PERISCOPE was created to facilitate the development of a new generation of pertussis vaccines by increasing collaboration between Pertussis stakeholders, particularly vaccine developers/manufacturers and the academic and public research communities in Europe. The key objective...
PERISCOPE was created to facilitate the development of a new generation of pertussis vaccines by increasing collaboration between Pertussis stakeholders, particularly vaccine developers/manufacturers and the academic and public research communities in Europe. The key objective of the consortium is to gain a better understanding of the immune mechanisms needed to ensure long lasting immunity to Pertussis in humans. This is to be achieved by developing clinical and preclinical models of pertussis infection and conducting vaccination studies for which a toolbox of several novel immunoassays will be developed and deployed.
PERISCOPE has in its third year accomplished the following key objectives:
1. Completion of initial phase (Phase A) towards the establishment of an experimental human challenge colonisation model for pertussis (HCM). The development of the model was initiated in 2017 at NIHR Wellcome Trust Clinical Research Facility in the UK. The approved protocol for the development of the model was published (de Graaf et al., BMJ 2017). Phase A of the model development program was successfully completed in 2018. Biological samples from volunteers were collected and used in several immune assays to develop a better understanding of the human immune response to infection. It is the first study in humans to demonstrate safe, deliberate B. pertussis colonization in volunteers in a manner leading to a concomitant boost of the pertussis-specific immune response, but in the absence of pertussis disease symptoms. Preliminary results were presented at the ID-week in San Francisco (Oct. 2018) and a scientific manuscript is in preparation to describe the outcomes in detail. Preparations are underway to continue into Phase B of the model development program.
2. Completion of all inclusions in the BERT clinical study (Booster pertussis vaccine study). Main purpose of BERT is to investigate the effects of an aP booster vaccination on the magnitude, quality and persistence of immunological memory against pertussis, in children, young adults and elderly with different epidemiological and priming backgrounds for pertussis. The study is conducted, under the sponsorship of RIVM, in the Netherlands, at the Oxford Vaccine Group (UK) and at Turku University Hospital (Finland), three countries with a different epidemiological background for pertussis incidence. In 2018 the protocol was approved in the UK and Finland (as previously done in the Netherlands). Inclusion of all participants on all 3 sites was successfully completed (366 volunteers in total). A large number of biological samples was collected, processed and sent to the Biobank and to partnering laboratory sites for analysis. The partners conducted a first joint review of the trial progress in January 2019. The analysis of immune responses in this study will allow us to assess biomarkers that can be used to detect early signs of the waning of immunological memory to pertussis and biomarkers that can be used to assess long lasting immunological memory to pertussis.
3. Launch of the GAPs study (Gambia Pertussis Study), under sponsorship of LSHTM. The aim of this study is to use immunological assays to investigate the functional humoral and cellular responses to pertussis in infants born to mothers who are randomized to receiving pertussis vaccine in pregnancy or not, and their infants who will receive either aP or wP vaccine. The clinical trial to be conducted in the Gambia, involves the recruitment of 600 mother/infant pairs. Pregnant women will be randomised to receive the usually recommended tetanus vaccination or a combination vaccine against whooping cough, diphtheria, tetanus and polio. Their infants will receive aP or wP as part of their EPI vaccines, and resulting immune responses will be characterized in detail up to the age of 9 months. The clinical protocol for the study was finalised and approved by the medical ethical authorities in the Gambia in 2018. Inclusions started in January 2019.
Notable achievements in earlier years evolved in year three of PERISCOPE:
A laboratory model for infection with Bordetella pertussis has been transferred to the CEA from the laboratory of Dr. Tod Merkel at the Center for Biologics Evaluation and Research (FDA). This preclinical model has been successfully established by CEA and is currently used to allow in-depth studies of immune responses elicited by infection and vaccination against B. pertussis.
Work performed in the mouse model at TCD successfully contributed to insights in the pathogenesis of pertussis infection and to further studies in the preclinic
In addition to the public health objectives of PERISCOPE, the project will revitalize and connect the Pertussis research community in Europe and beyond. It is expected that this network of stakeholders will continue to contribute to the development of novel vaccines and immunization methodologies beyond the life of the project. A variety of discussion forums and meetings have been held throughout this third year of the program in order to review and discuss the results of the PERISCOPE program as they emerge. Through these discussions, areas for future work were identified, new interfaces created among partners and long-standing collaborative links strengthened. This has already had a positive impact on the Pertussis community in Europe and beyond.
Bringing together industrial and academic partners with different approaches and working practices means that both learn from each other.
More info: http://www.periscope-project.eu.