Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

Pneumonia Clinical Trial

— P?CTPV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04087460
• Other study ID #: CS-CTP-PBPV-?a
• Status: Completed
• Phase: Early Phase 1
• Start date: April 10, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: CanSino Biologics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Respiratory Tract Diseases
• Respiratory Tract Infections

Intervention

Biological:
• Protein based pneumococcal vaccine(Low dose)
0.2mL,Intramuscular other name:PBPV
• Protein based pneumococcal vaccine placebo(Low dose)
0.2mL,Intramuscular other name:PBPV placebo
• Protein based pneumococcal vaccine(Middle dose)
0.5mL,Intramuscular other name:PBPV
• Protein based pneumococcal vaccine placebo(Middle dose)
0.5mL,Intramuscular other name:PBPV placebo
• Protein based pneumococcal vaccine(High dose)
1.0mL,Intramuscular other name:PBPV
• Protein based pneumococcal vaccine placebo(High dose)
1.0mL,Intramuscular other name:PBPV placebo

Locations

Country	Name	City	State
China	Suixian Center for Disease Control and Prevention	Shangqiu	Henan

Sponsors (2)

Lead Sponsor	Collaborator
CanSino Biologics Inc.	Henan Center for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA)	Geometric mean titer(GMT) and Geometric mean increase(GMI)of antibodies in serum	day30,60 post each vaccination
Other	immunogencity indexes of neutralization test	neutralization test activity of anti-Ply antibody in serum	day30,60 post each vaccination
Primary	Safety indexes of solicited and unsolicited adverse reactions	Occurrence of solicited and unsolicited reactions post each vaccination	within 30 minutes,0-7 days,0-30 days post-vaccination
Primary	Safety indexes of lab measures	Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs	day 3 and 8 post the first vaccination
Primary	Safety indexes of lab measures	Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs	day 14 and 30 post each vaccination
Secondary	safety indexes of SAE	Occurrence of SAE	within 180 days post vaccination
Secondary	immunogencity indexes of GMC and GMI by ELISA	Geometric mean concentration(GMC) and Geometric mean increase(GMI)of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum	day 8, 14,30,60 post each vaccination
Secondary	immunogencity indexes of the seropositivity rates by ELISA	the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum	day 8, 14,30,60 post each vaccination