Justin R Ortiz1, Doli Goswami2, Kristen D C Lewis3, Amina Tahia Sharmeen2, Moshtaq Ahmed2, Mustafizur Rahman2, Mohammed Z Rahman2, Jodi Feser3, Kathleen M Neuzil4, W Abdullah Brooks5. 1. PATH, Seattle, WA, USA; University of Washington, Departments of Global Health and Medicine, Seattle, WA, USA. Electronic address: jrortiz@uw.edu. 2. International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh. 3. PATH, Seattle, WA, USA. 4. PATH, Seattle, WA, USA; University of Washington, Departments of Global Health and Medicine, Seattle, WA, USA. 5. International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Dhaka, Bangladesh; Johns Hopkins University, Baltimore, MD, USA.
Abstract
INTRODUCTION:Live-attenuated influenza vaccines (LAIVs) have the potential to be affordable, effective, and logistically feasible for immunization of children in low-resource settings. MATERIAL AND METHODS: We conducted a phase II, randomized, double-blind, parallel group, placebo-controlled trial on the safety of the Russian-backbone, seasonal trivalent LAIV among children aged 24 through 59 months in Dhaka, Bangladesh in 2012. After vaccination, we monitored participants for six months with weekly home visits and study clinic surveillance for solicited and unsolicited adverse events, protocol-defined wheezing illness (PDWI), and serious adverse events (SAEs), including all cause hospitalizations. RESULTS:Three hundred children were randomized and administered LAIV (n=150) or placebo (n=150). No immediate post-vaccination reactions occurred in either group. Solicited reactions were similar between vaccine and placebo groups during the first 7 days post-vaccination and throughout the entire trial. There were no statistically significant differences in participants experiencing PDWI between LAIV and placebo groups throughout the trial (n=13 vs. n=16, p=0.697). Of 131 children with a history of medical treatment or hospitalization for asthma or wheezing at study entry, 65 received LAIV and 66 receivedplacebo. Among this subset, there was no statistical difference in PDWI occurring throughout the trial between the LAIV or placebo groups (7.7% vs. 19.7%, p=0.074). While there were no related SAEs, LAIV recipients had six unrelated SAEs and placebo recipients had none. These SAEs included three due to traumatic injury and bone fracture, and one each due to accidental overdose of paracetamol, abdominal pain, and acute gastroenteritis. None of the participants with SAEs had laboratory-confirmed influenza, wheezing illness, or other signs of acute respiratory illness at the time of their events. CONCLUSIONS: In this randomized, controlled trial among 300 children aged 24 through 59 months in urban Bangladesh, Russian-backbone LAIV was safe and well tolerated. Further evaluation of LAIV safety and efficacy in a larger cohort is warranted.
RCT Entities:
INTRODUCTION: Live-attenuated influenza vaccines (LAIVs) have the potential to be affordable, effective, and logistically feasible for immunization of children in low-resource settings. MATERIAL AND METHODS: We conducted a phase II, randomized, double-blind, parallel group, placebo-controlled trial on the safety of the Russian-backbone, seasonal trivalent LAIV among children aged 24 through 59 months in Dhaka, Bangladesh in 2012. After vaccination, we monitored participants for six months with weekly home visits and study clinic surveillance for solicited and unsolicited adverse events, protocol-defined wheezing illness (PDWI), and serious adverse events (SAEs), including all cause hospitalizations. RESULTS: Three hundred children were randomized and administered LAIV (n=150) or placebo (n=150). No immediate post-vaccination reactions occurred in either group. Solicited reactions were similar between vaccine and placebo groups during the first 7 days post-vaccination and throughout the entire trial. There were no statistically significant differences in participants experiencing PDWI between LAIV and placebo groups throughout the trial (n=13 vs. n=16, p=0.697). Of 131 children with a history of medical treatment or hospitalization for asthma or wheezing at study entry, 65 received LAIV and 66 received placebo. Among this subset, there was no statistical difference in PDWI occurring throughout the trial between the LAIV or placebo groups (7.7% vs. 19.7%, p=0.074). While there were no related SAEs, LAIV recipients had six unrelated SAEs and placebo recipients had none. These SAEs included three due to traumatic injury and bone fracture, and one each due to accidental overdose of paracetamol, abdominal pain, and acute gastroenteritis. None of the participants with SAEs had laboratory-confirmed influenza, wheezing illness, or other signs of acute respiratory illness at the time of their events. CONCLUSIONS: In this randomized, controlled trial among 300 children aged 24 through 59 months in urban Bangladesh, Russian-backbone LAIV was safe and well tolerated. Further evaluation of LAIV safety and efficacy in a larger cohort is warranted.
Authors: Prashant V Nigwekar; Anuj Kumar; Vikram V Padbidri; Amlan Choudhury; Amol B Chaudhari; Prasad S Kulkarni Journal: Drug Saf Date: 2018-02 Impact factor: 5.228
Authors: John C Victor; Kristen D C Lewis; Aldiouma Diallo; Mbayame N Niang; Bou Diarra; Ndongo Dia; Justin R Ortiz; Marc-Alain Widdowson; Jodi Feser; Rebecca Hoagland; Shannon L Emery; Kathryn E Lafond; Kathleen M Neuzil Journal: Lancet Glob Health Date: 2016-10-13 Impact factor: 26.763
Authors: W Abdullah Brooks; K Zaman; Kristen D C Lewis; Justin R Ortiz; Doli Goswami; Jodi Feser; Amina Tahia Sharmeen; Kamrun Nahar; Mustafizur Rahman; Mohammed Ziaur Rahman; Burc Barin; Muhammad Yunus; Alicia M Fry; Joseph Bresee; Tasnim Azim; Kathleen M Neuzil Journal: Lancet Glob Health Date: 2016-10-13 Impact factor: 26.763
Authors: Roger P Baxter; Ned Lewis; Bruce Fireman; John Hansen; Nicola P Klein; Justin R Ortiz Journal: Pediatr Infect Dis J Date: 2018-05 Impact factor: 2.129
Authors: Kristen D C Lewis; Justin R Ortiz; Mohammed Z Rahman; Min Z Levine; Larisa Rudenko; Peter F Wright; Jacqueline M Katz; Len Dally; Mustafizur Rahman; Irina Isakova-Sivak; Natalia A Ilyushina; Victoria Matyushenko; Alicia M Fry; Stephen E Lindstrom; Joseph S Bresee; W Abdullah Brooks; Kathleen M Neuzil Journal: Clin Infect Dis Date: 2019-08-16 Impact factor: 9.079
Authors: Elizabeth B Brickley; Peter F Wright; Alexey Khalenkov; Kathleen M Neuzil; Justin R Ortiz; Larisa Rudenko; Min Z Levine; Jacqueline M Katz; W Abdullah Brooks Journal: Clin Infect Dis Date: 2019-08-16 Impact factor: 9.079