Clinical trial NCT02775942: Safety and Immunogenicity of IPOVAC in Young Children
Official title: Safety and Immunogenicity of an Inactivated Poliomyelitis Vaccine (IPOVAC) in Vietnamese Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Poliomyelitis
Lead sponsor: National Institute of Hygiene and Epidemiology, Vietnam
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Vietnam
First posted: 2016-05-18
Enrollment: 240
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with treatment-related adverse events after each dose of vaccine
timeFrame: Upto 30 days after each dose
measure: Number of participants with 4-fold or more increase in in antibody titers after 2 or 3 doses of vaccine (compared to pre-vaccination)
timeFrame: Upto 30 days after the final dose
Secondary outcomes:
measure: Number of participants with treatment-related SAE after each vaccination dose
timeFrame: Upto 30 days after vaccine dose
measure: Number of participants with abnormal laboratory value
timeFrame: Upto 30 days after each vaccine dose
Other outcomes:
Locations:
city: Thanh Son
country: Vietnam
facility: Preventive Medicine center
state: Phu Tho
city: Viet tri
country: Vietnam
facility: Phu Tho Preventive Medicine Center
state: Phu Tho
Study officials:
affiliation: National Institute of Hygiene and Epidemiology, Vietnam
name: Dang D Anh, PhD
role: PRINCIPAL_INVESTIGATOR
References: