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Clinical Trial of Recombinant Pneumococcal Protein Vaccine

Primary Purpose

Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
PBPV
PPV23
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 Vaccine, PspA, Pneumolysin, Safety, Immunogenicity, >=50 years

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Adults 50 years and older at the time of screening Willingness to provide legal proof of identity Ability to understand the clinical study and voluntarily sign an informed consent form and complete a 6-month follow-up Ability to comply with the requirements of the clinical research protocol Exclusion Criteria: Fever, axillary body temperature >37.0℃ before vaccination Positive human immunodeficiency virus (HIV) screening History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history Received immunosuppressive therapy, cytotoxic therapy, glucocorticoid therapy (excluding topical therapy, surface therapy for acute uncomplicated dermatitis, spray therapy for allergic rhinitis) within the past 6 months (interval <6 months) Suffering from serious chronic diseases or conditions in progress that can't be controlled smoothly, such as serious cardiovascular diseases, chronic hemolytic anemia, thyroid diseases, etc. (except thyroid nodules) History of severe anaphylactic reactions (e.g., systemic allergic reactions) to any component of the test drug and/or history of serious adverse reactions associated with other vaccines, such as allergy, urticaria, dyspnea, angioneurotic edema, or abdominal pain People with hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure is ≥ 100 mmHg) Pre-immune hemoglobin, white blood cell count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatine phosphokinase (CPK), and troponin (CTN) test results are abnormal and are judged by the investigator to be clinically significant Positive urine pregnancy test or lactating women, volunteers or their partners planning to become pregnant Diseases caused by Streptococcus pneumoniae such as pneumococcal pneumonia, pneumococcal meningitis, etc. within the last 5 years Allergic persons, such as those who are allergic to two or more drugs or foods or those who are severely allergic to one drug or food Immunocompromised individuals with known or suspected congenital/acquired immunodeficiency as determined by medical history and/or physical examination, uncontrolled autoimmune diseases, etc Abnormal coagulation (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders No spleen or splenectomy due to any condition Acute attack of various acute or chronic diseases within the last 7 days Pneumococcal vaccination within the last 5 years Received or planned to receive blood/plasma products or immunoglobulins during the study period or 3 months prior to vaccination Received or plan to participate in an interventional study, receive another investigational drug, vaccine or treatment during the study within the last 1 month Received live attenuated vaccine within the last 14 days Received subunit vaccine or inactivated vaccine within the last 7 days Those planning to have surgery during the study period Subject has any other factors that, in the judgment of the investigator, make them unsuitable for participation in the clinical trial

Sites / Locations

  • Lancang Lahu Autonomous County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recombinant Pneumococcal Protein Vaccine(PBPV)

Pneumococcal Polysaccharide Vaccine-23-valent (PPV23)

Arm Description

Subjects received 1 dose of PBPV

Subjects received 1 dose of PPV23

Outcomes

Primary Outcome Measures

Incidence of adverse reactions 0~7 days after vaccination
Incidence of adverse reactions 0~30 days after vaccination
Positive (4-fold change) rate of serum Pneumococcal surface protein A(PspA)-RX1, PspA-3296, PspA-5668 and PlyLD protein antibodies at day 30, 3 months and 6 months after vaccination

Secondary Outcome Measures

Incidence of adverse reactions within 30 minutes after vaccination
Incidence of adverse events within 30 days after vaccination
Incidence of Serious Adverse Event (SAE) within 6 months after vaccination
Evaluation of the incidence of abnormal laboratory hematology values, including hemoglobin, white blood cell count, alanine aminotransferase (AT), aspartate AT, total bilirubin, creatine phosphokinase , before and on day 8 of the subject's exemption
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Titer (GMT) at 30 days, 3 months and 6 months before and after vaccination
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Increase (GMI) at 30 days, 3 months and 6 months before and after vaccination
Serum Ply antibody neutralization test activity at 30 days, 3 months and 6 months before and after vaccination
GMT of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Positive conversion rate of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
GMI of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination

Full Information

First Posted
November 3, 2022
Last Updated
October 19, 2023
Sponsor
CanSino Biologics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05622942
Brief Title
Clinical Trial of Recombinant Pneumococcal Protein Vaccine
Official Title
Randomized, Blinded, Positive-controlled Phase Ib Clinical Trial for Preliminary Evaluation of Safety and Immunogenicity of Recombinant Pneumococcal Protein Vaccine in Adults Aged 50 Years and Older After Vaccination
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 11, 2023 (Actual)
Primary Completion Date
December 11, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CanSino Biologics Inc.

4. Oversight

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

5. Study Description

Brief Summary
Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children. The purpose of this study was to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine applied to adults aged 50 years and older to provide a basis for subsequent clinical trial design.
Detailed Description
The risk of Streptococcus pneumoniae infection varies widely with age, underlying disease, and living environment. Worldwide, infants and the elderly are at high risk for pneumococcal disease. Disease from pneumococcal infections can affect multiple organ systems and lead to multiple disease syndromes. This vaccine has a higher coverage rate, capable of reaching more than 94%. With the high coverage rate, it can effectively prevent the occurrence of serotype substitution and the outbreak of antibiotic-resistant pneumococcal-associated diseases. This clinical trial is a Phase Ib clinical trial in adults aged 50 years and older based on the Phase Ia clinical trial.

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
Vaccine, PspA, Pneumolysin, Safety, Immunogenicity, >=50 years

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Pneumococcal Protein Vaccine(PBPV)
Arm Type
Experimental
Arm Description
Subjects received 1 dose of PBPV
Arm Title
Pneumococcal Polysaccharide Vaccine-23-valent (PPV23)
Arm Type
Active Comparator
Arm Description
Subjects received 1 dose of PPV23
Intervention Type
Biological
Intervention Name(s)
PBPV
Intervention Description
Intramuscular injection, 1 dose of 0.5ml inoculated on day 0
Intervention Type
Biological
Intervention Name(s)
PPV23
Intervention Description
Intramuscular injection, 1 dose of 0.5ml inoculated on day 0
Primary Outcome Measure Information:
Title
Incidence of adverse reactions 0~7 days after vaccination
Time Frame
0~7 days after vaccination
Title
Incidence of adverse reactions 0~30 days after vaccination
Time Frame
0~30 days after vaccination
Title
Positive (4-fold change) rate of serum Pneumococcal surface protein A(PspA)-RX1, PspA-3296, PspA-5668 and PlyLD protein antibodies at day 30, 3 months and 6 months after vaccination
Time Frame
Day 30, 3 months and 6 months after vaccination
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions within 30 minutes after vaccination
Time Frame
30 minutes after vaccination
Title
Incidence of adverse events within 30 days after vaccination
Time Frame
30 days after vaccination
Title
Incidence of Serious Adverse Event (SAE) within 6 months after vaccination
Time Frame
6 months after vaccination
Title
Evaluation of the incidence of abnormal laboratory hematology values, including hemoglobin, white blood cell count, alanine aminotransferase (AT), aspartate AT, total bilirubin, creatine phosphokinase , before and on day 8 of the subject's exemption
Time Frame
Before and on day 8 of the subject's exemption
Title
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Titer (GMT) at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination
Title
Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Increase (GMI) at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination
Title
Serum Ply antibody neutralization test activity at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination
Title
GMT of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination
Title
Positive conversion rate of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination
Title
GMI of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination
Time Frame
30 days, 3 months and 6 months before and after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults 50 years and older at the time of screening Willingness to provide legal proof of identity Ability to understand the clinical study and voluntarily sign an informed consent form and complete a 6-month follow-up Ability to comply with the requirements of the clinical research protocol Exclusion Criteria: Fever, axillary body temperature >37.0℃ before vaccination Positive human immunodeficiency virus (HIV) screening History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history Received immunosuppressive therapy, cytotoxic therapy, glucocorticoid therapy (excluding topical therapy, surface therapy for acute uncomplicated dermatitis, spray therapy for allergic rhinitis) within the past 6 months (interval <6 months) Suffering from serious chronic diseases or conditions in progress that can't be controlled smoothly, such as serious cardiovascular diseases, chronic hemolytic anemia, thyroid diseases, etc. (except thyroid nodules) History of severe anaphylactic reactions (e.g., systemic allergic reactions) to any component of the test drug and/or history of serious adverse reactions associated with other vaccines, such as allergy, urticaria, dyspnea, angioneurotic edema, or abdominal pain People with hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure is ≥ 100 mmHg) Pre-immune hemoglobin, white blood cell count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatine phosphokinase (CPK), and troponin (CTN) test results are abnormal and are judged by the investigator to be clinically significant Positive urine pregnancy test or lactating women, volunteers or their partners planning to become pregnant Diseases caused by Streptococcus pneumoniae such as pneumococcal pneumonia, pneumococcal meningitis, etc. within the last 5 years Allergic persons, such as those who are allergic to two or more drugs or foods or those who are severely allergic to one drug or food Immunocompromised individuals with known or suspected congenital/acquired immunodeficiency as determined by medical history and/or physical examination, uncontrolled autoimmune diseases, etc Abnormal coagulation (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders No spleen or splenectomy due to any condition Acute attack of various acute or chronic diseases within the last 7 days Pneumococcal vaccination within the last 5 years Received or planned to receive blood/plasma products or immunoglobulins during the study period or 3 months prior to vaccination Received or plan to participate in an interventional study, receive another investigational drug, vaccine or treatment during the study within the last 1 month Received live attenuated vaccine within the last 14 days Received subunit vaccine or inactivated vaccine within the last 7 days Those planning to have surgery during the study period Subject has any other factors that, in the judgment of the investigator, make them unsuitable for participation in the clinical trial
Facility Information:
Facility Name
Lancang Lahu Autonomous County Center for Disease Control and Prevention
City
Puer
State/Province
Yunnan
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 Individual Participant Data (IPD)

Learn more about this trial

Clinical Trial of Recombinant Pneumococcal Protein Vaccine

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