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

NCT01708720 | Completed Phase 1

• 2 other identifiers: NVI-256A2010-024581-22
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Poliomyelitis

Keywords

Vaccination; Inactivated Poliomyelitis Vaccine; Polio; Sabin

Outcome Measures

Primary Outcomes (1)

• Number of adverse reactions following vaccination

  4 days or until adverse reactions have resolved

Secondary Outcomes (1)

• Level of virus neutralizing titers in serum

  28 days

Study Arms (3)

Sabin-IPV

EXPERIMENTAL

Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, and 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose

Drug: Sabin-IPV

Adjuvanted Sabin-IPV

EXPERIMENTAL

Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, and 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose, adjuvanted with 0.5 mg aluminium hydroxide

Drug: Adjuvanted Sabin-IPV

IPV

ACTIVE COMPARATOR

Single intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose

Drug: IPV

Interventions

IPV DRUG

Also known as: Inactivated poliomyelitis vaccine, Inactivated polio vaccine, Inactivated poliovirus vaccine

IPV

Sabin-IPV DRUG

Sabin-IPV

Adjuvanted Sabin-IPV DRUG

Adjuvanted Sabin-IPV

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Pauline Verdijk: lead
• World Health Organization: collaborator

Study Sites (1)

Szpital Internistyczny cetrum Badan Farmakologii Klinicznej Monipol Sp. z o.o.

Krakow, Poland

Location

Related 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.

  PMID: 21651934 BACKGROUND

• 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.

  PMID: 21604984 BACKGROUND

• 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. 2013 Nov 12;31(47):5531-6. doi: 10.1016/j.vaccine.2013.09.021. Epub 2013 Sep 21.

  PMID: 24063976 RESULT

MeSH Terms

Conditions

Poliomyelitis

Interventions

Poliovirus Vaccine, Inactivated

Condition Hierarchy (Ancestors)

Myelitis; Central Nervous System Infections; Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Vaccines, Inactivated; Vaccines; Biological Products; Complex Mixtures; Poliovirus Vaccines; Viral Vaccines

Study Officials

• Pauline Verdijk, PhD

  Institute for Public Health and the Environment

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Research Scientist

Study Record Dates

• First Submitted: October 15, 2012
• First Posted: October 17, 2012
• Study Start: August 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: February 1, 2012
• Last Updated: February 21, 2014

Record last verified: 2014-02

Locations

PL (1)