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Related Publications Vaccine: X. Vaccine welcomes new editors. Introducing the editors Dr. What subjects will you be covering in Vaccine? Why are these subjects important? Introduction In outbreaks of emerging infectious diseases for which no proven efficacious vaccines exist but investigational vaccines have been developed, it is important both to rapidly test the investigational vaccines and, if effective, to deploy them.

Scope When designing and implementing randomized efficacy trials for investigational vaccines after safety and immunogenicity data have been collected in Phase 1 and 2 trials , some key choices must be made. Randomized vaccine trial design choices during epidemics Table 1 summarizes the major designs that have been used or proposed for vaccine trials. Download: PPT. Table 1. Possible trial designs to evaluate the efficacy of investigational vaccines during epidemics of emerging infectious diseases. Randomization unit Table 2 summarizes key features of iRCTs, in which vaccination is randomized between individuals in the same population, and cRCTs, in which groups of individuals are randomized.

Table 2. Key features of individually randomized and cluster-randomized trials. Trial population Trial participants may be selected either from the general population or from a group at high risk of exposure to infection. Comparator intervention A trial may compare participants randomized to receive an investigational vaccine with those randomized to receive placebo, an active control most commonly a proven effective vaccine against another infection , or delayed administration of the investigational vaccine. Conclusion We argue that individually randomized trials with a placebo control should be the default strategy for evaluating investigational vaccines during epidemics.

In non-blinded trials, bias can arise in intervention allocation if, for example, the investigators knowingly put the more or less vulnerable participants in the investigational vaccine arm, or if participants change their behavior if they know they did or did not receive the investigational vaccine.

Direct effects : The extent by which the risk of disease is reduced when an individual is exposed to the infectious agent. The direct effect of a vaccine is mainly a characteristic of the vaccine itself and how it interacts with individuals rather than of the way the vaccine is deployed in a particular population.

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While direct vaccine effects are not always generalizable [ 29 , 40 , 41 , 53 ], they are often assumed to be more easily extrapolated to other settings because direct effects are measured at the individual level and not typically thought to depend much on the patterns of exposure and transmission in the population. Indirect effects : Indirect effects occur when the number of persons vaccinated in a community reduces the overall transmission rate of the infection in the community. Sometimes called herd effects, indirect effects benefit both vaccinated and unvaccinated individuals, and the size of the effect will depend both on the level of the direct effect and the proportion of persons vaccinated in the population [ 20 ].

The indirect effects of a vaccine depend not only on the direct effects on vaccinated individuals but on such factors as the incidence rate of the disease, the level of pre-existing immunity in the population, the contact network structure, the coverage of the vaccine, and the phase of the epidemic growing or declining , among others. Each of these factors will vary across populations that may consider using the investigational vaccine if it proves effective, and some of them e.

References 1. WHO workshop on prioritization of pathogens report. National Academy of Sciences Engineering and Medicine. Integrating clinical research into epidemic response: the Ebola experience. National Academies Press; Cohen J, Kupferschmidt K. Tough choices ahead in Ebola vaccine trials. Cohen J. Issues continue to dog the testing of Ebola drugs and vaccines. Observational studies and the difficult quest for causality: Lessons from vaccine effectiveness and impact studies.

Int J Epidemiol. Lipsitch M, Eyal N. Improving vaccine trials in infectious disease emergencies. International ethical guidelines for health-related research involving humans. What makes clinical research ethical?

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Efficacy, safety and immunogenicity of heptavalent pneumococcal conjugate vaccine in children. Pediatr Infect Dis J. N Engl J Med. Implementation of an Ebola virus disease vaccine clinical trial during the Ebola epidemic in Liberia: Design, procedures, and challenges.

Clin Trials. MMWR Suppl. Efficacy and safety of seven-valent conjugate pneumococcal vaccine in American Indian children: Group randomised trial. The Gambia Hepatitis Intervention Study. Cancer Res. Statistical power and validity of Ebola vaccine trials in Sierra Leone: a simulation study of trial design and analysis.

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Lancet Infect Dis. Design and Analysis of Vaccine Studies: Introduction. Springer; Eyal N, Lipsitch M. Vaccine testing for emerging infections: the case for individual randomisation. J Med Ethics.

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Randomization by cluster: sample size requirements and analysis. Am J Epidemiol. Donner A, Klar N. Methods for comparing event rates in intervention studies when the unit of allocation is a cluster.

source Design and analysis issues in cluster-randomized trials of interventions against infectious diseases. Stat Methods Med Res. Cholera modeling: challenges to quantitative analysis and predicting the impact of interventions. Spread of Zika virus in the Americas. Sci Rep.

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Herd immunity conferred by killed oral cholera vaccines in Bangladesh: A reanalysis. On the relative role of different age groups in influenza epidemics. PLoS Med. Using simulation to aid trial design: Ring-vaccination trials. Ethical issues related to study design for trials on therapeutics for Ebola Virus Disease. The second wave: Toward responsible inclusion of pregnant women in research. Int J Fem Approaches Bioeth. Dresser R.

Wanted: single, white male for medical research. Hastings Cent Rep. View Article Google Scholar The special issue seeks to publish high quality manuscripts focused on innovative approaches and reviews related to the statistical design, modeling and analysis of clinical and nonclinical studies of vaccines and biologics.

Innovative statistical designs in clinical trials, statistical approaches to biosimilarity, especially as relating to regulatory considerations and reviews of the literature are especially welcome, although a broad range of statistical topics is anticipated. The window for submission will be November 1, — June 30, Submissions are made through the SBR portal.

At the time of the submission of the manuscript, authors are asked to check the VB selection box at Step 1 on the submission page, so the manuscript will be designated for the Vaccines and Biologics special issue. Manuscripts will go through the standard SBR refereeing process. Goal is to have a set of papers ready for publication in late We appreciate your consideration and contributions to make the special issue of the SBR a showcase for cutting edge statistical methods and applications on vaccines and biologics.

Because of biological nature, there are many unique statistical issues and challenges in vaccine development.