The Immunogenicity and Safety of Live Attenuated Poliomyelitis Vaccine (Human Diploid Cell)

Phase 2

Completed

• Conditions: Poliomyelitis
• Interventions: Biological: Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell); Biological: Live attenuated Poliomyelitis vaccine (Human Diploid Cell)

• Registration Number: NCT02231632
• Lead Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

Brief Summary

The purpose of this Phase 2/3 trial is to assess the safety and immunogenicity of Live attenuated Poliomyelitis vaccine (human diploid cell)

Detailed Description

Live attenuated Poliomyelitis vaccine (human diploid cell) is used for poliovirus prevention in children above 2 years old , Which was developed by Institute of Medical Biology , Chinese Academy of Medical Sciences , based on the other two products : Poliomyelitis Vaccine in Dragee Candy (Monkey Kidney Cell), Live ; and Poliomyelitis（Live）Vaccine (Monkey Kidney Cell),Oral . After its safety been proved in phase 1 clinical trail evaluation , the phase 2/3 trail was started in Guangxi Province, China during 2011-2012. The purpose of this trial is to assess the safety and immunogenicity in healthy children of 2,3 and 4 months old .

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-03
• Study Completion: 2012-08
• Study First Submitted: 2014-08-01
• Study First Submitted QC: 2014-09-01
• Study First Posted: 2014-09-04
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-07
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

Only subjects fulfilling all of the following criteria will be eligible for the study:

• People aged from 2 months to 4 months old.
• The subjects or subjects' guardians are able to understand and sign the informed consent
• The subjects or subjects' guardians allow to comply with the requirements of the protocol
• Subjects with temperature <=37.0°C on axillary setting
• The subjects have signed informed consent already

Exclusion Criteria

The subjects have never been vaccinated with any Poliomyelitis Vaccine.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Poliomyelitis（Live）Vaccine(Monkey Kidney Cell),Oral	Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)	6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).
Live attenuated Poliomyelitis vaccine (human diploid cell)	Live attenuated Poliomyelitis vaccine (Human Diploid Cell)	6.15 lgCCID50(containing typeⅠattenuated poliomyelitis not lower than 6.0 lgCCID50，typeⅡnot lower than 5.0 lgCCID50，type Ⅲ not lower than 5.5 lgCCID50).

Primary Outcome Measures

Name	Time	Method
Comparison of virogene VP1 genovariation between vaccinal I-III Sabin strains and poliovirus separated from faeces of study objects after vaccinated	up to 90 days	20 children aged 4 years old and 20 infants aged 2 months were vaccinated with 3 dose of Live attenuated Poliomyelitis vaccine (human diploid cell). Their faeces on day 0,7,30,60 and 90 were collected and incubated in L20B and RD cells for 2 generations, in order to separate and amplify poliovirus I-III Sabin strains in faeces of study objects . Extract total viral RNA from the culture supernatants and detect virogene VP1 through RT-PCR and sequencing ,in order to test the genovariation of vaccinal I-III Sabin strains in faeces after vaccinated .

Secondary Outcome Measures

Name	Time	Method
Change of seroconversion from baseline to 3 months	up to 3 months	Randomly chose 600 infants respectively from two study arms, get 2.5ml of the blood on the first day and 3 months during vaccination .Reciprocal antibody titers of at least 1:8, the lowest detectable titer, is considered to indicate seropositivity with regards to the presence of poliovirus neutralizing antibodies. Seroconversion is defined as either seronegative participants (\<1:8 titers) who become seropositive (≥1:8) or participants who demonstrate a 4-fold change in titers between two specimens, e.g. a change from 1:8 to 1:32. Chi-square tests will be used to test the statistical significance among seroconversion rates across study arms.
The frequency of all the adverse events in vaccine group and placebo group	up to 30 days	compare frequency of all the solicited events, unsolicited adverse events and serious adverse events between vaccine groups.

Trial Locations

Locations (1)

Institute of Medical Biology -Chinese Academy of Medical Sciences Kunming, Yunnan, China 650118; 🇨🇳 Kunming, Yunnan, China