PertussisPhase 2/3Pertagen2xNCT05193734
Safety and Immunogenicity of 2 Doses Versus 1 Dose of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines
A Phase 2/3 study testing Pertagen® and Revaxis® in people with Pertussis and Vaccine-Preventable Diseases, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
A significant increase of pertussis incidence is reported in a growing number of countries. This resurgence is considered as resulting from the limited durability of aP-vaccine-induced immunity and is associated with increased mortality in young infants and morbidity at all age groups. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Pertussis, Vaccine-Preventable Diseases
- What is being tested?
- Pertagen® and Revaxis®
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 Feb 2022to 30 Mar 2023
- Phase
- Phase 2/3
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Has provided written informed consent;
- Male or female, ages 18 to 30 years (inclusive) at the time of enrollment;
- With documented history of acellular pertussis immunization (5 doses);
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
- Non-pregnant, non-lactating females :
- Able to attend all scheduled visits during one year and to understand and comply with the study procedures;
Who cannot join
- Prior dTpa immunization within the last 5 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;
- History of severe local or systemic reactions to any vaccination;
- Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis-containing vaccines (including excipients);
- Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical trial;
- Receipt of licensed vaccines within 30 days of planned study immunization or ongoing participation in another clinical interventional trial likely to interfere with study results;
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- Acute or chronic, clinically significant psychiatric, hematologic, pulmonary, cardiovascular, or hepatic or renal functional abnormality as determined by the Investigator based on medical history and physical exam;
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection, asplenia, cytotoxic therapy in the previous 5 years, and/or diabetes;
- Has a known history of vaccine-induced Guillain-Barré Syndrome;
- Has an active malignancy or recent (<10 years) history of metastatic or hematologic malignancy;
- Suspected or known alcohol and/or illicit drug abuse within the past 5 years;
- Pregnant or lactating female, or female intending to becoming pregnant during the study period;
- Administration of immunoglobulins within the 120 days preceding study entry or planned administration during the study period;
- History of blood donation (at least 450 ml) within 30 days of enrollment or plans to donate within the 30 days following and preceding each blood draw;
- Receipt of chronic (>14 days) immunosuppressants or other immune-modifying drugs within 6 months of study entry:
- Any other significant finding that, in the opinion of the investigator, would increase the risk of the individual's having an adverse outcome by participating in this study.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Geneva
Geneva, 1205
Gualtieri Renato, MD, +41 (0)79 55 35 509, renato.gualtieri@hcuge.ch
About this study
Official title: A Phase II/III Randomized, Double-blind Controlled Study to Compare the Safety and Immunogenicity of 1 or 2 Doses of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines
A significant increase of pertussis incidence is reported in a growing number of countries. This resurgence is considered as resulting from the limited durability of aP-vaccine-induced immunity and is associated with increased mortality in young infants and morbidity at all age groups. As the pertussis immunity acquired through immunization or infection is short-lived, its maintenance or reactivation requires repeat boosting at regular time points. Thus, novel strategies capable of reactivating pertussis immunity are needed.
The efficacy of current acellular pertussis vaccines (which contain chemically-detoxified pertussis toxoid (PT)) rapidly wanes, in part because priming and repeat immunization with acellular vaccines induce antibodies specific for the chemically-detoxified PT but unable to efficiently recognize the native PT expressed by B. pertussis.
Read more
Clinical studies have shown the superior immunogenicity profile of acellular pertussis vaccines including genetically-detoxified PT (rPT) in adults and adolescents previously primed with aP. In particular, the investigators showed in a past Geneva study in teenagers previously primed with aP that rPT/FHA induced a stronger recall response than the current aP-vaccine at one month post-vaccination. However, the difference was less clear one year after vaccination, suggesting that 2 doses may be needed for more sustained immunity.
In the present study, the investigators would like to assess whether giving two doses of rPT/FHA at 6 months interval induces stronger immune responses than a single dose.
- Conditions
- Pertussis, Vaccine-Preventable Diseases
- Being tested
- Pertagen®, Revaxis®
- Medical subject headings
- Whooping Cough, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pertagen®Drug
Also called Genetically detoxified pertussis toxin (rPT) and filamentous hemagglutinin (FHA), alum adsorbed
Schedule:
Group Pertagen will receive two doses of Pertagen®. (one vaccination on Day 0 and 6 months later for each volunteer.)
Mode of Administration:
Intramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle.
Revaxis®Drug
Schedule:
Group Control will receive one dose of Revaxis® on Day 0 followed by 1 dose of Pertagen® 6 months later for each volunteer.
Mode of Administration:
Intramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle.
| Study group | Role | What they receive |
|---|---|---|
| Group Pertagen | Experimental | Not described Receives: Drug: Pertagen® |
| Group Control | Active comparator | Not described Receives: Drug: Revaxis® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine
The primary objective is to assess the immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine (Pertagen®) including genetically-detoxified pertussis toxin (rPT) administered at 6 months interval and delivered by the intramuscular route to adults aged 18-30 years previously primed and boosted with chemically-detoxified PT.
The main immunogenicity endpoints will be the geometric mean concentration (GMC) of anti-PT neutralizing antibodies assessed 4 weeks (early immunity) and 6 months (sustained immunity) following one or two injections of Pertagen® given at 6 months interval
Measured: 1 year
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events OBJECTIVE
Safety endpoints evaluated by solicited local and systemic reactions and unsolicited adverse events (AEs)
Measured: Solicited local and systemic reactions will be followed up for 7 days and AEs for 28 days after vaccination
Humoral immune response
GMCs and seroresponse rates of PT, FHA, tetanus and diphtheria-toxoid specific IgG antibodies measured by ELISA and specific elicited by two doses of Pertagen® as compared to a single dose.
Measured: At 28 days after vaccination
Cellular immune response
Concentration of specific memory B cells for PT, tetanus
Measured: At 28 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study start7 Feb 2022 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion30 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PertussisStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blanchard-Rohner Geraldine, University Hospital, Geneva
- Investigators
- BLANCHARD ROHNER Geraldine, MD, Principal investigator, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193734
- Sponsor's protocol ID
- PERTAGEN2x
- Acronym
- Pertagen2x
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 18 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Randomized, Double-blind Controlled Study to Compare the Safety and Immunogenicity of 1 or 2 Doses of Acellular Pertussis Vaccines Containing Genetically-detoxified Pertussis Toxin in Young Adults Previously Primed With Acellular Pertussis Vaccines
- ClinicalTrials.gov ID
- NCT05193734
- Acronym / sponsor ID
- Pertagen2x / PERTAGEN2x
- Conditions
- Pertussis, Vaccine-Preventable Diseases
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 7 Feb 2022 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 30 Mar 2023 (estimated)
- First posted
- 18 Jan 2022 (actual)
- 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.
A significant increase of pertussis incidence is reported in a growing number of countries. This resurgence is considered as resulting from the limited durability of aP-vaccine-induced immunity and is associated with increased mortality in young infants and morbidity at all age groups. As the pertussis immunity acquired through immunization or infection is short-lived, its maintenance or reactivation requires repeat boosting at regular time points. Thus, novel strategies capable of reactivating pertussis immunity are needed.
The efficacy of current acellular pertussis vaccines (which contain chemically-detoxified pertussis toxoid (PT)) rapidly wanes, in part because priming and repeat immunization with acellular vaccines induce antibodies specific for the chemically-detoxified PT but unable to efficiently recognize the native PT expressed by B. pertussis.
Clinical studies have shown the superior immunogenicity profile of acellular pertussis vaccines including genetically-detoxified PT (rPT) in adults and adolescents previously primed with aP. In particular, the investigators showed in a past Geneva study in teenagers previously primed with aP that rPT/FHA induced a stronger recall response than the current aP-vaccine at one month post-vaccination. However, the difference was less clear one year after vaccination, suggesting that 2 doses may be needed for more sustained immunity.
In the present study, the investigators would like to assess whether giving two doses of rPT/FHA at 6 months interval induces stronger immune responses than a single dose.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Pertagen | Experimental | Drug: Pertagen® |
| Group Control | Active comparator | Drug: Revaxis® |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Has provided written informed consent;
- Male or female, ages 18 to 30 years (inclusive) at the time of enrollment;
- With documented history of acellular pertussis immunization (5 doses);
- Free of clinically significant health problems, as determined by pertinent medical history and clinical examination at study screening;
- Non-pregnant, non-lactating females :
Key exclusion criteria (16 listed)
- Prior dTpa immunization within the last 5 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;
- History of severe local or systemic reactions to any vaccination;
- Known hypersensitivity or allergy to diphtheria, tetanus, or pertussis-containing vaccines (including excipients);
- Receipt of investigational product up to 30 days prior to enrollment or ongoing participation in another interventional clinical 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 |
|---|---|---|
| Pertagen®Also: Genetically detoxified pertussis toxin (rPT) and filamentous hemagglutinin (FHA), alum adsorbedSchedule: Group Pertagen will receive two doses of Pertagen®. (one vaccination on Day 0 and 6 months later for each volunteer.) Mode of Administration: Intramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle. | Drug | Group Pertagen |
| Revaxis®Schedule: Group Control will receive one dose of Revaxis® on Day 0 followed by 1 dose of Pertagen® 6 months later for each volunteer. Mode of Administration: Intramuscular injection into the deltoid region of the upper extremity, using a syringe with a 1 to 1.5 inch #25-gauge sterile needle. | Drug | Group Control |
Primary outcome
Immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine
Time frame: 1 year
The primary objective is to assess the immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine (Pertagen®) including genetically-detoxified pertussis toxin (rPT) administered at 6 months interval and delivered by the intramuscular route to adults aged 18-30 years previously primed and boosted with chemically-detoxified PT. The main immunogenicity endpoints will be the geometric mean concentration (GMC) of anti-PT neutralizing antibodies assessed 4 weeks (early immunity) and 6 months (sustained immunity) following one or two injections of Pertagen® given at 6 months interval
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events OBJECTIVE
Time frame: Solicited local and systemic reactions will be followed up for 7 days and AEs for 28 days after vaccination
Humoral immune response
Time frame: At 28 days after vaccination
Cellular immune response
Time frame: At 28 days after vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
Related trials for Pertussis
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A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
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RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
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Assessment of the Acceptability of, and Factors Associated With, Recommended Vaccinations During Pregnancy in Maternity Units in the Ile-de-France Region
Vaccination Coverage Among Pregnant Women
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
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.
BLANCHARD ROHNER Geraldine, MD principal investigator
University of Geneva, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pertagen® and Revaxis® in people with Pertussis and Vaccine-Preventable Diseases, run by University Hospital, Geneva 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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 18 Jan 2022. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GUALTIERI Renato, MD (+41 (0)79 55 35 509, renato.gualtieri@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunogenicity of two doses compared to a single dose of an acellular pertussis vaccine (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2022.