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Assessing the Safety, Immunogenicity and Ex-vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Assessing the Safety, Immunogenicity and Ex-vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant

A Phase Ib Open Label Clinical Trial of the Safety, Immunogenicity and ex Vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant in Healthy Adults, Adolescents and Young Children in Burkina Faso

NCT06549257•University of Oxford

View on ClinicalTrials.gov

Summary

Assessing the safety, immunogenicity and ex-vivo efficacy of two transmission blocking vaccines (Pfs25-IMX313 in Matrix M and Pfs48/45 in Matrix M alone and co-administered) in Burkina Faso, in 18-45 years, 12-17 years and 05-11 year olds.

Eligibility

Age

5 - 45 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•All volunteers must satisfy all the following criteria to be eligible for the study
•Healthy adults, adolescents and children based on medical history, physical examination and baseline blood tests
•Age: 5-45 years of age at the time of enrollment (i.e. up to the day before their 46th birthday).
•Signed informed consent/thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the participant to join the trial (if under the age of 18). For participants aged 18 and above, signed informed consent/thumb-printed of the participant.
•Signed informed assent/thumb-printed and witnessed assent obtained from participants (for age group 12-17 years old only).
•The investigator believes that the participant and their parents/guardians (if participant aged under 18) can and will comply with the requirements of the protocol.
•The participant is a permanent resident of the study area and likely to remain a resident for the duration of the trial.
•Agreement to refrain from blood donation for the duration of the study
•Female participants of childbearing potential (WOCBP) must agree to avoid pregnancy during the duration of the study and practice continuous effective contraception if sexually active.
•Acceptable forms of contraception for female volunteers of childbearing potential include:
+4 more criteria

Exclusion Criteria

•The volunteer has previously received a malaria vaccine.
•The volunteer is enrolled in another malaria intervention trial.
•The volunteer is currently participating in another clinical trial if likely to affect data interpretation of either trial.
•The volunteer has a history of allergic disease or reactions likely to be exacerbated by any component of the study vaccines.
•The volunteer has a history of allergic reactions, significant IgE-mediated events or anaphylaxis to previous immunisations.
•The volunteer has anaemia associated with clinical signs of decompensation, or a haemoglobin of ≤ 7.4 g/dL
•The volunteer has been administered immunoglobulins and/or any blood products including blood transfusion within the three months preceding the planned administration of the vaccine candidate.
•Receipt of a vaccine 30 days prior to study vaccine administration or planning to receive one within 30 days after administration of any of the doses of the study vaccine.
•The volunteer has malnutrition requiring hospital admission.
•The volunteer has an acute or chronic, clinically significant pulmonary, cardiovascular, gastrointestinal, endocrine, neurological, skin, hepatic or renal functional abnormality, as determined by medical history, physical examination or laboratory tests
+7 more criteria

Locations (1)

Institut des Sciences et Techniques (INSTech)

Bobo-Dioulasso, Burkina Faso

Key Dates

Start Date

July 7, 2025

Primary Completion Date

September 1, 2026

Completion Date

September 1, 2026

Last Updated

February 23, 2026

Enrollment

ACTUAL participants

Conditions

Plasmodium Falciparum Malaria

Interventions

Pfs25-IMX313, Pfs48/45

BIOLOGICAL

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COMPLETEDPHASE3

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COMPLETED

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Assessing the Safety, Immunogenicity and Ex-vivo Efficacy of Two Candidate Malaria Transmission Blocking Vaccines, Pfs25-IMX313 and Pfs45/48 Administered Alone and in Combination, in Matrix-M Adjuvant

Inclusion Criteria

Exclusion Criteria

Triple Artemisinin-based Combination Therapy for Delaying Drug Resistance Development - a Randomized Clinical Trial

A Trial to Compare the Efficacy, Safety and Tolerability of Combinations of 3 Anti-malarial Drugs Against Combina-tions of 2 Anti-malarial Drugs.

Diagnostic and Prognostic Biomarkers for Childhood Bacterial Pneumonia

Efficacy and Safety of KAF156 in Combination With LUM-SDF in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria

Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria

Artemisinin-resistant Malaria in Cambodia