Interim analysis of a phase 1 randomized clinical trial on the safety and immunogenicity of the mRNA-1283 SARS-CoV-2 vaccine in adults

References

• FDA. Package Insert - SPIKEVAX. 2022 [accessed 2022 Mar 15]. https://www.fda.gov/media/155675/download.
   Google Scholar
• World Health Organization. Interim recommendations for use of the Moderna mRNA-1273 vaccine against COVID-19. 2022. [accessed 2023 Mar 13]. https://www.who.int/publications/i/item/WHO-2019-nCoV-vaccines-SAGE-recommendation-mRNA-1273-2021.3.
   Google Scholar
• Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N Engl J Med. 2021;384(5):403–9. doi:10.1056/NEJMoa2035389.
   PubMed Web of Science ®Google Scholar
• Bruxvoort KJ, Sy LS, Qian L, Ackerson BK, Luo Y, Lee GS, Tian Y, Florea A, Takhar HS, Tubert JE, et al. Real-world effectiveness of the mRNA-1273 vaccine against COVID-19: interim results from a prospective observational cohort study. Lancet Reg Health Am. 2021:100134. doi:10.2139/ssrn.3916094.
   Google Scholar
• Chemaitelly H, Yassine HM, Benslimane FM, Al Khatib HA, Tang P, Hasan MR, Malek JA, Coyle P, Ayoub HH, Al Kanaani Z, et al. mRNA-1273 COVID-19 vaccine effectiveness against the B.1.1.7 and B.1.351 variants and severe COVID-19 disease in Qatar. Nat Med. 2021;27(9):1614–21. doi:10.1038/s41591-021-01446-y.
   PubMed Web of Science ®Google Scholar
• Pilishvili T, Gierke R, Fleming-Dutra KE, Farrar JL, Mohr NM, Talan DA, Krishnadasan A, Harland KK, Smithline HA, Hou PC, et al. Effectiveness of mRNA Covid-19 vaccine among U.S. health care personnel. N Engl J Med. 2021;385(25):e90. doi:10.1056/NEJMoa2106599.
   PubMed Web of Science ®Google Scholar
• Bruxvoort KJ, Sy LS, Qian L, Ackerson BK, Luo Y, Lee GS, Tian Y, Florea A, Aragones M, Tubert JE, et al. Effectiveness of mRNA-1273 against delta, mu, and other emerging variants of SARS-CoV-2: test negative case-control study. BMJ. 2021;375:e068848. doi:10.1136/bmj-2021-068848.
   PubMed Web of Science ®Google Scholar
• Tang P, Hasan MR, Chemaitelly H, Yassine HM, Benslimane FM, Al Khatib HA, AlMukdad S, Coyle P, Ayoub HH, Al Kanaani Z, et al. BNT162b2 and mRNA-1273 COVID-19 vaccine effectiveness against the SARS-CoV-2 delta variant in Qatar. Nat Med. 2021;27(12):2136–43. doi:10.1038/s41591-021-01583-4.
   PubMed Web of Science ®Google Scholar
• Tseng HF, Ackerson BK, Luo Y, Sy LS, Talarico CA, Tian Y, Bruxvoort KJ, Tubert JE, Florea A, Ku JH, et al. Effectiveness of mRNA-1273 against SARS-CoV-2 omicron and delta variants. Nat Med. 2022;28(5):1063–71. doi:10.1038/s41591-022-01753-y.
   PubMed Web of Science ®Google Scholar
• Ferdinands JM, Rao S, Dixon BE, Mitchell PK, DeSilva MB, Irving SA, Lewis N, Natarajan K, Stenehjem E, Grannis SJ, et al. Waning 2-dose and 3-dose effectiveness of mRNA vaccines against COVID-19-associated emergency department and urgent care encounters and hospitalizations among adults during periods of delta and omicron variant predominance - VISION network, 10 states, August 2021-January 2022. MMWR Morb Mortal Wkly Rep. 2022;71(7):255–63. doi:10.15585/mmwr.mm7107e2.
   PubMed Web of Science ®Google Scholar
• Chaudhary N, Weissman D, Whitehead KA. mRNA vaccines for infectious diseases: principles, delivery and clinical translation. Nat Rev Drug Discov. 2021;20(11):817–38. doi:10.1038/s41573-021-00283-5.
   PubMed Web of Science ®Google Scholar
• Uddin MN, Roni MA. Challenges of storage and stability of mRNA-Based COVID-19 vaccines. Vaccines. 2021;9(9):1033. doi:10.3390/vaccines9091033.
   PubMed Web of Science ®Google Scholar
• Wouters OJ, Shadlen KC, Salcher-Konrad M, Pollard AJ, Larson HJ, Teerawattananon Y, Jit M. Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment. Lancet. 2021;397(10278):1023–34. doi:10.1016/S0140-6736(21)00306-8.
   PubMed Web of Science ®Google Scholar
• Acharya KP, Ghimire TR, Subramanya SH. Access to and equitable distribution of COVID-19 vaccine in low-income countries. NPJ Vaccines. 2021;6(1):54. doi:10.1038/s41541-021-00323-6.
   PubMed Web of Science ®Google Scholar
• Crommelin DJA, Anchordoquy TJ, Volkin DB, Jiskoot W, Mastrobattista E. Addressing the cold reality of mRNA vaccine stability. J Pharm Sci. 2021;110(3):997–1001. doi:10.1016/j.xphs.2020.12.006.
   PubMed Web of Science ®Google Scholar
• Brouwer PJM, Caniels TG, van der Straten K, Snitselaar JL, Aldon Y, Bangaru S, Torres JL, Okba NMA, Claireaux M, Kerster G, et al. Potent neutralizing antibodies from COVID-19 patients define multiple targets of vulnerability. Science. 2020;369(6504):643–50. doi:10.1126/science.abc5902.
   PubMed Web of Science ®Google Scholar
• Liu L, Wang P, Nair MS, Yu J, Rapp M, Wang Q, Luo Y, Chan JFW, Sahi V, Figueroa A, et al. Potent neutralizing antibodies against multiple epitopes on SARS-CoV-2 spike. Nature. 2020;584(7821):450–56. doi:10.1038/s41586-020-2571-7.
   PubMed Web of Science ®Google Scholar
• Stewart-Jones GBE, Elbashir SM, Wu K, Lee D, Renzi I, Ying B, Koch M, Sein CE, Choi A, Whitener B, et al. Development of SARS-CoV-2 mRNA vaccines encoding spike N-terminal and receptor binding domains. bioRxiv. 2022; 2022.10.07.511319.
   Google Scholar
• Shen X, Tang H, McDanal C, Wagh K, Fischer W, Theiler J, Yoon H, Li D, Haynes BF, Sanders KO, et al. SARS-CoV-2 variant B.1.1.7 is susceptible to neutralizing antibodies elicited by ancestral spike vaccines. Cell Host Microbe. 2021;29(4):529–39.e3. doi:10.1016/j.chom.2021.03.002.
   PubMed Web of Science ®Google Scholar
• Choi A, Koch M, Wu K, Chu L, Ma L, Hill A, Nunna N, Huang W, Oestreicher J, Colpitts T, et al. Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis. Nat Med. 2021;27(11):2025–31. doi:10.1038/s41591-021-01527-y.
   PubMed Web of Science ®Google Scholar
• Chu L, McPhee R, Huang W, Bennett H, Pajon R, Nestorova B, Leav B. A preliminary report of a randomized controlled phase 2 trial of the safety and immunogenicity of mRNA-1273 SARS-CoV-2 vaccine. Vaccine. 2021;39(20):2791–99. doi:10.1016/j.vaccine.2021.02.007.
   PubMed Web of Science ®Google Scholar
• Chu L, Vrbicky K, Montefiori D, Huang W, Nestorova B, Chang Y, Carfi A, Edwards DK, Oestreicher J, Legault H, et al. Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial. Nat Med. 2022;28(5):1042–49. doi:10.1038/s41591-022-01739-w.
   PubMed Web of Science ®Google Scholar
• El Sahly HM, Baden LR, Essink B, Montefiori D, McDermont A, Rupp R, Lewis M, Swaminathan S, Griffin C, Fragoso V, et al. Humoral immunogenicity of the mRNA-1273 vaccine in the phase 3 COVE trial. J Infect Dis. 2022;226(10):1731–42. doi:10.1093/infdis/jiac188.
   PubMed Web of Science ®Google Scholar
• El Sahly HM, Baden LR, Essink B, Doblecki-Lewis S, Martin JM, Anderson EJ, Campbell TB, Clark J, Jackson LA, Fichtenbaum CJ, et al. Efficacy of the mRNA-1273 SARS-CoV-2 vaccine at completion of blinded phase. N Engl J Med. 2021;385(19):1774–85. doi:10.1056/NEJMoa2113017.
   PubMed Web of Science ®Google Scholar
• ClinicalTrials.gov. A study to evaluate the immunogenicity and safety of mRNA-1283 COVID-19 vaccine boosters. 2021.
   Google Scholar
• Jackson LA, Anderson EJ, Rouphael NG, Roberts PC, Makhene M, Coler RN, McCullough MP, Chappell JD, Denison MR, Stevens LJ, et al. An mRNA vaccine against SARS-CoV-2 — preliminary report. N Engl J Med. 2020;383(20):1920–31. doi:10.1056/NEJMoa2022483.
   PubMed Web of Science ®Google Scholar
• McCallum M, De Marco A, Lempp FA, Tortorici MA, Pinto D, Walls AC, Beltramello M, Chen A, Liu Z, Zatta F, et al. N-terminal domain antigenic mapping reveals a site of vulnerability for SARS-CoV-2. Cell. 2021;184(9): SS0092-1 doi:10.1016/j.cell.2021.03.028.
   PubMed Web of Science ®Google Scholar
• Farrell AG, Dadonaite B, Greaney AJ, Eguia R, Loes AN, Franko NM, Logue J, Carreño JM, Abbad A, Chu HY, et al. Receptor-binding domain (RBD) antibodies contribute more to SARS-CoV-2 neutralization when target cells express high levels of ACE2. Viruses. 2022;14(9):2061. doi:10.3390/v14092061.
   PubMed Web of Science ®Google Scholar
• McNab F, Mayer-Barber K, Sher A, Wack A, O’Garra A. Type I interferons in infectious disease. Nat Rev Immunol. 2015;15(2):87–103. doi:10.1038/nri3787.
   PubMed Web of Science ®Google Scholar
• Darrah PA, Hegde ST, Patel DT, Lindsay RW, Chen L, Roederer M, Seder RA. IL-10 production differentially influences the magnitude, quality, and protective capacity of Th1 responses depending on the vaccine platform. J Exp Med. 2010;207(7):1421–33. doi:10.1084/jem.20092532.
   PubMed Web of Science ®Google Scholar
• Arunachalam PS, Scott MKD, Hagan T, Li C, Feng Y, Wimmers F, Grigoryan L, Trisal M, Edara VV, Lai L, et al. Systems vaccinology of the BNT162b2 mRNA vaccine in humans. Nature. 2021;596(7872):410–16. doi:10.1038/s41586-021-03791-x.
   PubMed Web of Science ®Google Scholar
• Pegu A, O’Connell SE, Schmidt SD, O’Dell S, Talana CA, Lai L, Albert J, Anderson E, Bennett H, Corbett KS, et al. Durability of mRNA-1273 vaccine–induced antibodies against SARS-CoV-2 variants. Science. 2021;373(6561):1372–77. doi:10.1126/science.abj4176.
   PubMed Web of Science ®Google Scholar