MSP3-CRM-Vac4All/ Alhydrogel® Malaria Vaccine (MSP3CRMV4All)

February 25, 2023 updated by: Vac4All

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Zarifah H Reed, MD MPH
  • Phone Number: +33695695786
  • Email: za@vac4all.org

Study Locations

  • Mali
      • Bamako, Mali, 1805
        • Malaria Research and Training Center (MRTC), University of Sciences Techniques and Technologies of Bamako, Mali

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 3 µg dose cohort
3 µg MSP3-CRM-Vac4All/Alhydrogel®
Biological: MSP3-CRM-Vac4All/ Alhydrogel®
The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine
Experimental: 10 µg dose cohort
10 µg MSP3-CRM-Vac4All/Alhydrogel®
Biological: MSP3-CRM-Vac4All/ Alhydrogel®
The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine
Experimental: 30 µg dose cohort
30 µg MSP3-CRM-Vac4All/Alhydrogel®
Biological: MSP3-CRM-Vac4All/ Alhydrogel®
The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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
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.
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.
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.
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
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.
Over 28 days following vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Frequency and grade of solicited systemic and local reaction during the 7 days following each vaccination, for the combined active vaccination group.
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
Frequency and grade of unsolicited systemic and local reaction during the 28 days following each vaccination, for the combined active vaccination group.
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
the number of subjects with Adverse Events during the 28 days each vaccination, for the combined active vaccination group.
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
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.
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
Geometric mean titres (GMT) of anti-MSP3 antibodies 28 days after each vaccination, by treatment group (total IgG and IgG sub classes).
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
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).
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
Proportion of participants with seroresponse across all time points
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
Seroresponse rates, GMTs and GMFI of anti-MSP3 antibodies 3, 6 and 12 months after first vaccination (total IgG and IgG sub classes).
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
IgG ability to recognize the native protein on merozoite by using Western Blot (WB) and IFAT methods
one month after each vaccination and 3 months, 6 months and 12 months after first vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vac4All

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mahamadou Thera, MD, MRTC, University of Sciences Techniques and Technologies of Bamako, Mali

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 19, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V4ALL/MSP3/008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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