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PneumoniaPhase 1NCT05622942

Clinical Trial of Recombinant Pneumococcal Protein Vaccine

A Phase 1 study testing PBPV and PPV23 in people with Pneumonia and Respiratory Tract Diseases, run by CanSino Biologics Inc. 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

Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children. Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
What is being tested?
PBPV and PPV23
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteChina
Study dates
11 Mar 2023to 30 Jan 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 50 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults 50 years and older at the time of screening
  • Willingness to provide legal proof of identity
  • Ability to understand the clinical study and voluntarily sign an informed consent form and complete a 6-month follow-up
  • Ability to comply with the requirements of the clinical research protocol

Who cannot join

  • Fever, axillary body temperature >37.0℃ before vaccination
  • Positive human immunodeficiency virus (HIV) screening
  • History of epilepsy, convulsions or seizures or a history of psychiatric illness or family history
  • Received immunosuppressive therapy, cytotoxic therapy, glucocorticoid therapy (excluding topical therapy, surface therapy for acute uncomplicated dermatitis, spray therapy for allergic rhinitis) within the past 6 months (interval <6 months)
  • Suffering from serious chronic diseases or conditions in progress that can't be controlled smoothly, such as serious cardiovascular diseases, chronic hemolytic anemia, thyroid diseases, etc. (except thyroid nodules)
  • History of severe anaphylactic reactions (e.g., systemic allergic reactions) to any component of the test drug and/or history of serious adverse reactions associated with other vaccines, such as allergy, urticaria, dyspnea, angioneurotic edema, or abdominal pain
Show all 22Show fewer
  • People with hypertension that cannot be controlled by medication (when measured on site: systolic blood pressure ≥ 160 mmHg, diastolic blood pressure is ≥ 100 mmHg)
  • Pre-immune hemoglobin, white blood cell count, alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatine phosphokinase (CPK), and troponin (CTN) test results are abnormal and are judged by the investigator to be clinically significant
  • Positive urine pregnancy test or lactating women, volunteers or their partners planning to become pregnant
  • Diseases caused by Streptococcus pneumoniae such as pneumococcal pneumonia, pneumococcal meningitis, etc. within the last 5 years
  • Allergic persons, such as those who are allergic to two or more drugs or foods or those who are severely allergic to one drug or food
  • Immunocompromised individuals with known or suspected congenital/acquired immunodeficiency as determined by medical history and/or physical examination, uncontrolled autoimmune diseases, etc
  • Abnormal coagulation (e.g., clotting factor deficiency, coagulopathy, platelet abnormalities) or significant bruising or clotting disorders
  • No spleen or splenectomy due to any condition
  • Acute attack of various acute or chronic diseases within the last 7 days
  • Pneumococcal vaccination within the last 5 years
  • Received or planned to receive blood/plasma products or immunoglobulins during the study period or 3 months prior to vaccination
  • Received or plan to participate in an interventional study, receive another investigational drug, vaccine or treatment during the study within the last 1 month
  • Received live attenuated vaccine within the last 14 days
  • Received subunit vaccine or inactivated vaccine within the last 7 days
  • Those planning to have surgery during the study period
  • Subject has any other factors that, in the judgment of the investigator, make them unsuitable for participation in the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

  • Lancang Lahu Autonomous County Center for Disease Control and Prevention

    Puer, Yunnan

Other trials in China

About this study

Official title: Randomized, Blinded, Positive-controlled Phase Ib Clinical Trial for Preliminary Evaluation of Safety and Immunogenicity of Recombinant Pneumococcal Protein Vaccine in Adults Aged 50 Years and Older After Vaccination

Streptococcus pneumoniae infections often cause serious health problems, especially in infants and the elderly. Failure to cover all polysaccharide types of vaccines is a greater problem for adults than for children.

The purpose of this study was to preliminarily evaluate the safety and immunogenicity of a recombinant pneumococcal protein vaccine applied to adults aged 50 years and older to provide a basis for subsequent clinical trial design.

Read the detailed description

The risk of Streptococcus pneumoniae infection varies widely with age, underlying disease, and living environment. Worldwide, infants and the elderly are at high risk for pneumococcal disease. Disease from pneumococcal infections can affect multiple organ systems and lead to multiple disease syndromes. This vaccine has a higher coverage rate, capable of reaching more than 94%. With the high coverage rate, it can effectively prevent the occurrence of serotype substitution and the outbreak of antibiotic-resistant pneumococcal-associated diseases.

This clinical trial is a Phase Ib clinical trial in adults aged 50 years and older based on the Phase Ia clinical trial.

Being tested
PBPV, PPV23
Keywords
Vaccine, PspA, Pneumolysin, Safety, Immunogenicity, >=50 years
Medical subject headings
Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections

What participants receive

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

  • PBPVBiological

    Intramuscular injection, 1 dose of 0.5ml inoculated on day 0

  • PPV23Biological

    Intramuscular injection, 1 dose of 0.5ml inoculated on day 0

Study groups in NCT05622942
Study groupRoleWhat they receive
Recombinant Pneumococcal Protein Vaccine（PBPV）ExperimentalSubjects received 1 dose of PBPV
Receives: Biological: PBPV
Pneumococcal Polysaccharide Vaccine-23-valent (PPV23)Active comparatorSubjects received 1 dose of PPV23
Receives: Biological: PPV23

What is being measured

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

  1. Incidence of adverse reactions 0~7 days after vaccination

    Measured: 0~7 days after vaccination

  2. Incidence of adverse reactions 0~30 days after vaccination

    Measured: 0~30 days after vaccination

  3. Positive (4-fold change) rate of serum Pneumococcal surface protein A(PspA)-RX1, PspA-3296, PspA-5668 and PlyLD protein antibodies at day 30, 3 months and 6 months after vaccination

    Measured: Day 30, 3 months and 6 months after vaccination

Secondary outcomes (10)

  1. Incidence of adverse reactions within 30 minutes after vaccination

    Measured: 30 minutes after vaccination

  2. Incidence of adverse events within 30 days after vaccination

    Measured: 30 days after vaccination

  3. Incidence of Serious Adverse Event (SAE) within 6 months after vaccination

    Measured: 6 months after vaccination

  4. Evaluation of the incidence of abnormal laboratory hematology values, including hemoglobin, white blood cell count, alanine aminotransferase (AT), aspartate AT, total bilirubin, creatine phosphokinase , before and on day 8 of the subject's exemption

    Measured: Before and on day 8 of the subject's exemption

  5. Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Titer (GMT) at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and after vaccination

  6. Serum PspA-RX1, PspA-3296, PspA-5668, PlyLD protein antibody Geometric Mean Increase (GMI) at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and after vaccination

  7. Serum Ply antibody neutralization test activity at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and after vaccination

  8. GMT of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and after vaccination

  9. Positive conversion rate of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and after vaccination

  10. GMI of serotype specific Multiplexed Opsonophagocytic Killing Assay (MOPA) at 30 days, 3 months and 6 months before and after vaccination

    Measured: 30 days, 3 months and 6 months before and 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 posted21 Nov 2022
  2. Study start11 Mar 2023
  3. Primary completion14 Sep 2023
  4. Study completion30 Jan 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 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622942
Sponsor's protocol ID
CTP-PBPV-002
Status last verified
Dec 2024
First submitted
3 Nov 2022
Last updated
4 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: In order to maintain the rights of the subject, do not open the Individual Participant Data (IPD)

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PBPV and PPV23 in people with Pneumonia and Respiratory Tract Diseases, run by CanSino Biologics Inc. 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 22 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 4 Dec 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. 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 0~7 days after vaccination (time frame: 0~7 days after vaccination). The study lists 3 primary outcomes in all. 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 NCT05622942.

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 4 Dec 2024.

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