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

NCT ID: NCT06549257

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-09-30

Brief 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.

Conditions

Plasmodium Falciparum Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1 - Pfs25-IMX313

Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M.

Group Type: EXPERIMENTAL

Pfs25-IMX313, Pfs48/45

Intervention Type: BIOLOGICAL

Two soluble protein vaccines.

Group 2 - Pfs48/45

Vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M.

Group Type: EXPERIMENTAL

Pfs25-IMX313, Pfs48/45

Intervention Type: BIOLOGICAL

Two soluble protein vaccines.

Group 3 - Pfs25-IMX313 and Pfs48/45

Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M and vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M.

Group Type: EXPERIMENTAL

Pfs25-IMX313, Pfs48/45

Intervention Type: BIOLOGICAL

Two soluble protein vaccines.

Interventions

Pfs25-IMX313, Pfs48/45

Two soluble protein vaccines.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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:

• Established use of oral, injected or implanted hormonal methods of contraception.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
• Total abdominal hysterectomy.
• Sex abstinence/not sexually active

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
• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
• Pregnancy, lactation or intention to become pregnant during the study.
• Hepatitis B surface antigen (HBsAg) detected in serum.
• Antibodies to HCV (HCV-Ab) detected in serum.
• Any other significant disease, disorder, or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

The following criteria should be checked during the study, prior to each vaccination:

• Any significant disease, disorder or situation which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

European and Developing Countries Clinical Trials Partnership (EDCTP)

OTHER_GOV

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paola Cicconi, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Central Contacts

Chris L williams, PhD

Role: CONTACT

chris.williams@ndm.ox.ac.uk

07979513371

Sumi Biswas, PhD

Role: CONTACT

SUMI.BISWAS@NDM.OX.AC.UK

Other Identifiers

VAC099

Identifier Type: -

Identifier Source: org_study_id