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

• Published in: Current controlled trials in cardiovascular medicine 2020-06, Vol.21 (1), p.534-534, Article 534
• Main Authors: Knobel, Darryn, Odita, Christianah Ibironke, Conan, Anne, Barry, Donna, Smith-Anthony, Marshalette, Battice, Juliet, England, Shianne, Gessner, Bradford D
• Format: Article
• Language: English
• 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
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04467-z

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.