Poliomyelitis MedDRA version: 20.0 Level: HLT Classification code 10036017 Term: Poliomyelitis viral infections System Organ Class: 100000004862
Conditions
Interventions
Product Name: nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3)
Product Code: nOPV2 candidate 1
Pharmaceutical Form: Oral drops
INN or Proposed INN: Poliom
Sponsors
University of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. For Groups 1, 2, 3 and 4: healthy males or females, from 18 to 50 years of age inclusive, having previously received at least 3 doses of OPV more than 12 months before the start of the study; 2. For Groups 5, 6 and 7: healthy males or females, from 18 to 50 years of age inclusive, having previously received at least 3 doses of IPV more than 12 months before the start of the study; 3. Having residence in Belgium; 4. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0; 5. 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 (see Section 7); 6. Willing to adhere to the prohibitions and restrictions specified in this protocol (see Section 7); 7. Informed Consent Form (ICF) and Code of Conduct signed voluntarily by the subject before any study-related procedure is performed, indicating that the subject understands the purpose of any 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 332 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. For Groups 5, 6 and 7: ever having received any OPV in the past; 3. Any travel to polio endemic countries or countries with evidence of recent (within last 6 months) wild or vaccine-derived poliovirus circulation during the total duration of the study 4. Professional handling of food, catering or food production activities during the total duration of the study; 5. Having Crohn’s disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel; 6. A known allergy, hypersensitivity, or intolerance to the study vaccine or the placebo, or to any of their components or to any antibiotics; 7. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus [HIV] infection, hepatitis B or C infections or total serum IgA level below lab lower limit of normal (LNN)); 8. Will have household or professional contact with known immunosuppressed people or people without full polio vaccination (i.e. complete primary infant immunization series), e.g. babysitting during the total duration of the study; 9. Neonatal nurses or others having professional contact with children under 6 months old during the total duration of the study; 10. 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); 11. 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; 12. Indications of drug abuse or excessive use of alcohol at Day 0 (males: > 21 units per week (m); females > 14 units per week); 13. Being pregnant or breastfeeding. Women of childbearing potential will undergo a urine pregnancy test at each vaccination visit. Subjects with a positive pregnancy test will be excluded; 14. 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; 15. Administration of any vaccine other than the study vaccine within 28 days prior to the first dose of study vaccine and during the entire study period; 16. Administration of any polio vaccine within 12 months before the start of the study; 17. 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; 18. Subject is an employee of the Investigator or study site, with direct involvement in th
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]) of novel monovalent live attenuated oral serotype 2 poliovirus vaccine (nOPV2) candidate 1 and novel monovalent live attenuated oral serotype 2 poliovirus vaccine (nOPV2) candidate 2 in healthy OPV-vaccinated adults, relative to historical controls given Sabin OPV2; - To compare the immunogenicity (seroprotection rate) of novel monovalent live attenuated oral serotype 2 poliovirus vaccine (nOPV2) candidate 1 and novel monovalent live attenuated oral serotype 2 poliovirus vaccine (nOPV2) candidate 2 in healthy OPV-vaccinated adults to historical controls given Sabin OPV2; - To assess the safety (serious adverse events [SAEs] and severe adverse events [AEs]) of nOPV2 candidate 1 and nOPV2 candidate 2 in healthy IPV-only vaccinated adults, compared with placebo. ; Secondary Objective: Secondary objectives are - To assess the safety (any solicited and unsolicited AEs, laboratory assessments) of nOPV2 candidate 1 and nOPV2 candidate 2 in healthy OPV-vaccinated adults, compared with historical controls given Sabin OPV2; - To assess the safety (any solicited and unsolicited AEs, laboratory assessments) of nOPV2 candidate 1 and nOPV2 candidate 2 in healthy IPV-only vaccinated adults, compared with placebo; - To compare the immunogenicity (seroconversion rate, median antibody titer (post-vaccination)) of nOPV2 candidate 1 and nOPV2 candidate 2 in healthy OPV-vaccinated adults, with historical control of Sabin OPV2; - To assess the immunogenicity (seroprotection rate, seroconversion rate, median post-vaccination antibody titer) of nOPV2 candidate 1 and nOPV2 candidate 2 in healthy IPV-only vaccinated adults. ; Primary end point(s): Safety: The following endpoints will | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety: The following endpoints will be evaluated by group and overall: - incidence, type, causality and severity of solicited adverse events for days 0-7 in Groups 1 and 2 combined and days 28-35 in Group 2; - incidence, type, causality and severity of solicited adverse events for days 0-7 in Groups 3 and 4 combined and days 28-35 in Group 4; - incidence, type, causality and severity of solicited adverse events for days 0-7 and days 28-35 in Groups 5, 6 and 7; - incidence, type, causality and severity of unsolicited adverse events throughout the study period in all groups; - incidence, causality and description of deviations from normal safety labs at Day 0, Day 7, Day 14 and Day 28 for Groups 1 through 4, and at Day 35, Day 42 and Day 56 for Groups 2 and 4; - incidence, causality and description of deviations from normal safety labs at Day 0, Day 7, Day 14, Day 28, Day 35, Day 42 and Day 56 for Groups 5, 6, and 7. Immunogenicity: - Median titers of type 2 polio antibodies at Day 28 in Groups 1 and 2 combined; - Median titers of type 2 polio antibodies at Day 28 in Groups 3 and 4 combined; - Median titers of type 2 polio antibodies at Day 28 in Groups 5, 6 and 7. - Seroprotection rate and median titers of type 2 polio antibodies at Day 56 in Groups 2 and 4; - Seroprotection rate of type 2 polio antibodies at Day 28 and at Day 56 in Groups 5, 6 and 7. - Seroconversion rate of type 2 polio antibodies at Day 28 for Groups 1 and 2 combined and at Day 56 in Group 2; - Seroconversion rate of type 2 polio antibodies at Day 28 for Groups 3 and 4 combined and at Day 56 in Group 4; - Seroconversion rate of type 2 polio antibodies at Day 28 and at Day 56 for Groups 5, 6 and 7. Seroconversion is de | — |
Countries
Belgium
Contacts
Public ContactProf.Dr.PhD. Pierre Van Damme
University of Antwerp
Outcome results
None listed