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

Polio Clinical Trial

Official title:

A Phase Ib Study to Evaluate the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine (Vero Cell)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264546
• Other study ID #: 2017L00935-1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 24, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: February 2020
• Source: Jiangsu Province Centers for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 28, 2018
• Est. primary completion date: March 9, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Days to 45 Years

Eligibility

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;

Related Conditions & MeSH terms

• Polio

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
China	Jiangsu Provincial Center for Disease Control and Prevention	Nanjing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Province Centers for Disease Control and Prevention

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	28~42 days
Primary	The geometric mean fold increase (GMI) of each group 30 days after three-dose regimen	The GMI is the increase of post-immune GMT from pre-immune GMT	28~42 days
Secondary	The incidences of adverse reactions of each group occurred within 30 days after each injection	The number of participants who had adverse reactions divided by the number of all participants	30 days
Secondary	The incidences of adverse events (AEs) of each group occurred within 30 days after each injection	The number of participants who had adverse events (AEs) divided by the number of all participants	30 days