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PreprintCited by 105SARS-CoV-2 and COVID-19 ResearchCOVID-19 Clinical Research StudiesImmune responses and vaccinations

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Immune Memory Response After a Booster Injection of mRNA-1273 for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)

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Chu, Laurence, Montefiori, David, Huang, Wenmei, Nestorova, Biliana, Chang, Ying, Carfi, Andrea, Edwards, Darin K., Oestreicher, Judy, Legault, Holly, Girard, Bethany, Pajon, Rolando, Miller, Jacqueline M., Das, Rituparna, Leav, Brett, McPhee, Roderick·2021·Nature Medicine
DOI 10.1101/2021.09.29.21264089PMC PMC9117133
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Abstract

Rising breakthrough infections of coronavirus-2 (SARS-CoV-2) in previously immunized individuals has raised concerns for a booster to combat suspected waning immunity and new variants. Participants immunized 6-8 months earlier with a primary series of two doses of 50 or 100 µg of mRNA-1273 were administered a booster injection of 50 µg of mRNA-1273. Neutralizing antibody levels against wild-type virus and the Delta variant at one month after the booster were 1.7-fold and 2.1-fold higher, respectively, than those 28 days post primary series second injection indicating an immune memory response. The reactogenicity after the booster dose was similar to that after the second dose in the primary series of two doses of mRNA-1273 (50 or 100 µg) with no serious adverse events reported in the one-month follow-up period. These results demonstrate that a booster injection of mRNA-1273 in previously immunized individuals stimulated an immune response greater than the primary vaccination series.

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Fig. 1 Trial profile for phase 2, parts A and B. Participants who received two doses of mRNA-1273 in part A were offered a booster injection of 50 µg of mRNA-1273 in part B. Completion of part A was defined as participants who completed 6 months of follow-up after the last injection received in part B (open-label phase). Data cutoff was 11 June 2021. *15 participants declined to receive a booster of 50 μg of mRNA-1273; †14 participants declined to receive a booster of 50 μg of mRNA-1273.
Fig. 1 Trial profile for phase 2, parts A and B. Participants who received two doses of mRNA-1273 in part A were offered a booster injection of 50 µg of mRNA-1273 in part B. Completion of part A was defined as participants who completed 6 months of follow-up after the last injection received in part B (open-label phase). Data cutoff was 11 June 2021. *15 participants declined to receive a booster of 50 μg of mRNA-1273; †14 participants declined to receive a booster of 50 μg of mRNA-1273.CC BY · PubMed Central
Fig. 2 Solicited adverse reactions within 7 days after booster injection. a, Solicited local adverse reactions. b, Solicited systemic adverse reactions. The percentage of participants in the solicited safety set who reported local (a) or systemic (b) solicited adverse reactions is shown for 330 participants who received a booster dose of mRNA-1273 (50 μg) after a primary series of two doses of 50 µg or 100 µg of mRNA-1273 in part B; 198 participants who received a booster dose of mRNA-1273 (50 μg) after a primary series of two doses of 100 µg of mRNA-1273 in part B; and 14,691 participants who received two doses of 100 µg of mRNA-1273 in the phase 3 COVE trial. The percentages of participants who submitted any data for the adverse event within 7 days after the booster injection or the second dose during the primary series are shown. Grade 1 adverse reactions are indicated by gray bars, grade 2 adverse reactions by blue bars and grade 3 adverse reactions by red bars.
Fig. 2 Solicited adverse reactions within 7 days after booster injection. a, Solicited local adverse reactions. b, Solicited systemic adverse reactions. The percentage of participants in the solicited safety set who reported local (a) or systemic (b) solicited adverse reactions is shown for 330 participants who received a booster dose of mRNA-1273 (50 μg) after a primary series of two doses of 50 µg or 100 µg of mRNA-1273 in part B; 198 participants who received a booster dose of mRNA-1273 (50 μg) after a primary series of two doses of 100 µg of mRNA-1273 in part B; and 14,691 participants who received two doses of 100 µg of mRNA-1273 in the phase 3 COVE trial. The percentages of participants who submitted any data for the adverse event within 7 days after the booster injection or the second dose during the primary series are shown. Grade 1 adverse reactions are indicated by gray bars, grade 2 adverse reactions by blue bars and grade 3 adverse reactions by red bars.CC BY · PubMed Central
Fig. 3 nAb titers (pseudovirus ID50; D614G) after the primary series and after a booster injection of 50 µg of mRNA-1273 (per-protocol set). The nAb titers in the pseudovirus assay against the D614G virus are shown for serum samples collected in part A at baseline, 28 days after the first dose of mRNA-1273, 28 days after the second dose of mRNA-1273 and in part B before the booster injection of 50 µg of mRNA-1273 (pre-booster) and 28 days after the booster injection. Titers from the group that received two priming doses of 50 µg of mRNA-1273 are shown in green, and those from the group that received two priming doses of 100 µg of mRNA-1273 are shown in blue. The dots show the results from individual serum samples. The tops of the bars show the GMTs. The whiskers were determined using the Tukey method. The tops of the whiskers show the 75th percentile minus the IQR (the difference between the 25th and 75th percentiles). The bottoms of the whiskers show the 25th percentile minus the IQR. Antibody values in the pseudovirus assay reported as below the LLOQ (18.5) were replaced by 0.5× LLOQ. Values that were greater than the ULOQ (45,118) were changed to the ULOQ if actual values were not available.
Fig. 3 nAb titers (pseudovirus ID50; D614G) after the primary series and after a booster injection of 50 µg of mRNA-1273 (per-protocol set). The nAb titers in the pseudovirus assay against the D614G virus are shown for serum samples collected in part A at baseline, 28 days after the first dose of mRNA-1273, 28 days after the second dose of mRNA-1273 and in part B before the booster injection of 50 µg of mRNA-1273 (pre-booster) and 28 days after the booster injection. Titers from the group that received two priming doses of 50 µg of mRNA-1273 are shown in green, and those from the group that received two priming doses of 100 µg of mRNA-1273 are shown in blue. The dots show the results from individual serum samples. The tops of the bars show the GMTs. The whiskers were determined using the Tukey method. The tops of the whiskers show the 75th percentile minus the IQR (the difference between the 25th and 75th percentiles). The bottoms of the whiskers show the 25th percentile minus the IQR. Antibody values in the pseudovirus assay reported as below the LLOQ (18.5) were replaced by 0.5× LLOQ. Values that were greater than the ULOQ (45,118) were changed to the ULOQ if actual values were not available.CC BY · PubMed Central

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References 56 · Cited by 105

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  1. 10.1016/j.vaccine.2021.02.007 · DOI

Metadata

Authors
Chu, L., Montefiori, D., Huang, W., Nestorova, B., Chang, Y., Carfi, A., Edwards, D. K., Oestreicher, J., Legault, H., Girard, B., Pajon, R., Miller, J. M., Das, R., Leav, B., & McPhee, R.
Affiliations
  • Benchmark Research (United States) (US)
  • Duke University (US)
  • Moderna Therapeutics (United States) (US)
Corresponding author
McPhee, Roderick
ORCID
Venue
Nature Medicine
Publisher
openRxiv
Published
2021-10-01
Volume
28
Issue
5
Pages
1042-1049
ISSN
1078-8956 (ISSN-L)
DOI
10.1101/2021.09.29.21264089
PMC
PMC9117133
OpenAlex
W4220654690
Cited by
105
References
56
Citations by year
2026: 8 · 2025: 13 · 2024: 21 · 2023: 27 · 2022: 34 · 2021: 2
FWCI
11.59
Type
journal article
Language
en
Open access
Licence
cc-by
Locations
  • Nature Medicine (publishedVersion, cc-by)
  • medRxiv (acceptedVersion)
  • PubMed Central (publishedVersion, cc-by)
  • PubMed (publishedVersion)
Funders
  • Moderna
  • Biomedical Advanced Research and Development Authority (75A50120C00034)
Topics
  • Health Sciences › Medicine › Infectious Diseases › SARS-CoV-2 and COVID-19 Research
  • Health Sciences › Medicine › Infectious Diseases › COVID-19 Clinical Research Studies
  • Life Sciences › Immunology and Microbiology › Immunology › Immune responses and vaccinations
Keywords
SARS-CoV-2, COVID-19 vaccines, mRNA-1273, booster vaccination, immunogenicity, neutralizing antibodies, Delta variant, antibody waning, seroconversion, anti-spike IgG, vaccine safety, adverse events, memory B cells, non-inferiority, breakthrough infection
MeSH terms
Immunogenicity, Vaccine, COVID-19, SARS-CoV-2, COVID-19 Vaccines, 2019-nCoV Vaccine mRNA-1273, Adult, Antibodies, Viral, Humans, Immunity

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CoChat. (2026). Citation check: Immune Memory Response After a Booster Injection of mRNA-1273 for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). https://app.cochat.ai/papers/10.1101/2021.09.29.21264089
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Chu, L., Montefiori, D., Huang, W., Nestorova, B., Chang, Y., Carfi, A., Edwards, D. K., Oestreicher, J., Legault, H., Girard, B., Pajon, R., Miller, J. M., Das, R., Leav, B., & McPhee, R. (2021). Immune Memory Response After a Booster Injection of mRNA-1273 for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2). Nature Medicine. https://doi.org/10.1101/2021.09.29.21264089