Pneumococcal Infectious DiseasePhase 1NCT06678607

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

A Phase 1 study testing Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2 and PPSV23 in people with Pneumococcal Infectious Disease, run by Reinovax Biologics Co., LTD 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: Pneumococcal Infectious Disease
What is being tested?: Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2 and PPSV23
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: 19 Nov 2023to 28 Jul 2024
Phase: 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

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.

Who cannot join

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.;

Show all 19Show fewer

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;
Any other condition that, in the opinion of the investigator, may interfere with the study evaluation;
Those who have abnormal laboratory tests such as blood routine, blood biochemistry, and urine routine that are clinically significant and cannot be enrolled according to the comprehensive judgment of the investigator;
Exclusion Criteria for Partial Populations:
Females of childbearing potential (18~49 years old): positive urine pregnancy test on the day of enrollment, lactation, or pregnancy plans within 6 months.

Trial locations and contacts

1 site in 1 country.

China1 site

Zhenjiang Center for Disease Control and Prevention
Zhenjiang, Jiangsu

Other trials in China

About this study

Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older

Read the detailed description

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 active control vaccine is a 23-valent pneumococcal polysaccharide vaccine (23-valent pneumococcal polysaccharide vaccine, PPSV23) produced by the Chengdu Institute of Biological Products. The 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 developed by Shanghai Ruizhou Biotechnology Co., Ltd. and Vinorelite Biopharmaceutical Co., Ltd.

A total of at least 240 participants will be enrolled, including 84 adults aged 18-60years and 120 elderly people aged ≥61 years. Participants will be randomized in a 1:1:1:1 ratio to receive one dose of PCV24 formulation 1, PCV24 formulation 2, PPSV23 or placebo.

Conditions: Pneumococcal Infectious Disease
Being tested: Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2, PPSV23, Placebo
Medical subject headings: Pneumococcal Infections

What participants receive

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

Reinovax PCV24 formulation 1Biological
One dose of Reinovax PCV24 formulation 1（0.5mL）
Reinovax PCV24 formulation 2Biological
One dose of Reinovax PCV24 formulation 1（0.5mL）
PPSV23Biological
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.
PlaceboBiological
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

Study groups in NCT06678607
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Biological: Placebo

What is being measured

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

Incidence of adverse reactions
Incidence of adverse reactions within 7 days after vaccination
Measured: 0-7days after vaccination

Secondary outcomes (3)

incidence of adverse events
The incidence of adverse events within 30 days after vaccination.
Measured: 0~30 days after vaccination.
Incidence of serious adverse events (SAE)
Incidence of SAE during the period of safety monitoring
Measured: 0-6 months after vaccination
Incidence of clinically significant abnormality in laboratory examination tests
Incidence of clinically significant abnormality in blood routine, blood biochemistry,coagulation function and urine routine test results within 3 days after vaccination
Measured: 0-3days after vaccination

Timeline

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

19 Nov 202328 Jul 2024

First posted7 Nov 2024
Study start19 Nov 2023
Primary completion28 Jul 2024
Study completion28 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Pneumococcal Infectious DiseaseStudies 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: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06678607
Sponsor's protocol ID: JSVCT182
Status last verified: Nov 2024
First submitted: 5 Nov 2024
Last updated: 7 Nov 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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 Pneumococcal Infectious Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Trial to Evaluate the Safety and Tolerability of 24-valent Pneumococcal Polysaccharide Conjugate Vaccine in People Aged 18 Years and Older
ClinicalTrials.gov ID: NCT06678607
Acronym / sponsor ID: JSVCT182
Conditions: Pneumococcal Infectious Disease
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: Reinovax Biologics Co., LTDIndustry (pharma, biotech, devices)
Study start: 19 Nov 2023 (actual)
Primary completion: 28 Jul 2024 (actual)
Study completion: 28 Jul 2024 (actual)
First posted: 7 Nov 2024 (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: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Experimental group 1	Experimental	Biological: Reinovax PCV24 formulation 160 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.
Experimental group 2	Experimental	Biological: Reinovax PCV24 formulation 260 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.
Active control group	Active comparator	Biological: PPSV2360 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.
Placebo group	Placebo comparator	Biological: Placebo60 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.

Who may qualify

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

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (19 listed)

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.;

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
Reinovax PCV24 formulation 1One dose of Reinovax PCV24 formulation 1（0.5mL）	Biological	Experimental group 1
Reinovax PCV24 formulation 2One dose of Reinovax PCV24 formulation 1（0.5mL）	Biological	Experimental group 2
PPSV23One 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.	Biological	Active control group
PlaceboOne 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	Biological	Placebo group

Primary outcome

Incidence of adverse reactions
Time frame: 0-7days after vaccination
Incidence of adverse reactions within 7 days after vaccination

3 secondary outcomes

incidence of adverse events
Time frame: 0~30 days after vaccination.
Incidence of serious adverse events (SAE)
Time frame: 0-6 months after vaccination
Incidence of clinically significant abnormality in laboratory examination tests
Time frame: 0-3days 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 7 Nov 2024.
Individual participant dataSharing planned: No

Related trials for Pneumococcal Infectious Disease

Active, not recruitingPhase 2
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RecruitingPhase 3
A Study to Learn About the Safety of an Expanded Pneumococcal Vaccine in Healthy Infants
Pneumococcal Disease
Active, not recruitingObservational study
A Study to Learn About the Safety of PREVENAR 20 Vaccine in Infants Aged Between Two to Six Months
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Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
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RecruitingObservational study
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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?

A Phase 1 study testing Reinovax PCV24 formulation 1, Reinovax PCV24 formulation 2 and PPSV23 in people with Pneumococcal Infectious Disease, run by Reinovax Biologics Co., LTD 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 19 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 7 Nov 2024. 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?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Incidence of adverse reactions (time frame: 0-7days 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 NCT06678607.

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 7 Nov 2024.