Phase I Clinical Trial of PCV24 in People Aged 18 Years and Older

NCT06678607 | Completed Phase 1 DMC

• 1 other identifier: JSVCT182
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I clinical trial of 24-valent pneumococcal conjugate vaccine (PCV24) developed by Shanghai Reinovax Biologics Co., LTD will be conducted in Chinese adults aged 18 years and older . The objective of the study is to evaluate the safety and tolerability of PCV24. The trial is a single-center, randomized, blind,parallel-controlled design I clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse reactions

  Incidence of adverse reactions within 7 days after vaccination

  0-7days after vaccination

Secondary Outcomes (3)

• incidence of adverse events

  0~30 days after vaccination.

• Incidence of serious adverse events (SAE)

  0-6 months after vaccination

• Incidence of clinically significant abnormality in laboratory examination tests

  0-3days after vaccination

Study Arms (4)

Experimental group 1

EXPERIMENTAL

60 participants will be randomized to receive Reinovax PCV24 formulation 1. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.

Biological: Reinovax PCV24 formulation 1

Experimental group 2

EXPERIMENTAL

60 participants will be randomized to receive Reinovax PCV24 formulation 2. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.

Biological: Reinovax PCV24 formulation 2

Active control group

ACTIVE COMPARATOR

60 participants will be randomized to receive PPSV23. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.

Biological: PPSV23

Placebo group

PLACEBO COMPARATOR

60 participants will be randomized to receive placebo. The route of administration is intramuscular injection at the deltoid muscle of the upper arm. The immunization schedule is 1 dose.

Biological: Placebo

Interventions

Reinovax PCV24 formulation 1 BIOLOGICAL

One dose of Reinovax PCV24 formulation 1（0.5mL）

Experimental group 1

Reinovax PCV24 formulation 2 BIOLOGICAL

One dose of Reinovax PCV24 formulation 1（0.5mL）

Experimental group 2

PPSV23 BIOLOGICAL

One dose of PPSV23 (0.5 mL) contains 1、2、3、4、5、6B、7F、8、9N、9V、10A、11A、12F、14、15B、17F、18C、19A、19F、20、22F、23F and33F saccharides.

Active control group

Placebo BIOLOGICAL

One dose of 0.5 mL placebo is aluminum phosphate adjuvant (aluminum content 0.25mg/dose), sodium chloride, succinic acid, polysorbate 80, and water for injection except for antigen components in 24-valent pneumococcal polysaccharide conjugate vaccine

Placebo group

Eligibility Criteria

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

You may qualify if:

• Volunteers over the age of 18 on the day of screening, and can provide legal identification;
• Informed consent must be obtained from the volunteer and signed informed consent form;
• Volunteers are able and willing to comply with the requirements of the clinical trial protocol and can attend all visits;
• Armpit body temperature ≤ 37.0 °C on the day of enrollment.

You may not qualify if:

• Previous pneumococcal vaccination, or history of invasive disease caused by pneumococcal in the past;
• Have any previous history of severe allergies to vaccines or drugs, such as anaphylactic shock, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenic purpura, local allergic necrosis reaction (Athus reaction), etc.;
• Have been diagnosed with congenital or acquired immunodeficiency, or have recently received immunosuppressant therapy, such as systemic glucocorticoid therapy such as prednisone or similar drugs \> 5 mg/day for more than 2 consecutive weeks in 1 month before vaccination (Note: the use of topical and inhaled/nebulized steroids can participate);
• Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure ≥100 mmHg), etc.;
• Suffering from acute febrile illness or infectious diseases, such as tuberculosis, viral hepatitis, etc.;
• History of nervous system damage, severe congenital malformations, severe developmental disabilities, severe genetic defects, severe malnutrition, etc.;
• Have a history or family history of epilepsy, encephalopathy, or psychiatric disorders;
• Those who have been diagnosed with thrombocytopenia, any abnormal coagulation function (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities, etc.) or contraindications to intramuscular injection such as anticoagulant therapy;
• asplenia, functional asplenia, and asplenia or splenectomy due to any cause;
• Suffering from severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes, thyroid disease, etc.;
• Have received blood or blood-related products or immunoglobulins within 3 months;
• Received live attenuated vaccine within 14 days;
• Received other vaccines within 7 days;
• Received other investigational drugs or vaccines within 1 month;
• Is participating in or plans to participate in clinical studies of other drugs or vaccines during the study period;

Sponsors & Collaborators

• Shanghai Reinovax Biologics Co.,LTD: lead

Study Sites (1)

Zhenjiang Center for Disease Control and Prevention

Zhenjiang, Jiangsu, China

Location

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

23-valent pneumococcal capsular polysaccharide vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

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 5, 2024
• First Posted: November 7, 2024
• Study Start: November 19, 2023
• Primary Completion: July 28, 2024
• Study Completion: July 28, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)