Historic tOPV can result in the emergence of circulating vaccine-derived polioviruses (cVDPVs): the attenuated strains of poliovirus from the vaccine infect un-immunized individuals, replicate, circulate in the population, and may eventually mutate enough to become virulent and effect vaccine-associated paralytic poliomyelitis (VAPP). MedDRA version: 18.0 Level: HLT Classification code 10036017 Term: Poliomyelitis viral infections System Organ Class: 100000004862
Conditions
Interventions
Trade Name: Polio Sabin™ Trivalent
Product Name: SABIN trivalent Oral Polio Vaccine
Product Code: tOPV
Pharmaceutical Form: Oral drops, suspension
INN or Proposed INN: Poliomyelitits vaccine type 1
Sponsors
University of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy male or female, between 18 and 50 years old, extremes included 2. Received at least 4 doses of OPV in the past (more than 12 months before the start of the study) 3. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0 4. Female subjects of childbearing potential must agree to the use of an effective method of birth control throughout the study and up to 3 months after last vaccine dose 5. Willing to adhere to the prohibitions and restrictions specified in this protocol 6. Informed Consent Form (ICF) signed voluntarily by the subject before any study-related procedure is performed, indicating that the subject understands the purpose of and procedures required for the study and is willing to participate in the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 128 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. A condition that, in the opinion of the Investigator, could compromise the well being of the subject or course of the study, or prevent the subject from meeting or performing any study requirements 2. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel 3. A known allergy, hypersensitivity, or intolerance to the study vaccine, or to any of its components or to any antibiotics 4. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus [HIV] infection) 5. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete priming) within 28 days after vaccination 6. Neonatal nurses or others having professional contact with children under 6 months old within 28 days after vaccination 7. Chronic administration (i.e., longer than 14 days) of immunosuppressant drugs or other immune-modifying drugs within 6 months prior to the first vaccine dose or planned use during the study. For instance, for corticosteroids, this means prednisone, or equivalent, = 0.5 mg/kg/day (inhaled and topical steroids are allowed whereas intra-articular and epidural injection/administration of steroids are not allowed) 8. Presence of contraindications to administration of the study vaccine on Day 0: acute severe febrile illness deemed by the Investigator to be a contraindication for vaccination or persistent diarrhea or vomiting 9. Indications of drug abuse or excessive use of alcohol at Day 0 10. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at Day 0. Subjects with a positive pregnancy test will be excluded 11. Participation in another clinical study within 28 days prior to entry in this study or receipt of any investigational product (drug or vaccine) other than the study vaccine within 28 days prior to the first administration of study vaccine, or planned use during the study period 12. Planned administration or administration of any vaccine other than the study vaccine within 28 days of the first dose of study vaccine and up to 28 days after administration of each study vaccine dose 13. Administration of polio vaccine within 12 months before the start of the study 14. Having had a transfusion of any blood product or application of immunoglobulins within the 4 weeks prior to the first administration of study vaccine or during the study 15. Subject is an employee of the Investigator or study site, with direct involvement in the proposed study or other studies under the direction of that Investigator or study site, or is a family member of an employee or the Investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objectives of the study are to assess the safety (serious adverse events [SAEs] and severe adverse events [AEs]) and immunogenicity (seroprotection rate) of SABIN tOPV in healthy OPV-vaccinated adults. ;Secondary Objective: Secondary objectives are to assess: - the safety (solicited and unsolicited AEs, important medical events [IMEs], laboratory assessments) of SABIN tOPV in healthy OPV-vaccinated adults; - the immunogenicity (seroconversion rate, median antibody titer) of SABIN tOPV in healthy OPV-vaccinated adults. ;Primary end point(s): The following endpoints will be evaluated by group and overall: - Safety: incidence of SAEs and severe§ AEs considered related or possibly related to study vaccine throughout the study period. - Immunogenicity: seroprotection rate of type-specific polio antibodies at Day 28, following a single dose of tOPV (combined Groups 1 and 2). Seroprotection is defined as type-specific antibody titers =1:8. ;Timepoint(s) of evaluation of this end point: - Safety: throughout the study period - Immunogenicity: at Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The following safety and immunogenicity endpoints will be evaluated by group and overall. Safety: 1) The incidence of any SAEs and important medical events (IMEs) throughout the study period. The following will be considered IMEs: medically significant events that do not meet any of the SAE criteria, but may require medical or surgical consultation or intervention to prevent one of the other serious outcomes listed in the SAE definition. 2) The incidence and severity of solicited adverse events for Days 0-7 in both groups and days 28-35 and 56-63 in Group 2 3) The incidence and severity of unsolicited adverse events throughout the study period 4) Incidence and description of deviations from normal of safety chemistry at Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day 35 (Group 2), Day 56 (Group 2), Day 63 (Group 2) and Day 84 (Group 2). Immunogenicity: 5) Median titers of type-specific polio antibodies at Day 28 in Group 1 6) Seroprotection rate and median titers of type-specific polio antibodies at Days 56 and 84 in Group 2 7) Seroconversion rate of type-specific polio antibodies at Day 28 in both groups and at Day 84 in Group 2. Seroconversion is defined as a change from seronegative to seropositive and antibody titers of =1:8, and in seropositive subjects, as an antibody titer increase of = 4 fold over baseline titers. ;Timepoint(s) of evaluation of this end point: Safety: 1) Throughout the study period 2) Day 0-7 (both groups) and Day 28-35 & 56-63 (Group 2) 3) Throughout the study period 4) Day 0 (both groups), Day 7 (both groups), Day 28 (both groups), Day 35 (Group 2), Day 56 (Group 2), Day 63 (Group 2) and Day 84 (Group 2) Immunogenicity: 5) Day 28 (Group 1) 6) Day 56 & 84 (Group 2) 7) Day 28 (both groups) and Day 84 (Group 2) | — |
Countries
Belgium
Contacts
Public ContactProf. Dr. PhD.
University of Antwerp
Outcome results
None listed