Host Immune Dynamics Following Seasonal Malaria Chemoprevention in African Children

NCT06524336 | Active Not Recruiting

• 1 other identifier: MCUGSMC24001
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to identify immune features linked to protection against malaria, examining variations by age and sex, and measuring changes in immune responses over time following seasonal malaria chemoprevention (SMC). The primary objectives are:

• Face-to-face interviews by trained research assistants.
• Clinical assessments, including temperature, weight, and mid-upper arm circumference (MUAC).
• Sickle cell status testing at enrolment via samples analyzed at the Molecular Research Laboratory (MOLAB).
• Hemoglobin measurement using a HemoCue analyzer. Malaria Diagnosis:
• Blood samples collected for malaria diagnosis using rapid diagnostic tests (RDTs) and microscopy.
• RDTs, such as Paracheck Pf, will be performed according to manufacturer instructions, with results available within 15 minutes.
• Participants testing positive for malaria will receive a full course of antimalarial treatment and counselling to visit the nearest health facility if symptoms worsen. Thick Blood Smears:
• New glass slides labelled with participant ID will be used for thick blood smears.
• Blood smears will be dried and stored in a cool, dust-free environment before transportation to central laboratories.
• Slides will be stained with 2% Giemsa for 30 minutes and evaluated for parasitemia and gametocytes, with densities calculated accordingly. The study will help understand the immune responses to malaria and the efficacy of SMC in different age groups.

Conditions

Malaria,Falciparum

Keywords

malaria; blood stage immunity; anti-disease immunity; SMC

Outcome Measures

Primary Outcomes (2)

• Antibody immune response

  Number of study participants with protective antimalarial antibodies

  one year

• Innate and adaptive immune responses

  Number of study participants with cellular phenotypes and functions that are protective from malaria

  one year

Secondary Outcomes (1)

• surrogate markers that predict risk of malaria

  one year

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of children aged 3 to 59 months - the target age group for SMC. We will also enroll a representative sample of children in the 5-15 years age group to characterize immune dynamics and responses in this age group as a comparator age group. These children will be further categorized into different groups according to their previous exposure to SMC to include the following; * Group 1: Children with no prior intake of SMC (Katakwi district) - we will enroll a total of 40 children in this group in the two age categories (3 to 59 months and 5-15 years) * Group 2: Children who have received at least two rounds of SMC (Napak district) - we will enroll 130 children aged 3 to 59 months in this group * Group 3: Children who have received at least three rounds of SMC (Moroto district) - we will enroll 130 children aged 3 to 59 months in this group

You may qualify if:

• Children aged 3 to 59 months and 5-15 years in the selected districts
• Provision of Informed consent by parents/caregivers

You may not qualify if:

• Children known to be immunosuppressed due to malnutrition, HIV or other chronic diseases

Sponsors & Collaborators

• Malaria Consortium: lead
• Stanford University: collaborator

Study Sites (1)

Moroto Hospital

Moroto, Karamoja, Uganda

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

filter paper, plasma

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

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

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: July 29, 2024
• Study Start: June 12, 2024
• Primary Completion: October 28, 2024
• Study Completion: October 28, 2024
• Last Updated: July 29, 2024

Record last verified: 2024-07

Locations

UG (1)