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

Primary Purpose

Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections

Status
Completed
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
Protein based pneumococcal vaccine(Low dose)
Protein based pneumococcal vaccine placebo(Low dose)
Protein based pneumococcal vaccine(Middle dose)
Protein based pneumococcal vaccine placebo(Middle dose)
Protein based pneumococcal vaccine(High dose)
Protein based pneumococcal vaccine placebo(High dose)
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumonia focused on measuring Vaccnie, PspA, Pneomolysin

Eligibility Criteria

18 Years - 49 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Suixian Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

Low-dose Group A

Low-dose Group B

Middle-dose Group A

Middle-dose Group B

High-dose Group A

High-dose Group B

Arm Description

Subjects received three doses of PBPV with 20μg each antigen

Subjects received three doses of placebo

Subjects received three doses of PBPV with 50μg each antigen

Subjects received three doses of placebo

Subjects received three doses of PBPV with 100μg each antigen

Subjects received three doses of placebo

Outcomes

Primary Outcome Measures

Safety indexes of solicited and unsolicited adverse reactions
Occurrence of solicited and unsolicited reactions post each vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Safety indexes of lab measures
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs

Secondary Outcome Measures

safety indexes of SAE
Occurrence of SAE
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
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

Full Information

First Posted
September 10, 2019
Last Updated
November 3, 2022
Sponsor
CanSino Biologics Inc.
Collaborators
Henan Center for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT04087460
Brief Title
Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine
Acronym
PⅠCTPV
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2020 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.
Collaborators
Henan Center for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
Keywords
Vaccnie, PspA, Pneomolysin

7. Study Design

Primary Purpose
Prevention
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Low-dose Group A
Arm Type
Experimental
Arm Description
Subjects received three doses of PBPV with 20μg each antigen
Arm Title
Low-dose Group B
Arm Type
Placebo Comparator
Arm Description
Subjects received three doses of placebo
Arm Title
Middle-dose Group A
Arm Type
Experimental
Arm Description
Subjects received three doses of PBPV with 50μg each antigen
Arm Title
Middle-dose Group B
Arm Type
Placebo Comparator
Arm Description
Subjects received three doses of placebo
Arm Title
High-dose Group A
Arm Type
Experimental
Arm Description
Subjects received three doses of PBPV with 100μg each antigen
Arm Title
High-dose Group B
Arm Type
Placebo Comparator
Arm Description
Subjects received three doses of placebo
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine(Low dose)
Intervention Description
0.2mL,Intramuscular other name:PBPV
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine placebo(Low dose)
Intervention Description
0.2mL,Intramuscular other name:PBPV placebo
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine(Middle dose)
Intervention Description
0.5mL,Intramuscular other name:PBPV
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine placebo(Middle dose)
Intervention Description
0.5mL,Intramuscular other name:PBPV placebo
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine(High dose)
Intervention Description
1.0mL,Intramuscular other name:PBPV
Intervention Type
Biological
Intervention Name(s)
Protein based pneumococcal vaccine placebo(High dose)
Intervention Description
1.0mL,Intramuscular other name:PBPV placebo
Primary Outcome Measure Information:
Title
Safety indexes of solicited and unsolicited adverse reactions
Description
Occurrence of solicited and unsolicited reactions post each vaccination
Time Frame
within 30 minutes,0-7 days,0-30 days post-vaccination
Title
Safety indexes of lab measures
Description
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Time Frame
day 3 and 8 post the first vaccination
Title
Safety indexes of lab measures
Description
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs
Time Frame
day 14 and 30 post each vaccination
Secondary Outcome Measure Information:
Title
safety indexes of SAE
Description
Occurrence of SAE
Time Frame
within 180 days post vaccination
Title
immunogencity indexes of GMC and GMI by ELISA
Description
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
Time Frame
day 8, 14,30,60 post each vaccination
Title
immunogencity indexes of the seropositivity rates by ELISA
Description
the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum
Time Frame
day 8, 14,30,60 post each vaccination
Other Pre-specified Outcome Measures:
Title
immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA)
Description
Geometric mean titer(GMT) and Geometric mean increase（GMI）of antibodies in serum
Time Frame
day30,60 post each vaccination
Title
immunogencity indexes of neutralization test
Description
neutralization test activity of anti-Ply antibody in serum
Time Frame
day30,60 post each vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xia Shengli
Organizational Affiliation
Henan Province Center for Disease Control and Prevention
Official's Role
Principal Investigator
Facility Information:
Facility Name
Suixian Center for Disease Control and Prevention
City
Shangqiu
State/Province
Henan
ZIP/Postal Code
450016
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
In order to maintain the rights of the subject, do not open the IPD

Learn more about this trial

Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

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