Whooping CoughPhase 1NCT03035370
Viaskin Pertussis Vaccine Trial
A Phase 1 study testing Viaskin PT 25 mcg, Viaskin PT 50 mcg and Boostrix™ in people with Whooping Cough, run by DBV Technologies at 1 site in Switzerland.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Whooping Cough
- What is being tested?
- Viaskin PT 25 mcg, Viaskin PT 50 mcg and Boostrix™
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteSwitzerland
- Study dates
- 5 Sep 2016to 25 Apr 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Vaccinology Medical faculty UNIGE and University of Geneva (HUG)
Geneva, 1211
About this study
Official title: A Phase I Dose Escalation Randomized, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Reactivation of Pertussis Toxin Immunity With the Viaskin Epicutaneous Delivery System in Healthy Adults
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.
- Conditions
- Whooping Cough
- Being tested
- Viaskin PT 25 mcg, Viaskin PT 50 mcg, Viaskin PT Placebo, Boostrix™
- Keywords
- Pertussis, Epicutaneous ImmunoTherapy (EPIT), Vaccine, Viaskin PT
- Medical subject headings
- Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Viaskin PT 25 mcgBiological
Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
Viaskin PT 50 mcgBiological
Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
Viaskin PT PlaceboBiological
Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).
Boostrix™Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| Viaskin PT 25 mcg | Experimental | Viaskin PT 25 mcg Receives: Biological: Viaskin PT 25 mcg; Biological: Boostrix™ |
| Viaskin PT 50 mcg | Experimental | Viaskin PT 50 mcg Receives: Biological: Viaskin PT 50 mcg; Biological: Boostrix™ |
| Viaskin PT Placebo | Placebo comparator | Viaskin PT Placebo Receives: Biological: Viaskin PT Placebo; Biological: Boostrix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (AE).
- Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application;
- Unsolicited AEs from the time of application through 28 days following the 1st application;
- Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
Measured: From Day 0 to Day 70.
Secondary outcomes (1)
PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
Measured: Day 14, Day 28, Day 42, Day 70.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start5 Sep 2016
- Primary completion25 Apr 2018
- Study completion25 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Whooping CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- DBV Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva
- Responsible party
- Sponsor
- Investigators
- Claire Anne Siegrist, M.D, Principal investigator, Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035370
- Sponsor's protocol ID
- VBEST
- Status last verified
- Feb 2020
- First submitted
- 15 Mar 2016
- Last updated
- 2 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Chatzis O, Blanchard-Rohner G, Mondoulet L, Pelletier B, De Gea-Hominal A, Roux M, Huttner A, Herve PL, Rohr M, Matthey A, Gutknecht G, Lemaitre B, Hayem C, Pham HT, Wijagkanalan W, Lambert PH, Benhamou PH, Siegrist CA. Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial. Clin Microbiol Infect. 2021 Jun;27(6):878-885. doi: 10.1016/j.cmi.2020.08.033. Epub 2020 Sep 5.
PubMed 32896653
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Randomized, Double-blind, Placebo-controlled Safety and Immunogenicity Trial of the Reactivation of Pertussis Toxin Immunity With the Viaskin Epicutaneous Delivery System in Healthy Adults
- ClinicalTrials.gov ID
- NCT03035370
- Acronym / sponsor ID
- VBEST
- Conditions
- Whooping Cough
- Keywords
- Pertussis, Epicutaneous ImmunoTherapy (EPIT), Vaccine, Viaskin PT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- DBV TechnologiesIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Geneva
- Study start
- 5 Sep 2016 (actual)
- Primary completion
- 25 Apr 2018 (actual)
- Study completion
- 25 Apr 2018 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Viaskin PT 25 mcg | Experimental | Biological: Viaskin PT 25 mcg, Biological: Boostrix™Viaskin PT 25 mcg |
| Viaskin PT 50 mcg | Experimental | Biological: Viaskin PT 50 mcg, Biological: Boostrix™Viaskin PT 50 mcg |
| Viaskin PT Placebo | Placebo comparator | Biological: Viaskin PT Placebo, Biological: Boostrix™Viaskin PT Placebo |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Viaskin PT 25 mcgTwo applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14). | Biological | Viaskin PT 25 mcg |
| Viaskin PT 50 mcgTwo applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14). | Biological | Viaskin PT 50 mcg |
| Viaskin PT PlaceboTwo applications of Viaskin PT Placebo at a 2-week interval (D0 and D14). | Biological | Viaskin PT Placebo |
| Boostrix™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. | Biological | Viaskin PT 25 mcg, Viaskin PT 50 mcg, Viaskin PT Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (AE).
Time frame: From Day 0 to Day 70.
* Solicited AEs occurring from the time of each application through 14 days following Viaskin PT application; * Unsolicited AEs from the time of application through 28 days following the 1st application; * Serious Adverse Events from the time of the inform consent form signature through the final study visit of subject.
1 secondary outcome
PT-specific antibody response (anti-PT IgG antibodies and PT-specific neutralizing antibodies).
Time frame: Day 14, Day 28, Day 42, Day 70.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2020.
- Derived from this study: PubMed 32896653Chatzis O, Blanchard-Rohner G, Mondoulet L, Pelletier B, De Gea-Hominal A, Roux M, Huttner A, Herve PL, Rohr M, Matthey A, Gutknecht G, Lemaitre B, Hayem C, Pham HT, Wijagkanalan W, Lambert PH, Benhamou PH, Siegrist CA. Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial. Clin Microbiol Infect. 2021 Jun;27(6):878-885. doi: 10.1016/j.cmi.2020.08.033. Epub 2020 Sep 5.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claire Anne Siegrist, M.D principal investigator
Medical Faculty (UNIGE) and University hospital of Geneva , Center of Vaccinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Viaskin PT 25 mcg, Viaskin PT 50 mcg and Boostrix™ in people with Whooping Cough, run by DBV Technologies at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (AE). (time frame: From Day 0 to Day 70.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.