Plasmodium Falciparum MalariaPhase 1/2NCT06549257
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 1/2 study testing Pfs25-IMX313, Pfs48/45 in people with Plasmodium Falciparum Malaria, run by University of Oxford at 1 site in Burkina Faso.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Plasmodium Falciparum Malaria
- What is being tested?
- Pfs25-IMX313, Pfs48/45
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteBurkina Faso
- Study dates
- 7 Jul 2025to Sep 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Burkina Faso1 site
Institut des Sciences et Techniques (INSTech)
Bobo-Dioulasso, 01 BP 2779
About this study
Official title: 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
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
- Being tested
- Pfs25-IMX313, Pfs48/45
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pfs25-IMX313, Pfs48/45Biological
Two soluble protein vaccines.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 - Pfs25-IMX313 | Experimental | Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M. Receives: Biological: Pfs25-IMX313, Pfs48/45 |
| Group 2 - Pfs48/45 | Experimental | Vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M. Receives: Biological: Pfs25-IMX313, Pfs48/45 |
| Group 3 - Pfs25-IMX313 and Pfs48/45 | Experimental | 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. Receives: Biological: Pfs25-IMX313, Pfs48/45 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria.
Occurrence of solicited local and systemic reactogenicity signs and symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3, 5 and 6 after vaccination).
- Occurrence of unsolicited adverse events (AE) including safety laboratory measures for 28 days following each vaccination
- Occurrence of serious adverse events (SAEs) during the whole study duration
- Occurrence of AEs of special interest (AESIs) during the whole study duration
Measured: Through study completion, an average of 8 months from enrollment
Secondary outcomes (2)
To determine the Pfs25 and Pfs48/45 humoral immune response
Pfs25 and Pfs48/45 antibody levels elicited by Pfs25IMX313-Matrix-M and Pfs48/45 in Matrix-M as measured by ELISA at Days 0, 14, 28, 42, 56, 72, 140, 236
Measured: Through study completion, an average of 8 months from enrolment
To determine the ex-vivo functional transmission blocking activity of Pfs25 and Pfs48/45 administered alone and in combination
Standard membrane feeding assays (SMFA) and direct membrane feeding assays (DMFA) at Days 0, 14, 28, 42, 56, 72, 140, 236, reported as a percentage of transmission reducing activity compared to controls (% TRA).
Measured: Through study completion, an average of 8 months from enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start7 Jul 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plasmodium Falciparum MalariaStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Paola Cicconi, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06549257
- Sponsor's protocol ID
- VAC099
- Status last verified
- Feb 2026
- First submitted
- 12 Mar 2024
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication of the trial results via a peer reviewed journal
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06549257
- Acronym / sponsor ID
- VAC099
- Conditions
- Plasmodium Falciparum Malaria
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 - Pfs25-IMX313 | Experimental | Biological: Pfs25-IMX313, Pfs48/45Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M. |
| Group 2 - Pfs48/45 | Experimental | Biological: Pfs25-IMX313, Pfs48/45Vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M. |
| Group 3 - Pfs25-IMX313 and Pfs48/45 | Experimental | Biological: Pfs25-IMX313, Pfs48/45Vaccination with three doses of Pfs25-IMX313 10ug in 50ug Matrix M and vaccination with three doses of Pfs48/45 10ug in 50ug Matrix M. |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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).
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pfs25-IMX313, Pfs48/45Two soluble protein vaccines. | Biological | Group 1 - Pfs25-IMX313, Group 2 - Pfs48/45, Group 3 - Pfs25-IMX313 and Pfs48/45 |
Primary outcome
To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria.
Time frame: Through study completion, an average of 8 months from enrollment
Occurrence of solicited local and systemic reactogenicity signs and symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3, 5 and 6 after vaccination). * Occurrence of unsolicited adverse events (AE) including safety laboratory measures for 28 days following each vaccination * Occurrence of serious adverse events (SAEs) during the whole study duration * Occurrence of AEs of special interest (AESIs) during the whole study duration
2 secondary outcomes
To determine the Pfs25 and Pfs48/45 humoral immune response
Time frame: Through study completion, an average of 8 months from enrolment
To determine the ex-vivo functional transmission blocking activity of Pfs25 and Pfs48/45 administered alone and in combination
Time frame: Through study completion, an average of 8 months from enrolment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: Yes. Publication of the trial results via a peer reviewed journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paola Cicconi, PhD principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pfs25-IMX313, Pfs48/45 in people with Plasmodium Falciparum Malaria, run by University of Oxford at 1 site in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety and reactogenicity of Pfs25-IMX313-Matrix-M, Pfs48/45-Matrix M administered alone or in combination, in healthy Burkinabé adolescents and children naturally exposed to malaria. (time frame: Through study completion, an average of 8 months from enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.