Randomized Pragmatic Trial of the Comparative Effectiveness of Chicken Egg-Based Inactivated, Mammalian Cell Culture-Based Inactivated, and Recombinant Protein Quadrivalent Seasonal Influenza Vaccines in United States Military Health System Beneficiaries.
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Colombo Rhonda E, Richard Stephanie A, Schmidt Kat, Schofield Christina, Ganesan Anuradha, Campbell Wesley, Hrncir David, Lalani Tahaniyat, Mende Katrin, Markelz Ana E, Berjohn Catherine M, Housel Laurie, Becher Dorothy, Zell Elizabeth R, Ewing Daniel, Sundaram Appavu K, Modi Jitendrakumar R, Saperstein Adam, Tilley Drake H, Williams Alan, McClenathan Bruce, Collins Limone, Spooner Christina, Seshadri Srihari, Fries Anthony, Maves Ryan C, Powers Iii John H, O'Connell Robert J, Pollett Simon D, Simons Mark P, Coles Christian L, Burgess Timothy H, PAIVED Study Group
Аннотация
METHODS: Between 2018 and 2021, PAIVED randomized (1:1:1) eligible Military Health System beneficiaries to receive eIIV, ccIIV, or RIV during an influenza season. Participants received weekly surveys querying influenza-like illness (ILI); those reporting ILI completed an online symptom diary, were interviewed by research staff, and underwent nasal swab collection. Laboratory-confirmed influenza was the primary outcome. Immunogenicity assessment was conducted in a subset of participants.
RESULTS: Among 15 432 participants, influenza was identified in 87/5130 (1.7%) ccIIV recipients, 79/5154 (1.5%) RIV recipients, and 69/5148 (1.3%) eIIV recipients during their season of enrollment. rVE of ccIIV compared to eIIV was -27% (95% confidence interval [CI], -73%, 8%), and rVE of RIV compared to eIIV was -14% (95% CI -58%, 17%). RIV (N = 375) recipients were more likely to seroconvert (4-fold increase) than those who received eIIV (N = 355) (A/H1N1: 49.1% vs 29.0%; A/H3N2: 71.2% vs 30.4%; B/Victoria 24.5% vs 13.8%; B/Yamagata 17.1% vs 5.4%; P < .001 for all). ccIIV (N = 357) recipients were more likely to seroconvert only against A/H3N2 compared with eIIV recipients (44.0% vs 30.4%) (P < .001).
CONCLUSIONS: Significant differences in VE were not detected comparing egg-based to non-egg-based influenza vaccines, although immunogenicity differences were observed; low influenza case numbers impacted VE estimate precision.
TRIAL REGISTRATION: ClinicalTrials.gov NCT03734237.