Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Phase Ib)

NCT ID: NCT04264546

Last Updated: 2020-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-24
• Study Completion Date: 2018-12-28

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.

Conditions

Polio

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental Adult Group - High dosage

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

Group Type: EXPERIMENTAL

sIPV

Intervention Type: BIOLOGICAL

The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Experimental Children Group - High dosage

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

Group Type: EXPERIMENTAL

sIPV

Intervention Type: BIOLOGICAL

The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Experimental Infant Group - High dosage

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

Group Type: EXPERIMENTAL

sIPV

Intervention Type: BIOLOGICAL

The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Interventions

sIPV

The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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;

• Minimum Eligible Age: 60 Days
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu Province Centers for Disease Control and Prevention

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fengcai Zhu, Master

Role: PRINCIPAL_INVESTIGATOR

Jiangsu Provincial Center for Disease Control and Prevention

Locations

Jiangsu Provincial Center for Disease Control and Prevention

Nanjing, , China

Countries

China

References

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.

Reference Type: DERIVED

PMID: 32867698 (View on PubMed)

Other Identifiers

2017L00935-1

Identifier Type: -

Identifier Source: org_study_id