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COMPLETEDPHASE1

Clinical Trial of Recombinant Pneumococcal Protein Vaccine

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

NCT05622942•CanSino Biologics Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+12 more criteria

Locations (1)

Lancang Lahu Autonomous County Center for Disease Control and Prevention

Puer, Yunnan, China

Key Dates

Start Date

March 11, 2023

Primary Completion Date

September 14, 2023

Completion Date

January 30, 2024

Last Updated

December 4, 2024

Enrollment

ACTUAL participants

Conditions

PneumoniaRespiratory Tract DiseasesRespiratory Tract Infections

Interventions

PBPV

BIOLOGICAL

PPV23

BIOLOGICAL

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Ventilation Acquired Pneumonia

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RECRUITINGNA

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

NCT07186933

Postoperative Pulmonary AtelectasisPostoperative Pulmonary Complications+8 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Clinical Trial of Recombinant Pneumococcal Protein Vaccine

Inclusion Criteria

Exclusion Criteria

Effect of Acetylcysteine Inhalation on Incidence and Time to Develop Ventilator Associated Pneumonia in Critically Ill Mechanically Ventilated Patients

Driving Pressure During Surgeries With High Risk for Postoperative Pulmonary Complications

Performance of New Diagnostic Methods in Older Adults With Pneumonia

Health Systems and Policy Contexts of Medical Oxygen

High PEEP in Noninvasive Ventilation Patients With Pneumonia or ARDS

Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure