Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

Allison L Naleway; Sarah Ball; Jeffrey C Kwong; Brandy E Wyant; Mark A Katz; Annette K Regan; Margaret L Russell; Nicola P Klein; Hannah Chung; Kimberley A Simmonds; Eduardo Azziz-Baumgartner; Becca S Feldman; Avram Levy; Deshayne B Fell; Steven J Drews; Shikha Garg; Paul Effler; Noam Barda; Stephanie A Irving; Patricia Shifflett; Michael L Jackson; Mark G Thompson

doi:10.2196/11333

Estimating Vaccine Effectiveness Against Hospitalized Influenza During Pregnancy: Multicountry Protocol for a Retrospective Cohort Study

JMIR Res Protoc. 2019 Jan 21;8(1):e11333. doi: 10.2196/11333.

Authors

Allison L Naleway^#¹, Sarah Ball^#², Jeffrey C Kwong³, Brandy E Wyant², Mark A Katz⁴, Annette K Regan⁵, Margaret L Russell⁶, Nicola P Klein⁷, Hannah Chung³, Kimberley A Simmonds⁸, Eduardo Azziz-Baumgartner⁹, Becca S Feldman⁴, Avram Levy¹⁰, Deshayne B Fell¹¹, Steven J Drews¹², Shikha Garg⁹, Paul Effler¹³, Noam Barda⁴, Stephanie A Irving¹, Patricia Shifflett², Michael L Jackson¹⁴, Mark G Thompson^#⁹

Affiliations

¹ Kaiser Permanente Northwest, Center for Health Research, Portland, OR, United States.
² Abt Associates, Inc, Cambridge, MA, United States.
³ ICES, Toronto, ON, Canada.
⁴ Chief Physician's Office, Clalit Health Services, Clalit Research Institute, Tel Aviv, Israel.
⁵ School of Public Health, Curtin University, Perth, Australia.
⁶ Cumming School of Medicine, University of Calgary, Calgary, AB, Canada.
⁷ Kaiser Permanente Vaccine Study Center, Oakland, CA, United States.
⁸ Alberta Health, Edmonton, AB, Canada.
⁹ Influenza Division, Centers for Disease Control and Prevention, Atlanta, GA, United States.
¹⁰ PathWest Laboratory Medicine Western Australia, Perth, Australia.
¹¹ School of Epidemiology and Public Health, University of Ottawa, Ottawa, ON, Canada.
¹² Department of Laboratory Medicine and Pathology, University of Alberta, Edmonton, AB, Canada.
¹³ Western Australia Department of Health, Perth, Australia.
¹⁴ Kaiser Permanente Washington Health Research Institute, Seattle, WA, United States.

^# Contributed equally.

PMID: 30664495
PMCID: PMC6360380
DOI: 10.2196/11333

Abstract

Background: Although pregnant women are believed to have elevated risks of severe influenza infection and are targeted for influenza vaccination, no study to date has examined influenza vaccine effectiveness (IVE) against laboratory-confirmed influenza-associated hospitalizations during pregnancy, primarily because this outcome poses many methodological challenges.

Objective: The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international collaboration with the Centers for Disease Control and Prevention; Abt Associates; and study sites in Australia, Canada, Israel, and the United States. The primary goal of this collaboration is to estimate IVE in preventing acute respiratory or febrile illness (ARFI) hospitalizations associated with laboratory-confirmed influenza virus infection during pregnancy. Secondary aims include (1) describing the incidence, clinical course, and severity of influenza-associated ARFI hospitalization during pregnancy; (2) comparing the characteristics of ARFI-hospitalized pregnant women who were tested for influenza with those who were not tested; (3) describing influenza vaccination coverage in pregnant women; and (4) comparing birth outcomes among women with laboratory-confirmed influenza-associated hospitalization versus other noninfluenza ARFI hospitalizations.

Methods: For an initial assessment of IVE, sites identified a retrospective cohort of pregnant women aged from 18 to 50 years whose pregnancies overlapped with local influenza seasons from 2010 to 2016. Pregnancies were defined as those that ended in a live birth or stillbirth of at least 20 weeks gestation. The analytic sample for the primary IVE analysis was restricted to pregnant women who were hospitalized for ARFI during site-specific influenza seasons and clinically tested for influenza virus infection using real-time reverse transcription polymerase chain reaction.

Results: We identified approximately 2 million women whose pregnancies overlapped with influenza seasons; 550,344 had at least one hospitalization during this time. After restricting to women who were hospitalized for ARFI and tested for influenza, the IVE analytic sample included 1005 women.

Conclusions: In addition to addressing the primary question about the effectiveness of influenza vaccination, PREVENT data will address other important knowledge gaps including understanding the incidence, clinical course, and severity of influenza-related hospitalizations during pregnancy. The data infrastructure and international partnerships created for these analyses may be useful and informative for future influenza studies.

International registered report identifier (irrid): DERR1-10.2196/11333.

Keywords: epidemiology; hospitalization; influenza; pregnancy; vaccines.

©Allison L Naleway, Sarah Ball, Jeffrey C Kwong, Brandy E Wyant, Mark A Katz, Annette K Regan, Margaret L Russell, Nicola P Klein, Hannah Chung, Kimberley A Simmonds, Eduardo Azziz-Baumgartner, Becca S Feldman, Avram Levy, Deshayne B Fell, Steven J Drews, Shikha Garg, Paul Effler, Noam Barda, Stephanie A Irving, Patricia Shifflett, Michael L Jackson, Mark G Thompson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.01.2019.