Safety and immunogenicity of a third dose of mRNA-1273 vaccine among cancer patients

Sep 24, 2026

Cancer patients face higher morbidity and mortality risk after SARS-CoV-2 infection than the general population, and immune responses to two-dose mRNA vaccines are typically lower than in immunocompetent individuals. Booster dosing may strengthen immunity in this setting. An observational study evaluated immunogenicity of a third dose (100 μg) of mRNA-1273 as the primary objective, and assessed safety at 14 and 28 days as a secondary objective.

LanguageEnglish

CategoryHealthcare

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Pages16

Reading Time40 min

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Abstract

Background

Methods

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DOI: 10.1002/cac2.12453 ORIGINAL ARTICLE Safety and immunogenicity of a third dose of mRNA-1273 vaccine among cancer patients Anna Giuliano1 Barbara Kuter2 Shari Pilon-Thomas3 Junmin Whiting4 Qianxing Mo4 Brett Leav2 Bradley Sirak1 Christopher Cubitt5 Christopher Dukes3 Kimberly Isaacs-Soriano6 Kayoko Kennedy6 Somedeb Ball7 Ning Dong7 Akriti Jain7 Patrick Hwu3 Jeffrey Lancet7 1 Department of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida, USA 2Moderna, Cambridge, Massachusetts, USA 3 Department of Immunology, Moffitt Cancer Center, Tampa, Florida, USA 4 Department of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA 5 Immune Monitoring Core, Moffitt Cancer Center, Tampa, Florida, USA 6Non-Therapeutic Research Office (NTRO), Moffitt Cancer Center, Tampa, Florida, USA 7 Department of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA Correspondence Jeffrey E Lancet, MD, Chair, Department of Malignant Hematology; Moffitt Cancer Center, Tampa, 33612, Florida, United States of America. [Email:](Email: jeffrey.lancet@moffitt.org)[ jeffrey.lancet@moffitt.org](Email: jeffrey.lancet@moffitt.org) Funding information Biostatistics and Bioinformatics Shared Resource; NCI-designated Comprehensive Cancer Center, Grant/Award Number: P30-CA076292 Abstract Background: Compared to the general population, cancer patients are at higher risk of morbidity and mortality following SARS-CoV-2 infection. The immune response to a two-dose regimen of mRNA vaccines in cancer patients is generally lower than in immunocompetent individuals. Booster doses may meaningfully augment immune response in this population. We conducted an observational study with the primary objective of determining the immunogenicity of vaccine dose three (100 μg) of mRNA-1273 among cancer patients and a secondary objective of evaluating safety at 14 and 28 days. Methods: The mRNA-1273 vaccine was administered ∼7 to 9 months after administering two vaccine doses (i.e., the primary series) . Immune responses (enzyme-linked immunosorbent assay [ELISA]) were assessed 28 days post-dose three. Adverse events were collected at days 14 (± 5) and 28 (+5) post-dose three. Fisher exact or X2 tests were used to compare SARS-CoV-2 antibody positivity Abbreviations: ACIP, Advisory Committee on Immunization Practices; BTK, Bruton’s tyrosine kinase; CAR-T, chimeric antigen receptor T-cell; COVID-19, coronavirus disease 2019; ELISA, enzyme-linked immunosorbent assay; GMTs, geometric mean titers; HM, hematologic malignancies; IgA, immunoglobulin A; IgG, immunoglobulin G; IgM, immunoglobulin M; IRB, Institutional Review Board; MCC, Moffitt Cancer Center; STROBE, STrengthening the Reporting of OBservational Studies in Epidemiology. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. © 2023 The Authors. Cancer Communications published by John Wiley & Sons Australia, Ltd. on behalf of Sun Yat-sen University Cancer Center. GIULIANO et al. rates, and paired t-tests were used to compare SARS-CoV-2 antibody geometric mean titers (GMTs) across different time intervals. Results: Among 284 adults diagnosed with solid tumors or hematologic malignancies, dose three of mRNA-1273 increased the percentage of patients seropositive for SARS-CoV-2 antibody from 81.7% pre-dose three to 94.4% 28 days post-dose three. GMTs increased 19.0-fold (15.8-22.8) . Patients with lymphoid cancers or solid tumors had the lowest and highest antibody titers post–dose three, respectively. Antibody responses after dose three were reduced among those who received anti-CD20 antibody treatment, had lower total lymphocyte counts and received anticancer therapy within 3 months. Among patients ser

FAQs

What was the primary objective of the study?

To determine the immunogenicity of vaccine dose three (100 μg) of mRNA-1273 among cancer patients.

How did the researchers assess immune responses and safety?

Immune responses were assessed using ELISA 28 days after dose three, and adverse events were collected at days 14 (±5) and 28 (+5) post-dose three.

What were the main safety and immunogenicity findings for the third dose?

Dose three increased SARS-CoV-2 seropositivity and antibody geometric mean titers, and it was well tolerated, with mostly mild, transient adverse reactions within 14 days and very rare severe events within 28 days.

Sep 24, 2026

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