Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:147 |
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| Enthalten in: |
Journal of clinical epidemiology - 147(2022) vom: 15. Juli, Seite 11-20 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Billard, Marie-Noëlle [VerfasserIn] |
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| Links: |
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| Themen: |
Attack rate |
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| Anmerkungen: |
Date Completed 11.10.2022 Date Revised 31.10.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1016/j.jclinepi.2022.02.003 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM337486638 |
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| 100 | 1 | |a Billard, Marie-Noëlle |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Year-to-year variation in attack rates could result in underpowered respiratory syncytial virus vaccine efficacy trials |
| 264 | 1 | |c 2022 | |
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| 500 | |a Date Completed 11.10.2022 | ||
| 500 | |a Date Revised 31.10.2022 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved. | ||
| 520 | |a 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) | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Attack rate | |
| 650 | 4 | |a Incidence | |
| 650 | 4 | |a RSV | |
| 650 | 4 | |a Sample size | |
| 650 | 4 | |a Seasonality | |
| 650 | 4 | |a Statistical power | |
| 650 | 7 | |a Respiratory Syncytial Virus Vaccines |2 NLM | |
| 700 | 1 | |a Wildenbeest, Joanne |e verfasserin |4 aut | |
| 700 | 1 | |a Bont, Louis J |e verfasserin |4 aut | |
| 700 | 1 | |a Nair, Harish |e verfasserin |4 aut | |
| 700 | 1 | |a McCracken, John P |e verfasserin |4 aut | |
| 700 | 1 | |a Oude Rengerink, Katrien |e verfasserin |4 aut | |
| 700 | 0 | |a RESCEU Investigators |e verfasserin |4 aut | |
| 700 | 1 | |a Marie-Noelle Billard |e investigator |4 oth | |
| 700 | 1 | |a Rengerink, Katrien Oude |e investigator |4 oth | |
| 700 | 1 | |a Bont, Louis |e investigator |4 oth | |
| 700 | 1 | |a Wildenbeest, Joanne |e investigator |4 oth | |
| 700 | 1 | |a Nair, Harish |e investigator |4 oth | |
| 700 | 1 | |a Campbell, Harry |e investigator |4 oth | |
| 700 | 1 | |a Beutels, Philippe |e investigator |4 oth | |
| 700 | 1 | |a Openshaw, Peter |e investigator |4 oth | |
| 700 | 1 | |a Pollard, Andrew |e investigator |4 oth | |
| 700 | 1 | |a Martinon-Torres, Federico |e investigator |4 oth | |
| 700 | 1 | |a Heikkinen, Terho |e investigator |4 oth | |
| 700 | 1 | |a Meijer, Adam |e investigator |4 oth | |
| 700 | 1 | |a Fischer, Thea Kølsen |e investigator |4 oth | |
| 700 | 1 | |a van den Berge, Maarten |e investigator |4 oth | |
| 700 | 1 | |a Giaquinto, Carlo |e investigator |4 oth | |
| 700 | 1 | |a Aerssens, Jeroen |e investigator |4 oth | |
| 700 | 1 | |a Abram, Michael |e investigator |4 oth | |
| 700 | 1 | |a Swanson, Kena |e investigator |4 oth | |
| 700 | 1 | |a Demont, Clarisse |e investigator |4 oth | |
| 700 | 1 | |a Gallichan, Scott |e investigator |4 oth | |
| 700 | 1 | |a Kumar, Veena |e investigator |4 oth | |
| 700 | 1 | |a Stoszek, Sonia |e investigator |4 oth | |
| 700 | 1 | |a Molero, Eva |e investigator |4 oth | |
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