Comparison of the Immunogenicity of Cell Culture-Based and Recombinant Quadrivalent Influenza Vaccines to Conventional Egg-Based Quadrivalent Influenza Vaccines Among Healthcare Personnel Aged 18–64 Years: A Randomized Open-Label Trial
Author:
Dawood Fatimah S1, Naleway Allison L2, Flannery Brendan1, Levine Min Z1, Murthy Kempapura3, Sambhara Suryaprakash1, Gangappa Shivaprakash1, Edwards Laura4, Ball Sarah56, Grant Lauren1, Belongia Edward6, Bounds Kelsey3, Cao Weiping1, Gross F Liaini1, Groom Holly2, Fry Alicia M1, Rentz Hunt Danielle4, Jeddy Zuha4, Mishina Margarita1, Kim Sara S1, Wesley Meredith G14, Spencer Sarah1, Thompson Mark G1, Gaglani Manjusha3
Affiliation:
1. Centers for Disease Control and Prevention, Atlanta, Georgia, USA 2. Center for Health Research, Kaiser Permanente Northwest, Portland, Oregon, USA 3. Baylor Scott & White Health, Texas A&M University, College of Medicine, Temple, Texas, USA 4. Abt Associates, Atlanta, Georgia, USA 5. Marshfield Clinic Research Institute, Marshfield, Wisconsin, USA 6. Westat, Rockville, Maryland, USA
Abstract
Abstract
Background
RIV4 and cell-culture based inactivated influenza vaccine (ccIIV4) have not been compared to egg-based IIV4 in healthcare personnel, a population with frequent influenza vaccination that may blunt vaccine immune responses over time. We conducted a randomized trial among healthcare personnel (HCP) aged 18–64 years to compare humoral immune responses to ccIIV4 and RIV4 to IIV4.
Methods
During the 2018–2019 season, participants were randomized to receive ccIIV4, RIV4, or IIV4 and had serum samples collected prevaccination, 1 and 6 months postvaccination. Serum samples were tested by hemagglutination inhibition (HI) for influenza A/H1N1, B/Yamagata, and B/Victoria and microneutralization (MN) for A/H3N2 against cell-grown vaccine reference viruses. Primary outcomes at 1 month were seroconversion rate (SCR), geometric mean titers (GMT), GMT ratio, and mean fold rise (MFR) in the intention-to-treat population.
Results
In total, 727 participants were included (283 ccIIV4, 202 RIV4, and 242 IIV4). At 1 month, responses to ccIIV4 were similar to IIV4 by SCR, GMT, GMT ratio, and MFR. RIV4 induced higher SCRs, GMTs, and MFRs than IIV4 against A/H1N1, A/H3N2, and B/Yamagata. The GMT ratio of RIV4 to egg-based vaccines was 1.5 (95% confidence interval [CI] 1.2–1.9) for A/H1N1, 3.0 (95% CI: 2.4–3.7) for A/H3N2, 1.1 (95% CI: .9–1.4) for B/Yamagata, and 1.1 (95% CI: .9–1.3) for B/Victoria. At 6 months, ccIIV4 recipients had similar GMTs to IIV4, whereas RIV4 recipients had higher GMTs against A/H3N2 and B/Yamagata.
Conclusions
RIV4 resulted in improved antibody responses by HI and MN compared to egg-based vaccines against 3 of 4 cell-grown vaccine strains 1 month postvaccination, suggesting a possible additional benefit from RIV4.
Clinical Trials Registration
NCT03722589.
Funder
US Centers for Disease Control and Prevention
Publisher
Oxford University Press (OUP)
Subject
Infectious Diseases,Microbiology (medical)
Reference29 articles.
1. Variable influenza vaccine effectiveness by subtype: a systematic review and meta-analysis of test-negative design studies;Belongia;Lancet Infect Dis,2016 2. Interim estimates of 2017–18 seasonal influenza vaccine effectiveness—United States, February 2018;Flannery;MMWR Morb Mortal Wkly Rep,2018 3. Estimates of deaths associated with seasonal influenza—United States, 1976–2007;Centers for Disease Control and Prevention.;MMWR Morb Mortal Wkly Rep,2010
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