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Outcome Measures

Primary Outcomes (8)

Number of Participants with Immediate adverse events in all participants
Occurrence of immediate adverse events
Up to 30-minutes following each dose
Number of Participants with solicited local adverse events in reactogenicity group
Occurrence of solicited local adverse events
Up to 7 days following each dose
Number of Participants with Solicited systemic adverse events in reactogenicity group
Occurrence of solicited systemic adverse events
Up to 7 days following each dose
Number of Participants with Unsolicited adverse events in all participants
Occurrence of unsolicited adverse events
Up to 28 days following each vaccination
Number of Participants with Serious adverse events in all participants
Occurrence of serious adverse events
Through the whole study duration, 24 months post dose 3 or 12 months post dose 4

Secondary Outcomes (5)

To assess vaccine functional activity against transmission by DSF
from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
To assess vaccine functional activity against transmission by DSF
from 2 weeks to 24 weeks after completion of the primary vaccine course +/- booster
humoral immunogenicity time trends and durability
at baseline, 28 days after each dose and through study completion, at an average of 1 month
humoral immunogenicity time trends and durability
at baseline, 28 days after each dose and through study completion, at an average of 1 month
To assess the protective efficacy against clinical malaria caused by Pf
At 24 and 52 weeks after completion of the primary and booster vaccine course

Study Arms (10)

Arm 1a (n=180), 9-17 years of age, Immunobridging cohort

EXPERIMENTAL

10µg of R21 with 50µg Matrix-M1

Biological: 10µg of R21 with 50µg Matrix-M1

Arm 2a (n=180), 9-17 years of age, Immunobridging cohort

EXPERIMENTAL

Control vaccine (rabies vaccine)

Biological: RABIVAX-S

Arm 3a (n=90), 9-17 years of age, Immunobridging cohort

EXPERIMENTAL

6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulation

Interventions

10µg of R21 with 50µg Matrix-M1Biological

R21 is a portion of Pf circumsporozoite protein fused with hepatitis B surface antigen in the form of non-infectious virus-like particles (VLPs) produced in yeast cells (Hansenula) by recombinant DNA technology. Matrix-M1 (Adjuvanted) is cGMP manufactured by Serum Institute of India, PVD, LTD (SIIPL), Pune.

Arm 1a (n=180), 9-17 years of age, Immunobridging cohortArm 1b (n=120), 9-17 years of age, main cohortArm 1c (n=100), 18-50 years of age, main cohort

6µg of Pfs230D1-CRM197 + 10µg of R21 with 50µg Matrix-M1 single vial coformulationBiological

Study Design

Study Type

interventional

Phase

phase 2

Allocation

RANDOMIZED

Masking

QUADRUPLE

Who Masked

PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR

Masking Details

The study will be conducted with a double blind. Because there is some variation in vaccine volumes, the unblinded pharmacy team will cover all syringes (after vaccine preparation) with opaque tape to maintain blinding. The participants, the clinical staff, laboratory staff and the study team involved in study endpoint assessments will be blinded to study treatment allocation. An additional layer to be implemented to promote blinding is that designated clinical staff who administer the vaccinations will only participate in study product administration and will remain separate from the team of blinded investigators who conduct all subsequent follow-up study assessments. The pharmacy team at the study site where vaccine preparation and administration is taking place will be unblinded, and they are responsible for maintaining security of study treatment assignments.

Purpose

PREVENTION

Intervention Model

PARALLEL

Model Details: 1200 Healthy male and non-pregnant female participants of age 9-50 years will be enrolled in VIMT002 study in Bancoumana, Mali and surrounding villages. Participants aged 9 - 17 years in the immunobridging cohort (n=540) will be randomized to one of the study arms (2:2:1:1) to receive 10µg R21 in 50µg of Matrix-M1 single vial formulation, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10µg R21 in 50µg of Matrix-M1 as either a bedside mixture or a single-vial coformulation. Participants in the main cohort will be randomized to one of the study arms (1:1:1) to receive 10µg R21 in 50µg of Matrix-M1, control vaccine (RABIVAX-S), or 6µg Pfs230D1-CRM197 with 10 µg R21 in 50µg of Matrix-M1 single-vial coformulation.

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (5)

Study Arms (10)

Arm 1a (n=180), 9-17 years of age, Immunobridging cohort

Arm 2a (n=180), 9-17 years of age, Immunobridging cohort

Arm 3a (n=90), 9-17 years of age, Immunobridging cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Arm 4a (n=90), 9-17 years of age, Immunobridging cohort

Arm 1b (n=120), 9-17 years of age, main cohort

Arm 2b (n=120), 9-17 years of age, main cohort

Arm 3b (n=120), 9-17 years of age, main cohort

Arm 1c (n=100), 18-50 years of age, main cohort

Arm 2c (n=100), 18-50 years of age, main cohort

Arm 3c (n=100), 18-50 years of age, main cohort

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (8)

Secondary Outcomes (5)

Study Arms (10)

Arm 1a (n=180), 9-17 years of age, Immunobridging cohort

Arm 2a (n=180), 9-17 years of age, Immunobridging cohort

Arm 3a (n=90), 9-17 years of age, Immunobridging cohort

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Enrollment

Study Design

Study Record Dates

Arm 4a (n=90), 9-17 years of age, Immunobridging cohort

Arm 1b (n=120), 9-17 years of age, main cohort

Arm 2b (n=120), 9-17 years of age, main cohort

Arm 3b (n=120), 9-17 years of age, main cohort

Arm 1c (n=100), 18-50 years of age, main cohort

Arm 2c (n=100), 18-50 years of age, main cohort

Arm 3c (n=100), 18-50 years of age, main cohort

You may not qualify if:

Data Sharing

Source record

Locations