PoliomyelitisNCT04618783
Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization
A study testing Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses and Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses and Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2019to 10 Jan 2020
- Phase
- Interventional
- 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 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participants of the already finished phase 2 clinical trial;
- Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
- Provide written informed consent.
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou Center for Disease Control and Prevention
Pizhou, Jiangsu, 221300
About this study
Official title: Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial.
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.
Read the detailed description
This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).
All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.
- Conditions
- Poliomyelitis
- Being tested
- Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of control wIPV, vaccinated within one-month interval between doses, Three doses of control sIPV, vaccinated within one-month interval between doses
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between dosesBiological
Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between dosesBiological
Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between dosesBiological
Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Three doses of control wIPV, vaccinated within one-month interval between dosesBiological
Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
Three doses of control sIPV, vaccinated within one-month interval between dosesBiological
Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
| Study group | Role | What they receive |
|---|---|---|
| Low-dosage experimental group | Experimental | Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses Receives: Biological: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses |
| Medium-dosage experimental group | Experimental | Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses Receives: Biological: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses |
| High-dosage experimental group | Experimental | Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses Receives: Biological: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses |
| Control wIPV group | Active comparator | Three doses of control wIPV, vaccinated within one-month interval between doses Receives: Biological: Three doses of control wIPV, vaccinated within one-month interval between doses |
| Control sIPV group | Active comparator | Three doses of control sIPV, vaccinated within one-month interval between doses Receives: Biological: Three doses of control sIPV, vaccinated within one-month interval between doses |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunity index of seroconversion rate
The seroconversion rates of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
Measured: One month after three doses of vaccination
Secondary outcomes (3)
Immunity index of geometric mean titer (GMT)
The GMT of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
Measured: One month after three doses of vaccination
Immunity index of geometric mean ratio (GMR)
The GMR of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
Measured: One month after three doses of vaccination
Immunity index of seropositivity rate
The seropositivity rate of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
Measured: One month after three doses of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start20 Jul 2019
- Primary completion10 Dec 2019
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- More trials run by Sinovac Biotech Co., LtdThe 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Bachelor, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04618783
- Sponsor's protocol ID
- PRO-sIPV-1001-1
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cross-neutralization Capacity of Immune Serum From Different Dosage of Sabin Inactivated Poliovirus Vaccine Immunization Against Multiple Individual Wild and Vaccine-derived Polioviruses, Supplementary Study of a Phase 2 Clinical Trial.
- ClinicalTrials.gov ID
- NCT04618783
- Acronym / sponsor ID
- PRO-sIPV-1001-1
- Conditions
- Poliomyelitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2019 (actual)
- Primary completion
- 10 Dec 2019 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 6 Nov 2020 (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.
This study is a supplementary study of an already finished randomised, double-blinded, and placebo controlled phase 2 clinical trial of an Sabin strain inactivated poliovirus vaccine (sIPV) manufactured by Sinovac Biotech Ltd., Beijing China. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains.
Detailed description
This study is a open-labelled study conducted based on an already finished phase 2 study of the investigational sIPV in 600 healthy infants aged 2-months old. The purpose of this study is to evaluate the cross-neutralization capacity of the serum immuned by the investigational sIPV against 10 individual virus strains. Paired pre-immune and post-immune serum from 250 participants of the phase 2 trial, with 50 in each group including the low-, medium- and high- dosage group, control wild poliovirus vaccine (wIPV) group and control sIPV group, was selected and sent to China Center for Disease Control and Prevention (CDC) for the cross-neutralization assay to determine the neutralizing antibody titer against 10 individual virus strains including Sabin strains (type 1, 2, and 3), Salk strains (Mahoney, MEF-1, and Saukett), cVDPV (type 1, 2, and 3) and Xinjiang wild strain of type 1(Xinjiang wIPV1).
All the subjects in this study had been vaccinated at the schedule of month 0,1, and 2 in the phase 2 clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Low-dosage experimental group | Experimental | Biological: Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between dosesThree doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses |
| Medium-dosage experimental group | Experimental | Biological: Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between dosesThree doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses |
| High-dosage experimental group | Experimental | Biological: Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between dosesThree doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses |
| Control wIPV group | Active comparator | Biological: Three doses of control wIPV, vaccinated within one-month interval between dosesThree doses of control wIPV, vaccinated within one-month interval between doses |
| Control sIPV group | Active comparator | Biological: Three doses of control sIPV, vaccinated within one-month interval between dosesThree doses of control sIPV, vaccinated within one-month interval between doses |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Participants of the already finished phase 2 clinical trial;
- Subjects who received the three-doses full schedule vaccination required in the phase 2 tril and can provide the backup paired pre-immune and post-immune serum collected in the phase trial;
- Provide written informed consent.
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between dosesAntigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose | Biological | Low-dosage experimental group |
| Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between dosesAntigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose | Biological | Medium-dosage experimental group |
| Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between dosesAntigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose | Biological | High-dosage experimental group |
| Three doses of control wIPV, vaccinated within one-month interval between dosesAntigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose | Biological | Control wIPV group |
| Three doses of control sIPV, vaccinated within one-month interval between dosesAntigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose | Biological | Control sIPV group |
Primary outcome
Immunity index of seroconversion rate
Time frame: One month after three doses of vaccination
The seroconversion rates of neutralizing antibody against 10 individual virus strains (Sabin 1, Sabin2， Sabin 3, Mahoney 1, MEF-1, Saukett, cVDPV1, cVDPV2, cVDPV3, and Xinjiang wIPV1)
3 secondary outcomes
Immunity index of geometric mean titer (GMT)
Time frame: One month after three doses of vaccination
Immunity index of geometric mean ratio (GMR)
Time frame: One month after three doses of vaccination
Immunity index of seropositivity rate
Time frame: One month after three doses of 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 6 Nov 2020.
- 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.
Yuemei Hu, Bachelor principal investigator
Jiangsu Province Centers 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?
A study testing Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses, Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses and Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses in people with Poliomyelitis, run by Sinovac Biotech 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 3 inclusion and 1 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 6 Nov 2020. 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.
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?
Immunity index of seroconversion rate (time frame: One month after three doses of vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Nov 2020.