Dataset Information

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

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.

SUBMITTER: Naleway AL

PROVIDER: S-EPMC6360380 | biostudies-literature | 2019 Jan

REPOSITORIES: biostudies-literature

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Publications

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

Naleway Allison L AL Ball Sarah S Kwong Jeffrey C JC Wyant Brandy E BE Katz Mark A MA Regan Annette K AK Russell Margaret L ML Klein Nicola P NP Chung Hannah H Simmonds Kimberley A KA Azziz-Baumgartner Eduardo E Feldman Becca S BS Levy Avram A Fell Deshayne B DB Drews Steven J SJ Garg Shikha S Effler Paul P Barda Noam N Irving Stephanie A SA Shifflett Patricia P Jackson Michael L ML Thompson Mark G MG

JMIR research protocols 20190121 1

<h4>Background</h4>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.<h4>Objective</h4>The Pregnancy Influenza Vaccine Effectiveness Network (PREVENT) was formed in 2016 as an international colla ...[more]

PMID: 30664495

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Project description:Abstract Background More effective influenza vaccines are needed to prevent influenza and its complications. Recombinant influenza vaccines may offer better protection than traditional egg-based vaccines. Using a cluster randomized design to estimate the relative vaccine effectiveness (rVE) of Flublok Quadrivalent recombinant influenza vaccine (RIV4) vs. standard dose inactivated influenza vaccine (SD-IIV4), we separately reported that RIV4 provided significantly better protection against primary outcome of confirmed influenza in adults 50–64 yrs in the 2018–20 moderately severe influenza seasons. Here we report the rVE against the secondary and exploratory outcomes of hospitalized influenza-related outcomes. Methods We randomized 66 facilities within Kaiser Permanente Northern California (KPNC) to routinely administer RIV4 or SD-IIV4 to adults, alternating vaccine formulations weekly by facility during the influenza season (ClinicalTrials.gov NCT03694392). Hospitalized cases of PCR-confirmed influenza, community-acquired pneumonia, and cardio-respiratory events were prespecified as secondary in 50–64 yrs and exploratory in 18–49 yrs. We estimated the relative hazard ratio (rHR) using Cox regression on a calendar timeline, adjusting for age, sex, and race, using facility-specific stabilized propensity scores. We calculated rVE as (1–rHR) x 100%. Results During the 2018–19 and 2019–20 seasons, the study consisted of 1,630,328 vaccinees 18–64 yrs (RIV4=632,962; SD-IIV4=997,366), and included 95 hospitalized influenza cases after RIV4 and 153 after SD-IIV4 among 50–64 yrs (Table 1). RIV4 vs. SD-IIV4 was not significantly more protective against hospitalized influenza-related outcomes in adults 50–64 yrs or 18–49 yrs. Conclusion While this large cluster randomized study found that RIV4 vs. SD-IIV4 reduced the risk of lab-confirmed influenza in adults 50–64 yrs across 2 influenza seasons, RIV4 and SD-IIV4 performed similarly against hospitalized influenza-related outcomes. Evaluating influenza-related hospitalizations during influenza seasons when more hospital outcomes occur may help to better understand the relative effectiveness of recombinant versus standard inactivated influenza vaccines against severe disease. Disclosures All Authors: No reported disclosures.

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Dataset Information

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

Background

Objective

Methods

Results

Conclusions

International registered report identifier (irrid)

Publications

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

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