Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

NCT04087460 | Completed Early Phase 1 DMC

• 1 other identifier: CS-CTP-PBPV-Ⅰa
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections

Keywords

Vaccnie; PspA; Pneomolysin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• safety indexes of SAE

  within 180 days post vaccination

• immunogencity indexes of GMC and GMI by ELISA

  day 8, 14,30,60 post each vaccination

• immunogencity indexes of the seropositivity rates by ELISA

  day 8, 14,30,60 post each vaccination

Other Outcomes (2)

• immunogencity indexes of GMT and GMI by Opsonophagocytic assay (OPA)

  day30,60 post each vaccination

• immunogencity indexes of neutralization test

  day30,60 post each vaccination

Study Arms (6)

Low-dose Group A

EXPERIMENTAL

Subjects received three doses of PBPV with 20μg each antigen

Biological: Protein based pneumococcal vaccine(Low dose)

Low-dose Group B

PLACEBO COMPARATOR

Subjects received three doses of placebo

Biological: Protein based pneumococcal vaccine placebo(Low dose)

Middle-dose Group A

EXPERIMENTAL

Subjects received three doses of PBPV with 50μg each antigen

Biological: Protein based pneumococcal vaccine(Middle dose)

Middle-dose Group B

PLACEBO COMPARATOR

Subjects received three doses of placebo

Biological: Protein based pneumococcal vaccine placebo(Middle dose)

High-dose Group A

EXPERIMENTAL

Subjects received three doses of PBPV with 100μg each antigen

Biological: Protein based pneumococcal vaccine(High dose)

High-dose Group B

PLACEBO COMPARATOR

Subjects received three doses of placebo

Biological: Protein based pneumococcal vaccine placebo(High dose)

Interventions

Protein based pneumococcal vaccine(Low dose) BIOLOGICAL

0.2mL,Intramuscular other name:PBPV

Low-dose Group A

Protein based pneumococcal vaccine placebo(Low dose) BIOLOGICAL

0.2mL,Intramuscular other name:PBPV placebo

Low-dose Group B

Protein based pneumococcal vaccine(Middle dose) BIOLOGICAL

0.5mL,Intramuscular other name:PBPV

Middle-dose Group A

Protein based pneumococcal vaccine placebo(Middle dose) BIOLOGICAL

0.5mL,Intramuscular other name:PBPV placebo

Middle-dose Group B

Protein based pneumococcal vaccine(High dose) BIOLOGICAL

1.0mL,Intramuscular other name:PBPV

High-dose Group A

Protein based pneumococcal vaccine placebo(High dose) BIOLOGICAL

1.0mL,Intramuscular other name:PBPV placebo

High-dose Group B

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead
• Henan Center for Disease Control and Prevention: collaborator

Study Sites (1)

Suixian Center for Disease Control and Prevention

Shangqiu, Henan, 450016, China

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Lung Diseases

Study Officials

• Xia Shengli

  Henan Province Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 12, 2019
• Study Start: April 10, 2020
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)