Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults >75 years (EU-COVAT-1)

被引：5

作者：

Neuhann, Julia M. ^{[1
,2
,3
,4
,5
,6
]}

Stemler, Jannik ^{[1
,2
,3
,4
,5
,6
]}

Carcas, Antonio J. ^{[7
]}

Frias-Iniesta, Jesus ^{[7
]}

Akova, Murat ^{[8
]}

Bethe, Ullrich ^{[1
,2
,3
,4
,5
,6
]}

Heringer, Sarah ^{[1
,2
,3
,4
,5
,6
]}

Salmanton-Garcia, Jon ^{[1
,2
,3
,4
,5
,6
]}

Tischmann, Lea ^{[1
,2
,3
,4
,5
,6
]}

Zarrouk, Marouan ^{[1
,2
,4
,5
]}

Cueppers, Arnd ^{[9
]}

Grothe, Jan ^{[1
,2
,3
,4
,5
,6
]}

Leon, Alejandro Garcia ^{[10
]}

Mallon, Patrick ^{[10
]}

Negi, Riya ^{[10
]}

Gaillard, Colette ^{[10
]}

Saini, Gurvin ^{[10
]}

Lammens, Christine ^{[11
,12
]}

Hotterbeekx, An ^{[13
,14
]}

Loens, Katherine ^{[11
,12
]}

Malhotra-Kumar, Surbhi ^{[11
,12
]}

Goossens, Herman ^{[11
,12
]}

Kumar-Singh, Samir ^{[13
,14
]}

Koenig, Franz ^{[15
]}

Yeghiazaryan, Lusine ^{[15
]}

Posch, Martin ^{[15
]}

Koehler, Philipp ^{[1
,2
,3
,4
,5
]}

Cornely, Oliver A. ^{[1
,2
,3
,4
,5
,6
,9
,16
]}

机构：

[1] Univ Cologne, Fac Med, Herderstr 52, D-50931 Cologne, Germany

[2] Univ Hosp Cologne, Translat Res, Cologne Excellence Cluster Cellular Stress Respons, Herderstr 52, D-50931 Cologne, Germany

[3] Univ Cologne, Fac Med, Kerpener Str 62, D-50937 Cologne, Germany

[4] Univ Hosp Cologne, Ctr Integrated Oncol Aachen Bonn Cologne Duesseldo, Dept Internal Med 1, Kerpener Str 62, D-50937 Cologne, Germany

[5] Excellence Ctr Med Mycol ECMM, Kerpener Str 62, D-50937 Cologne, Germany

[6] German Ctr Infect Res DZ, Partner Site Bonn Cologne Dept, Herderstr 52, D-50931 Cologne, Germany

[7] Univ Autonoma Madrid, Hosp La Paz, Inst Hlth Res IdiPAZ, Fac Med, Madrid, Spain

[8] Hacettepe Univ, Sch Med, Dept Infect Dis, Ankara, Turkiye

[9] Univ Cologne, Fac Med, Clin Trials Ctr Cologne CTCC Cologne, Gleueler Str 269, D-50935 Cologne, Germany

[10] Univ Coll Dublin, UCD Ctr Expt Pathogen Host Res CEPHR, Sch Med, Dublin, Ireland

[11] Univ Antwerp, Vaccine & Infect Dis Inst, Lab Med Microbiol LMM, Antwerp, Belgium

[12] Univ Antwerp, Biobank Antwerp, Antwerp, Belgium

[13] Univ Antwerp, Fac Med, Lab Cell Biol & Histol, Mol Pathol Grp, Antwerp, Belgium

[14] Univ Antwerp, Vaccine & Infect Dis Inst CBH, Fac Med, Antwerp, Belgium

[15] Med Univ Vienna, Ctr Med Data Sci, Spitalgasse 23, A-1090 Vienna, Austria

[16] CECAD Translat Res, Herderstr 52, D-50931 Cologne, Germany

来源：

VACCINE | 2023年 / 41卷 / 48期

关键词：

Belgium; SARS-CoV-2; Advanced age; Third dose; Variants of concern; Anti-RBD IgG; Neutralising antibodies; VACCINATION;

D O I：

10.1016/j.vaccine.2023.10.029

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

Background: Vaccination remains crucial for protection against severe SARS-CoV-2 infection, especially for people of advanced age, however, optimal dosing regimens are as yet lacking.Methods: EU-COVAT-1-AGED Part A is a randomised controlled, adaptive, multicentre phase II trial evaluating safety and immunogenicity of a 3rd vaccination (1st booster) in individuals >= 75 years. Fifty-three participants were randomised to full-doses of either mRNA-1273 (Spikevax (R), 100 mu g) or BNT162b2 (Comirnaty (R), 30 mu g). The primary endpoint was the rate of 2-fold circulating antibody titre increase 14 days post-vaccination measured by quantitative electrochemiluminescence (ECL) immunoassay, targeting RBD region of Wuhan wild-type SARS-CoV-2. Secondary endpoints included the changes in neutralising capacity against wild-type and 25 variants of concern at 14 days and up to 12 months. Safety was assessed by monitoring of solicited adverse events (AEs) for seven days after on-study vaccination. Unsolicited AEs were collected until the end of follow-up at 12 months, SAEs were pursued for a further 30 days.Results: Between 08th of November 2021 and 04th of January 2022, 53 participants >= 75 years received a COVID-19 vaccine as 1st booster. Fifty subjects (BNT162b2 n = 25/mRNA-1273 n = 25) were included in the analyses for immunogenicity at day 14. The primary endpoint of a 2-fold anti-RBD IgG titre increase 14 days after vaccination was reached for all subjects. A 3rd vaccination of full-dose mRNA-1273 provided higher anti-RBD IgG titres (Geometric mean titre) D14 mRNA-127310711 IU/mL (95 %-CI: 8003;14336) vs. BNT162b2: 7090 IU/mL (95 %-CI: 5688;8837). We detected a pattern showing higher neutralising capacity of full-dose mRNA-1273 against wild-type as well as for 23 out of 25 tested variants.Interpretation: Third doses of either BNT162b2 or mRNA-1273 provide substantial circulating antibody increase 14 days after vaccination. Full-dose mRNA-1273 provides higher antibody levels with an overall similar safety profile for people >= 75 years.

引用

页码：7166 / 7175

页数：10

共 47 条

[1] Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥75 years (EU-COVAT-1-AGED Part B)
Stemler, Jannik
Yeghiazaryan, Lusine
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Carcas-Sansuan, Antonio-Jose
Rodriguez, Esperanza Romero
Molto, Jose
Mitxeltorena, Itziar Vergara
Welte, Tobias
Zablockiene, Birute
Akova, Murat
Bethe, Ullrich
Heringer, Sarah
Salmanton-Garcia, Jon
Jeck, Julia
Tischmann, Lea
Zarrouk, Marouan
Cueppers, Arnd
Biehl, Lena M.
Grothe, Jan
Mellinghoff, Sibylle C.
Nacov, Julia A.
Neuhann, Julia M.
Sprute, Rosanne
Frias-Iniesta, Jesus
Negi, Riya
Gaillard, Colette
Saini, Gurvin
Leon, Alejandro Garcia
Mallon, Patrick W. G.
Lammens, Christine
Hotterbeekx, An
Loens, Katherine
Malhotra-Kumar, Surbhi
Goossens, Herman
Kumar-Singh, Samir
Koenig, Franz
Posch, Martin
Koehler, Philipp
Cornely, Oliver A.
INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES, 2024, 146
[2] Second booster of BNT162b2 or full-dose mRNA-1273 in adults ≥ 75 years
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LANCET REGIONAL HEALTH-EUROPE, 2024, 42
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ECLINICALMEDICINE, 2022, 48
[4] Reactogenicity and immunogenicity of BNT162b2 or mRNA-1273 COVID-19 booster vaccinations after two doses of BNT162b2 among healthcare workers in Japan: a prospective observational study
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[5] Immunogenicity of Monovalent mRNA-1273 and BNT162b2 Vaccines in Children <5 Years of Age
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Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults &gt;75 years (EU-COVAT-1)

Immunogenicity and reactogenicity of a first booster with BNT162b2 or full-dose mRNA-1273: A randomised VACCELERATE trial in adults >75 years (EU-COVAT-1)