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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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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

Other trials in Mali

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 groups in NCT05197751
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.

1 Dec 20219 May 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Malaria,Falciparum trials

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

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?

On the ClinicalTrials.gov record for NCT05197751.

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.