MSP3-CRM-Vac4All/ Alhydrogel® Malaria Vaccine

NCT ID: NCT05197751

Last Updated: 2023-02-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-05-09

Brief 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

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

3 µg dose cohort

3 µg MSP3-CRM-Vac4All/Alhydrogel®

Group Type: EXPERIMENTAL

MSP3-CRM-Vac4All/ Alhydrogel®

Intervention Type: BIOLOGICAL

The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine

10 µg dose cohort

10 µg MSP3-CRM-Vac4All/Alhydrogel®

Group Type: EXPERIMENTAL

MSP3-CRM-Vac4All/ Alhydrogel®

Intervention Type: BIOLOGICAL

The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine

30 µg dose cohort

30 µg MSP3-CRM-Vac4All/Alhydrogel®

Group Type: EXPERIMENTAL

MSP3-CRM-Vac4All/ Alhydrogel®

Intervention Type: BIOLOGICAL

The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine

Interventions

MSP3-CRM-Vac4All/ Alhydrogel®

The Investigational Medicinal Product (IMP) or in short Investigational Product (IP) is the MSP3-CRM-Vac4All/ Alhydrogel® vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vac4All

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahamadou Thera, MD

Role: STUDY_DIRECTOR

MRTC, University of Sciences Techniques and Technologies of Bamako, Mali

Locations

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

Bamako, , Mali

Countries

Mali

Other Identifiers

V4ALL/MSP3/008

Identifier Type: -

Identifier Source: org_study_id