A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates (NCT04544787) | Clinical Trial Compass
CompletedPhase 2
A Phase 2 Study to Evaluate the Safety and Immunogenicity of Two Oral Poliovirus Vaccine Candidates
Belgium250 participantsStarted 2018-10-22
Plain-language summary
This study is designed to evaluate the safety and immunogenicity of two novel type 2 oral poliovirus vaccine (nOPV2) candidates (nOPV2 candidate 1 and nOPV2 candidate 2) in adults. The primary objectives of the study include the general safety and immunogenicity of the two candidate vaccines in healthy volunteers previously vaccinated with Sabin monovalent OPV or inactivated polio vaccine (IPV) only.
Who can participate
Age range18 Years – 50 Years
SexALL
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Inclusion criteria
✓. 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;
✓. 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;
✓. Having residence in Belgium;
✓. In good physical and mental health as determined on the basis of medical history and general physical examination performed at Day 0;
✓. 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;
✓. Willing to adhere to the prohibitions and restrictions specified in this protocol;
✓. 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.
Exclusion criteria
✕. 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;
✕. For Groups 5, 6 and 7: ever having received any OPV in the past;
✕. 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;
What they're measuring
1
Number of Participants With Serious Adverse Events (SAEs) and Severe Adverse Events
Timeframe: Up to 42 days after each vaccination
2
Seroprotection Rate After a Single Dose of Novel OPV2 in Former OPV Recipients
Timeframe: Baseline (Day 0 prior to vaccination) and Day 28
✕. Professional handling of food, catering or food production activities during the total duration of the study;
✕. Having Crohn's disease or ulcerative colitis or having had major surgery of the gastrointestinal tract involving significant loss or resection of the bowel;
✕. A known allergy, hypersensitivity, or intolerance to the study vaccine or the placebo, or to any of their components or to any antibiotics;
✕. Any confirmed or suspected immunosuppressive or immunodeficiency condition (including human immunodeficiency virus \[HIV\] infection, hepatitis B or C infections or total serum immunoglobulin A \[IgA\] level below laboratory lower limit of normal \[LLN\]);
✕. 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;