 14.

  PMID: 30872477 BACKGROUND

• Niangaly A, Karthigayan Gunalan, Amed Ouattara, Coulibaly D, Sa JM, Adams M, Travassos MA, Ferrero J, Laurens MB, Kone AK, Thera MA, Plowe CV, Miller LH, Doumbo OK. Plasmodium vivax Infections over 3 Years in Duffy Blood Group Negative Malians in Bandiagara, Mali. Am J Trop Med Hyg. 2017 Sep;97(3):744-752. doi: 10.4269/ajtmh.17-0254. Epub 2017 Jul 27.

  PMID: 28749772 BACKGROUND

MeSH Terms

Conditions

Malaria; Parasitemia; Anemia

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Louis H Miller, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2017
• First Posted: October 9, 2017
• Study Start: June 30, 2021
• Primary Completion: March 1, 2023
• Study Completion: March 30, 2023
• Last Updated: October 31, 2023

Record last verified: 2023-02

Locations

MA (2)