Boosting Teenagers With Acellular Pertussis Vaccines Containing Recombinant or Chemically Inactivated Pertussis Toxin: A Randomized Clinical Trial

Blanchard-Rohner, Géraldine; Chatzis, Olga; Chinwangso, Pailinrut; Rohr, Marie; Grillet, Stéphane; Salomon, Carole; Lemaître, Barbara; Boonrak, Pitchaya; Lawpoolsri, Saranath; Clutterbuck, Elizabeth A.; Poredi, Indrajeet Kumar; Wijagkanalan, Wassana; Spiegel, Jane; Pham, Hong; Viviani, Simonetta; Siegrist, Claire‐Anne

doi:10.1093/cid/ciy594

Cited by 16 publications

(17 citation statements)

References 37 publications

(31 reference statements)

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“…This persisted 1 year later [12]. In aP-primed adolescents also, stronger anti-PT responses were elicited than by the Tdap comparator [13].…”

Section: Introductionmentioning

confidence: 85%

“…Hence, epicutaneous administration targeting Langerhans cells with more immunogenic antigens may more effectively recall pre-existing immunity: in murine models the addition of filamentous haemagglutinin to PT further increased anti-PT responses, possibly through bystander T cells [16]. In a recent clinical trial, a higher PT-specific B memory cell response was observed after aP vaccines containing PTgen and filamentous haemagglutinin [13]. This approach could be interesting to deliver antigens when avoidance of adjuvants is preferred.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial

Chatzis

Blanchard-Rohner

Mondoulet

et al. 2021

Clinical Microbiology and Infection

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Objectives: Protection induced by acellular vaccines can be short, requiring novel immunization strategies. Objectives of this study were to evaluate safety and capacity of a recombinant pertussis toxin (PTgen) -coated Viaskin® epicutaneous patch to recall memory responses in healthy adults. Methods: This double-blind, placebo-controlled randomized trial (Phase I) assessed the safety and immunogenicity of PTgen administered on days 0 and 14 to healthy adults using Viaskin® patches applied directly or after epidermal laser-based skin preparation. Patch administration was followed by Boostrix®dTpa on day 42. Antibodies were assessed at days 0, 14, 28, 42 and 70.Results: Among 102 volunteers enrolled, 80 received Viaskin-PT (Viaskin-PT 25 mgIncidence of adverse events was similar across groups (any local event: 21/25 (84.0%), 24/25 (96.0%), 4/5 (80.0%), 24/25 (96.0%), 8/10 (80.0%), 10/12 (83.0%), respectively). Direct application induced no detectable response. On day 42, PT-IgG geometric mean concentrations were significantly higher following laser þ Viaskin-PT 25 mg and 50 mg (139.87 (95% CI 87.30e224.10) and 121.76 (95% CI 95.04e156.00), respectively), than laser þ Viaskin-placebo (59.49, 95% CI 39.37e89.90). Seroresponse rates were higher following laser þ Viaskin-PT 25 mg (4/5 (80.0%), 95% CI 28.4e99.5) and 50 mg (22/25 (88.0%), 95% CI 68.8e97.5) than laser þ Viaskin-placebo (0/12 (0.0%), 95% CI 0.0e26.5). Conclusions: Viaskin-PT applied after laser-based epidermal skin preparation showed encouraging safety and immunogenicity results: anti-PT booster responses were not inferior to those elicited by Boos-trix®dTpa. This study is registered at ClinicalTrials.gov (NCT 03035370) and was funded by DBV Technologies.

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“…This persisted 1 year later [12]. In aP-primed adolescents also, stronger anti-PT responses were elicited than by the Tdap comparator [13].…”

Section: Introductionmentioning

confidence: 85%

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial

Chatzis

Blanchard-Rohner

Mondoulet

et al. 2021

Clinical Microbiology and Infection

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“…Hence, insufficient neutralization of the locally produced PT in mucosal tissue may support the establishment of long-term bacterial colonization. This hypothesis can now be tested with a reformulated aP vaccine containing the genetically detoxified gdPT antigen with superior protective immunogenicity, which has a preserved tertiary structure with fully preserved conformational neutralizing epitopes [62][63][64][65].…”

Section: Discussionmentioning

confidence: 99%

Acellular Pertussis Vaccine Inhibits Bordetella pertussis Clearance from the Nasal Mucosa of Mice

et al. 2020

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Bordetella pertussis whole-cell vaccines (wP) caused a spectacular drop of global pertussis incidence, but since the replacement of wP with acellular pertussis vaccines (aP), pertussis has resurged in developed countries within 7 to 12 years of the change from wP to aP. In the mouse infection model, we examined whether addition of further protective antigens into the aP vaccine, such as type 2 and type 3 fimbriae (FIM2/3) with outer membrane lipooligosaccharide (LOS) and/or of the adenylate cyclase toxoid (dACT), which elicits antibodies neutralizing the CyaA toxin, could enhance the capacity of the aP vaccine to prevent colonization of the nasal mucosa by B. pertussis. The addition of the toxoid and of the opsonizing antibody-inducing agglutinogens modestly enhanced the already high capacity of intraperitoneally-administered aP vaccine to elicit sterilizing immunity, protecting mouse lungs from B. pertussis infection. At the same time, irrespective of FIM2/3 with LOS and dACT addition, the aP vaccination ablated the natural capacity of BALB/c mice to clear B. pertussis infection from the nasal cavity. While wP or sham-vaccinated animals cleared the nasal infection with similar kinetics within 7 weeks, administration of the aP vaccine promoted persistent colonization of mouse nasal mucosa by B. pertussis.

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“…Over a third of our participants perceived the lack of a pertussis-only vaccine to be a barrier to some extent, with a resultant lower likelihood of performing the vaccination. Availability of such a vaccine as recently licensed in Thailand [59] and studied in Switzerland [60] would therefore likely additionally increase acceptance and coverage [61].…”

Section: Discussionmentioning

confidence: 99%

Influenza and pertussis vaccination during pregnancy – attitudes, practices and barriers in gynaecological practices in Germany

Böhm

Röbl-Mathieu

Scheele³

et al. 2019

BMC Health Serv Res

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Background In Germany, antenatal influenza vaccination is recommended since 2010, but uptake remains low. Several countries recently introduced antenatal pertussis vaccination, which is currently under consideration in Germany. We conducted a survey among gynaecologists on attitudes, practices and barriers regarding influenza and pertussis vaccination during pregnancy. Methods Gynaecologists were invited to complete a pre-tested, 24-item questionnaire published in the German Professional Association of Gynaecologists’ journal in September 2017 within 2 months. Associations between variables were examined using Chi-Squared, Fischer’s Exact or t-tests. Variables associated with gynaecologists’ self-reported implementation of vaccination in pregnant women were identified using univariate and multivariate logistic regression analyses. Results Of 867 participants (response 11%), 91.4 and 59.4% reported currently vaccinating pregnant women against influenza and pertussis, respectively. Gynaecologists who reported obtaining annual influenza vaccination and actively informing their patients about these vaccinations were significantly more likely to vaccinate pregnant women against influenza (96.5% vs. 65.7 and 95.1% vs. 62.2%) and pertussis (63.1% vs. 44.3 and 82.4% vs. 12.9%). Performing influenza vaccination was least likely among gynaecologists who perceived logistical difficulties as a vaccination barrier (35.9%), while pertussis vaccination was least likely if the lacking official recommendation (32.0%), logistical difficulties (27.1%), safety concerns (17.5%) and limited vaccine effectiveness (11.1%) were perceived as barriers. Of participants not yet vaccinating pregnant women against pertussis, 86.5% reported they would follow an official recommendation. Including vaccination recommendations in the maternity record (95.2%) and informing the public (88.7%) and health care professionals (86.6%) were considered the most suitable measures to achieve high pertussis vaccination coverage. Conclusions The large proportion reporting performance of influenza vaccination during pregnancy and high acceptance of a potential recommendation for pertussis vaccination reflected positive attitudes towards vaccination among participants. However, factors associated with failure to vaccinate may be more prevalent among non-participants. Results suggest that gynaecologists’ confidence in vaccination is crucial for implementing vaccination in pregnancy. Thus, doubts on vaccine effectiveness and safety should be allayed among gynaecologists and pregnant women via various communication channels, and solutions for logistical barriers sought. Including antenatal vaccination recommendations in the maternity record would serve as an important reminder for both groups. Electronic supplementary material The online version of this article (10.1186/s12913-019-4437-y) contains supplementary material, which is avail...

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Boosting Teenagers With Acellular Pertussis Vaccines Containing Recombinant or Chemically Inactivated Pertussis Toxin: A Randomized Clinical Trial

Cited by 16 publications

References 37 publications

Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial

Safety and immunogenicity of the epicutaneous reactivation of pertussis toxin immunity in healthy adults: a phase I, randomized, double-blind, placebo-controlled trial

Acellular Pertussis Vaccine Inhibits Bordetella pertussis Clearance from the Nasal Mucosa of Mice

Influenza and pertussis vaccination during pregnancy – attitudes, practices and barriers in gynaecological practices in Germany

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