Streptococcus Pneumoniae PneumoniaEarly Phase 1NCT07025876

PhaseⅠClinical Trial of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine

A Early Phase 1 study testing low dose PCV24, high dose PCV24 and PPV23 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

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 PCV24, high dose PCV24 and PPV23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 240 participants
Where: 1 siteChina
Study dates: 18 Nov 2023to 30 Jul 2024
Phase: Early Phase 1
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.
4.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.

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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 PhaseⅠClinical 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.

Conditions: Streptococcus Pneumoniae Pneumonia
Being tested: low dose PCV24, high dose PCV24, PPV23, Placebo
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 PCV24Biological
The 24-valent pneumococcal polysaccharide conjugate vaccine (low-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 serotypes (3, 6B, 12F): 4.0 μg per vial each
- 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).
high dose PCV24Biological
The 24-valent pneumococcal polysaccharide conjugate vaccine (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 serotypes (3, 6B, 12F): 8.0 μg per vial each 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).
PPV23Biological
The 23-valent pneumococcal polysaccharide vaccine (PPV23) produced by Chengdu Institute of Biological Products is available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration. It contains the following pneumococcal polysaccharides for each serotype:
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: 25 μg per vial for each serotype.
Additionally, it contains sodium chloride and water for injection.
PlaceboBiological
In addition to the antigen components, the 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. contains the following excipients:
Aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose) Sodium chloride Succinic acid Polysorbate 80 Water for injection It is a liquid formulation, available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration.

Study groups in NCT07025876
Study group	Role	What they receive
Low-dose group	Experimental	Adults receive one dose of 0.5ml low-dose PCV24 vaccine. Receives: Biological: low dose PCV24
High-dose group.	Experimental	Adults receive one dose of 0.5ml high-dose PCV24 vaccine. Receives: Biological: high dose PCV24
Positive control group	Active comparator	Adults receive one dose of 0.5ml PPV23 vaccine. Receives: Biological: PPV23
placebo control group	Placebo comparator	Adults receive one dose of 0.5ml normal saline. Receives: Biological: Placebo

What is being measured

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

To evaluate The incidence of adverse reactions after vaccination
The proportion of subjects reporting adverse reactions within 7 days after vaccination
Measured: Within 0-7 days after vaccination

Secondary outcomes (6)

To evaluate The incidenceof adverse events after vaccination.
The proportion of subjects reporting adverse events within 0-30 days after vaccination.
Measured: Within 0-30 days after vaccination
To evaluate The occurrence of serious adverse events after vaccination.
The proportion of subjects reporting serious adverse events after vaccination.
Measured: Within 6 months after vaccination
Number of participants with clinically significant changes in blood routine after vaccination
Changes in blood routine indicators on day 3 after vaccination
Measured: Day 3 after vaccination
Number of participants with clinically significant changes in blood biochemistry after vaccination
Measurement: Changes in blood biochemistry indicators on day 3 after vaccination
Measured: Day 3 after vaccination
Number of participants with clinically significant changes in coagulation function after vaccination
Changes in coagulation function indicators on day 3 after vaccination
Measured: Day 3 after vaccination
Number of participants with clinically significant changes in urinalysis after vaccination
Changes in urinalysis indicators on day 3 after vaccination
Measured: Day 3 after vaccination

Timeline

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

18 Nov 202330 Jul 2024

First posted18 Jun 2025
Study start18 Nov 2023
Primary completion15 Jun 2024
Study completion30 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Streptococcus Pneumoniae PneumoniaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

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

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07025876
Sponsor's protocol ID: JSVCT182
Status last verified: Jun 2025
First submitted: 6 Jun 2025
Last updated: 18 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Streptococcus Pneumoniae Pneumonia trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in Individuals Aged 18 Years and Above: A Random PhaseⅠClinical Trial
ClinicalTrials.gov ID: NCT07025876
Acronym / sponsor ID: JSVCT182
Conditions: Streptococcus Pneumoniae Pneumonia
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Jiangsu Province Centers for Disease Control and PreventionResearch network
Study start: 18 Nov 2023 (actual)
Primary completion: 15 Jun 2024 (actual)
Study completion: 30 Jul 2024 (actual)
First posted: 18 Jun 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Low-dose group	Experimental	Biological: low dose PCV24Adults receive one dose of 0.5ml low-dose PCV24 vaccine.
High-dose group.	Experimental	Biological: high dose PCV24Adults receive one dose of 0.5ml high-dose PCV24 vaccine.
Positive control group	Active comparator	Biological: PPV23Adults receive one dose of 0.5ml PPV23 vaccine.
placebo control group	Placebo comparator	Biological: PlaceboAdults receive one dose of 0.5ml normal saline.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.
4.Baseline Temperature: Axillary temperature ≤37.0°C on the enrollment day.

Key exclusion criteria (16 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
low dose PCV24The 24-valent pneumococcal polysaccharide conjugate vaccine (low-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 serotypes (3, 6B, 12F): 4.0 μg per vial each * 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).	Biological	Low-dose group
high dose PCV24The 24-valent pneumococcal polysaccharide conjugate vaccine (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 serotypes (3, 6B, 12F): 8.0 μg per vial each 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 each After conjugation with carrier proteins, the polysaccharides of each serotype are adsorbed onto an aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose).	Biological	High-dose group.
PPV23The 23-valent pneumococcal polysaccharide vaccine (PPV23) produced by Chengdu Institute of Biological Products is available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration. It contains the following pneumococcal polysaccharides for each serotype: 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: 25 μg per vial for each serotype. Additionally, it contains sodium chloride and water for injection.	Biological	Positive control group
PlaceboIn addition to the antigen components, the 24-valent pneumococcal polysaccharide conjugate vaccine developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Changchun Ruizhou Biopharmaceutical Co., Ltd. contains the following excipients: Aluminum phosphate adjuvant (aluminum content: 0.25 mg per dose) Sodium chloride Succinic acid Polysorbate 80 Water for injection It is a liquid formulation, available in vials of 0.5 ml, with a dosage of 0.5 ml per person per administration.	Biological	placebo control group

Primary outcome

To evaluate The incidence of adverse reactions after vaccination
Time frame: Within 0-7 days after vaccination
The proportion of subjects reporting adverse reactions within 7 days after vaccination

6 secondary outcomes

To evaluate The incidenceof adverse events after vaccination.
Time frame: Within 0-30 days after vaccination
To evaluate The occurrence of serious adverse events after vaccination.
Time frame: Within 6 months after vaccination
Number of participants with clinically significant changes in blood routine after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in blood biochemistry after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in coagulation function after vaccination
Time frame: Day 3 after vaccination
Number of participants with clinically significant changes in urinalysis after vaccination
Time frame: Day 3 after vaccination

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
Derived from this study: PubMed 42908339Wang 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 18 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. Some participants in this study may receive a placebo. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 incidence of adverse reactions after vaccination (time frame: Within 0-7 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 NCT07025876, 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 18 Jun 2025.