The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains

Phase 1

Completed

• Conditions: Poliomyelitis
• Interventions: Biological: Inactivated Poliomyelitis Vaccine (Sabin strains)

• Registration Number: NCT01048190
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

The purpose of this study is to evaluate the safety and the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.

Detailed Description

The Sabin IPV was manufactured with poliovirus type1, 2, 3 Sabin strains and Vero cells by micro-carrier culture in 550 liter bioreactors. The virus suspension was harvested ,ultra-concentrated, purified and inactivated with formalin. Three formulations A,B,C of Sabin IPV were used, the DAg contents for A were type1 45,type2 64,type3 67.5 DU /0.5ml/per dose; for B 30,32,45 DU/0.5ml/per dose; for C 15,16,22.5 DU/0.5ml/per dose.

This is a randomized, double-blind, placebo control phase 1 clinical trial. Total 130 individuals were selected ,including adults (n=20), children(n= 20) and infants(n= 90). Adults were randomized to two groups A1(n=10) and A2(n=10).Group A1 received one dose of B ,one month later group A2 received one dose of A for safety observation. Children were randomized to two groups C1(n=10) and C2(n=10) and followed the same vaccination and safety observation procedures as adults. Infants were randomly allocated to three groups I-1,I-2,I-3 for safety and immunogenicity study. Group I-1 were vaccinated with three doses of C(n=15) or placebo (n=15) on day 0,30,60,serum samples were collected before and 30 days after dose 3 for detecting neutralization antibody. The same procedures were followed by GroupI-2 for B and group I-3 for A as groupI-1 with 30 days intermission.

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-08
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Study First Submitted: 2010-01-12
• Study First Submitted QC: 2010-01-12
• Study First Posted: 2010-01-13
• Last Update Submitted: 2010-01-13
• Last Update Posted: 2010-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Males and females, age from 60 days to 60 years old;
• Routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions are normal before vaccination;
• Adults, parent(s) or guardians are able to understand and sign informed consent for participation;
• Participants or guardians are able to attend all planned clinical appointment and obey and follow all study instructions;
• Infants no vaccinated with poliovaccine or other preventive biologicals in recent 7 days;
• Axillary temperature ≤37℃.

Exclusion Criteria

• Have medical record of participants or their family on allergy, convulsion, falling sickness, encephalopathy and psychopathy;
• Abnormal results of routine blood assaying (white blood cell, red blood cell, hemoglobin), liver (alanine transaminase)and kidney(blood urea nitrogen) functions before vaccination;
• Low platelet or bleeding disorder do not allow vaccination into the muscle;
• Have damaged or lower immunological function;
• Received blood, plasma or immunoglobulin treatment since birth;
• Have inborn abnormality, develop obstacles or clinical diagnostic serious chronic ( Down Syndrome, diabetes, sickle cell anemia or neural Guillain-Barre Syndrome ).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Infants I-1	Inactivated Poliomyelitis Vaccine (Sabin strains)	Biological: Inactivated Poliomyelitis Vaccine (Sabin strains). Group I-1: 15 infants received 3 doses of formulation C vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;
Infant I-3	Inactivated Poliomyelitis Vaccine (Sabin strains)	15 infants received 3 doses of formulation A vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart.
Infants I-2	Inactivated Poliomyelitis Vaccine (Sabin strains)	15 infants received 3 doses of formulation B vaccine and 15infants received 3 doses of placebo 3x0.5ml intramuscular injections, one month apart;

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.	one year

Secondary Outcome Measures

Name	Time	Method
To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.	one year

Trial Locations

Locations (1)

Hezhou Center for Disease Prevention and Control; 🇨🇳 He Zhou, Guangxi, China