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Safety and immunogenicity of SARS-CoV-2 variant mRNA vaccine boosters in healthy adults: an interim analysis
Open accessAbstract
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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Six months after two mRNA-1273 injections, booster with 50 μg mRNA-1273, mRNA-1273.211, or mRNA-1273.351 induced neutralization against Beta, Gamma, and Delta comparable to wild-type D614G.
“The neutralization effect of the booster in each immunization group against SARS-CoV-2 variants Beta, Gamma and Delta reached a level comparable to that observed against the wild-type D614G strain.”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [415]
Among the three booster vaccines evaluated, multivalent mRNA-1273.211 induced the largest geometric mean titers for Beta, Gamma, and Delta.
“Among the three booster vaccines evaluated, the multivalent mRNA-1273.211 induced the largest geometric mean titers (GMT) for variants Beta, Gamma and Delta.415,416”
From Advances in COVID-19 mRNA vaccine development (2022) · cites this paper as [415]
In an interim analysis of a single booster dose following prime-boost vaccination, mRNA-1273 and multiple variant-modified versions had high safety and tolerability and increased neutralization titers against key SARS-CoV-2 variants of concern and interest, including beta, gamma, delta, and omicron.
“In an interim analysis of a single booster dose following p-b vaccination, Moderna tested mRNA-1273 and multiple variant-modified versions and found high safety and tolerability, as well as increased neutralization titers against key variants of concern and variants of interest of SARS-CoV-2, including beta (B.1.351), gamma (P.1), delta (B.1.617.2), and omicron (B.1.1.529).86”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [86]
mRNA-1273.211 boosters increased neutralization titers against key variants.
“boosters increased neutralization titers against key variants86”
From COVID-19 mRNA vaccines: Platforms and current developments (2022) · cites this paper as [86]
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Metadata
- Authors
- Choi, A., Koch, M., Wu, K., Chu, L., Ma, L., Hill, A., Nunna, N., Huang, W., Oestreicher, J., Colpitts, T., Bennett, H., Legault, H., Paila, Y., Nestorova, B., Ding, B., Montefiori, D., Pajon, R., Miller, J. M., Leav, B., Carfi, A., McPhee, R., & Edwards, D. K.
- Affiliations
- Moderna Therapeutics (United States) (US)
- Benchmark Research (United States) (US)
- Duke University (US)
- Corresponding author
- Edwards, Darin K.
- ORCID
- Venue
- Nature Medicine
- Published
- 2021-09-15
- Volume
- 27
- Issue
- 11
- Pages
- 2025-2031
- ISSN
- 1078-8956 (ISSN-L)
- 1546-170X
- PMC
- PMC8604720
- OpenAlex
- W3200674187
- Cited by
- 396
- References
- 18
- Citations by year
- 2026: 5 · 2025: 27 · 2024: 42 · 2023: 79 · 2022: 202 · 2021: 41
- FWCI
- 28.79
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Nature Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- Moderna
- Health Science Center, University of Tennessee
- Topics
- Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
- Social Sciences › Health › Vaccine Coverage and Hesitancy
- Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
- Keywords
- SARS-CoV-2, COVID-19 vaccines, mRNA-1273, booster vaccination, vaccine safety, immunogenicity, neutralizing antibodies, variants of concern, variants of interest, Beta variant, P.1, Delta variant, antibody waning, D614G
- MeSH terms
- Immunogenicity, Vaccine, Preliminary Data, COVID-19, SARS-CoV-2, COVID-19 Vaccines, Adult, Aged, Antibodies, Viral, Female, Humans, Immunization, Secondary, Male, Middle Aged, RNA, Messenger, United States, Vaccination, Treatment Outcome, Antibodies, Neutralizing, Healthy Volunteers
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