NCT04087460

Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

A Phase Ⅰa Randomized,Double-Blind, Placebo-controlled Clinical Trial to Preliminary Evaluate the Safety and Immunogenicity of Protein Based Pneumococcal Vaccine（PBPV） in Healthy People Aged Between 18 and 49 Years Old

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: CanSino Biologics Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children. The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

Detailed description

The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.This experimental vaccine was covered 70% of all pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.

Conditions

• Pneumonia
• Respiratory Tract Diseases
• Respiratory Tract Infections

Interventions

Type	Name	Description
BIOLOGICAL	Protein based pneumococcal vaccine(Low dose)	0.2mL,Intramuscular other name:PBPV
BIOLOGICAL	Protein based pneumococcal vaccine placebo(Low dose)	0.2mL,Intramuscular other name:PBPV placebo
BIOLOGICAL	Protein based pneumococcal vaccine(Middle dose)	0.5mL,Intramuscular other name:PBPV
BIOLOGICAL	Protein based pneumococcal vaccine placebo(Middle dose)	0.5mL,Intramuscular other name:PBPV placebo
BIOLOGICAL	Protein based pneumococcal vaccine(High dose)	1.0mL,Intramuscular other name:PBPV
BIOLOGICAL	Protein based pneumococcal vaccine placebo(High dose)	1.0mL,Intramuscular other name:PBPV placebo

Timeline

• Start date: 2020-04-10
• Primary completion: 2021-05-30
• Completion: 2022-06-30
• First posted: 2019-09-12
• Last updated: 2022-11-04

Locations

1 site across 1 country: China