Safety and Immunogenicity of IPOVAC in Young Children

Poliomyelitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775942
• Other study ID #: 2015-IPOVAC-02
• Status: Completed
• Phase: Phase 2
• First received: May 5, 2016
• Last updated: June 28, 2017
• Start date: November 2015
• Est. completion date: October 31, 2016

Study information

• Verified date: May 2016
• Source: National Institute of Hygiene and Epidemiology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 31, 2016
• Est. primary completion date: July 25, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

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
• 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
• 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
• 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

Locations

Country	Name	City	State
Vietnam	Preventive Medicine center	Thanh Son	Phu Tho
Vietnam	Phu Tho Preventive Medicine Center	Viet tri	Phu Tho

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Hygiene and Epidemiology, Vietnam	Ministry of Science and Technology, Vietnam

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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