Ignite Creation Date:
2025-12-24 @ 5:49 PM
Ignite Modification Date:
2025-12-29 @ 2:29 AM
Study NCT ID:
NCT07194668
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-19
First Post:
2025-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
R21/MM Dosing, Presentations, and Preservatives
Sponsor:
University of Oxford
Organization:
Study Overview
Official Title:
Immunogenicity of a Fractional Adult Dose of the Malaria Vaccine R21/Matrix-M - A Noninferiority Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VAC100
Brief Summary:
This is a single blind randomised controlled trial. This study aims to assess whether a half-dose of the R21/Matrix-M malaria vaccine is as effective as the full dose in child and adults. The results will help optimize vaccine usage and improve malaria prevention strategies.
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).
or
2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.
If participant receive the half dose, it will come from one of two types of vaccine:
2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
* Standardized symptom questionnaire
* Physical examination:
* Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature.
* Spleen and liver size will be recorded if palpable.
* Pregnancy test (for female of child bearing potential)
* Venous blood collection (Pre-vaccination) 3mL
* Vaccination
All participants will receive the same number of injections and will be randomly assigned to receive one of the followings:
1. The standard dose (10μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11 (n=125).
or
2. A half dose (5μg R21/50μg Matrix-M) of the malaria vaccine is administered in three doses over a two-month period (at Month 0, 1, and 2), followed by a booster dose at Month 11.
If participant receive the half dose, it will come from one of two types of vaccine:
2a. 10 dose vials with adaptor Preservative Free (n=125) 2b. 10 dose vials with 2PE Preservative (n=125)
Clinical procedure for participants:
* Standardized symptom questionnaire
* Physical examination:
* Weight, height, pulse, blood pressure, respiratory rate, tympanic temperature.
* Spleen and liver size will be recorded if palpable.
* Pregnancy test (for female of child bearing potential)
* Venous blood collection (Pre-vaccination) 3mL
* Vaccination
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: