Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

NCT ID: NCT04087460

Last Updated: 2022-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-10
• Study Completion Date: 2022-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Low-dose Group A

Subjects received three doses of PBPV with 20μg each antigen

Group Type: EXPERIMENTAL

Protein based pneumococcal vaccine(Low dose)

Intervention Type: BIOLOGICAL

0.2mL,Intramuscular other name:PBPV

Low-dose Group B

Subjects received three doses of placebo

Group Type: PLACEBO_COMPARATOR

Protein based pneumococcal vaccine placebo(Low dose)

Intervention Type: BIOLOGICAL

0.2mL,Intramuscular other name:PBPV placebo

Middle-dose Group A

Subjects received three doses of PBPV with 50μg each antigen

Group Type: EXPERIMENTAL

Protein based pneumococcal vaccine(Middle dose)

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PBPV

Middle-dose Group B

Subjects received three doses of placebo

Group Type: PLACEBO_COMPARATOR

Protein based pneumococcal vaccine placebo(Middle dose)

Intervention Type: BIOLOGICAL

0.5mL,Intramuscular other name:PBPV placebo

High-dose Group A

Subjects received three doses of PBPV with 100μg each antigen

Group Type: EXPERIMENTAL

Protein based pneumococcal vaccine(High dose)

Intervention Type: BIOLOGICAL

1.0mL,Intramuscular other name:PBPV

High-dose Group B

Subjects received three doses of placebo

Group Type: PLACEBO_COMPARATOR

Protein based pneumococcal vaccine placebo(High dose)

Intervention Type: BIOLOGICAL

1.0mL,Intramuscular other name:PBPV placebo

Interventions

Protein based pneumococcal vaccine(Low dose)

0.2mL,Intramuscular other name:PBPV

Intervention Type: BIOLOGICAL

Protein based pneumococcal vaccine placebo(Low dose)

0.2mL,Intramuscular other name:PBPV placebo

Intervention Type: BIOLOGICAL

Protein based pneumococcal vaccine(Middle dose)

0.5mL,Intramuscular other name:PBPV

Intervention Type: BIOLOGICAL

Protein based pneumococcal vaccine placebo(Middle dose)

0.5mL,Intramuscular other name:PBPV placebo

Intervention Type: BIOLOGICAL

Protein based pneumococcal vaccine(High dose)

1.0mL,Intramuscular other name:PBPV

Intervention Type: BIOLOGICAL

Protein based pneumococcal vaccine placebo(High dose)

1.0mL,Intramuscular other name:PBPV placebo

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers aged 18 to 49 years old;
• Willing to provide proof of identity;
• Able to understand and sign the informed consent;
• Able and willing comply with the requirements of the protocol

Exclusion Criteria

• Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
• Abnormal changes of laboratory measures (with clinical significance);
• Woman is pregnant and lactating (by urine pregnancy test)
• Suffered from pneumonia in the past three years;
• Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;
• Allergic person;
• Any prior administration of blood products in last 3 month;
• Any prior administration of other research medicines in last 1 month;
• Plans to participate in or is participating in any other drug clinical study;
• Any prior administration of attenuated live vaccine in last 14 days;
• Any prior administration of subunit or inactivated vaccines in last 7 days;
• Had fever before vaccination, volunteers with temperature >37.0℃ on axillary setting;
• According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CanSino Biologics Inc.

INDUSTRY

Sponsor Role: lead

Henan Center for Disease Control and Prevention

OTHER_GOV

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xia Shengli

Role: PRINCIPAL_INVESTIGATOR

Henan Province Center for Disease Control and Prevention

Locations

Suixian Center for Disease Control and Prevention

Shangqiu, Henan, China

Countries

China

Other Identifiers

CS-CTP-PBPV-Ⅰa

Identifier Type: -

Identifier Source: org_study_id