Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine

Jiangsu Provincial Center for Disease Control and Prevention

Status and phase: Completed; Phase 1

Conditions: Polio

Treatments: Biological: Commercialized IPV; Biological: Commercialized sIPV; Biological: sIPV

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04264598

2017L00935

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 60 days to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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;

Exclusion criteria

• 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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 5 patient groups

Experimental Adult Group - Medium dosage

Experimental group

Description:

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

Treatment:

Biological: sIPV

Experimental Children Group - Medium dosage

Experimental group

Description:

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

Treatment:

Biological: sIPV

Experimental Infant Group - Medium dosage

Experimental group

Description:

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

Treatment:

Biological: sIPV

Control Infant Group - commercialized sIPV

Active Comparator group

Description:

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

Treatment:

Biological: Commercialized sIPV

Control Infant Group - commercialized IPV

Active Comparator group

Description:

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

Treatment:

Biological: Commercialized IPV