Malaria,FalciparumPhase 1NCT04271306
Safety, Immunogenicity and ex Vivo Efficacy of Pfs25-IMX313/Matrix-M in Healthy Volunteers in Bagamoyo, Tanzania.
A Phase 1 study testing Pfs25-IMX313 (10ug)/Matrix-M (50ug), Pfs25-IMX313 (50ug)/Matrix-M (50ug) and Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug) in people with Malaria,Falciparum, run by University of Oxford at 1 site in Tanzania.
Trial summary
A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania Read more about this study
- Who is it for?
- Ages 5 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- Pfs25-IMX313 (10ug)/Matrix-M (50ug), Pfs25-IMX313 (50ug)/Matrix-M (50ug) and Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTanzania
- Study dates
- 25 May 2021to 19 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Healthy adult aged 18 to 45 years or children aged 5-12 years.
- Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town.
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or children (5-12 years) with the BMI between 13 and 25 Kg/m2.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Agreement to refrain from blood donation for the duration of the study
- Written informed consent to participate in the trial.
- Women only: Must practice continuous effective contraception* for the duration of the study.
Who cannot join
- Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
- Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 days following each vaccination.
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- Concurrent involvement in another clinical trial or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
- Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed).
Show all 17Show fewer
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (e.g. egg products)
- Any history of anaphylaxis in reaction to vaccinations
- Pregnancy, lactation or intention to become pregnant during the study.
- History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).
- History of serious psychiatric condition that may affect participation in the study.
- Any other serious chronic illness requiring hospital specialist supervision.
- Suspected or known injecting drug abuse in the 5 years preceding enrolment.
- Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C (HCV IgG).
- Volunteers unable to be closely followed for social, geographic or psychological reasons.
- Any clinically significant abnormal finding on biochemistry or haematology blood tests, urinalysis or clinical examination. In the event of clinically significant abnormal test results, confirmatory repeat tests will be requested. Procedures for identifying laboratory values meeting exclusion criteria will be described in a study specific SOP.
- Any other significant disease, disorder, or finding which 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Age De-escalation and Dose Escalation Open Label Clinical Trial of the Safety, Immunogenicity and ex Vivo Efficacy of a Candidate Malaria Vaccine Pfs25-IMX313/Matrix-M Administered Intramuscularly in Healthy Adults and Young Children in Tanzania.
A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania
Read the detailed description
This study aims to evaluate safety, immunogenicity, and transmission blocking activity of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria in Bagamoyo district, Tanzania. The study will enrol 45 volunteers comprising of 13 adults (18-45 years) and 32 children (5-12 years).
- Conditions
- Malaria,Falciparum
- Being tested
- Pfs25-IMX313 (10ug)/Matrix-M (50ug), Pfs25-IMX313 (50ug)/Matrix-M (50ug), Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)
- Keywords
- Vaccine
- 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 (10ug)/Matrix-M (50ug)Biological
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
Pfs25-IMX313 (50ug)/Matrix-M (50ug)Biological
3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)Biological
2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)
| Study group | Role | What they receive |
|---|---|---|
| Groups 1A & 1B | Experimental | Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 Receives: Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug) |
| Groups 2A & 2B | Experimental | Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 Receives: Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug) |
| Groups 3A & 3B | Experimental | Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 Receives: Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug) |
| Group 3C | Experimental | Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5 Receives: Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug) |
| Groups 4A & 4B | Experimental | Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5 Receives: Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug) |
| Group 4C | Experimental | Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0 and 1 and a dose of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at month 6.5 Receives: Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination).
Measured: Assessment of solicited symptoms in the first 7 days post vaccination
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days).
Measured: Assessment of unsolicited symptoms in the first 30 days post vaccination
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Occurrence of serious adverse events throughout the study period.
Measured: Assessment of SAEs until the end of the study (approx 2 years)
Secondary outcomes (4)
Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.
Pfs25 antibody levels elicited by Pfs25IMX313-Matrix-M as measured by ELISA at each time point where serology samples are analysed.
Measured: Duration of the study (approx 2 years)
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Transmission blocking activity (TBA) of induced antibody as measured in standard membrane feeding assays (SMFA) and Direct Membrane feeding assays (DMFA).
Measured: Duration of the study (approx 2 years)
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Correlation of TBA with antibody levels at each time point where the membrane feeding assays are conducted.
Measured: Duration of the study (approx 2 years)
Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
The vaccination schedule that lead to the highest peak and duration of anti-Pfs25 antibody response post vaccination, and the highest transmission blocking activity (TBA) as measured by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
Measured: Duration of the study (approx 2 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start25 May 2021
- Primary completion19 Feb 2024
- Study completion19 Feb 2024
Why it stopped: Due to significant delays in receiving local regulatory approval to extend the shelf-life of the IMP.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria,FalciparumStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute
- Responsible party
- Sponsor
- Investigators
- Angela Minassian, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271306
- Sponsor's protocol ID
- VAC082
- Status last verified
- Jan 2025
- First submitted
- 7 Feb 2020
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Age De-escalation and Dose Escalation Open Label Clinical Trial of the Safety, Immunogenicity and ex Vivo Efficacy of a Candidate Malaria Vaccine Pfs25-IMX313/Matrix-M Administered Intramuscularly in Healthy Adults and Young Children in Tanzania.
- ClinicalTrials.gov ID
- NCT04271306
- Acronym / sponsor ID
- VAC082
- Conditions
- Malaria,Falciparum
- Keywords
- Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to significant delays in receiving local regulatory approval to extend the shelf-life of the IMP.
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Ifakara Health Institute
- Study start
- 25 May 2021 (actual)
- Primary completion
- 19 Feb 2024 (actual)
- Study completion
- 19 Feb 2024 (actual)
- First posted
- 17 Feb 2020 (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.
A phase Ib age de-escalation and dose escalation open label clinical trial of the safety, immunogenicity and ex-vivo efficacy of a candidate malaria vaccine Pfs25-IMX313/Matrix-M administered intramuscularly in healthy adults and young children in Tanzania
Detailed description
This study aims to evaluate safety, immunogenicity, and transmission blocking activity of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria in Bagamoyo district, Tanzania. The study will enrol 45 volunteers comprising of 13 adults (18-45 years) and 32 children (5-12 years).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Groups 1A & 1B | Experimental | Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug)Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 |
| Groups 2A & 2B | Experimental | Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug)Volunteers aged 18-45 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 |
| Groups 3A & 3B | Experimental | Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug)Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 2 |
| Group 3C | Experimental | Biological: Pfs25-IMX313 (10ug)/Matrix-M (50ug)Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5 |
| Groups 4A & 4B | Experimental | Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug)Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0, 1 and 6.5 |
| Group 4C | Experimental | Biological: Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)Volunteers aged 5-12 years will receive doses of Pfs25-IMX313 (50µg)/Matrix-M (50µg) intramuscularly at months 0 and 1 and a dose of Pfs25-IMX313 (10µg)/Matrix-M (50µg) intramuscularly at month 6.5 |
Who may qualify
- Ages
- 5 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Healthy adult aged 18 to 45 years or children aged 5-12 years.
- Planned long-term (at least 30 months from the date of recruitment) or permanent residence in Bagamoyo town.
- Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or children (5-12 years) with the BMI between 13 and 25 Kg/m2.
- Able and willing (in the Investigator's opinion) to comply with all study requirements.
- Agreement to refrain from blood donation for the duration of the study
Key exclusion criteria (17 listed)
- Use of immunoglobulins or blood products (e.g., blood transfusion) at any time in the past.
- Receipt of any vaccine in the 14 days preceding enrolment, or planned receipt of any other vaccine within 14 days following each vaccination.
- Receipt of an investigational product in the 30 days preceding enrolment, or planned receipt during the study period.
- Concurrent involvement in another clinical trial or planned involvement during the study period
- Prior receipt of an investigational vaccine likely to impact on interpretation of the trial data, as assessed by the Investigator
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 (10ug)/Matrix-M (50ug)3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg) | Biological | Group 3C, Groups 1A & 1B, Groups 3A & 3B |
| Pfs25-IMX313 (50ug)/Matrix-M (50ug)3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) | Biological | Groups 2A & 2B, Groups 4A & 4B |
| Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg) | Biological | Group 4C |
Primary outcome
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Time frame: Assessment of solicited symptoms in the first 7 days post vaccination
Occurrence of solicited symptoms after each vaccination during a 7-day surveillance period (day of vaccination and days 1, 2, 3 and 7 after vaccination).
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Time frame: Assessment of unsolicited symptoms in the first 30 days post vaccination
Occurrence of unsolicited symptoms after each vaccination during a 30-day surveillance period (day of vaccination and 30 subsequent days).
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria.
Time frame: Assessment of SAEs until the end of the study (approx 2 years)
Occurrence of serious adverse events throughout the study period.
4 secondary outcomes
Determine the Pfs25 specific antibody responses following immunization with different vaccination regimens in healthy Tanzanian adults and children.
Time frame: Duration of the study (approx 2 years)
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Time frame: Duration of the study (approx 2 years)
Determine the transmission blocking activity of Pfs25 specific antibodies elicited by the different vaccination regimens in healthy Tanzanian adults and children using Standard Membrane Feeding Assay (SMFA) and Direct Membrane feeding assay (DMFA).
Time frame: Duration of the study (approx 2 years)
Select the best vaccination regimen based on the peak Pfs25 specific antibodies after final immunization, their duration and transmission blocking activity by standard membrane feeding assay (SMFA) and direct membrane feeding assay (DMFA).
Time frame: Duration of the study (approx 2 years)
Results and safety
The study was stopped early (reason given: Due to significant delays in receiving local regulatory approval to extend the shelf-life of the IMP.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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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.
Angela Minassian 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 study testing Pfs25-IMX313 (10ug)/Matrix-M (50ug), Pfs25-IMX313 (50ug)/Matrix-M (50ug) and Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug) in people with Malaria,Falciparum, run by University of Oxford at 1 site in Tanzania.
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 7 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: stopped early, as of the sponsor's last update on 27 Jan 2025. 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 Tanzania. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Due to significant delays in receiving local regulatory approval to extend the shelf-life of the IMP.). Results are not available in the source record.
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?
Determine the safety of Pfs25IMX313-Matrix-M in healthy Tanzanian adults and children naturally exposed to malaria. (time frame: Assessment of solicited symptoms in the first 7 days post vaccination). The study lists 3 primary outcomes in all. 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 27 Jan 2025.