Malaria,FalciparumPhase 1/2NCT05776017
MSP3-CRM-Vac4All/ Alhydrogel® Vaccine
A Phase 1/2 study testing MSP3-CRM-Vac4All/ Alhydrogel® and Anti-Rabies Vaccine in people with Malaria,Falciparum, run by Vac4All at 1 site in Mali.
Trial summary
Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living in highly seasonal malaria areas of Mali Read more about this study
- Who is it for?
- Ages 12 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- MSP3-CRM-Vac4All/ Alhydrogel® and Anti-Rabies Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 1 siteMali
- Study dates
- 27 Mar 2023to 31 Aug 2024
- Phase
- Phase 1/2
- 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 12 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 12-59 months years old
- Healthy by medical history, physical examination and laboratory investigation
- Signed/thumb printed informed Consent by guardian/parent
- Resident in the study area villages during the whole trial period
Who cannot join
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the participants
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, more or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- Clinically significant laboratory abnormalities on screened blood samples.
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- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an childhood immunization program or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/pertussis/tetanus vaccines) which may be given before or after vaccination*.
- Evidence of chronic or active hepatitis B or C infection
- Presence of chronic illness that, in the judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening based on clinical judgement.
- o (Weight-for-age Z score of less than -3 or other clinical signs of malnutrition).
- Previous participation to a malaria vaccine trial
- Known history of HIV infection
Trial locations and contacts
1 site in 1 country.
Mali1 site, 1 recruiting
- Recruiting
Malaria Research and Training Center (MRTC), University of Sciences Techniques and Technologies of Bamako, Mali
Bamako, 1805
Mahamadou Thera, MD, +223 66 74 09 61, mthera@icermali.org
Karim Traore, +223 66 72 50 63, Karim@icermali.org
About this study
Official title: A Phase 1b/2b Double Blind, Randomized, Controlled Study of the Safety, Immunogenicity, and Efficacy of Malaria Vaccine Candidate MSP3-CRM-Vac4All/ Alhydrogel® in Young Children in Mali
Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living in highly seasonal malaria areas of Mali
Read the detailed description
This study is designed to be executed in two steps to achieve the primary efficacy objective:
The first step is a Phase 1b safety study, involving injections in a small safety subgroup for each dose before age-de-escalation into the younger age group and then proceeding to the second step of dosing the corresponding injection in the larger Phase 2b efficacy cohort.
Vaccination of the Phase 2b cohort will require an acceptable reactogenicity data over the first week following the corresponding vaccination of the older and younger age groups in the Phase 1 subgroup. The study DSMB will be charged with this review and ensuring that vaccination proceeds only if the reactogenicity profile meet study "go" criteria (Table 1).
The objectives of each phase are:
Phase 1b: The primary objective is to assess the safety and tolerability of the vaccine for each injection. The secondary objective is to evaluate the immune response to the vaccine and safety for up to 12 months after the first dose.
Phase 2b: The primary objective is to assess the efficacy in young children* against clinical malaria** during one transmission season. The timeline for the primary analysis assessment is from 14 days to 6 months after Dose 3.
Should the primary analysis data demonstrate that the vaccine gives good efficacy, a boost vaccination will be programmed to be administered to willing subjects before the start of the subsequent transmission season. The study protocol will be amended with the precise details in this event.
- Conditions
- Malaria,Falciparum
- Being tested
- MSP3-CRM-Vac4All/ Alhydrogel®, Anti-Rabies Vaccine
- Keywords
- malaria, malaria vaccine, vaccine efficacy
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP3-CRM-Vac4All/ Alhydrogel®Biological
30 microgram MSP3-CRM-Vac4All protein extemporaneously formulated with Alhydrogel® adjuvant
Anti-Rabies VaccineBiological
Control vaccine
| Study group | Role | What they receive |
|---|---|---|
| Test Vaccine | Experimental | MSP3-CRM-Vac4All/ Alhydrogel® Receives: Biological: MSP3-CRM-Vac4All/ Alhydrogel® |
| Control Vaccine | Active comparator | Anti-rabies vaccine Receives: Biological: Anti-Rabies Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protective Efficacy against Clinical Malaria
To assess the efficacy of 30 µg MSP3-CRM-Vac4All/Alhydrogel® vaccine in children ages 12-60 months old, against clinical malaria occurring over one transmission season.
The primary efficacy outcome is clinical malaria, with the primary case definition of clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥5000/µL
Measured: The timeline for assessment will be from 14 days to 6 months after Dose 3.
Secondary outcomes (10)
Efficacy- different definitions of malaria fever and parasite thresholds on microscopy
To compare efficacy against clinical malaria for different case definitions using
- Fever thresholds that are higher than 37.5ºC, such as 38.5ºC and 39.5ºC
- History of fever instead of measured fever
- Different parasitemia by microscopy thresholds [any parasitemia, 1000, 10,000 and 20,000/µL]
Efficacy outcomes
- clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 38.5ºC with P. falciparum parasitemia ≥5000/µL or ≥ 39.5ºC with P. falciparum parasitemia ≥5000/µL or
- clinical malaria episodes defined as history of fever with P. falciparum parasitemia of the following levels: any parasitemia, 1000, 10,000 and 20,000/µL clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 38.5ºC with or ≥ 39.5ºC with P. falciparum parasitemia of the following levels: any parasitemia, 1000, 10,000 and 20,000/µL
Measured: For 12 months after first vaccination
Efficacy duration
To assess the efficacy of MSP3-CRM-Vac4All/Alhydrogel® in young children against clinical malaria occurring during the 12 months following dose 3.
Measured: For 12 months following the first vaccination
Efficacy against first malaria episodes
To assess the efficacy of MSP3-CRM-Vac4All/Alhydrogel® in young children against first clinical malaria episodes occurring from over the 6 month period 14 days after 2nd and 3rd vaccination and up to the end of study follow-up (12 months after first vaccination).
The efficacy outcome is first episode of clinical malaria, with the case definition of clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥5000/µL
Measured: From 14 days post 2nd or 3rd vaccination to 6 months following and up to the end of study follow-up (12 months after first vaccination
Efficacy (conditional boost)
To assess the efficacy of MSP3-CRM-Vac4All/Alhydrogel® in young children against clinical malaria occurring The efficacy outcome is clinical malaria, with the primary case definition of clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥5000/µL
Measured: For the 6 months following boost vaccination
Efficacy (conditional boost)
To assess the efficacy of MSP3-CRM-Vac4All/Alhydrogel® in young children against clinical malaria occurring.
The efficacy outcome is clinical malaria, with the primary case definition of clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥5000/µL
Measured: For the 12 months following boost vaccination
Number of adverse events
To assess the safety and reactogenicity of 3 doses of 30 µg MSP3-CRM-Vac4All/Alhydrogel® given at D0, D28 and D56 in healthy young children
Measured: During the month following each vaccination, and 6 months and 12 months after first vaccination.
Number of adverse events for conditional boost vaccination
Safety and reactogenicity of boost vaccination doses of MSP3-CRM-Vac4All/Alhydrogel® in healthy young children
Measured: At one month, 6 month and 12 months following boost vaccination
Immune response
To examine the duration of immune responses of a 3-dose regimen of during periods corresponding to that used for primary and other secondary efficacy endpoints as measured through a > 5-fold decrease of MSP3-specific serum IgG antibody titers after each vaccination in comparison to baseline levels (14 days post last dose)
Measured: From 14 days post last dose to up to a month after last dose, 6 months after last dose and 12 months after first dose
Immune response
To determine immunogenicity in terms of the proportion with titres either more than 3SD above the median for negative controls (positive) or at least 50% of the positive controls (strongly positive) after dose 3.
Measured: A month after dose 3
Parasite densities
To measure effect on parasitemia by comparing parasite densities in malaria episodes occurring in vaccinees compared to control
Measured: From vaccination to up to 6 months after last dose and 12 months after first dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start27 Mar 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Aug 2024 (estimated)
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.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 465 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vac4All
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Malaria Research and Training Center, Bamako, Mali
- Responsible party
- Sponsor
- Investigators
- Manamadou Thera, MD, Study director, MRTC, University of Sciences Techniques and Technologies of Bamako, Mali Locations:
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776017
- Sponsor's protocol ID
- V4ALL/MSP3/009
- Status last verified
- Apr 2023
- First submitted
- 25 Feb 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2b Double Blind, Randomized, Controlled Study of the Safety, Immunogenicity, and Efficacy of Malaria Vaccine Candidate MSP3-CRM-Vac4All/ Alhydrogel® in Young Children in Mali
- ClinicalTrials.gov ID
- NCT05776017
- Acronym / sponsor ID
- V4ALL/MSP3/009
- Conditions
- Malaria,Falciparum
- Keywords
- malaria, malaria vaccine, vaccine efficacy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 465 participants (estimated)
- Lead sponsor
- Vac4AllIndustry (pharma, biotech, devices)
- Collaborators
- Malaria Research and Training Center, Bamako, Mali
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 20 Mar 2023 (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.
Two-arm, randomized, double-blinded and controlled clinical trial to first assess the safety and tolerability of the vaccine in a Phase 1b trial and proceed to assess its efficacy against clinical malaria in young children living in highly seasonal malaria areas of Mali
Detailed description
This study is designed to be executed in two steps to achieve the primary efficacy objective:
The first step is a Phase 1b safety study, involving injections in a small safety subgroup for each dose before age-de-escalation into the younger age group and then proceeding to the second step of dosing the corresponding injection in the larger Phase 2b efficacy cohort.
Vaccination of the Phase 2b cohort will require an acceptable reactogenicity data over the first week following the corresponding vaccination of the older and younger age groups in the Phase 1 subgroup. The study DSMB will be charged with this review and ensuring that vaccination proceeds only if the reactogenicity profile meet study "go" criteria (Table 1).
The objectives of each phase are:
Phase 1b: The primary objective is to assess the safety and tolerability of the vaccine for each injection. The secondary objective is to evaluate the immune response to the vaccine and safety for up to 12 months after the first dose.
Phase 2b: The primary objective is to assess the efficacy in young children* against clinical malaria** during one transmission season. The timeline for the primary analysis assessment is from 14 days to 6 months after Dose 3.
Should the primary analysis data demonstrate that the vaccine gives good efficacy, a boost vaccination will be programmed to be administered to willing subjects before the start of the subsequent transmission season. The study protocol will be amended with the precise details in this event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Vaccine | Experimental | Biological: MSP3-CRM-Vac4All/ Alhydrogel®MSP3-CRM-Vac4All/ Alhydrogel® |
| Control Vaccine | Active comparator | Biological: Anti-Rabies VaccineAnti-rabies vaccine |
Who may qualify
- Ages
- 12 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 12-59 months years old
- Healthy by medical history, physical examination and laboratory investigation
- Signed/thumb printed informed Consent by guardian/parent
- Resident in the study area villages during the whole trial period
Key exclusion criteria (15 listed)
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the participants
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (For corticosteroids, this will mean prednisone, or equivalent, more or equal to 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
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 |
|---|---|---|
| MSP3-CRM-Vac4All/ Alhydrogel®30 microgram MSP3-CRM-Vac4All protein extemporaneously formulated with Alhydrogel® adjuvant | Biological | Test Vaccine |
| Anti-Rabies VaccineControl vaccine | Biological | Control Vaccine |
Primary outcome
Protective Efficacy against Clinical Malaria
Time frame: The timeline for assessment will be from 14 days to 6 months after Dose 3.
To assess the efficacy of 30 µg MSP3-CRM-Vac4All/Alhydrogel® vaccine in children ages 12-60 months old, against clinical malaria occurring over one transmission season. The primary efficacy outcome is clinical malaria, with the primary case definition of clinical malaria episodes defined as a febrile episode with an axillary temperature of ≥ 37.5ºC with P. falciparum parasitemia ≥5000/µL
10 secondary outcomes
Efficacy- different definitions of malaria fever and parasite thresholds on microscopy
Time frame: For 12 months after first vaccination
Efficacy duration
Time frame: For 12 months following the first vaccination
Efficacy against first malaria episodes
Time frame: From 14 days post 2nd or 3rd vaccination to 6 months following and up to the end of study follow-up (12 months after first vaccination
Efficacy (conditional boost)
Time frame: For the 6 months following boost vaccination
Efficacy (conditional boost)
Time frame: For the 12 months following boost vaccination
Number of adverse events
Time frame: During the month following each vaccination, and 6 months and 12 months after first vaccination.
Number of adverse events for conditional boost vaccination
Time frame: At one month, 6 month and 12 months following boost vaccination
Immune response
Time frame: From 14 days post last dose to up to a month after last dose, 6 months after last dose and 12 months after first dose
Immune response
Time frame: A month after dose 3
Parasite densities
Time frame: From vaccination to up to 6 months after last dose and 12 months after first dose.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Manamadou Thera, MD study director
MRTC, University of Sciences Techniques and Technologies of Bamako, Mali Locations:
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 MSP3-CRM-Vac4All/ Alhydrogel® and Anti-Rabies Vaccine in people with Malaria,Falciparum, run by Vac4All at 1 site in Mali.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 26 Apr 2023. 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 Mali. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zarifah H Reed, MD, MPH (+33695695786, zahussain22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protective Efficacy against Clinical Malaria (time frame: The timeline for assessment will be from 14 days to 6 months after Dose 3.). 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 26 Apr 2023; AzTrials last refreshed its copy on 26 Oct 2026.