Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
A Phase I Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)
1 other identifier
interventional
100
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Aug 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2018
CompletedFirst Submitted
Initial submission to the registry
February 9, 2020
CompletedFirst Posted
Study publicly available on registry
February 11, 2020
CompletedFebruary 11, 2020
February 1, 2020
4 months
February 9, 2020
February 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
28~42 days
Secondary Outcomes (4)
The geometric mean titer (GMT) of each group 30 days after three-dose regimen
28~42 days
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen
28~42 days
The number of participants who have adverse reactions divided by the total number of participants
30 days
The number of participants who have adverse events (AEs) divided by the total number of participants.
30 day
Study Arms (5)
Experimental Adult Group - Medium dosage
EXPERIMENTALOne 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
EXPERIMENTALOne 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
EXPERIMENTALThree 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 COMPARATORThree 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 COMPARATORThree 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
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- 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;
- 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;
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangsu Provincial Center for Diseases Control and Prevention
Nanjing, China
Related Publications (1)
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.
PMID: 32867698DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fengcai Zhu, Master
Jiangsu Provincial Center for Disease Control and Prevention
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2020
First Posted
February 11, 2020
Study Start
August 21, 2017
Primary Completion
December 19, 2017
Study Completion
December 28, 2018
Last Updated
February 11, 2020
Record last verified: 2020-02