NCT06153862

Brief Summary

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,640

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 23, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2023

Completed
8 months until next milestone

First Posted

Study publicly available on registry

December 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 1, 2023

Status Verified

November 1, 2023

Enrollment Period

1.9 years

First QC Date

March 31, 2023

Last Update Submit

November 22, 2023

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

  • MSP1-19 malaria antigen

    Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.

    one year

Secondary Outcomes (1)

  • Anti-MSP1-19 malaria antibody

    three years

Study Arms (2)

Malaria patients

ACTIVE COMPARATOR

Malaria patients

Diagnostic Test: Immuno analytical assay

Non malaria donors

ACTIVE COMPARATOR

Healthy individuals (donors; controls)

Diagnostic Test: Immuno analytical assay

Interventions

Immuno analytical assayDIAGNOSTIC_TEST

The eluted antibodies will be used in immuno-analytical assays, such as ELISA or Western blot, or surface-coated bead-based screening platforms using either recombinantly produced MSP119 fusion protein or synthetic peptides derived from MSP119 as antigens according to standard protocols.

Malaria patientsNon malaria donors

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with confirmed malaria (uncomplicated and complicated cases) are diagnosed by the national guidelines.
  • Healthy individuals without confirmed malaria per the national guidelines.
  • Adults and parents or guardians of children below 12 years willing to participate based on signed informed consent.
  • Willing to give assent to adolescents between the ages of 12 and below 18 years.
  • Willing to give a blood sample for the necessary investigations as explained in the informed consent.
  • Willing to adhere to study procedures and a follow-up visit at the clinic, hospital, or health facility.

You may not qualify if:

  • Anyone refusing informed consent (or assent for adolescents) to be part of the study.
  • Refusal to study procedures or giving of sample for the necessary investigations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shai-Osudoku District Hospital

Dodowa, Outside North America, GAR, Ghana

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Adjei

    Shai-Osudoku District Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 31, 2023

First Posted

December 1, 2023

Study Start

September 23, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

December 1, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

Data will be deposited in Zenodo's open data repository service (CERN). Additionally, all datasets will be stored on external drives and in-house computers. The data will be deposited as soon as possible unless there is a legitimate reason and a decision has been agreed upon to protect the data. Before the upload of datasets, a unique DOI will be assigned, which will be stated in publications to direct readers to the primary datasets. Due to the public health interest of the outcome of this work, the datasets will be shared directly with relevant stakeholders for a wider public audience. There will be restricted datasets on the subject partaking in the study to protect their identity. This restriction will not affect the dissemination of the research outputs to the broader public. Although the datasets will be stored in the Zenodo repository for long-term preservation, the in-house datasets will be stored on an external drive for additional long-term benefit.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Five years
Access Criteria
The IPD can be accessed by requesting the Principal Investigator or accessing the information directly from Zenodo's open data repository service.

Locations

GH(1)