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

Pneumococcal Vaccine Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Pneumococcal Vaccine

• NCT number: NCT06337643
• Study type: Interventional
• Source: Matrivax Research and Development Corporation
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: March 7, 2023
• Completion date: April 16, 2024