Non-specific effects of rabies vaccine on the incidence of self-reported common infectious disease episodes: A randomized controlled trial |
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| Affiliation: | 1. Department of Veterinary Tropical Diseases, University of Pretoria, Pretoria, South Africa;2. Department of Biomedical Sciences, Ross University School of Veterinary Medicine, Basseterre, Saint Kitts and Nevis;3. Center for One Health Research and Policy Advice, City University of Hong Kong, Kowloon, Hong Kong Special Administrative Region;4. EpiVac Consulting Services, Anchorage, AK, United States;1. Toronto General Hospital Research Institute, University Health Network, Toronto, Canada and Department of Immunology, University of Toronto, Toronto, Canada;2. Bandim Health Project, Department of Clinical Research, Odense University Hospital, University of Southern Denmark, Denmark;3. Department of Molecular Microbiology and Immunology, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD, USA |
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| Abstract: | Vaccines may affect recipients’ immune systems in ways that change morbidity or mortality rates to unrelated infections in vaccinated populations. It has been proposed that these non-specific effects differ by type of vaccine and by sex, with non-live vaccines enhancing susceptibility of females to unrelated infections, and live vaccines enhancing resistance in both sexes. Rabies vaccine–a non-live vaccine–has been associated with protection against unrelated central nervous system infections. Data from randomized controlled trials are needed to assess this effect against other illnesses. This phase IV, single-site, participant-blinded, randomized, placebo-controlled trial in a population of veterinary students on the rabies-free island of St. Kitts assessed the effect of a primary course of rabies vaccine on the incidence rate of weekly self-reported new episodes of common infectious disease (CID) syndromes, defined as a new episode of any one of the following syndromes in a particular week: upper respiratory illness (URI), influenza-like illness (ILI), diarrheal illness (DIA) or undifferentiated febrile illness (UFI). As a secondary objective, we tested for modification of the effect of rabies vaccine on study outcomes by sex. 546 participants were randomized (274 to rabies vaccine and 272 to placebo). No statistically significant differences between groups were observed for any study outcomes: CID incidence rate ratio (IRR) 0.95 (95% CI 0.77–1.18); URI IRR 1.15 (95% CI 0.86–1.54); ILI IRR 0.83 (95% CI 0.54–1.27); DIA IRR 0.93 (95% CI 0.70–1.24) and UFI IRR 1.09 (95% CI 0.48–2.44). In a secondary analysis, there was little evidence that sex modified the effect of vaccination on any of the evaluated outcomes, although the power to detect this was low. In conclusion, rabies vaccine did not provide protection against mild self-reported illness among a young and healthy group of adults attending veterinary school.Clinical trial registration. ClinicalTrials.gov: NCT03656198. |
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| Keywords: | Rabies vaccine Non-specific effects of vaccines Sex Influenza-like illness Upper respiratory disease Diarrhea Fever |
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