Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials
Objectives: Year-to-year variation in respiratory viruses may result in lower attack rates than expected. We aimed to illustrate the impact of year-to-year variation in attack rates on the likelihood of demonstrating vaccine efficacy (VE). Study Design and Setting: We considered an individually rand...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Elsevier
2022
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| _version_ | 1797106683080605696 |
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| author | Billard, MN Wildenbeest, J Bont, LJ Nair, H McCracken, JP Oude Rengerink, K Marie-Noelle Billard Bont, L Campbell, H Beutels, P Openshaw, P Pollard, A Martinon-Torres, F Heikkinen, T Meijer, A Fischer, TK van den Berge, M Giaquinto, C Aerssens, J Abram, M Swanson, K Demont, C Gallichan, S Kumar, V Stoszek, S Molero, E |
| author_facet | Billard, MN Wildenbeest, J Bont, LJ Nair, H McCracken, JP Oude Rengerink, K Marie-Noelle Billard Bont, L Campbell, H Beutels, P Openshaw, P Pollard, A Martinon-Torres, F Heikkinen, T Meijer, A Fischer, TK van den Berge, M Giaquinto, C Aerssens, J Abram, M Swanson, K Demont, C Gallichan, S Kumar, V Stoszek, S Molero, E |
| author_sort | Billard, MN |
| collection | OXFORD |
| description | Objectives: Year-to-year variation in respiratory viruses may result in lower attack rates than expected. We aimed to illustrate the impact of year-to-year variation in attack rates on the likelihood of demonstrating vaccine efficacy (VE). Study Design and Setting: We considered an individually randomized maternal vaccine trial against respiratory syncytial virus (RSV)-associated hospitalizations. For 10 RSV-associated hospitalizations per 1,000 infants, sample size to have 80% power for true VE of 50% and 70% was 9,846 and 4,424 participants. We reported power to show VE for varying attack rates, selected to reflect realistic year-to-year variation using observational studies. Eight scenarios including varying number of countries and seasons were developed to assess the influence of these trial parameters. Results: Including up to three seasons decreased the width of the interquartile range for power. Including more seasons concentrated statistical power closer to 80%. Least powered trials had higher statistical power with more seasons. In all scenarios, at least half of the trials had <80% power. For three-season trials, increasing the sample size by 10% reduced the percentage of underpowered trials to less than one-quarter of trials. Conclusion: Year-to-year variation in RSV attack rates should be accounted for during trial design. Mitigation strategies include recruiting over more seasons, or adaptive trial designs. |
| first_indexed | 2024-03-07T07:04:34Z |
| format | Journal article |
| id | oxford-uuid:4d870c46-e426-4303-98db-95d7f651fb6e |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-07T07:04:34Z |
| publishDate | 2022 |
| publisher | Elsevier |
| record_format | dspace |
| spelling | oxford-uuid:4d870c46-e426-4303-98db-95d7f651fb6e2022-04-28T13:24:41ZYear-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:4d870c46-e426-4303-98db-95d7f651fb6eEnglishSymplectic ElementsElsevier2022Billard, MNWildenbeest, JBont, LJNair, HMcCracken, JPOude Rengerink, KMarie-Noelle BillardBont, LCampbell, HBeutels, POpenshaw, PPollard, AMartinon-Torres, FHeikkinen, TMeijer, AFischer, TKvan den Berge, MGiaquinto, CAerssens, JAbram, MSwanson, KDemont, CGallichan, SKumar, VStoszek, SMolero, EObjectives: Year-to-year variation in respiratory viruses may result in lower attack rates than expected. We aimed to illustrate the impact of year-to-year variation in attack rates on the likelihood of demonstrating vaccine efficacy (VE). Study Design and Setting: We considered an individually randomized maternal vaccine trial against respiratory syncytial virus (RSV)-associated hospitalizations. For 10 RSV-associated hospitalizations per 1,000 infants, sample size to have 80% power for true VE of 50% and 70% was 9,846 and 4,424 participants. We reported power to show VE for varying attack rates, selected to reflect realistic year-to-year variation using observational studies. Eight scenarios including varying number of countries and seasons were developed to assess the influence of these trial parameters. Results: Including up to three seasons decreased the width of the interquartile range for power. Including more seasons concentrated statistical power closer to 80%. Least powered trials had higher statistical power with more seasons. In all scenarios, at least half of the trials had <80% power. For three-season trials, increasing the sample size by 10% reduced the percentage of underpowered trials to less than one-quarter of trials. Conclusion: Year-to-year variation in RSV attack rates should be accounted for during trial design. Mitigation strategies include recruiting over more seasons, or adaptive trial designs. |
| spellingShingle | Billard, MN Wildenbeest, J Bont, LJ Nair, H McCracken, JP Oude Rengerink, K Marie-Noelle Billard Bont, L Campbell, H Beutels, P Openshaw, P Pollard, A Martinon-Torres, F Heikkinen, T Meijer, A Fischer, TK van den Berge, M Giaquinto, C Aerssens, J Abram, M Swanson, K Demont, C Gallichan, S Kumar, V Stoszek, S Molero, E Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title | Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title_full | Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title_fullStr | Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title_full_unstemmed | Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title_short | Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| title_sort | year to year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
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