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

Pauline Verdijk

Status and phase: Completed; Phase 1

Conditions: Poliomyelitis

Treatments: Drug: Adjuvanted Sabin-IPV; Drug: Sabin-IPV; Drug: IPV

Study type: Interventional

Funder types: Other

Identifiers

NCT01708720

NVI-256A

2010-024581-22 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: Male

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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45 participants in 3 patient groups

Sabin-IPV

Experimental group

Description:

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

Treatment:

Drug: Sabin-IPV

Adjuvanted Sabin-IPV

Experimental group

Description:

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

Treatment:

Drug: Adjuvanted Sabin-IPV

IPV

Active Comparator group

Description:

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

Treatment:

Drug: IPV