PneumoniaEarly Phase 1PⅠCTPVNCT04087460

Phase Ⅰa Clinical Trial of a Pneumococcal Vaccine

A Early Phase 1 study testing Protein based pneumococcal vaccine(Low dose), Protein based pneumococcal vaccine(Middle dose) and Protein based pneumococcal vaccine(High dose) 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

Infections with Streptococcus pneumoniae often cause serious health problems, especially for infants and the elderly.Failure to cover all polysaccharide types is an even greater problem with adults than with children. Read more about this study

Who is it for?: Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for: Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
What is being tested?: Protein based pneumococcal vaccine(Low dose), Protein based pneumococcal vaccine(Middle dose) and Protein based pneumococcal vaccine(High dose)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 120 participants
Where: 1 siteChina
Study dates: 10 Apr 2020to 30 Jun 2022
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 to 49 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers aged 18 to 49 years old;
Willing to provide proof of identity;
Able to understand and sign the informed consent;
Able and willing comply with the requirements of the protocol

Who cannot join

Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
Abnormal changes of laboratory measures (with clinical significance);
Woman is pregnant and lactating (by urine pregnancy test)
Suffered from pneumonia in the past three years;
Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;
Allergic person;

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Any prior administration of blood products in last 3 month;
Any prior administration of other research medicines in last 1 month;
Plans to participate in or is participating in any other drug clinical study;
Any prior administration of attenuated live vaccine in last 14 days;
Any prior administration of subunit or inactivated vaccines in last 7 days;
Had fever before vaccination, volunteers with temperature >37.0℃ on axillary setting;
According to the investigator's judgment, the volunteers have any otherfactors that make them unfit to participate in the clinical trial

Trial locations and contacts

1 site in 1 country.

China1 site

Suixian Center for Disease Control and Prevention
Shangqiu, Henan, 450016

Other trials in China

About this study

Official title: A Phase Ⅰa Randomized,Double-Blind, Placebo-controlled Clinical Trial to Preliminary Evaluate the Safety and Immunogenicity of Protein Based Pneumococcal Vaccine（PBPV） in Healthy People Aged Between 18 and 49 Years Old

The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

Read the detailed description

The polysaccharide vaccine protected 60% of elderly adults who were at risk for pneumococcal infection.However, pneumococci are highly diverse with respect to their capsular types , and the polysaccharide-protein conjugate vaccines will not protect against strains of the many capsular types not included in the vaccine.This experimental vaccine was covered 70% of all pneumococcal types, Subjects will receive three doses of PBPV vaccine on day 0,60 and 120 with different contents of 20μg,50μg,100μg each antigen in 18 to 49 years of age.

Conditions: Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
Being tested: Protein based pneumococcal vaccine(Low dose), Protein based pneumococcal vaccine placebo(Low dose), Protein based pneumococcal vaccine(Middle dose), Protein based pneumococcal vaccine placebo(Middle dose), Protein based pneumococcal vaccine(High dose)
Keywords: Vaccnie, PspA, Pneomolysin
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.

Protein based pneumococcal vaccine(Low dose)Biological
0.2mL,Intramuscular other name:PBPV
Protein based pneumococcal vaccine placebo(Low dose)Biological
0.2mL,Intramuscular other name:PBPV placebo
Protein based pneumococcal vaccine(Middle dose)Biological
0.5mL,Intramuscular other name:PBPV
Protein based pneumococcal vaccine placebo(Middle dose)Biological
0.5mL,Intramuscular other name:PBPV placebo
Protein based pneumococcal vaccine(High dose)Biological
1.0mL,Intramuscular other name:PBPV
Protein based pneumococcal vaccine placebo(High dose)Biological
1.0mL,Intramuscular other name:PBPV placebo

Study groups in NCT04087460
Study group	Role	What they receive
Low-dose Group A	Experimental	Subjects received three doses of PBPV with 20μg each antigen Receives: Biological: Protein based pneumococcal vaccine(Low dose)
Low-dose Group B	Placebo comparator	Subjects received three doses of placebo Receives: Biological: Protein based pneumococcal vaccine placebo(Low dose)
Middle-dose Group A	Experimental	Subjects received three doses of PBPV with 50μg each antigen Receives: Biological: Protein based pneumococcal vaccine(Middle dose)
Middle-dose Group B	Placebo comparator	Subjects received three doses of placebo Receives: Biological: Protein based pneumococcal vaccine placebo(Middle dose)
High-dose Group A	Experimental	Subjects received three doses of PBPV with 100μg each antigen Receives: Biological: Protein based pneumococcal vaccine(High dose)
High-dose Group B	Placebo comparator	Subjects received three doses of placebo Receives: Biological: Protein based pneumococcal vaccine placebo(High dose)

What is being measured

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

Safety indexes of solicited and unsolicited adverse reactions
Occurrence of solicited and unsolicited reactions post each vaccination
Measured: within 30 minutes,0-7 days,0-30 days post-vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Measured: day 3 and 8 post the first vaccination
Safety indexes of lab measures
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs
Measured: day 14 and 30 post each vaccination

Secondary outcomes (3)

safety indexes of SAE
Occurrence of SAE
Measured: within 180 days post vaccination
immunogencity indexes of GMC and GMI by ELISA
Geometric mean concentration(GMC) and Geometric mean increase（GMI）of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum
Measured: day 8, 14,30,60 post each vaccination
immunogencity indexes of the seropositivity rates by ELISA
the seropositivity rates of anti-PspA-RX1 , anti-PspA-3296, anti-PspA-5668 and anti-PlyLD antibodies in serum
Measured: day 8, 14,30,60 post each vaccination

Timeline

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

10 Apr 202030 Jun 2022

First posted12 Sep 2019
Study start10 Apr 2020
Primary completion30 May 2021
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for PneumoniaStudies of the same condition, open and under way.
More trials run by CanSino Biologics Inc.The sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04087460
Sponsor's protocol ID: CS-CTP-PBPV-Ⅰa
Acronym: PⅠCTPV
Status last verified: Oct 2022
First submitted: 10 Sep 2019
Last updated: 4 Nov 2022
Results posted: No
Data monitoring committee: Yes
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 IPD

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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Study at a glance

From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase Ⅰa Randomized,Double-Blind, Placebo-controlled Clinical Trial to Preliminary Evaluate the Safety and Immunogenicity of Protein Based Pneumococcal Vaccine（PBPV） in Healthy People Aged Between 18 and 49 Years Old
ClinicalTrials.gov ID: NCT04087460
Acronym / sponsor ID: PⅠCTPV / CS-CTP-PBPV-Ⅰa
Conditions: Pneumonia, Respiratory Tract Diseases, Respiratory Tract Infections
Keywords: Vaccnie, PspA, Pneomolysin
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: CanSino Biologics Inc.Industry (pharma, biotech, devices)
Collaborators: Henan Center for Disease Control and Prevention
Study start: 10 Apr 2020 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 12 Sep 2019 (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.

The aim of the study is to preliminary evaluate the safety and immunogenicity of PBPV vaccine compared to placebo,in order to provide a basis for subsequent clinical trial design.

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: 6

Arm	Type	Receives
Low-dose Group A	Experimental	Biological: Protein based pneumococcal vaccine(Low dose)Subjects received three doses of PBPV with 20μg each antigen
Low-dose Group B	Placebo comparator	Biological: Protein based pneumococcal vaccine placebo(Low dose)Subjects received three doses of placebo
Middle-dose Group A	Experimental	Biological: Protein based pneumococcal vaccine(Middle dose)Subjects received three doses of PBPV with 50μg each antigen
Middle-dose Group B	Placebo comparator	Biological: Protein based pneumococcal vaccine placebo(Middle dose)Subjects received three doses of placebo
High-dose Group A	Experimental	Biological: Protein based pneumococcal vaccine(High dose)Subjects received three doses of PBPV with 100μg each antigen
High-dose Group B	Placebo comparator	Biological: Protein based pneumococcal vaccine placebo(High dose)Subjects received three doses of placebo

Who may qualify

Ages: 18 to 49 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy volunteers aged 18 to 49 years old;
Willing to provide proof of identity;
Able to understand and sign the informed consent;
Able and willing comply with the requirements of the protocol

Key exclusion criteria (13 listed)

Hypertensive volunteers with uncontrollable medications (on-site measurement: systolic blood pressure > 140 mmHg, diastolic blood pressure > 90 mmHg);
Abnormal changes of laboratory measures (with clinical significance);
Woman is pregnant and lactating (by urine pregnancy test)
Suffered from pneumonia in the past three years;
Invasive diseases caused by Streptococcus pneumoniae (such as meningitis, bacteremia, pericarditis, peritonitis, etc.) in the past three years;

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
Protein based pneumococcal vaccine(Low dose)0.2mL,Intramuscular other name:PBPV	Biological	Low-dose Group A
Protein based pneumococcal vaccine placebo(Low dose)0.2mL,Intramuscular other name:PBPV placebo	Biological	Low-dose Group B
Protein based pneumococcal vaccine(Middle dose)0.5mL,Intramuscular other name:PBPV	Biological	Middle-dose Group A
Protein based pneumococcal vaccine placebo(Middle dose)0.5mL,Intramuscular other name:PBPV placebo	Biological	Middle-dose Group B
Protein based pneumococcal vaccine(High dose)1.0mL,Intramuscular other name:PBPV	Biological	High-dose Group A
Protein based pneumococcal vaccine placebo(High dose)1.0mL,Intramuscular other name:PBPV placebo	Biological	High-dose Group B

Primary outcome

Safety indexes of solicited and unsolicited adverse reactions
Time frame: within 30 minutes,0-7 days,0-30 days post-vaccination
Occurrence of solicited and unsolicited reactions post each vaccination
Safety indexes of lab measures
Time frame: day 3 and 8 post the first vaccination
Occurrence of abnormal changes of hematological examination,clinical chemistry test,urine test and vital signs
Safety indexes of lab measures
Time frame: day 14 and 30 post each vaccination
Occurrence of abnormal changes of CK-MB,CTN,urine test and vital signs

3 secondary outcomes

safety indexes of SAE
Time frame: within 180 days post vaccination
immunogencity indexes of GMC and GMI by ELISA
Time frame: day 8, 14,30,60 post each vaccination
immunogencity indexes of the seropositivity rates by ELISA
Time frame: day 8, 14,30,60 post each 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 4 Nov 2022.
Individual participant dataSharing planned: No. In order to maintain the rights of the subject, do not open the IPD

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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.

Xia Shengli principal investigator

Henan Province Center for Disease Control and Prevention

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 13 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 Nov 2022. 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?

Safety indexes of solicited and unsolicited adverse reactions (time frame: within 30 minutes,0-7 days,0-30 days post-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 NCT04087460.

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 Nov 2022.