Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial
Nature Medicine·
- DOI
- 10.1038/s41591-022-01739-w
- PMID
- 35241844
- PMCID
- PMC9117133
- OpenAlex
- W4220654690
- Study type
- Journal article
- Publisher
- Springer Science and Business Media LLC
- Article type
- journal-article
- Integrity
- current
Publication version
This article has a linked preprint
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Open linked preprint →Why this research matters now
The study addresses waning antibody levels and breakthrough infections in vaccinated individuals by evaluating whether a booster dose can restore or enhance immune response. Findings suggest a booster dose of mRNA-1273 may increase vaccine effectiveness against SARS-CoV-2 infection and disease.
Structured evidence summary
Research question
This open-label phase 2 trial evaluated the safety and immunogenicity of a 50 µg booster dose of mRNA-1273 administered 6-8 months after completion of a two-dose primary vaccination series.
Study design
Open-label, non-randomized phase 2 trial with 344 adult participants who had received a primary series of two doses (50 µg or 100 µg) of mRNA-1273 approximately 6-8 months prior to the booster injection. Immunogenicity was assessed at 28 days post-booster and compared to titers measured 28 days after the second dose of the primary series.
Population and setting
344 adults previously immunized with a two-dose primary series of mRNA-1273 (50 µg or 100 µg per dose) 6-8 months before booster administration.
Main findings
Neutralizing antibody titers against wild-type SARS-CoV-2 at one month post-booster were 1.7-fold higher than peak titers after the primary series, meeting the pre-specified non-inferiority criterion. Titers against the Delta variant were 2.1-fold higher than primary series peak levels. Seroresponse rate (four-fold rise from baseline) was 100% at 28 days post-booster compared to 98.3% after the primary series. The safety profile of the booster dose was similar to that of the second primary dose, with no new adverse event signals and no serious adverse events reported during the one-month follow-up.
Public-health relevance
The study addresses waning antibody levels and breakthrough infections in vaccinated individuals by evaluating whether a booster dose can restore or enhance immune response. Findings suggest a booster dose of mRNA-1273 may increase vaccine effectiveness against SARS-CoV-2 infection and disease.
Important limitations
This summary relies on the supplied single-article abstract and bibliographic metadata. The open-label, non-randomized design and the one-month follow-up period are noted. Full interpretation of study limitations, including generalizability and longer-term outcomes, requires access to the complete published article.
GIDS interpretation
The article is indexed under COVID-19, SARS, treatment, vaccination, and vaccine effectiveness topics, reflecting its focus on booster immunogenicity and safety for mRNA-1273. It provides evidence relevant to vaccine policy and booster dose strategies but does not itself represent a live surveillance signal.
Related GIDS surveillance
Literature context does not validate, explain, or change a surveillance signal. Exact and contextual relationships are shown separately.
Evidence relationships
This article has 11 auditable classifier relationships to diseases, places, topics, and study design.