Safety and Immunogenicity of a New Inactivated Polio Vaccine in Healthy Adults

Poliomyelitis Clinical Trial

Official title:

Safety and Immunogenicity of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01708720
• Other study ID #: NVI-256A
• Secondary ID: 2010-024581-22
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2012
• Last updated: February 20, 2014
• Start date: August 2011
• Est. completion date: February 2012

Study information

• Verified date: February 2014
• Source: National Institute for Public Health and the Environment (RIVM)
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to determine whether the new inactivated polio vaccine that is based on attenuated poliovirus strains is safe and to evaluate the immune response in healthy adults.

Description:

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

• The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy adults (first in human).

• The secondary objective is to evaluate immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV in healthy immunized adults.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2012
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 49 Years

Eligibility

Inclusion Criteria:

• Age 18 to 49, inclusive at the time of enrolment

• in good health as determined by the outcome of medical history, physical examination screening/baseline labs and clinical judgment of the investigator

• Male

• Must have received polio vaccinations with OPV according to the Polish National Immunization Program as a child based on vaccination cards or information given by subjects during interview with investigator

• Preferred: number (and date) of polio vaccinations known

• Willingness and ability to adhere to the study regimen

• Having a signed informed consent form

Exclusion Criteria:

• IPV or OPV booster dose after the age of 12 years

• Positive for HIV, Hepatitis B or Hepatitis C

• Known or suspected allergy against any of the vaccine components

• History of unusual or severe reactions to any previous vaccination

• Known or suspected disease or use of medication that may influence the immune system

• Known or suspected immune deficiency

• Systemic treatment with corticosteroids within one month before screening

• Administration of plasma (including immunoglobulins) or blood products three months prior to the study

• Blood donation within one month before screening

• Any vaccination within three months before screening and during the study until the last visit

• History of any neurological disorder including epilepsy or febrile seizures

• Evidence of excessive alcohol use or drug use

• Any infectious disease at the time of screening and/or inclusion

• Participation in another clinical trial within three months before screening

• Abnormal pre-treatment laboratory parameters which are clinically relevant according to the investigator

• Bleeding disorders or the usage of anticoagulants

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Poliomyelitis

Intervention

Drug:
• IPV

• Sabin-IPV

• Adjuvanted Sabin-IPV

Locations

Country	Name	City	State
Poland	Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.	Krakow

Sponsors (2)

Lead Sponsor	Collaborator
Pauline Verdijk	World Health Organization

Country where clinical trial is conducted

Poland, 

References & Publications (3)

Bakker WA, Thomassen YE, van't Oever AG, Westdijk J, van Oijen MG, Sundermann LC, van't Veld P, Sleeman E, van Nimwegen FW, Hamidi A, Kersten GF, van den Heuvel N, Hendriks JT, van der Pol LA. Inactivated polio vaccine development for technology transfer using attenuated Sabin poliovirus strains to shift from Salk-IPV to Sabin-IPV. Vaccine. 2011 Sep 22;29(41):7188-96. doi: 10.1016/j.vaccine.2011.05.079. Epub 2011 Jun 7. — View Citation

Verdijk P, Rots NY, Bakker WA. Clinical development of a novel inactivated poliomyelitis vaccine based on attenuated Sabin poliovirus strains. Expert Rev Vaccines. 2011 May;10(5):635-44. doi: 10.1586/erv.11.51. Review. — View Citation

Verdijk P, Rots NY, van Oijen MG, Oberste MS, Boog CJ, Okayasu H, Sutter RW, Bakker WA. Safety and immunogenicity of inactivated poliovirus vaccine based on Sabin strains with and without aluminum hydroxide: a phase I trial in healthy adults. Vaccine. 201 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse reactions following vaccination		4 days or until adverse reactions have resolved	Yes
Secondary	Level of virus neutralizing titers in serum		28 days	No