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

被引：274

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
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.
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (20) : 1899 - 1909
[12] SARS-CoV-2 mRNA vaccines induce persistent human germinal centre responses
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.
[J]. 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
Whitt, Michael A.
[J]. JOURNAL OF VIROLOGICAL METHODS, 2010, 169 (02) : 365 - 374
[14] Serum Neutralizing Activity Elicited by mRNA-1273 Vaccine
Wu, Kai
Werner, Anne P.
Edwards, Darin K.
[J]. NEW ENGLAND JOURNAL OF MEDICINE, 2021, 384 (15) : 1468 - 1470

← 1 2 →