PⅠCTPV: Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

Sponsor

CanSino Biologics Inc. (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04087460

Collaborator

Henan Center for Disease Control and Prevention (Other)

120

Enrollment

Location

Arms

24.6

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Respiratory Tract Diseases Respiratory Tract Infections	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)	Early Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

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

Actual Study Start Date :

Apr 10, 2020

Anticipated Primary Completion Date :

May 30, 2021

Anticipated Study Completion Date :

Apr 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Safety indexes of solicited and unsolicited adverse reactions [within 30 minutes,0-7 days,0-30 days post-vaccination]
Occurrence of solicited and unsolicited reactions post each vaccination
Safety indexes of lab measures [day 3 and 8 post the first vaccination]
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Safety indexes of lab measures [day 14 and 30 post each vaccination]
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs

Secondary Outcome Measures

safety indexes of SAE [within 180 days post vaccination]
Occurrence of SAE
immunogencity indexes of GMC and GMI by ELISA [day 8, 14,30,60 post each vaccination]
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 [day 8, 14,30,60 post each vaccination]
the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum

Other Outcome Measures

immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA) [day30,60 post each vaccination]
Geometric mean titer(GMT) and Geometric mean increase（GMI）of antibodies in serum
immunogencity indexes of neutralization test [day30,60 post each vaccination]
neutralization test activity of anti-Ply antibody in serum

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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