Clinical trial NCT01048190: The Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Official title: The Phase I Clinical Trial Protocol for the Inactivated Poliomyelitis Vaccine Made From Sabin Strains
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Poliomyelitis
Keywords: Inactivated Poliomyelitis Vaccine
Sabin Strains
poliomyelitis
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
name: National Institute for the Control of Pharmaceutical and Biological Products, China
First posted: 2010-01-13
Enrollment: 130
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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 ).

Primary outcomes:
measure: To evaluate the safety of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
timeFrame: one year
Secondary outcomes:
measure: To evaluate the immunogenicity of Inactivated Poliomyelitis Vaccine made from Sabin Strains by different does.
timeFrame: one year
Other outcomes:
Locations:
city: He Zhou
country: China
facility: Hezhou Center for Disease Prevention and Control
state: Guangxi
Study officials:
affiliation: Institute of Medical Biology, Chinese Academy of Medical Sciences
name: Liao Guoyang, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Guangxi Zhuang Autonomous Region Center for Disease Prevention and Control
name: Li Rongcheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Institute for the Control of Pharmaceutical and Biological Products, China
name: Li Changgui, PhD
role: PRINCIPAL_INVESTIGATOR
References: