MSP3-CRM-Vac4All/ Alhydrogel® Vaccine

NCT05776017 | Unknown Phase 1 DMC

• 1 other identifier: V4ALL/MSP3/009
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Malaria,Falciparum

Keywords

malaria; malaria vaccine; vaccine efficacy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  For 12 months after first vaccination

• Efficacy duration

  For 12 months following the first vaccination

• Efficacy against first malaria episodes

  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)

  For the 6 months following boost vaccination

• Efficacy (conditional boost)

  For the 12 months following boost vaccination

Study Arms (2)

Test Vaccine

EXPERIMENTAL

MSP3-CRM-Vac4All/ Alhydrogel®

Biological: MSP3-CRM-Vac4All/ Alhydrogel®

Control Vaccine

ACTIVE COMPARATOR

Anti-rabies vaccine

Biological: Anti-Rabies Vaccine

Interventions

MSP3-CRM-Vac4All/ Alhydrogel® BIOLOGICAL

30 microgram MSP3-CRM-Vac4All protein extemporaneously formulated with Alhydrogel® adjuvant

Test Vaccine

Anti-Rabies Vaccine BIOLOGICAL

Control vaccine

Control Vaccine

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Vac4All: lead
• Malaria Research and Training Center, Bamako, Mali: collaborator

Study Sites (1)

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

Bamako, 1805, Mali

RECRUITING

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Interventions

Aluminum Hydroxide

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Aluminum Compounds; Anions; Ions; Electrolytes

Study Officials

• Manamadou Thera, MD

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

  STUDY DIRECTOR

Central Study Contacts

Zarifah H Reed, MD, MPH

CONTACT

+33695695786; zahussain22@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Vaccine recipients and their parent(s)/guardian(s) as well as all investigators and study personnel responsible for the vaccination, evaluation of safety and immunogenicity endpoints will all be unaware to the exact treatment given to the participant. Randomization will be programmed into the eCRF, as subjects are confirmed to be eligible for enrollment and to be vaccinated. A password protected electronic randomized vaccination allocation list will be sent to the designated vaccine pharmacist. The investigator will send a request for vaccination to the pharmacy using the subject randomization number (which will be the subject unique ID number) assigned by the eCRF. For each child, eligibility will have to be counter checked and signed by a second person before allocation of study ID number.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2023
• First Posted: March 20, 2023
• Study Start: March 27, 2023
• Primary Completion: December 31, 2023
• Study Completion: August 31, 2024
• Last Updated: April 26, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

MA (1)