Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337643
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2023-03-20
Brief Title:
A Study to Evaluate Tolerability Safety and Immunogenicity of MVX01 Pneumococcal Vaccine
Sponsor:
Matrivax Research and Development Corporation
Organization:
Matrivax Research and Development Corporation
Study Overview
Official Title:
A Phase 1 First-in Human Randomized Double-Blind Placebo-Controlled Dose-Escalation Study of the Tolerability Safety and Immunogenicity of MVX01 a Pneumococcal Vaccine Candidate in Healthy Adult Participants
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The objectives of this first-in-human study is to evaluate the tolerability safety and immunogenicity of MVX01 a pneumococcal vaccine candidate at four dose levels
Detailed Description:
The study will enroll five cohorts Ascending doses of MVX01 will be evaluated in cohorts 1-4 in participants 18-50 years of age The highest tolerated dose from cohorts 1-4 will be evaluated in cohort 5 in participants 60-75 years of age Cohort 1 will be open-label Cohorts 2-5 will enroll two open-label sentinel participants followed by the remainder of the cohort which will be randomized and double-blind Each participant will be administered two doses of study intervention via intramuscular injection approximately 1 month apart Immunogenicity will be evaluated up to approximately 6 months following administration of the second dose
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None