NCT06337643

A Study to Evaluate Tolerability, Safety and Immunogenicity of MVX01 Pneumococcal Vaccine

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: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Matrivax Research and Development Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pneumococcal Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVX01	Pneumococcal Vaccine Candidate
BIOLOGICAL	MVX01 Placebo	Placebo

Timeline

• Start date: 2023-03-07
• Primary completion: 2024-04-16
• Completion: 2024-04-16
• First posted: 2024-03-29
• Last updated: 2024-03-29

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study