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Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis.
Choi, Angela; Koch, Matthew; Wu, Kai; Chu, Laurence; Ma, LingZhi; Hill, Anna; Nunna, Naveen; Huang, Wenmei; Oestreicher, Judy; Colpitts, Tonya; Bennett, Hamilton; Legault, Holly; Paila, Yamuna; Nestorova, Biliana; Ding, Baoyu; Montefiori, David; Pajon, Rolando; Miller, Jacqueline M; Leav, Brett; Carfi, Andrea; McPhee, Roderick; Edwards, Darin K.
  • Choi A; Moderna Inc., Cambridge, MA, USA.
  • Koch M; Moderna Inc., Cambridge, MA, USA.
  • Wu K; Moderna Inc., Cambridge, MA, USA.
  • Chu L; Benchmark Research, Austin, TX, USA.
  • Ma L; Moderna Inc., Cambridge, MA, USA.
  • Hill A; Moderna Inc., Cambridge, MA, USA.
  • Nunna N; Moderna Inc., Cambridge, MA, USA.
  • Huang W; Moderna Inc., Cambridge, MA, USA.
  • Oestreicher J; Moderna Inc., Cambridge, MA, USA.
  • Colpitts T; Moderna Inc., Cambridge, MA, USA.
  • Bennett H; Moderna Inc., Cambridge, MA, USA.
  • Legault H; Moderna Inc., Cambridge, MA, USA.
  • Paila Y; Moderna Inc., Cambridge, MA, USA.
  • Nestorova B; Moderna Inc., Cambridge, MA, USA.
  • Ding B; Moderna Inc., Cambridge, MA, USA.
  • Montefiori D; Immune Assay Team at Duke University Medical Center, Duke University, Durham, NC, USA.
  • Pajon R; Moderna Inc., Cambridge, MA, USA.
  • Miller JM; Moderna Inc., Cambridge, MA, USA.
  • Leav B; Moderna Inc., Cambridge, MA, USA.
  • Carfi A; Moderna Inc., Cambridge, MA, USA.
  • McPhee R; Moderna Inc., Cambridge, MA, USA.
  • Edwards DK; Moderna Inc., Cambridge, MA, USA. darin.edwards@modernatx.com.
Nat Med ; 27(11): 2025-2031, 2021 11.
Article in English | MEDLINE | ID: covidwho-1412033
ABSTRACT
The emergence of SARS-CoV-2 variants of concern (VOCs) and variants of interest (VOIs) with decreased susceptibility to neutralization has generated interest in assessments of booster doses and variant-specific vaccines. Clinical trial participants who received a two-dose primary series of the COVID-19 vaccine mRNA-1273 approximately 6 months earlier entered an open-label phase 2a study ( NCT04405076 ) to evaluate the primary objectives of safety and immunogenicity of a single booster dose of mRNA-1273 or variant-modified mRNAs, including multivalent mRNA-1273.211. As the trial is currently ongoing, this exploratory interim analysis includes preliminary descriptive results only of four booster groups (n = 20 per group). Immediately before the booster dose, neutralizing antibodies against wild-type D614G virus had waned (P < 0.0001) relative to peak titers against wild-type D614G measured 1 month after the primary series, and neutralization titers against B.1.351 (Beta), P.1 (Gamma) and B.1.617.2 (Delta) VOCs were either low or undetectable. Both the mRNA-1273 booster and variant-modified boosters were safe and well-tolerated. All boosters, including mRNA-1273, numerically increased neutralization titers against the wild-type D614G virus compared to peak titers against wild-type D614G measured 1 month after the primary series; significant increases were observed for mRNA-1273 and mRNA-1273.211 (P < 0.0001). In addition, all boosters increased neutralization titers against key VOCs and VOIs, including B.1.351, P.1. and B.1.617.2, that were statistically equivalent to peak titers measured after the primary vaccine series against wild-type D614G virus, with superior titers against some VOIs. This trial is ongoing.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: North America Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2021 Document Type: Article Affiliation country: S41591-021-01527-y

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunization, Secondary / Immunogenicity, Vaccine / COVID-19 Vaccines / SARS-CoV-2 / COVID-19 Type of study: Experimental Studies / Prognostic study / Randomized controlled trials Topics: Vaccines / Variants Limits: Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: North America Language: English Journal: Nat Med Journal subject: Molecular Biology / Medicine Year: 2021 Document Type: Article Affiliation country: S41591-021-01527-y