Affiliation:
1. Department of Microbiology All India Institute of Medical Sciences New Delhi India
2. Centre for Community Medicine All India Institute of Medical Sciences New Delhi India
3. Influenza Division US Centers for Disease Control and Prevention New Delhi India
4. Influenza Division US Centers for Disease Control and Prevention Atlanta Georgia USA
Abstract
AbstractBackgroundWe present post‐vaccination nasal shedding findings from the phase IV, community‐based, triple‐blinded RCT conducted to assess efficacy of trivalent LAIV and inactivated influenza vaccines in rural north India.MethodsChildren aged 2–10 years received LAIV or intranasal placebo across 2015 and 2016, as per initial allocation. On days 2 and 4 post‐vaccination, trained study nurses collected nasal swabs from randomly selected subset of trial participants based on operational feasibility, accounting for 10.0% and 11.4% of enrolled participants in 2015 and 2016, respectively. Swabs were collected in viral transport medium and transported under cold chain to laboratory for testing by reverse transcriptase real‐time polymerase chain reaction.ResultsIn year 1, on day 2 post‐vaccination, 71.2% (74/104) of LAIV recipients shed at least one of vaccine virus strains compared to 42.3% (44/104) on day 4. During year 1, on day 2 post‐vaccination, LAIV‐A(H1N1)pdm09 was detected in nasal swabs of 12% LAIV recipients, LAIV‐A(H3N2) in 41%, and LAIV‐B in 59%. In year 2, virus shedding was substantially lower; 29.6% (32/108) of LAIV recipients shed one of the vaccine virus strains on day 2 compared to 21.3% on day 4 (23/108).ConclusionAt day 2 post‐vaccination in year 1, two‐thirds of LAIV recipients were shedding vaccine viruses. Shedding of vaccine viruses varied between strains and was lower in year 2. More research is needed to determine the reason for lower virus shedding and vaccine efficacy for LAIV‐A(H1N1)pdm09.
Funder
National Center for Immunization and Respiratory Diseases
Centers for Disease Control and Prevention
Subject
Infectious Diseases,Public Health, Environmental and Occupational Health,Pulmonary and Respiratory Medicine,Epidemiology