Evidence map›Paper›PMID 37377402›Full record

Observational studyCancer communications (London, England)2023

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

Anna Giuliano, Barbara Kuter, Shari Pilon-Thomas, Junmin Whiting, Qianxing Mo, Brett Leav, Bradley Sirak, Christopher Cubitt, Christopher Dukes, Kimberly Isaacs-Soriano and 6 more

Open access · goldAbstract readObservational Study
In one paragraph

Observational study in Cancer communications (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 8 citations in OpenAlex.

  1. Pooled it
  2. Review
  3. Review
  4. Article
  5. Article
  6. Article
  7. Cancer/Testis Antigens as Targets for RNA-Based Anticancer Therapy.International journal of molecular sciences · 2023
    Review
  8. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 2 countries.

Anna GiulianoDepartment of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida, USA.
Barbara KuterModerna, Cambridge, Massachusetts, USA.
Shari Pilon-ThomasDepartment of Immunology, Moffitt Cancer Center, Tampa, Florida, USA.
Junmin WhitingDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA.
Qianxing MoDepartment of Biostatistics and Bioinformatics, Moffitt Cancer Center, Tampa, Florida, USA.
Brett LeavModerna, Cambridge, Massachusetts, USA.
Bradley SirakDepartment of Cancer Epidemiology, Moffitt Cancer Center, Tampa, Florida, USA.
Christopher CubittImmune Monitoring Core, Moffitt Cancer Center, Tampa, Florida, USA.
Christopher DukesDepartment of Immunology, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-6322-1834
Kimberly Isaacs-SorianoNon-Therapeutic Research Office (NTRO), Moffitt Cancer Center, Tampa, Florida, USA.
Kayoko KennedyNon-Therapeutic Research Office (NTRO), Moffitt Cancer Center, Tampa, Florida, USA.
Somedeb BallDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA.
Ning DongDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA.
Akriti JainDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA.
Patrick HwuDepartment of Immunology, Moffitt Cancer Center, Tampa, Florida, USA.
Jeffrey LancetDepartment of Malignant Hematology, Moffitt Cancer Center, Tampa, Florida, USA.ORCID 0000-0002-7751-7310
Moffitt Cancer Center · USModerna Therapeutics (United States) · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI John L. Cleveland · 1998 to 2026
$93.5M
NCI NIH HHS P30 CA076292
6 · The paper itself

Abstract

backgroundCompared 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.

methodsThe 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 X

resultsAmong 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 seronegative for SARS-CoV-2 antibody pre-dose three, 69.2% seroconverted after dose three. A majority (70.4%) experienced mostly mild, transient adverse reactions within 14 days of dose three, whereas severe treatment-emergent events within 28 days were very rare (<2%).

conclusionDose three of the mRNA-1273 vaccine was well-tolerated and augmented SARS-CoV-2 seropositivity in cancer patients, especially those who did not seroconvert post-dose two or whose GMTs significantly waned post-dose two. Lymphoid cancer patients experienced lower humoral responses to dose three of the mRNA-1273 vaccine, suggesting that timely access to boosters is important for this population.

Indexed as

COVID-19Neoplasms2019-nCoV Vaccine mRNA-1273AdultHumansSARS-CoV-22019-nCoV Vaccine mRNA-1273CancerCoronavirus disease 2019ImmunogenicityObservational studyVaccination

Identifiers

PMID37377402
PMCPMC10354405
OpenAlexW4382345376

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.