Malaria,FalciparumPhase 1MSP3CRMV4AllNCT05197751
MSP3-CRM-Vac4All/ Alhydrogel® Malaria Vaccine
A Phase 1 study testing MSP3-CRM-Vac4All/ Alhydrogel® in people with Malaria,Falciparum, run by Vac4All at 1 site in Mali.
Trial summary
First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria,Falciparum
- What is being tested?
- MSP3-CRM-Vac4All/ Alhydrogel®
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteMali
- Study dates
- 1 Dec 2021to 9 May 2023
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female aged 18-55 years old
- In general good health by medical history, physical examination and laboratory investigation
- Resident in the study area for the duration of the study with mobile phone access (personal or family) during the first 4 months of trial participation.
- Negative pregnancy test and the use of effective contraception during the whole study period if deemed appropriate.
- Willingness to undergo an HIV test.
- Signed informed consent following demonstration of proper understanding of the meaning and procedures of the First-in-Human Phase I trial.
Who cannot join
- Any history of documented malaria over the last 3 years.
- Born and lived till adolescence (up to 15 years) in rural high transmission malaria endemic area
- Any plans to travel and stay in malaria endemic areas during the study period for more than one week.
- Positivity by Elisa at screening on either MSP3-C terminal antigen, or AMA1, or LSA3-R, or EBA 175 (positivity defined as optical density (OD) as high or higher than lower threshold of positivity post 1st generation MSP3 in Doneguebougou)
- Use of any investigational drug or vaccine other than the study vaccine within 30 days before the first dose up to 30 days after third and last dose of vaccination.
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment or planned administration during study period (for corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed).
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- 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
- Planned administration of any other vaccine not foreseen by the study protocol within 30 days before the first dose up to 30 days after third and last dose of vaccination. Some biologicals may be administered as emergency measure during the trial, such as tetanus toxoid or serum, rabies vaccine and immunoglobulins
- Suspected or known hypersensitivity or allergic reactions to any of the vaccine components or to previous vaccine.
- Any clinically significant deviation from the normal range in biochemistry or hematology blood tests or in urine analysis.
- Symptoms, physical signs and laboratory values suggestive of past or current history of significant neurological, cardiovascular, pulmonary, hepatic, rheumatic, autoimmune, hematological, metabolic, renal, psychiatric and other conditions, which could interfere with the interpretation of the study results or compromise the health of the volunteers
- Seropositive for HIV at screening
- 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.
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening based on appropriate Body Mass Index (BMI) thresholds (to be defined by site).
- Cannot be followed for any social, psychological or geographical reasons.
Trial locations and contacts
1 site in 1 country.
Mali1 site
Malaria Research and Training Center (MRTC), University of Sciences Techniques and Technologies of Bamako, Mali
Bamako, 1805
About this study
Official title: Phase 1 Randomized, Dose-finding Study to Evaluate the Safety, Tolerability and Immunogenicity of a Novel Malaria Vaccine, MSP3-CRM-Vac4All/ Alhydrogel®, in Healthy Adults
First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg
Read the detailed description
A total of 42 healthy male and female participants aged 18 to 55 years will be enrolled and randomized into one of three cohorts. Three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel®, will be evaluated: 3 µg, 10 µg and 30 µg total MSP3-CRM197 conjugate protein (corresponding to 1, 3, 10 µg MSP3 protein) administered as a primary series of three intramuscular (IM) injections, given on day 1, day 28, and day 56.
- Conditions
- Malaria,Falciparum
- Being tested
- MSP3-CRM-Vac4All/ Alhydrogel®
- Medical subject headings
- Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSP3-CRM-Vac4All/ Alhydrogel®Biological
The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine
| Study group | Role | What they receive |
|---|---|---|
| 3 µg dose cohort | Experimental | 3 µg MSP3-CRM-Vac4All/Alhydrogel® Receives: Biological: MSP3-CRM-Vac4All/ Alhydrogel® |
| 10 µg dose cohort | Experimental | 10 µg MSP3-CRM-Vac4All/Alhydrogel® Receives: Biological: MSP3-CRM-Vac4All/ Alhydrogel® |
| 30 µg dose cohort | Experimental | 30 µg MSP3-CRM-Vac4All/Alhydrogel® Receives: Biological: MSP3-CRM-Vac4All/ Alhydrogel® |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination, for each treatment group.
Measured: Over 7 days following vaccination
To measure the frequency and grade of any unsolicited AEs during the 28 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of any unsolicited AEs during the 28 days following each vaccination, for each treatment group.
Measured: Over 28 days following vaccination
To measure the frequency of Serious Adverse Events (AEs) following the first dose of the vaccine until the last follow-up visit.
Frequency of Serious Adverse Events (AEs) observed from the first dose of the vaccine until the last follow-up visit.
Measured: Over 12 month following first vaccination
To measure the number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each treatment group.
Measured: Over 28 days following vaccination
Secondary outcomes (9)
To measure the frequency and grade of each solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group
Frequency and grade of solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group.
Measured: 7 days following vaccination
To measure the frequency and grade of each unsolicited systemic and local reaction during the 28 days for the combined active vaccination group of each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Frequency and grade of unsolicited systemic and local reaction during the 28 days following each vaccination, for the combined active vaccination group.
Measured: 28 days following vaccination
To measure the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
Measured: 28 days after vaccination
To measure the seroresponse rates (defined as the proportion with 2, 3, and 4-fold rise in titre of anti-MSP3 antibodies) determined 28 days after each vaccination as compared to baseline (Day 1), by treatment group.
Seroresponse rates (defined as the proportion with 2, 3, and 4-fold rise in titre of anti-MSP3 antibodies) determined 28 days after each vaccination as compared to baseline (Day 1), by treatment group.
Measured: 28 days after vaccination
To measure the Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).observed during the 28 days following each vaccination, for the combined active vaccination group.
Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).
Measured: 28 days after each vaccination
To measure Geometric mean fold increase (GMFI) of anti-MSP3 antibodies determined 28 days after each vaccination as compared to baseline (total IgG and IgG sub classes).
Geometric mean fold increase (GMFI) of anti-MSP3 antibodies determined 28 days after each vaccination as compared to baseline (total IgG and IgG sub classes).
Measured: 28 days after each vaccination
To measure the Proportion of participants with seroresponse across all time points
Proportion of participants with seroresponse across all time points
Measured: one month, 3 months, 6 months and 12 months after first vaccination
To measure the Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
Measured: 3, 6 and 12 month after first vaccination
To measureIgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
IgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
Measured: one month after each vaccination and 3 months, 6 months and 12 months after first vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2022
- Study start1 Dec 2021
- Primary completion3 Aug 2022
- Study completion9 May 2023 (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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vac4All
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mahamadou Thera, MD, Study director, MRTC, University of Sciences Techniques and Technologies of Bamako, Mali
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05197751
- Sponsor's protocol ID
- V4ALL/MSP3/008
- Acronym
- MSP3CRMV4All
- Status last verified
- Feb 2023
- First submitted
- 24 Nov 2021
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Randomized, Dose-finding Study to Evaluate the Safety, Tolerability and Immunogenicity of a Novel Malaria Vaccine, MSP3-CRM-Vac4All/ Alhydrogel®, in Healthy Adults
- ClinicalTrials.gov ID
- NCT05197751
- Acronym / sponsor ID
- MSP3CRMV4All / V4ALL/MSP3/008
- Conditions
- Malaria,Falciparum
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Vac4AllIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 9 May 2023 (estimated)
- First posted
- 19 Jan 2022 (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.
First-in-Human, Randomised, Dose-Finding Single Center Study to evaluate three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel® : 3 µg, 10 µg and 30 µg
Detailed description
A total of 42 healthy male and female participants aged 18 to 55 years will be enrolled and randomized into one of three cohorts. Three dose levels of a novel malaria vaccine, MSP3-CRM-Vac4All/ Alhydrogel®, will be evaluated: 3 µg, 10 µg and 30 µg total MSP3-CRM197 conjugate protein (corresponding to 1, 3, 10 µg MSP3 protein) administered as a primary series of three intramuscular (IM) injections, given on day 1, day 28, and day 56.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 µg dose cohort | Experimental | Biological: MSP3-CRM-Vac4All/ Alhydrogel®3 µg MSP3-CRM-Vac4All/Alhydrogel® |
| 10 µg dose cohort | Experimental | Biological: MSP3-CRM-Vac4All/ Alhydrogel®10 µg MSP3-CRM-Vac4All/Alhydrogel® |
| 30 µg dose cohort | Experimental | Biological: MSP3-CRM-Vac4All/ Alhydrogel®30 µg MSP3-CRM-Vac4All/Alhydrogel® |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female aged 18-55 years old
- In general good health by medical history, physical examination and laboratory investigation
- Resident in the study area for the duration of the study with mobile phone access (personal or family) during the first 4 months of trial participation.
- Negative pregnancy test and the use of effective contraception during the whole study period if deemed appropriate.
- Willingness to undergo an HIV test.
Key exclusion criteria (16 listed)
- Any history of documented malaria over the last 3 years.
- Born and lived till adolescence (up to 15 years) in rural high transmission malaria endemic area
- Any plans to travel and stay in malaria endemic areas during the study period for more than one week.
- Positivity by Elisa at screening on either MSP3-C terminal antigen, or AMA1, or LSA3-R, or EBA 175 (positivity defined as optical density (OD) as high or higher than lower threshold of positivity post 1st generation MSP3 in Doneguebougou)
- Use of any investigational drug or vaccine other than the study vaccine within 30 days before the first dose up to 30 days after third and last dose of vaccination.
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®The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine | Biological | 10 µg dose cohort, 3 µg dose cohort, 30 µg dose cohort |
Primary outcome
To measure the frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Time frame: Over 7 days following vaccination
Frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination, for each treatment group.
To measure the frequency and grade of any unsolicited AEs during the 28 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Time frame: Over 28 days following vaccination
Frequency and grade of any unsolicited AEs during the 28 days following each vaccination, for each treatment group.
To measure the frequency of Serious Adverse Events (AEs) following the first dose of the vaccine until the last follow-up visit.
Time frame: Over 12 month following first vaccination
Frequency of Serious Adverse Events (AEs) observed from the first dose of the vaccine until the last follow-up visit.
To measure the number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Time frame: Over 28 days following vaccination
Number of subjects with Adverse Events (AEs) during the 28 days following each vaccination, for each treatment group.
9 secondary outcomes
To measure the frequency and grade of each solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group
Time frame: 7 days following vaccination
To measure the frequency and grade of each unsolicited systemic and local reaction during the 28 days for the combined active vaccination group of each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56
Time frame: 28 days following vaccination
To measure the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
Time frame: 28 days after vaccination
To measure the seroresponse rates (defined as the proportion with 2, 3, and 4-fold rise in titre of anti-MSP3 antibodies) determined 28 days after each vaccination as compared to baseline (Day 1), by treatment group.
Time frame: 28 days after vaccination
To measure the Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).observed during the 28 days following each vaccination, for the combined active vaccination group.
Time frame: 28 days after each vaccination
To measure Geometric mean fold increase (GMFI) of anti-MSP3 antibodies determined 28 days after each vaccination as compared to baseline (total IgG and IgG sub classes).
Time frame: 28 days after each vaccination
To measure the Proportion of participants with seroresponse across all time points
Time frame: one month, 3 months, 6 months and 12 months after first vaccination
To measure the Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
Time frame: 3, 6 and 12 month after first vaccination
To measureIgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
Time frame: one month after each vaccination and 3 months, 6 months and 12 months after first vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 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.
Mahamadou Thera, MD study director
MRTC, University of Sciences Techniques and Technologies of Bamako, Mali
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 MSP3-CRM-Vac4All/ Alhydrogel® 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 6 inclusion and 16 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 28 Feb 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 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?
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?
To measure the frequency and grade of each solicited local and systemic reactions during the 7 days following each vaccination of MSP3-CRM-Vac4All/ Alhydrogel® for each dose levels (3 µg, 10 µg and 30 µg), administered on Day 1, 28 and 56 (time frame: Over 7 days following vaccination). The study lists 4 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 28 Feb 2023.