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2. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Author

Seth Toback, Eva Galiza, Catherine Cosgrove, James Galloway, Anna L Goodman, Pauline A Swift, Sankarasubramanian Rajaram, Alison Graves-Jones, Jonathan Edelman, Fiona Burns, Angela M Minassian, Iksung Cho, Lakshmi Kumar, Joyce S Plested, E Joy Rivers, Andreana Robertson, Filip Dubovsky, Greg Glenn, Paul T Heath, Roy L. Soiza, Robin Brittain-Long, Chiara Scicluna, Carole Edwards, Lynn Mackay, Mariella D'Allesandro, Amy Nicol, Karen Norris, Sandra Mann, Heather Lawrence, Ruth Valentine, Marianne Elizabeth Viljoen, Carol H. Pretswell, Helen Nicholls, Imrozia Munsoor, Agnieszka Meyrick, Christina Kyriakidou, Shalini Iyengar, Arham Jamal, Nick Richards, Helen Price, Bridie Rowbotham, Danielle Bird, Karen Smith, Olga Littler, Kirsty Fielding, Anna Townsend-Rose, Karen Miller, Jessica Davis, Alison Elliot-Garwood, Lauren Trottier, Paul Edwards, Margaret McFarland, Orod Osanlou, Laura Longshaw, Jane Stockport, Lynne Grundy, Katharine Lucy Broad, Karen Regan, Kim Storton, Declan Ryan-Wakeling, Brad Wilson, Malathy Munisamy, John Wright, Anil Shenoy, Beverley English, Lucy Brear, Paola Cicconi, Marta Boffito, Ana Milinkovic, Ruth Byrne, Roya Movahedi, Rosalie Housman, Naveed Kara, Ellen Brown, Andrea Cipriani, Mary-Jane Attenburrow, Katharine A. Smith, Jonathan Packham, Geoff Sparrow, Richard Smith, Josephine M. Rosier, Khalid Saja, Nyasha Nago, Brian Camilleri, Anita Immanuel, Mike Hamblin, Rawlings Osagie, Mahalakshmi Mohan, Hilary Floyd, Suzanne Goddard, Sanjay Mutgi, John Evans, Sean McKeon, Neringa Vilimiene, Rosavic Chicano, Rachel Hayre, Alice Pandaan, Catherine Henshall, Sonia Serrano, Andrea Mazzella, Thurkka Rajeswaran, Moncy Mathew, Karen Bisnauthsing, Laura Bremner, Henry Fok, Franca Morselli, Paola Cinardo, Blair Merrick, Lucy Sowole, Samantha Broadhead, Natalie Palmer, Jessica Cordle, Jaimie Wilson Goldsmith, Enya Cooney, Beth Jackson, Thilina Jayatilleke, Zelda Cheng, Toby Helliwell, Adrian Chudyk, Rafaela Giemza, John Lord Villajin, Noah Yogo, Esther Makanju, Pearl Dulawan, Deepak Nagra, April Buazon, Alice Russell, Georgie Bird, Amardeep Heer, Rex Sarmiento, Balraj Sanghera, Melanie Mullin, Adam Champion, Aisling Bevan, Kinzah Iqbal, Alshia Johnson, Rebecca Clark, Sarah Shaw, Steven Shaw, Amanda Chalk, Martin Lovatt, Caroline Lillicrap, Angela Parker, Jan Hansel, Zhi Wong, Galvin Gan, Eyad Tuma, Jane Minton, Jennifer Murira, Razan Saman, Alistair Hall, Kyra Holliday, Zara Khan, James Calderwood, George Twigg, Helena Baker, Julie Corrigan, Katy Houseman, Subhra Raguvanshi, Dominic Heining, Jake Weddell, Liz Glaves, Kim Thompson, Francis Davies, Ruth Lambley Burke, Emma C. Thomson, Dinesh Saralaya, Lisa Berry, Nancy Hopewell, Leigh Gerdes, Mihaela Pacurar, Saul N. Faust, Jeremy Turner, Christopher Jeanes, Adele Cooper, Jocelyn Keshet-Price, Lou Coke, Melissa Cambell-Kelly, Ketan Dhatariya, Claire Williams, Georgina Marks, James Sudbury, Lisa Rodolico, Judy Bradley, Sharon Carr, Roisin Martin, Angelina Madden, Paul Biagioni, Sonia McKenna, Alison Clinton, Maurice O'Kane, Justin Carter, Matthew Dewhurst, Bill Wetherill, Thandiwe Hoggarth, Katrina Lennon Collins, Marie Chowdhury, Adil Nathoo, Anna Heinen, Orla MacDonald, Claudia Hurducas, Liliana Cifuentes, Harjeevan Gill, Andy Gibson, Raha West, Jane Ewing, Rachel Blacow, John Haughney, Jonathan MacDonald, John Paul Seenan, Stewart Webb, Colin O'Leary, Scott Muir, Beth White, Neil Ritchie, Daniel F. McAuley, Jonathan Stewart, Mariella D'Alessandro, Nicki Lakeman, Laura Purandare, Duncan Browne, David Tucker, Peter Luck, Angharad Everden, Lisa Trembath, Michael Visick, Nick Morley, Laura Reid, Helen Chenoweth, Kirsty Maclean, Ray P. Sheridan, Tom Burden, Craig Francis Lunt, Shirley Todd, Stephanie Estcourt, Jasmine Marie Pearce, Suzanne Wilkins, Cathryn Love-Rouse, Eva Torok-Pollok, Mike Youle, Sara Madge, Danielle Solomon, Aarti Nandani, Janet M. North, Nargis Hemat, Rachel Newport, Philip A. Kalra, Chukwuma Chukwu, Olivia Wickens, Vikki O'Loughlin, Hema Mistry, Louise Harrison, Robert Oliver, Anne-Marie Peers, Jess Zadik, Katie Doyle, David R. Chadwick, Kerry Colling, Caroline Wroe, Marie Branch, Alison Chilvers, Sarah Essex, Mark Stone, Alberto San Francisco Ramos, Emily Beales, Olivia Bird, Zsofia Danos, Hazel Fofie, Cecilia Hultin, Sabina Ikram, Fran Mabesa, Aoife Mescall, Josyanne Pereira, Jennifer Pearce, Natalina Sutton, Emma Snashall, David Neil Baxter, Sara Bennett, Debbie Suggitt, Kerry Hughes, Wiesia Woodyatt, Lynsey Beacon, Alissa Kent, Chris Cooper, Milan Rudic, Simon Tunstall, Matthew Jackson, Claire Hombersley, Patrick Moore, Rebecca Cutts, Andrew Higham, Marwan Bukhari, Mohamed Elnaggar, Michelle Glover, Fiona Richardson, Alexandra Dent, Shahzeb Mirza, Rajiv Ark, Jennie Han, Suzy V. Hope, Philip J. Mitchelmore, Rostam Osanlou, Andrew Freedman, Alison Cooper, Katherine Burton, Kashyap Katechia, Michael Barrett, Jo Salkeld, Natalie Hill, Nathaniel Lee, Jon Perkins, and Polly Fox

Subjects
Adult, Pulmonary and Respiratory Medicine, Trivalent influenza vaccine, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, Influenza vaccine, Population, Placebo, Young Adult, Immunogenicity, Vaccine, Double-Blind Method, Internal medicine, Humans, Medicine, education, Adverse effect, Aged, education.field_of_study, Reactogenicity, SARS-CoV-2, business.industry, COVID-19, Articles, Middle Aged, Vaccine efficacy, Vaccination, Influenza Vaccines, Seasons, business
Abstract

Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines. Methods We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria—with no contraindications to influenza vaccination—were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18–64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995. Findings Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to

Published
2022

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