Phase II Clinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT06678620 | Active Not Recruiting Phase 2

• 1 other identifier: JSVCT183
• Study Type: interventional
• Target: 992
• Locations: 1 country
• Sites: 2

Brief Summary

A phase II clinical trial of a 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 study's objective is to evaluate the safety and immunogenicity of PCV24. The trial is a single-center, randomized, blinded, parallel-controlled, non-inferiority design II clinical trial.

Conditions

Pneumococcal Infectious Disease

Outcome Measures

Primary Outcomes (3)

• incidence of adverse events

  The incidence of adverse events within 30 days after vaccination.

  0~30 days after vaccination

• Incidence of serious adverse events (SAE)

  Incidence of SAE during the period of safety monitoring

  0-6 months after vaccination

• Positive conversion rate of specific IgG antibodies by serotype

  The positive conversion rate of IgG antibody of each serotype covered by pneumococcal vaccine detected by Enzyme linked immunosorbent assay (ELISA) 30 days after immunization in each group.

  0~30 days after vaccination

Secondary Outcomes (1)

• The geometric mean concentration (GMC) of specific IgG antibodies detected by ELISA of each serotype of pneumococcus

  0~30 days after vaccination

Other Outcomes (3)

• the exploratory subgroup, the geometric mean concentration (GMT) of the pneumococcal vaccine was covered by multiplexed opsonophagocytic assay (MOPA)

  0~30 days after vaccination

• Exploratory subgroup, pneumococcal vaccine coverage of all serotypes/partial serotypes IgG and/or sIgA antibody levels in saliva

  before vaccination, 30 days, and 6 months after vaccination

• Exploratory subgroup, pneumococcal colonization in the nasopharynx of subjects

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

Study Arms (4)

Experimental group 1

EXPERIMENTAL

248 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

248 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

Experimental group 3

EXPERIMENTAL

248 participants will be randomized to receive Reinovax PCV24 formulation 3. 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 3

Active control group

ACTIVE COMPARATOR

248 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

Interventions

Reinovax PCV24 formulation 2 BIOLOGICAL

One dose of Reinovax PCV24 formulation 1（0.5mL）

Experimental group 2

Reinovax PCV24 formulation 3 BIOLOGICAL

One dose of Reinovax PCV24 formulation 1（0.5mL）

Experimental group 3

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

Reinovax PCV24 formulation 1 BIOLOGICAL

One dose of Reinovax PCV24 formulation 1（0.5mL）

Experimental group 1

Eligibility Criteria

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

You may qualify if:

• Volunteers aged 18 and above 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 vaccination with pneumococcal conjugate vaccine, prior vaccination with pneumococcal polysaccharide vaccine for less than 3 years, or previous history of invasive disease caused by Streptococcus pneumoniae;
• Have any history of severe allergies in the past, 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 prior to vaccination);
• Suffering from more serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥100 mmHg when measured on site);
• Those who have acute febrile illness or acute infectious disease or have cold symptoms, advanced influenza and take medication;
• History of nervous system damage, severe congenital malformations, severe developmental disorders, 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 the disease is in the advanced stage and cannot be controlled smoothly;
• Have received blood or blood-related products or immunoglobulins within 3 months;
• Received live attenuated vaccine within 14 days;
• Other vaccinations 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 (2)

Pizhou Center for Disease Control and Prevention

Pizhou, Jiangsu, China

Location

Xuzhou Center for Disease Control and Prevention

Xuzhou, 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 2
• 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: April 20, 2024
• Primary Completion: April 21, 2025
• Study Completion: March 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)