Clinical Trial of Recombinant Pneumococcal Protein Vaccine

NCT05622942 | Completed Phase 1

• 1 other identifier: CTP-PBPV-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse reactions 0~7 days after vaccination

  0~7 days after vaccination

• Incidence of adverse reactions 0~30 days after vaccination

  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

  Day 30, 3 months and 6 months after vaccination

Secondary Outcomes (10)

• Incidence of adverse reactions within 30 minutes after vaccination

  30 minutes after vaccination

• Incidence of adverse events within 30 days after vaccination

  30 days after vaccination

• Incidence of Serious Adverse Event (SAE) within 6 months after vaccination

  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

  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

  30 days, 3 months and 6 months before and after vaccination

Study Arms (2)

Recombinant Pneumococcal Protein Vaccine（PBPV）

EXPERIMENTAL

Subjects received 1 dose of PBPV

Biological: PBPV

Pneumococcal Polysaccharide Vaccine-23-valent (PPV23)

ACTIVE COMPARATOR

Subjects received 1 dose of PPV23

Biological: PPV23

Interventions

PBPV BIOLOGICAL

Intramuscular injection, 1 dose of 0.5ml inoculated on day 0

Recombinant Pneumococcal Protein Vaccine（PBPV）

PPV23 BIOLOGICAL

Intramuscular injection, 1 dose of 0.5ml inoculated on day 0

Pneumococcal Polysaccharide Vaccine-23-valent (PPV23)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CanSino Biologics Inc.: lead

Study Sites (1)

Lancang Lahu Autonomous County Center for Disease Control and Prevention

Puer, Yunnan, China

Location

MeSH Terms

Conditions

Pneumonia; Respiratory Tract Diseases; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Lung Diseases

Study Design

• Study Type: interventional
• Phase: 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: November 3, 2022
• First Posted: November 21, 2022
• Study Start: March 11, 2023
• Primary Completion: September 14, 2023
• Study Completion: January 30, 2024
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)