Non-specific effects of rabies vaccine on the incidence of common infectious disease episodes: study protocol for a randomized controlled trial

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 da...

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Published in:	Current controlled trials in cardiovascular medicine Vol. 21; no. 1; p. 534
Main Authors:	Knobel, Darryn, Odita, Christianah Ibironke, Conan, Anne, Barry, Donna, Smith-Anthony, Marshalette, Battice, Juliet, England, Shianne, Gessner, Bradford D
Format:	Journal Article
Language:	English
Published:	England BioMed Central Ltd 16-06-2020 BioMed Central BMC
Subjects:	Analysis BCG Clinical trials Clinical Trials, Phase IV as Topic Communicable diseases Control Diarrhea Diarrhea - epidemiology Diarrhea - prevention & control Disease prevention Drug dosages Educational services industry Fever Fever - epidemiology Fever - prevention & control Health aspects Humans Illnesses Immunity, Heterologous Immunology Incidence Infectious diseases Influenza Influenza vaccines Influenza, Human - epidemiology Influenza, Human - prevention & control Influenza-like illness Malaria Measles Medical research Meningitis Mortality Non-specific effects of vaccines Pilot Projects Prevention Rabies Rabies vaccine Rabies Vaccines - administration & dosage Rabies Vaccines - immunology Randomized Controlled Trials as Topic Respiratory diseases Respiratory Tract Infections - epidemiology Respiratory Tract Infections - prevention & control Saint Kitts and Nevis Self report Study Protocol Tropical diseases Upper respiratory disease Vaccines Veterinary colleges Veterinary medicine Saint Kitts and Nevis United States > US Diarrhea Rabies vaccine Influenza-like illness Non-specific effects of vaccines Fever Upper respiratory disease
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Summary:	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. 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. 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. ClinicalTrials.gov, ID: NCT03656198. Registered on 24 August 2018.
Bibliography:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23
ISSN:	1745-6215 1745-6215
DOI:	10.1186/s13063-020-04467-z