PolioPhase 1NCT04264598
Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
A Phase 1 study testing sIPV, Commercialized sIPV and Commercialized IPV in people with Polio, run by Jiangsu Province Centers for Disease Control and Prevention at 1 site in China.
Trial summary
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. Read more about this study
- Who is it for?
- Ages 60 days to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Polio
- What is being tested?
- sIPV, Commercialized sIPV and Commercialized IPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 21 Aug 2017to 28 Dec 2018
- 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 60 days to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy volunteer aged 18~45 years with/without prior vaccination of poliovirus and without any contraindication for vaccination;
- Healthy volunteer aged 4 years with/without prior vaccination of poliovirus but without booster vaccination and any contraindication for vaccination;
- Healthy volunteer aged 2 months (60~90 days) without prior vaccination of poliovirus and any contraindication for vaccination;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
Who cannot join
- Women aged 18~45 years with positive urine pregnancy test, pregnant or lactating women, or women with pregnancy plans within 3 months;
- Preterm or low birth weight infants;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- History of polio;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
Show all 16Show fewer
- Autoimmune disease or immunodeficiency/immunosuppressive;
- Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder), or significant bruising or coagulopathy;
- Serious chronic diseases, respiratory diseases, cardiovascular diseases, liver or kidney diseases or skin diseases;
- Mother of the participant has HIV infection;
- Acute illness or acute exacerbation of chronic disease within the past 7 days;
- Had a high fever within the past 3 days (axillary temperature ≥ 38.0°C);
- Receipt of any subunit or inactivated vaccine within the past 7 day;
- Receipt of any live attenuated vaccine within the past 14 days;
- Receipt of any blood product within the past 3 months;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing
About this study
Official title: A Phase I Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
Read the detailed description
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
The antigen contents of type I, type II and type III polioviruses in the investigational and control vaccines were as follows: medium-dose Sabin IPV (15 DU, 45 DU and 45 DU), control Sabin IPV (30 DU, 32 DU and 45 DU), control Salk IPV (40 DU, 8 DU and 32 DU). All vaccines were in liquid form, 0.5 ml per dose.
- Conditions
- Polio
- Being tested
- sIPV, Commercialized sIPV, Commercialized IPV
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.
Commercialized sIPVBiological
The commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.
Commercialized IPVBiological
The commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Adult Group - Medium dosage | Experimental | One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV Receives: Biological: sIPV |
| Experimental Children Group - Medium dosage | Experimental | One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV Receives: Biological: sIPV |
| Experimental Infant Group - Medium dosage | Experimental | Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV Intervention: Biological: Three-dose regimen of medium dosage investigational sIPV Receives: Biological: sIPV |
| Control Infant Group - commercialized sIPV | Active comparator | Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV Intervention: Biological: Three-dose regimen of commercialized sIPV Receives: Biological: Commercialized sIPV |
| Control Infant Group - commercialized IPV | Active comparator | Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV Intervention: Biological: Three-dose regimen of commercialized IPV Receives: Biological: Commercialized IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCRs) of each group 30 days after three-dose regimen
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Measured: 28~42 days
Secondary outcomes (4)
The geometric mean titer (GMT) of each group 30 days after three-dose regimen
GMT of each group 28~42 days after three-dose regimen.
Measured: 28~42 days
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen
Measured: 28~42 days
The number of participants who have adverse reactions divided by the total number of participants
Measured: 30 days
The number of participants who have adverse events (AEs) divided by the total number of participants.
occurred within 30 days after each injection
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start21 Aug 2017
- Primary completion19 Dec 2017
- Study completion28 Dec 2018
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 PolioStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Province Centers for Disease Control and Prevention
- Sponsor type
- Research network
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Master, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264598
- Sponsor's protocol ID
- 2017L00935
- Status last verified
- Feb 2020
- First submitted
- 9 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.
PubMed 32867698
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
- ClinicalTrials.gov ID
- NCT04264598
- Acronym / sponsor ID
- 2017L00935
- Conditions
- Polio
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jiangsu Province Centers for Disease Control and PreventionResearch network
- Collaborators
- Beijing Minhai Biotechnology Co., Ltd
- Study start
- 21 Aug 2017 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 11 Feb 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.
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
Detailed description
The purpose of this phase I study is to evaluate the safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in adults and children, and the safety and immunogenicity of it in infants. 20 adults aged 18~45 years and 20 children aged 4 years were only administered one dose of sIPV with medium D antigen content. 60 infants aged 2 months (60~90 days) were randomized to receive three doses of sIPV with medium D antigen content, conventional IPV (cIPV, manufactured by Sanofi Pasteur) or sIPV (manufactured by the Institute of Medical Biology, the Chinese Academy of Medical Biology), respectively, on the month 0, 1, 2 schedule. Serum samples were collected before the 1st dose and 30 days after the 3rd dose vaccination to assess the immunogenicity in infants. Adverse events occurring within 30 days after each dose were collected to assess the safety.
The antigen contents of type I, type II and type III polioviruses in the investigational and control vaccines were as follows: medium-dose Sabin IPV (15 DU, 45 DU and 45 DU), control Sabin IPV (30 DU, 32 DU and 45 DU), control Salk IPV (40 DU, 8 DU and 32 DU). All vaccines were in liquid form, 0.5 ml per dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Experimental Adult Group - Medium dosage | Experimental | Biological: sIPVOne intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV |
| Experimental Children Group - Medium dosage | Experimental | Biological: sIPVOne intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of medium dosage investigational sIPV Intervention: Biological: one-dose regimen of medium dosage investigational sIPV |
| Experimental Infant Group - Medium dosage | Experimental | Biological: sIPVThree intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of medium dosage investigational sIPV Intervention: Biological: Three-dose regimen of medium dosage investigational sIPV |
| Control Infant Group - commercialized sIPV | Active comparator | Biological: Commercialized sIPVThree intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized sIPV Intervention: Biological: Three-dose regimen of commercialized sIPV |
| Control Infant Group - commercialized IPV | Active comparator | Biological: Commercialized IPVThree intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of commercialized IPV Intervention: Biological: Three-dose regimen of commercialized IPV |
Who may qualify
- Ages
- 60 days to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy volunteer aged 18~45 years with/without prior vaccination of poliovirus and without any contraindication for vaccination;
- Healthy volunteer aged 4 years with/without prior vaccination of poliovirus but without booster vaccination and any contraindication for vaccination;
- Healthy volunteer aged 2 months (60~90 days) without prior vaccination of poliovirus and any contraindication for vaccination;
- Guardians of the participants should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
Key exclusion criteria (16 listed)
- Women aged 18~45 years with positive urine pregnancy test, pregnant or lactating women, or women with pregnancy plans within 3 months;
- Preterm or low birth weight infants;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- History of polio;
- Severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
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 |
|---|---|---|
| sIPVThe Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose. | Biological | Experimental Adult Group - Medium dosage, Experimental Children Group - Medium dosage, Experimental Infant Group - Medium dosage |
| Commercialized sIPVThe commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose. | Biological | Control Infant Group - commercialized sIPV |
| Commercialized IPVThe commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose. | Biological | Control Infant Group - commercialized IPV |
Primary outcome
The seroconversion rates (SCRs) of each group 30 days after three-dose regimen
Time frame: 28~42 days
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
4 secondary outcomes
The geometric mean titer (GMT) of each group 30 days after three-dose regimen
Time frame: 28~42 days
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen
Time frame: 28~42 days
The number of participants who have adverse reactions divided by the total number of participants
Time frame: 30 days
The number of participants who have adverse events (AEs) divided by the total number of participants.
Time frame: 30 day
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 11 Feb 2020.
- Derived from this study: PubMed 32867698Jia S, Tang R, Li G, Hu Y, Liang Q. The effect of maternal poliovirus antibodies on the immune responses of infants to poliovirus vaccines. BMC Infect Dis. 2020 Aug 31;20(1):641. doi: 10.1186/s12879-020-05348-1.
Related trials for Polio
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
RecruitingPhase 1
Safety and Immunogenicity of a Recombinant Poliomyelitis Vaccine (rPV) in Comparison With IPOL Vaccine in Healthy Adults
Polio Immunity
Active, not recruiting
Effects of Virtual Walking on Chronic Pain and Psychological Distress for Individuals With Severe Mobility Impairment
Severe Mobility Impairment, Spinal Cord Injuries (SCI)
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.
Fengcai Zhu, Master 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 Phase 1 study testing sIPV, Commercialized sIPV and Commercialized IPV in people with Polio, run by Jiangsu Province Centers for Disease Control and Prevention 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 6 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 11 Feb 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.
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?
The seroconversion rates (SCRs) of each group 30 days after three-dose regimen (time frame: 28~42 days). 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 NCT04264598, 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 11 Feb 2020.