Safety and Immunogenicity of IPOVAC in Young Children

Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children

A dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC- POLYVAC-Vietnam) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues included immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Immunogenicity outcomes include seroconversion of neutralising antibodies for each of vaccine serotypes.

Study Overview

• Status: Completed
• Conditions: Poliomyelitis
• Intervention / Treatment: Biological: IPOVAC 1.5:5:5; Biological: IPOVAC, 3:10:10; Biological: IPOVAC, 6:20:20; Biological: IMOVAC-POLIO

Detailed Description

The use of oral poliomyelitis vaccine (OPV) in Vietnam expanded immunisation program has resulted in successful eradication of polio in Vietnam. However due to the concern of OPV-related poliomyelitis cases occurred worldwide, WHO has recommended the countries to gradually change to inactivated polio vaccine (IPV). In Vietnam, POLYVAC has been approved and sponsored by the Ministry of Science and Technology to produce IPV under Japanese technology. The vaccine consisting of 3 serotypes (Serotype 1,2 and 3) has been proven safety in volunteer adults.

In this study, a dose escalating study with 3 different dosing regimens of the studied vaccine (IPOVAC) and a licensed vaccine (IMOVAC-Sanofi Pasteur- France) is conducted in Vietnamese children, aged 2 months and above to assess the safety and immunogenicity. Two hundred and forty children are enrolled and placed randomly into 4 groups (60 children/group), each of which receive 3 doses of vaccine subcutaneously, at 4 week interval. Safety issues evaluated include immediate reaction at the site of injection and systemic reaction within 30 min of administration, within 7 days after each dose, unexpected event occur within 30 days of each dose, SAE (from start of dose 1 to 30 days after dose 3), blood cell count, urea, ALT,AST. Seroconversion rates of neutralising antibodies for each of vaccine serotypes are to be assessed.

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• Vietnam
  • Phu Tho
    • Thanh Son, Phu Tho, Vietnam
      • Preventive Medicine Center
    • Viet tri, Phu Tho, Vietnam
      • Phu Tho Preventive Medicine Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children of both sexes, 2 months of ages
• Full term babies (>=37 weeks)
• Weight at birth (>=2500gr)
• Have not been vaccinated with polio vaccine or vaccine containing poliovirus components
• Not currently have acute infection (assessed via clinical check up and asking parents/care givers about health history before enrolment
• Parents/legal guardians agree to participate their children in this study and sign the informed consent.

Exclusion Criteria:

• Currently have chronic diseases (cardiovascular, liver and spleen related etc)
• Use (orally or through infection) with corticoid containing drug (>1mg/kg dose)
• Use of immunocompromised treatment within 4 weeks of enrolment
• Being immunocompromised and autoimmune diseases (HIV, lupus)
• the history of immunocompromised in the family
• history of high fever
• Allergic for any vaccine component
• Fever (>38oC) within 3 days before vaccination or at enrolment
• Malnourished (3rd level or above)
• Blood disorder
• use of vaccines which have not been licences 7 days before enrolment in this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IPOVAC 1.5:5:5; IPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form	Biological: IPOVAC 1.5:5:5; IPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form; Other Names: IPOVAC-low
Experimental: IPOVAC 3:10:10; IPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form	Biological: IPOVAC, 3:10:10; IPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form; Other Names: IPOVAC-medium
Experimental: IPOVAC 6:20:20; IPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form	Biological: IPOVAC, 6:20:20; IPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form; Other Names: IPOVAC-high
Active Comparator: IMOVAC-POLIO; IMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval	Biological: IMOVAC-POLIO; IMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval; Other Names: IMOVAC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events after each dose of vaccine	Number of participants with treatment-related adverse events after each dose of vaccine, immediately after vaccination (within 30 min), within 7 days and 30 days of vaccination, as assessed by CTCAE v.4.0	Upto 30 days after each dose
Number of participants with 4-fold or more increase in in antibody titers after 2 or 3 doses of vaccine (compared to pre-vaccination)	Seroconversion rate of each IPOVAC regimen and IMOVAC after 2 or 3 doses of vaccines	Upto 30 days after the final dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related SAE after each vaccination dose	Number of participants with treatment-related SAE after each vaccination doses of IPOVAC compared to that of IMOVAC, as assessed by CTCAE ver 4.0	Upto 30 days after vaccine dose
Number of participants with abnormal laboratory value	Numbers of participants with abnormal laboratory values (blood cell counts, urea concentration, liver function (ALT, AST concentration) when administered with different IPOVAC formulations and with IMOVAC before and after each dose of vaccination	Upto 30 days after each vaccine dose

Collaborators and Investigators

• Sponsor: National Institute of Hygiene and Epidemiology, Vietnam
• Collaborators: Ministry of Science and Technology, Vietnam
• Investigators: Principal Investigator: Dang D Anh, PhD, National Institute of Hygiene and Epidemiology, Vietnam

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): July 25, 2016
• Study Completion (Actual): October 31, 2016

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 15, 2016
• First Posted (Estimate): May 18, 2016

Study Record Updates

• Last Update Posted (Actual): June 29, 2017
• Last Update Submitted That Met QC Criteria: June 28, 2017
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; RNA Virus Infections; Virus Diseases; Infections; Neuromuscular Diseases; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; Spinal Cord Diseases; Myelitis; Poliomyelitis
• Other Study ID Numbers: 2015-IPOVAC-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

IPD Plan Description

Individual data with identification removed are to be available for Ethical committee, Ministry of Health and National Foundation of Science and Technology Development to avoid misuse of data.

Public shared data will be in the form of summarised tables and figures.