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

CanSino Biologics

Status and phase: Completed; Early Phase 1

Conditions: Respiratory Tract Diseases; Pneumonia; Respiratory Tract Infections

Treatments: Biological: Protein based pneumococcal vaccine(Middle dose); Biological: Protein based pneumococcal vaccine placebo(High dose); Biological: Protein based pneumococcal vaccine(High dose); Biological: Protein based pneumococcal vaccine placebo(Low dose); Biological: Protein based pneumococcal vaccine(Low dose); Biological: Protein based pneumococcal vaccine placebo(Middle dose)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04087460

CS-CTP-PBPV-Ⅰa

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 6 patient groups, including a placebo group

Low-dose Group A

Experimental group

Description:

Subjects received three doses of PBPV with 20μg each antigen

Treatment:

Biological: Protein based pneumococcal vaccine(Low dose)

Low-dose Group B

Placebo Comparator group

Description:

Subjects received three doses of placebo

Treatment:

Biological: Protein based pneumococcal vaccine placebo(Low dose)

Middle-dose Group A

Experimental group

Description:

Subjects received three doses of PBPV with 50μg each antigen

Treatment:

Biological: Protein based pneumococcal vaccine(Middle dose)

Middle-dose Group B

Placebo Comparator group

Description:

Subjects received three doses of placebo

Treatment:

Biological: Protein based pneumococcal vaccine placebo(Middle dose)

High-dose Group A

Experimental group

Description:

Subjects received three doses of PBPV with 100μg each antigen

Treatment:

Biological: Protein based pneumococcal vaccine(High dose)

High-dose Group B

Placebo Comparator group

Description:

Subjects received three doses of placebo

Treatment:

Biological: Protein based pneumococcal vaccine placebo(High dose)