Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis

被引：281

作者：

Choi, Angela ^{[1
]}

Koch, Matthew ^{[1
]}

Wu, Kai ^{[1
]}

Chu, Laurence ^{[2
]}

Ma, LingZhi ^{[1
]}

Hill, Anna ^{[1
]}

Nunna, Naveen ^{[1
]}

Huang, Wenmei ^{[1
]}

Oestreicher, Judy ^{[1
]}

Colpitts, Tonya ^{[1
]}

Bennett, Hamilton ^{[1
]}

Legault, Holly ^{[1
]}

Paila, Yamuna ^{[1
]}

Nestorova, Biliana ^{[1
]}

Ding, Baoyu ^{[1
]}

Montefiori, David ^{[3
]}

Pajon, Rolando ^{[1
]}

Miller, Jacqueline M. ^{[1
]}

Leav, Brett ^{[1
]}

Carfi, Andrea ^{[1
]}

McPhee, Roderick ^{[1
]}

Edwards, Darin K. ^{[1
]}

机构：

[1] Moderna Inc, Cambridge, MA 02139 USA

[2] Benchmark Res, Austin, TX USA

[3] Duke Univ, Med Ctr, Immune Assay Team, Durham, NC USA

来源：

NATURE MEDICINE | 2021年 / 27卷 / 11期

关键词：

D O I：

10.1038/s41591-021-01527-y

中图分类号：

Q5 [生物化学]; Q7 [分子生物学];

学科分类号：

071010 ; 081704 ;

摘要：

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.

引用

页码：2025 / +

页数：13

共 14 条

[11] Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant [J].

Shinde, V. ;

Bhikha, S. ;

Hoosain, Z. ;

Archary, M. ;

Bhorat, Q. ;

Fairlie, L. ;

Lalloo, U. ;

Masilela, M. S. L. ;

Moodley, D. ;

Hanley, S. ;

Fouche, L. ;

Louw, C. ;

Tameris, M. ;

Singh, N. ;

Goga, A. ;

Dheda, K. ;

Grobbelaar, C. ;

Kruger, G. ;

Carrim-Ganey, N. ;

Baillie, V. ;

de Oliveira, T. ;

Koen, A. Lombard ;

Lombaard, J. J. ;

Mngqibisa, R. ;

Bhorat, A. E. ;

Benade, G. ;

Lalloo, N. ;

Pitsi, A. ;

Vollgraaff, P. -L. ;

Luabeya, A. ;

Esmail, A. ;

Petrick, F. G. ;

Oommen-Jose, A. ;

Foulkes, S. ;

Ahmed, K. ;

Thombrayil, A. ;

Fries, L. ;

Cloney-Clark, S. ;

Zhu, M. ;

Bennett, C. ;

Albert, G. ;

Faust, E. ;

Plested, J. S. ;

Robertson, A. ;

Neal, S. ;

Cho, I. ;

Glenn, G. M. ;

Dubovsky, F. ;

Madhi, S. A. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (20) :1899-1909

[12] SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses [J].

Turner, Jackson S. ;

O'Halloran, Jane A. ;

Kalaidina, Elizaveta ;

Kim, Wooseob ;

Schmitz, Aaron J. ;

Zhou, Julian Q. ;

Lei, Tingting ;

Thapa, Mahima ;

Chen, Rita E. ;

Case, James Brett ;

Amanat, Fatima ;

Rauseo, Adriana M. ;

Haile, Alem ;

Xie, Xuping ;

Klebert, Michael K. ;

Suessen, Teresa ;

Middleton, William D. ;

Shi, Pei-Yong ;

Krammer, Florian ;

Teefey, Sharlene A. ;

Diamond, Michael S. ;

Presti, Rachel M. ;

Ellebedy, Ali H. .

NATURE, 2021, 596 (7870) :109-+

[13] Generation of VSV pseudotypes using recombinant ΔG-VSV for studies on virus entry, identification of entry inhibitors, and immune responses to vaccines [J].

Whitt, Michael A. .

JOURNAL OF VIROLOGICAL METHODS, 2010, 169 (02) :365-374

[14] Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine [J].

Wu, Kai ;

Werner, Anne P. ;

Edwards, Darin K. .

NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (15) :1468-1470

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