Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)
- Conditions
- Polio
- Interventions
- Biological: sIPV
- Registration Number
- NCT04264546
- Brief Summary
The purpose of this phase Ib 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 high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, 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 Ib 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 high D antigen content. 20 infants aged 2 months (60\~90 days) were administered three doses of sIPV with high D antigen content, 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 high-dose Sabin IPV were 22 DU, 65 DU and 65 DU. All vaccines were in liquid form, 0.5 ml per dose.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- 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;
- 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;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Infant Group - High dosage sIPV Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Intervention: Three-dose regimen of high dosage investigational sIPV Intervention: Biological: Three-dose regimen of high dosage investigational sIPV Experimental Children Group - High dosage sIPV One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV Experimental Adult Group - High dosage sIPV One intramuscular injection of the investigational vaccine (0.5 ml); Intervention: one-dose regimen of high dosage investigational sIPV Intervention: Biological: one-dose regimen of high dosage investigational sIPV
- Primary Outcome Measures
Name Time Method The seroconversion rates (SCRs) of each group 30 days after three-dose regimen 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.
The geometric mean titer (GMT) of each group 30 days after three-dose regimen 28~42 days GMT of each group 28\~42 days after three-dose regimen
The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen 28~42 days The GMI is the increase of post-immune GMT from pre-immune GMT
- Secondary Outcome Measures
Name Time Method The incidences of adverse events (AEs) of each group occurred within 30 days after each injection 30 days The number of participants who had adverse events (AEs) divided by the number of all participants
The incidences of adverse reactions of each group occurred within 30 days after each injection 30 days The number of participants who had adverse reactions divided by the number of all participants
Trial Locations
- Locations (1)
Jiangsu Provincial Center for Disease Control and Prevention
🇨🇳Nanjing, China