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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group Pertagen | Experimental |
| |
| Group Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertagen® | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events OBJECTIVE | Safety endpoints evaluated by solicited local and systemic reactions and unsolicited adverse events (AEs) | Solicited local and systemic reactions will be followed up for 7 days and AEs for 28 days after vaccination |
| Humoral immune response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GUALTIERI Renato, MD | Contact | +41 (0)79 55 35 509 | renato.gualtieri@hcuge.ch |
| Name | Affiliation | Role |
|---|---|---|
| BLANCHARD ROHNER Geraldine, MD | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Geneva | Recruiting | Geneva | 1205 | Switzerland |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2021 |
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| 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. |
|
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. |
| At 28 days after vaccination |
| Cellular immune response | Concentration of specific memory B cells for PT, tetanus | At 28 days after vaccination |
| Nov 23, 2021 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014917 | Whooping Cough |
| D000079263 | Vaccine-Preventable Diseases |
| ID | Term |
|---|---|
| D001885 | Bordetella Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C011820 | FHD |
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