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Viaskin Pertussis Vaccine Trial
The study is a Phase I, first in human, monocenter study, aiming at assessing the safety and immunogenicity of a genetically detoxified pertussis toxin (PT) when administered via the cutaneous route with Viaskin patches to healthy volunteers at 2 different doses of 25 mcg or 50 mcg PT protein compared to Viaskin placebo. Two cohorts of 30 subjects will be successively enrolled. Safety of the product will be assessed throughout the 10-week study and its immunogenicity will be assessed at regular intervals with collection of blood samples for immunological analyses. Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 40 Years|
- - Has provided written informed consent before enrollment; - Adult male or female, ages 18 to 40 years (inclusive) at the time of enrollment; - Non-pregnant, non-lactating female; - Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening; - With documented history of pertussis immunization (at least 4 doses); - Women of childbearing potential with a negative pregnancy test at entry; - Females of childbearing potential who are willing to use an effective method of contraception.
- - Prior dTpa immunization within the last 10 years or prior dT immunization within the last 2 years, or any other investigational vaccine likely to impact on interpretation of the trial data; - Suspected or confirmed pertussis infection within the last 10 years or documented pertussis infection in a household member within the last 10 years; - Receipt of licensed vaccines within 14 days of planned study immunization (30 days for live vaccines) or ongoing participation in another clinical interventional trial.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Claire Anne Siegrist, M.D|
|Principal Investigator Affiliation||Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Overall Status||Active, not recruiting|
The disease, disorder, syndrome, illness, or injury that is being studied.
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Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Geneva, , 1211