Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine (PⅠCTPV)

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia
• Intervention / Treatment: Biological: Protein based pneumococcal vaccine(Low dose); Biological: Protein based pneumococcal vaccine placebo(Low dose); Biological: Protein based pneumococcal vaccine(Middle dose); Biological: Protein based pneumococcal vaccine placebo(Middle dose); Biological: Protein based pneumococcal vaccine(High dose); Biological: Protein based pneumococcal vaccine placebo(High dose)

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Henan
    • Shangqiu, Henan, China, 450016
      • Suixian Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Low-dose Group A; Subjects received three doses of PBPV with 20μg each antigen	Biological: Protein based pneumococcal vaccine(Low dose); 0.2mL,Intramuscular other name:PBPV
PLACEBO_COMPARATOR: Low-dose Group B; Subjects received three doses of placebo	Biological: Protein based pneumococcal vaccine placebo(Low dose); 0.2mL,Intramuscular other name:PBPV placebo
EXPERIMENTAL: Middle-dose Group A; Subjects received three doses of PBPV with 50μg each antigen	Biological: Protein based pneumococcal vaccine(Middle dose); 0.5mL,Intramuscular other name:PBPV
PLACEBO_COMPARATOR: Middle-dose Group B; Subjects received three doses of placebo	Biological: Protein based pneumococcal vaccine placebo(Middle dose); 0.5mL,Intramuscular other name:PBPV placebo
EXPERIMENTAL: High-dose Group A; Subjects received three doses of PBPV with 100μg each antigen	Biological: Protein based pneumococcal vaccine(High dose); 1.0mL,Intramuscular other name:PBPV
PLACEBO_COMPARATOR: High-dose Group B; Subjects received three doses of placebo	Biological: Protein based pneumococcal vaccine placebo(High dose); 1.0mL,Intramuscular other name:PBPV placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
safety indexes of SAE	Occurrence of SAE	within 180 days post vaccination
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
immunogencity indexes of neutralization test	neutralization test activity of anti-Ply antibody in serum	day30,60 post each vaccination

Collaborators and Investigators

• Sponsor: CanSino Biologics Inc.
• Collaborators: Henan Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 10, 2020
• Primary Completion (ACTUAL): May 30, 2021
• Study Completion (ACTUAL): June 30, 2022

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 10, 2019
• First Posted (ACTUAL): September 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: PspA; Vaccnie; Pneomolysin
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: CS-CTP-PBPV-Ⅰa

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In order to maintain the rights of the subject, do not open the IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No