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Perspective

Pivoting to protein: the immunogenicity and safety of protein-based NVX-CoV2373 as a heterologous booster for inactivated and viral vector COVID-19 vaccines

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Pages 620-628 | Received 17 May 2023, Accepted 28 Jun 2023, Published online: 07 Jul 2023

References

  • Our World in Data. Coronavirus (COVID-19) vaccinations: global change data lab [cited 2023 May 8]. Available from: https://ourworldindata.org/covid-vaccinations
  • COVID-19 Vaccination Pharmaceutical Technology [updated 2023 Apr 13; cited 2023 Apr 27]. Available from: https://www.pharmaceutical-technology.com/covid-19-vaccination-tracker/
  • Sanders B, Koldijk M, Schuitemaker H. Inactivated viral vaccines. Vaccine analysis: strategies, principles, and control. 2014;45–80.
  • Awate S, Babiuk LA, Mutwiri G. Mechanisms of action of adjuvants. Front Immunol. 2013;4:114. doi: 10.3389/fimmu.2013.00114
  • Ella R, Reddy S, Blackwelder W, et al. Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial. Lancet. 2021 Dec 11;398(10317):2173–2184.
  • Al Kaabi N, Zhang Y, Xia S, et al. Effect of 2 inactivated SARS-CoV-2 vaccines on symptomatic COVID-19 infection in adults: a randomized clinical trial. JAMA. 2021 Jul 6;326(1):35–45.
  • Tanriover MD, Doganay HL, Akova M, et al. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213–222.
  • COVID-19 Vaccine Tracker [updated 2023 Mar 4; cited 2023 Apr 27]. Available from: https://covid19.trackvaccines.org/vaccines/#progress-meter
  • Dunkle LM, Kotloff KL, Gay CL, et al. Efficacy and safety of NVX-CoV2373 in adults in the United States and Mexico. N Engl J Med. 2022 Feb 10;386(6):531–543.
  • Dai L, Gao L, Tao L, et al. Efficacy and safety of the RBD-Dimer-based Covid-19 vaccine ZF2001 in adults. N Engl J Med. 2022 Jun 2;386(22):2097–2111.
  • Marchese AM, Zhou X, Kinol J, et al. NVX-Cov2373 vaccine efficacy against hospitalization: a post hoc analysis of the PREVENT-19 phase 3, randomized, placebo-controlled trial. medRxiv. 2023. Preprint. doi: 10.1101/2023.03.17.23287306.
  • Torales J, Cuenca-Torres O, Barrios L, et al. An evaluation of the safety and immunogenicity of MVC-COV1901: results of an interim analysis of a phase III, parallel group, randomized, double-blind, active-controlled study. medRxiv. 2022. Preprint. doi: 10.1101/2022.07.14.22277617.
  • ClinicalTrials.gov. Immuno-bridging study of COVID-19 protein subunit recombinant vaccine (NCT05433285) [cited 2023 Apr 27]. Available from: https://clinicaltrials.gov/ct2/show/NCT05433285
  • Lazarus R, Querton B, Corbic Ramljak I, et al. Immunogenicity and safety of an inactivated whole-virus COVID-19 vaccine (VLA2001) compared with the adenoviral vector vaccine ChAdOx1-S in adults in the UK (COV-COMPARE): interim analysis of a randomised, controlled, phase 3, immunobridging trial. Lancet Infect Dis. 2022 Dec;22(12):1716–1727.
  • Sadoff J, Gray G, Vandebosch A, et al. Safety and efficacy of single-dose ad26.COV2.S vaccine against covid-19. N Engl J Med. 2021 Jun 10;384(23):2187–2201.
  • Voysey M, Clemens SAC, Madhi SA, et al. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99–111.
  • Vetter V, Denizer G, Friedland LR, et al. Understanding modern-day vaccines: what you need to know. Ann Med. 2018 Mar;50(2):110–120.
  • Chang J. Adenovirus vectors: excellent tools for vaccine development. Immune Netw. 2021 Feb;21(1):e6. doi: 10.4110/in.2021.21.e6
  • Shirakawa T. The current status of adenovirus-based cancer gene therapy. Mol Cells. 2008 Jun 30;25(4):462–466.
  • Douglas JT. Adenoviral vectors for gene therapy. Mol Biotechnol. 2007 May;36(1):71–80. doi: 10.1007/s12033-007-0021-5
  • Campos SK, Barry MA. Current advances and future challenges in Adenoviral vector biology and targeting. Curr Gene Ther. 2007 Jun;7(3):189–204. doi: 10.2174/156652307780859062
  • Goncalves MA, de Vries AA. Adenovirus: from foe to friend. Rev Med Virol. 2006 May;16(3):167–186. doi: 10.1002/rmv.494
  • Vaxzevria, COVID-19 Vaccine (ChAdox1-S [recombinant]) SmPC.
  • COVSHIELD (ChAdOx1 nCoV-19 Corona Virus Vaccine [Recombinant]) Fact Sheet.
  • Falsey AR, Sobieszczyk ME, Hirsch I, et al. Phase 3 safety and efficacy of AZD1222 (ChAdox1 nCoV-19) Covid-19 vaccine. N Engl J Med. 2021 Dec 16;385(25):2348–2360.
  • Di Pasquale A, Preiss S, Tavares Da Silva F, et al. Vaccine adjuvants: from 1920 to 2015 and beyond. Vaccines (Basel). 2015 Apr 16;3(2):320–343.
  • Marchese AM, Beyhaghi H, Orenstein WA. With established safe and effective use, protein vaccines offer another choice against COVID-19. Vaccine. 2022 Nov 2;40(46):6567–6569.
  • Stertman L, Palm AE, Zarnegar B, et al. The matrix-M adjuvant: a critical component of vaccines for the 21(st) century. Hum Vaccin Immunother. 2023 Dec 31;19(1):2189885.
  • Heath PT, Galiza EP, Baxter DN, et al. Safety and Efficacy of NVX-CoV2373 Covid-19 vaccine. N Engl J Med. 2021 Sep 23;385(13):1172–1183.
  • VidPrevtyn Beta, COVID-19 Vaccine SmPC.
  • Thuluva S, Paradkar V, Gunneri SR, et al. Evaluation of safety and immunogenicity of receptor-binding domain-based COVID-19 vaccine (Corbevax) to select the optimum formulation in open-label, multicentre, and randomised phase-1/2 and phase-2 clinical trials. EBioMedicine. 2022 Sep;83:104217.
  • Gao L, Li Y, He P, et al. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269–279.
  • Chakraborty C, Sharma AR, Bhattacharya M, et al. Asian-origin approved COVID-19 vaccines and current status of COVID-19 vaccination program in Asia: a critical analysis. Vaccines (Basel). 2021 Jun 4;9(6):600.
  • Dolgin E. Omicron thwarts some of the world’s most-used COVID vaccines. Nature. 2022 Jan;601(7893):311. doi: 10.1038/d41586-022-00079-6
  • Pettersson H, Manley B, Hernandez S, et al. Tracking COVID-19 vaccinations worldwide: cNN Health [updated 2023 Mar 20; cited 2023 Apr 27]. Available from: https://edition.cnn.com/interactive/2021/health/global-covid-vaccinations/
  • Holder J Tracking Coronavirus Vaccinations Around the World. The New York Times; [updated 2023 Mar 13; cited 2023 Apr 27]. Available from: https://www.nytimes.com/interactive/2021/world/covid-vaccinations-tracker.html
  • Which COVID-19 vaccine is the most widely accepted for international travel? The Economist [updated 2021 Jul 20; cited 2023 Apr 27]. Available from: https://www.economist.com/graphic-detail/2021/07/20/which-covid-19-vaccine-is-the-most-widely-accepted-for-international-travel
  • Ministry of Health and Family Welfare. Co-win: winning over Covid-19 [cited 2023 Apr 27]. Available from: https://dashboard.cowin.gov.in/
  • Toback S, Marchese AM, Warren B, et al. Safety and Immunogenicity of the NVX-CoV2373 vaccine as a booster in adults previously vaccinated with the BBIBP-CorV vaccine: an interim analysis. medRxiv. 2023; Preprint:. doi: 10.1101/2023.03.24.23287658.
  • Kulkarni P, Gunale B, Kohli S, et al. A randomized, controlled study to evaluate the safety and immunogenicity of a heterologous booster dose of an adjuvanted SARS CoV-2 recombinant spike protein vaccine in adults. Res Square. 2023; Preprint. doi: 10.21203/rs.3.rs-2549560/v1.
  • Kanokudom S, Chansaenroj J, Suntronwong N, et al. Safety and immunogenicity of a third dose of COVID-19 protein subunit vaccine (Covovax(tm)) after homologous and heterologous two-dose regimens. Int J Infect Dis. 2023 Jan;126:64–72. doi: 10.1016/j.ijid.2022.11.022.
  • Munro APS, Janani L, Cornelius V, et al. Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet. 2021 Dec 18;398(10318):2258–2276. doi: 10.1016/S0140-6736(21)02717-3.
  • Liu X, Munro APS, Wright A, et al. Persistence of immune responses after heterologous and homologous third COVID-19 vaccine dose schedules in the UK: eight-month analyses of the COV-BOOST trial. J Infect. 2023 Apr 19;87(1):18–26. doi: 10.1016/j.jinf.2023.04.012.
  • Assawakosri S, Kanokudom S, Chansaenroj J, et al. Persistence of immunity against Omicron BA.1 and BA.2 variants following homologous and heterologous COVID-19 booster vaccines in healthy adults after a two-dose AZD1222 vaccination. Int J Infect Dis. 2022 Sep;122:793–801.
  • Mallory RM, Formica N, Pfeiffer S, et al. Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2022 Nov;22(11):1565–1576.
  • Polack FP, Thomas SJ, Kitchin N, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603–2615.
  • Baden LR, El Sahly HM, Essink B, et al. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403–416.
  • Garg I, Sheikh AB, Pal S, et al. Mix-and-match COVID-19 vaccinations (heterologous boost): a review. Infect Dis Rep. 2022 Jul 20;14(4):537–546. doi: 10.3390/idr14040057
  • Atmar RL, Lyke KE, Deming ME, et al. Homologous and heterologous Covid-19 booster vaccinations. N Engl J Med. 2022 Mar 17;386(11):1046–1057.
  • Barros-Martins J, Hammerschmidt SI, Cossmann A, et al. Immune responses against SARS-CoV-2 variants after heterologous and homologous ChAdOx1 nCoV-19/BNT162b2 vaccination. Nat Med. 2021 Sep;27(9):1525–1529.
  • Schmidt T, Klemis V, Schub D, et al. Immunogenicity and reactogenicity of heterologous ChAdOx1 nCoV-19/mRNA vaccination. Nat Med. 2021 Sep;27(9):1530–1535.
  • Liu X, Shaw RH, Stuart ASV, et al. Safety and immunogenicity of heterologous versus homologous prime-boost schedules with an adenoviral vectored and mRNA COVID-19 vaccine (Com-COV): a single-blind, randomised, non-inferiority trial. Lancet. 2021 Sep 4;398(10303):856–869.
  • Pozzetto B, Legros V, Djebali S, et al. Immunogenicity and efficacy of heterologous ChAdOx1-BNT162b2 vaccination. Nature. 2021 Dec;600(7890):701–706.
  • Tan CS, Collier AY, Yu J, et al. Durability of Heterologous and homologous COVID-19 vaccine boosts. JAMA Netw Open. 2022 Aug 1;5(8):e2226335.
  • Assawakosri S, Kanokudom S, Suntronwong N, et al. Neutralizing activities against the omicron variant after a heterologous booster in healthy adults receiving two doses of coronavac vaccination. J Infect Dis. 2022 Oct 17;226(8):1372–1381.
  • Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting, Zoom video conference [transcript]. 2023 Jan 26. Accessed 26 Jan 2023. Available from: https://www.fda.gov/media/165307/download
  • Raiser F, Davis M, Adelglass J, et al. Immunogenicity and safety of NVX-CoV2373 as a homologous or heterologous booster: a phase 3 randomized clinical trial in adults. medRxiv. 2023. Preprint. doi: 10.1101/2023.03.16.23287030.
  • Rubin R. COVID-19 vaccine makers plan for annual boosters, but it’s not clear they’ll be needed. JAMA. 2021 Dec 14;326(22):2247–2249.
  • Bergen N, Kirkby K, Fuertes CV, et al. Global state of education-related inequality in COVID-19 vaccine coverage, structural barriers, vaccine hesitancy, and vaccine refusal: findings from the Global COVID-19 Trends and Impact Survey. Lancet Glob Health. 2023 Feb;11(2):e207–e217.
  • Beleche T, Ross T, Marus J, et al. COVID-19 vaccine hesitancy and reasons for hesitancy among essential and non-essential workers. 2023 March. Accessed 30 June. Available from: https://aspe.hhs.gov/sites/default/files/documents/f2fbfbd9cdce16032233b6a9ff69f161/aspe-essential-worker-vaccine-hesitancy.pdf
  • Chrissian AA, Oyoyo UE, Patel P, et al. Impact of COVID-19 vaccine-associated side effects on health care worker absenteeism and future booster vaccination. Vaccine. 2022 May 20;40(23):3174–3181.
  • Costa K Older adults’ intentions and attitudes toward the updated bivalent COVID-19 booster: survey, United States, may 2023 HealthCanal2023 [cited 2023 May 8]. Available from: https://www.healthcanal.com/health/the-bivalent-covid-19-booster-survey
  • Sutton N, San Francisco Ramos A, Beales E, et al. Comparing reactogenicity of COVID-19 vaccines: a systematic review and meta-analysis. Expert Rev Vaccines. 2022 Sep;21(9):1301–1318.