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Streptococcus Pneumoniae PneumoniaPhase 2NCT07035054

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

A Phase 2 study testing low dose-1, low dose-2 and high dose in people with Streptococcus Pneumoniae Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the treatment of pneumococcal diseases, the common use of penicillin-based antimicrobial agents has led to drug resistance, which has become a global challenge. Therefore, disease prevention through vaccination is essential. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Streptococcus Pneumoniae Pneumonia
What is being tested?
low dose-1, low dose-2 and high dose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
992 participants
Where
1 siteChina
Study dates
20 Apr 2024to 30 Nov 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1.Age and Identification: Volunteers aged ≥18 years on the screening day, able to provide valid legal identification.
  • 2.Informed Consent: Volunteers who have received and understood the study information, voluntarily agreed to participate, and signed the Informed Consent Form.
  • 3.Compliance: Volunteers able and willing to adhere to the clinical trial protocol requirements and attend all scheduled visits.
  • Baseline Temperature: Axillary temperature ≤37.0°C on the enrollment day.

Who cannot join

  • 5.Vaccination History: Prior receipt of pneumococcal conjugate vaccine; pneumococcal polysaccharide vaccine within the past 3 years; or a history of invasive Streptococcus pneumoniae disease.
  • 6.Severe Allergic Reactions: History of severe allergic reactions, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrotic reaction (Arthus reaction), etc.
  • 7.Immunocompromised Status: Diagnosed congenital or acquired immunodeficiency; or receipt of systemic glucocorticoid therapy (e.g., prednisone or equivalent >5 mg/day for ≥2 consecutive weeks) within 1 month prior to vaccination (local, inhaled, or nebulized steroids are permitted).
  • 8.Severe Cardiovascular Diseases: History of arrhythmia, conduction block, myocardial infarction, or uncontrolled severe hypertension (on-site measurement: systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg).
  • 9.Acute Illness or Medication Use: Acute febrile illness, acute infectious disease, active cold symptoms, progressive influenza, or current use of related therapeutic medications.
  • 10.Neurological/Developmental Disorders: History of neurological impairment, severe congenital malformation, severe developmental disorder, severe genetic defect, or severe malnutrition.
Show all 16Show fewer
  • 11.Neuropsychiatric History: Personal or family history of epilepsy, encephalopathy, or psychiatric disorders.
  • 12.Coagulation Abnormalities: Diagnosed thrombocytopenia, coagulation dysfunction (e.g., coagulation factor deficiency, coagulation disorders, platelet abnormalities), or contraindications to intramuscular injection (e.g., anticoagulant therapy).
  • 13.Splenic Abnormalities: Asplenia, functional asplenia, or splenectomy for any reason.
  • 14.Uncontrolled Chronic Diseases: Severe chronic diseases or progressive conditions that cannot be stably controlled.
  • 15.Blood Products/Immunoglobulins: Receipt of blood or blood products, or immunoglobulins within the past 3 months.
  • 16.Live Attenuated Vaccines: Vaccination with live attenuated vaccines within the past 14 days.
  • 17.Other Vaccines: Vaccination with other vaccines within the past 7 days. 18.Investigational Products: Receipt of other investigational drugs or vaccines within the past 1 month.
  • 19.Concurrent Studies: Current participation or planned participation in another clinical study of drugs or vaccines during the research period.
  • 20.Investigator's Discretion: Any other condition that, in the investigator's judgment, may interfere with study evaluation.
  • 21.Additional Exclusions for Specific Populations: Females of Childbearing Potential (18-49 years): Positive urine pregnancy test on enrollment day; lactation; or planning to become pregnant within 6 months.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Diseases Control and Prevention

    Nanjing, Jiangsu, 210000

Other trials in China

About this study

Official title: Evaluation of the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in Individuals Aged 18 Years and Above: A Random PhaseⅡClinical Trial.

In the treatment of pneumococcal diseases, the common use of penicillin-based antimicrobial agents has led to drug resistance, which has become a global challenge. Therefore, disease prevention through vaccination is essential. The 23-valent pneumococcal polysaccharide vaccine, the first widely used vaccine, has limitations. Subsequent pneumococcal polysaccharide conjugate vaccines have improved protection rates but increased cases of infections caused by non-vaccine serotype strains. Currently, vaccines available in China for pneumococcal disease prevention include the 23-valent polysaccharide vaccine (approved only for adults) and the 13-valent conjugate vaccine. PCV24 expands serotype coverage and converts capsular polysaccharides into T-cell-dependent antigens by binding them to proteins, stimulating humoral immunity and the complement system to generate specific antibodies and immunological memory for disease prevention. This study aims to preliminarily investigate the safety and immunogenicity of PCV24 vaccination in Chinese adults.

Read the detailed description

Streptococcus pneumoniae is a Gram-positive diplococcus, and its capsular polysaccharide is a key virulence factor. According to differences in the composition and structure of capsular polysaccharides, it can be divided into more than 90 serotypes, with varying viability and pathogenicity among different serotypes. As an important opportunistic pathogen, this bacterium can breach mucosal defense systems to cause invasive infections when host immunity declines, leading to diseases such as pneumonia, bacterial meningitis, bacteremia, sinusitis, and otitis media.

Antimicrobial agents commonly used in the treatment of pneumococcal diseases, such as penicillins, macrolides, and cephalosporins, have faced global challenges due to drug resistance, making vaccination essential for disease prevention. The World Health Organization (WHO) has classified pneumococcal diseases as a top priority for vaccination. The early widely used 23-valent pneumococcal polysaccharide vaccine had limitations, while subsequent 7-valent, 10-valent, and 13-valent pneumococcal polysaccharide conjugate vaccines improved protection rates but were associated with increased infections from non-vaccine serotype strains. Currently, only the 23-valent polysaccharide vaccine is approved for adult use in China. Pneumococcal conjugate vaccines convert capsular polysaccharides into T-cell-dependent antigens by binding them to proteins, thereby stimulating humoral immunity and the complement system to generate specific antibodies and immunological memory for disease prevention. This study aims to evaluate the safety and tolerability of a 24-valent pneumococcal polysaccharide conjugate vaccine in individuals aged 18 years and older.

Being tested
low dose-1, low dose-2, high dose, positive control
Medical subject headings
Pneumonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • low dose-1Biological

    PCV24 (low-dose 1) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, and the dosage is 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows: 4.0 μg per vial for serotypes 3, 6B, and 12F; and 2.0 μg per vial for the other 21 serotypes, namely 1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant (aluminum content: 0.125 mg per dose).

  • low dose-2Biological

    PCV24 (low-dose 2) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows:

    3 types (3, 6B, 12F): 4.0 μg per vial 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 2.0 μg per vial After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant with an aluminum content of 0.25 mg per dose.

  • high doseBiological

    PCV24 (high-dose) developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. is a liquid formulation. Each vial contains 0.5 ml, with a dosage of 0.5 ml per person per administration. The polysaccharide content of each serotype is as follows:

    3 types (3, 6B, 12F): 8.0 μg per vial 21 other serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F): 4.0 μg per vial After binding to carrier proteins, the polysaccharides of each serotype are adsorbed on an aluminum phosphate adjuvant with an aluminum content of 0.25 mg per dose.

  • positive controlBiological

    PPV23 produced by Chengdu Institute of Biological Products is a formulation with each vial containing 0.5 ml, and the dosage is 0.5 ml per person per administration. It contains polysaccharides of the following pneumococcal serotypes: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F, with each serotype containing 25 μg of polysaccharide. In addition, it contains sodium chloride and water for injection.

Study groups in NCT07035054
Study groupRoleWhat they receive
PCV24 Low dose-1 groupExperimentalAdults receive one dose of 0.5ml low dose-1 PCV24 vaccine，the low dose-1 group contained 4.0 μg of polysaccharides per vial for serotypes 3, 6B, and 12F, and 2.0 μg of polysaccharides per vial for the other 21 serotypes (1, 2, 4, 5, 6A, 7F, 8, 9N, 9V, 10A, 11A, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F). The polysaccharides of each serotype were bound to carrier proteins and adsorbed onto aluminum phosphate adjuvant (aluminum content: 0.125 mg/dose)
Receives: Biological: low dose-1
PCV24 Low dose-2 groupExperimentalAdults receive one dose of 0.5ml low dose-2 PCV24 vaccine，the low dose-2 group is a liquid formulation of 0.5 ml per vial with a dosage of 0.5 ml per person per administration, containing 4.0 μg of polysaccharides per vial for serotypes 3, 6B and 12F and 2.0 μg per vial for each of the other 21 serotypes, with the polysaccharides of each serotype bound to carrier proteins and adsorbed on aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose)
Receives: Biological: low dose-2
PCV24 High dose groupExperimentalAdults receive one dose of 0.5ml High dose PCV24 vaccine， the high dose group is a liquid formulation of 0.5 ml per vial with a dosage of 0.5 ml per person per administration, containing 8.0 μg of polysaccharides per vial for serotypes 3, 6B and 12F and 4.0 μg per vial for each of the other 21 serotypes, with the polysaccharides of each serotype bound to carrier proteins and adsorbed on aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose)
Receives: Biological: high dose
Positive control groupActive comparatorAdults receive one dose of 0.5ml PPV23 vaccine， the positive control is the PPV23 produced by Chengdu Institute of Biological Products, which is 0.5 ml per vial and 0.5 ml per dose per person and contains 25 μg of pneumococcal polysaccharides for each serotype of 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F and 33F, as well as sodium chloride and water for injection.
Receives: Biological: positive control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the immunogenicity after vaccination

    The seroconversion rate of specific IgG antibodies against each serotype covered by the pneumococcal vaccine, detected by enzyme-linked immunosorbent assay (ELISA) at 30 days after immunization in each group.

    Measured: Within 30 days after vaccination

Secondary outcomes (2)

  1. To evaluate The incidence of adverse reactions after vaccination

    The proportion of subjects reporting adverse reactions within 30 days after vaccination

    Measured: within 30 days after vaccination

  2. To evaluate The incidence of serious adverse events after vaccination

    The proportion of subjects reporting serious adverse events within 6 months after vaccination

    Measured: Within 6 months after vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2025
  2. Study start20 Apr 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
992 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07035054
Sponsor's protocol ID
JSVCT183
Status last verified
Jun 2025
First submitted
6 Jun 2025
Last updated
24 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang K, Hu J, Chen H, Wang Z, Zhu X, Pan H. Safety and immunogenicity of the 24-valent pneumococcal conjugate vaccine in healthy Chinese adults: two single-center, randomized, double-blind Phase 1 and Phase 2 trials. Expert Rev Vaccines. 2026 Dec;25(1):2746803. doi: 10.1080/14760584.2026.2746803. Epub 2026 Oct 22.

    PubMed 42908339

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing low dose-1, low dose-2 and high dose in people with Streptococcus Pneumoniae Pneumonia, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the immunogenicity after vaccination (time frame: Within 30 days after vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07035054, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.

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