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“Efficacy Trials of Plague Vaccines: Endpoints, Trial Design, Site Selection” “Efficacy trials of Plague Vaccines: endpoints, trial design, site selection” WHO Workshop Meeting Report April 23, 2018 INSERM, Paris, France Table of contents TABLE OF CONTENTS 1 1. INTRODUCTION 2 2. EPIDEMIOLOGY OF PLAGUE, OUTBREAK CONDITIONS, AND PLAGUE CANDIDATE VACCINES 4 3. TRIAL DESIGN CONSIDERATIONS 7 3.1 CLINICAL ENDPOINTS SELECTION (BOTH REACTIVE AND PREVENTIVE) 7 3.2 STUDY POPULATION AND SITE SELECTION (BOTH REACTIVE AND PREVENTIVE) 8 3.3 RANDOMIZATION AND COMPARATOR (BOTH REACTIVE AND PREVENTIVE) 9 3.4 STATISTICAL ANALYSIS 10 4. ESTABLISHING A TRANSPARENT FRAMEWORK FOR SELECTING VACCINES TO BE EVALUATED IN PHASE 2B/PHASE 3 TRIALS 10 5. NEXT STEPS 11 1 1. Introduction Plague is an infectious disease caused by Yersinia pestis, a zoonotic bacterium, usually found in small mammals and their fleas. As an animal disease, plague is found in all continents, except Oceania. There is a risk of human plague wherever the presence of plague natural foci (the bacteria, an animal reservoir and a vector), and the human population co-exist. There are large plague reservoirs in African, Asian, and South American continents; but since the 1990s, most human cases have occurred in Africa. Plague endemicity throughout the world has resulted in sporadic infections, including recent outbreaks in the 21st century. The three countries with most reported cases in recent years are the Democratic Republic of Congo, Madagascar, and Peru. In 2017, there was a large plague outbreak in Madagascar. There are effective therapeutics to treat plague although evidence of antibiotic-resistance has been observed in Y. pestis strains naturally or those deliberately developed to serve as a biothreat agent. Antibiotic treatment and post-exposure prophylaxis are generally initiated on plague suspected cases (i.e., before laboratory confirmation of plague infection), given the extremely short incubation and infectious period of plague infection. Plague is usually associated with two major forms of infection: bubonic and pneumonic. Bubonic plague is transmitted to humans through flea bites and direct contact with infected rodents. Domestic cats and dogs that have been in contact with rodents can transport the infected fleas. Pneumonic plague, the most deadly form, occurs when bacteria infect the lungs either through direct inhalation or through secondary spread of bacteria from septicaemic or bubonic infection. Pneumonic plague infection can be transmitted from person to person by respiratory droplets, and can be fatal within 24 hours of disease onset, if left untreated. From 2010 to 2015, 3,248 cases were reported worldwide, including 584 deaths. In 2017, a total of 2,348 confirmed, probable and suspected cases of plague, including 202 deaths (case fatality rate: 8.6%), were reported by the Ministry of Health of Madagascar to WHO. Among the 2,348 cases of plague, 1,791 were pneumonic plague (76.3%), one case of septicaemic plague (<0.1%), 341 cases of bubonic plague (14.5%), and 215 cases of unspecified plague (9.2%). Of the 1,791 cases of pneumonic plague, 22% were confirmed, 34% were probable, and 44% were suspected. A WHO confirmed case definition was defined in 2006 to account for a universal plague definition in the context of the International Health Regulations. Currently, WHO does not recommend immunization with old-generation plague vaccines1. The recrudescence of plague outbreaks, the availability of new vaccine technologies, and biodefense concerns, have triggered renewed interest towards the development of new- generation plague vaccines. Furthermore, the need for a plague vaccine is also underscored in areas where plague infections may occur but where timely access to diagnosis and treatment is not guaranteed (e.g., remote rural areas, resources-limited settings, conflict areas, etc.). The WHO mapping tool currently registers 17 plague vaccine candidates under development, by private and public-sector laboratories. Two of these candidates have completed a Phase 2 clinical trial, and several candidates have plans to enter clinical trials in 2019. A WHO Plague vaccine Target Product Profile (TPP) was developed to provide aspirational guidance to vaccine developers. The TPP is informed by regulatory 1 except for high-risk groups (such as laboratory personnel who are constantly exposed to the risk of contamination, and health care workers). 2 expectations, by technological feasibility and to consider both a preventive and a reactive scenario when using a Plague vaccine. On April 23, 2018, WHO convened a group of about 30 experts in epidemiology, regulatory, preclinical and clinical vaccine trials, and mathematical modelling, in a workshop on planning for plague vaccine efficacy trials. The workshop aimed to define generic principles on how to best design, conduct and analyse vaccine trials against plague, based on the available scientific evidence as well as on lessons learned from the public health response to plague outbreaks. Participants reviewed available evidence on plague epidemiology and vaccine candidates, identified and discussed methodological options to evaluate vaccines, regardless of vaccine products, and agreed on some preliminary recommendations. The WHO Plague vaccine TPP was expected to help inform vaccine evaluation decisions during the workshop. It was recognised that the preliminary recommendations are likely to evolve as new evidence is generated, and also, they must be tailored to the social and cultural context of affected communities. 3 2. Epidemiology of plague, outbreak conditions, and plague candidate vaccines The population at-risk of plague infection is globally increasing. There is a risk of human plague wherever the presence of plague natural foci (the bacteria, an animal reservoir and a vector), and the human population co-exist. A global expansion of the geographic distribution of the natural foci, notably in urban settings, has been observed, although the geographic distribution of the foci remains patchy resulting in heterogeneous bubonic plague transmission in humans. Because the risk of pneumonic plague depends on the occurrence of bubonic plague, it is also expected that the at-risk population to pneumonic plague increases as well as the risk of plague outbreak in unexpected areas, particularly in urban settings. For instance, the 2017 plague outbreak in Madagascar has occurred in areas and time of the year (August to November) that differed from the usually observed seasonal occurrence (October to April) of plague cases in the endemic areas of the Central Plateau. The 2017 plague outbreak occurred unexpectedly in urban areas, and has been associated with an unusual ratio of pneumonic versus bubonic cases, suggesting that human to human aerosol transmission contributed significantly to the spread of the bacterium. The basic reproduction number (i.e., the average number of secondary cases generated in a fully susceptible population) of the 2017 Madagascar outbreak was estimated to be about 1.70. Several knowledge gaps remain: the role of factors such as age, socio-economic status, and other demographic factors as risk factors requires further investigation to identify at-risk populations and to understand what might potentially influence transmission rates. In particular, it is unclear whether the risk of pneumonic cases is due to the importation of human cases from rural to urban setting or due to the geographic expansion of the natural foci in urban settings, or both of these two reasons. In addition, it remains unclear whether plague infection confers lifelong immunity, although there is some evidence of a durable antibody response following immunization with old-generation live-attenuated plague vaccines. Asymptomatic and mild plague infections may also occur and there are uncertainties associated with the real burden of plague. Sero-prevalence studies and enhanced surveillance in Madagascar and other affected countries are needed to help inform the above gaps and a thorough analysis of the 2017 Madagascar plague outbreak data must be conducted to better estimate secondary attack rates and other epidemiological parameters. Outbreak circumstances provide challenging conditions to the conduct of a vaccine trial. The WHO TPP for plague vaccines notably considers a scenario for the reactive use of a plague vaccine associated with a public health emergency. Generating evidence to support a broader use of a plague vaccine under that scenario may necessitate a vaccine trial during a plague outbreak setting. Research has increasingly been a norm in responding to outbreaks of infectious diseases. The research response must be fully integrated in the broader control efforts and cannot be performed at the expense of the control efforts. For instance, during the 2017 Madagascar outbreak, a series of outbreak control measures were implemented, including enhanced epidemiological surveillance, rapid detection, isolation and treatment of plague cases, contact tracing, and community engagement strategies. Also, an uncontrolled consumption of antibiotics used as a chemoprophylaxis has 4 been observed among contacts of suspected pneumonic cases and less frequently among contacts of suspected bubonic cases. It is expected that the above public health response elements should be considered in the design of a vaccine trial in the context of an outbreak. Lastly, anthropological studies are needed to assess the acceptability of a vaccine trial from affected communities in such conditions. There is currently no licensed vaccine
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