Background: Vaccines may cause non-specific effects (NSEs) on morbidity and mortality through immune-mediated mechanisms that are not explained by the prevention of the targeted disease. Much of the evidence for NSEs comes from observational studies with a high risk of bias, and there is a clear need for new data from randomised controlled trials. Recently, it was proposed that rabies vaccine has protective NSEs in people and in animals. The aim of the proposed study is to determine if rabies vaccine reduces the incidence rate of episodes of common infectious disease syndromes in a population of veterinary students on the island of St. Kitts.Methods: The trial design is a single-site, two-arm, parallel-group, participant-blinded, randomized, placebo-controlled, two-sided comparative study, with an internal pilot study for blinded sample size re-estimation. Allocation to study arm is by block randomization stratified by sex within cohort with a 1:1 allocation ratio. The primary study endpoint is the number of new weekly episodes of common infectious diseases including respiratory, diarrheal, and febrile illnesses. A vaccine efficacy ancillary study is planned.Discussion: Demonstration of a non-specific protective effect of rabies vaccine against unrelated respiratory, gastrointestinal and febrile illnesses would provide supportive evidence for the design of similar studies in children in populations with a high burden of these illnesses.Trial registration: ClinicalTrials.gov, NCT03656198. Registered 24 August 2018.
Background: Vaccines may cause non-specific effects (NSEs) on morbidity and mortality through immune-mediated mechanisms that are not explained by the prevention of the targeted disease. Much of the evidence for NSEs comes from observational studies with a high risk of bias, and there is a clear need for new data from randomized controlled trials. Recently, it was proposed that rabies vaccine has protective NSEs in people and in animals. The aim of the proposed study is to determine whether rabies vaccine reduces the incidence rate of episodes of common infectious disease syndromes in a population of veterinary students on the island of St. Kitts. Methods: The trial design is a single-site, two-arm, parallel-group, participant-blinded, randomized, placebo-controlled, two-sided comparative study, with an internal pilot study for blinded sample size re-estimation. Allocation to study arm is by block randomization stratified by sex within cohort with a 1:1 allocation ratio. The primary study outcome is the number of new weekly episodes of common infectious diseases including respiratory, diarrheal and febrile illnesses. A vaccine immunogenicity ancillary study is planned. Discussion: Demonstration of a non-specific protective effect of rabies vaccine against unrelated respiratory, gastrointestinal and febrile illnesses would provide supportive evidence for the design of similar studies in children in populations with a high burden of these illnesses.
The risk of rabies exposure via atypical means such as handling dogs that have uncertain vaccination status, handling/processing and eating dog meat make public enlightenment inevitable. A cross-sectional study was conducted among dog handlers, dog meat handlers, and consumers at dog sales/slaughter locations and sales points of dog meat in the three major dog markets in Plateau State, Nigeria. Structured questionnaires were randomly administered to 150 respondents via face-to-face interviews or self-administered. Data collected were analyzed using IBM® SPSS® statistics version 23.0. Chi-squared test of association was conducted to determine the relationship between socio-demographic characteristics and perceived risk of rabies exposure among respondents. Binary logistic regression models were used to determine the strength of the association. Logistic regression models were statistically significant for the combination of sex and tertiary educational background to predict likelihood that respondents would eat all parts of dog meat, χ2 (2) = 7.023, P-value = 0.03. The effect size was between 6.2% (Cox and Snell R2) and 8.4% (Nagelkerke R2) of the variance in likelihood to eat all parts of dog meat and correctly classified as 60.9% of cases. Educational background was the only statistically significant predictor variable (p-value=0.016; 95% CI: 0.16– 0.83), as respondents in the higher educational cadre (tertiary) have a better perception of risk of rabies and are not likely to eat all parts of the dog meat nor a rabid dog. The study reveals the significance of taking appropriate actions to ensure rabies control and prevention, rather than having mere head knowledge of the disease. Strict policies against indiscriminate dog trade, uninspected slaughter, and improper processing of dog meat, are necessary steps to prevent disease incursions via atypical means.
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