Evidence map›Paper›PMID 40119775›Full record

Trial reportThe Journal of infectious diseases2025

Evaluation of Cellular Immune Responses After mRNA-1273 Vaccination in Children 6 Months to 11 Years of Age.

Christina A Rostad, James D Campbell, Grant C Paulsen, Sabine Schnyder Ghamloush, Wenqin Xu, Lingyi Zheng, M Juliana McElrath, Stephen C De Rosa, Bethany Girard, Rituparna Das and 2 more

Registry-linked trialAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in The Journal of infectious diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04796896 (A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
–field-weighted citation impact
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.

NCT04796896 phase2 / phase3completednot on this map

A Phase 2/3, Three-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age

TypeinterventionalSponsorModernaTX, Inc.Ran2021 to 2024Enrolled11,942ConditionsSARS-CoV-2ArmsmRNA-1273, Placebo, mRNA-1273.214
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Article
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

12 authors.

Christina A RostadDepartment of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.ORCID 0000-0001-8439-0592
James D CampbellCenter for Vaccine Development and Global Health, University of Maryland School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0002-2931-9643
Grant C PaulsenDepartment of Pediatrics, Division of Pediatric Infectious Diseases, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, Ohio, USA.
Sabine Schnyder GhamloushModerna, Inc, Cambridge, Massachusetts, USA.
Wenqin XuModerna, Inc, Cambridge, Massachusetts, USA.
Lingyi ZhengModerna, Inc, Cambridge, Massachusetts, USA.
M Juliana McElrathVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Stephen C De RosaVaccine and Infectious Disease Division, Fred Hutchinson Cancer Center, Seattle, Washington, USA.
Bethany GirardModerna, Inc, Cambridge, Massachusetts, USA.ORCID 0000-0001-9390-230X
Rituparna DasModerna, Inc, Cambridge, Massachusetts, USA.
Evan J AndersonDepartment of Pediatrics, Emory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, Georgia, USA.ORCID 0000-0002-1576-4420
C Buddy CreechVanderbilt Vaccine Research Program, Vanderbilt University Medical Center, Nashville, Tennessee, USA.

Funding

LC: HIV Vaccine Trials NetworkUM1AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI Margaret Juliana McElrath · 2011 to 2026
$483.6M
HVTN Laboratory ProgramU01AI068618 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI MCELRATH, MARGARET JULIANA · 2006 to 2010
$82.6M
Leadership Group for the Infectious Diseases Clinical Research Consortium (IDCRCLG) - Momi-Vax DMID #21-0004 {Supplement #6}UM1AI148684 · NIAID · EMORY UNIVERSITY · PI DAVID S STEPHENS · 2020 to 2026
$77.2M
Cincinnati Children's Hospital Medical Center Vaccine and Treatment Evaluation Units (UM1 Clinical Trial Required) - Moderna Pediatric StudyUM1AI148372 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI Robert Wilson Frenck · 2020 to 2026
$20.5M
Administration for Strategic Preparedness and ResponseBiomedical Advanced Research and Development Authority 75A50120C00034HHSHIV Vaccine Trials Network UM1AI068618National Institute of Allergy and Infectious DiseasesNIAID NIH HHS U01 AI068618NIAID NIH HHS UM1 AI068618NIAID NIH HHS UM1 AI148372NIAID NIH HHS UM1 AI148684NIH HHS AI068618NIH HHS UM1NIH HHS UM1AI148684
6 · The paper itself

Abstract

backgroundCell-mediated immunity (CMI) may help protect against emerging severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants that are less susceptible to neutralizing antibodies. We present CMI data after the mRNA-1273 primary series in a subset of participants aged 6 months to 11 years from the phase 2/3 KidCOVE trial.

methodsT-cell responses were assessed after 2 doses of mRNA-1273 (6 months to 5 years, 25 μg; 6-11 years, 50 μg) or placebo administered 28 days apart. Magnitude, phenotype, and percentage of ancestral SARS-CoV-2 spike (S) protein T-cell responses to pooled peptides were assessed by intracellular cytokine staining and polyfunctionality analyses.

resultsA total of 68 children aged 6 months to 11 years received either the 2-dose mRNA-1273 primary series or placebo (51 and 17, respectively) at 28-day interval. mRNA-1273 induced S-protein-specific CD4+ T-cell responses exhibiting a type 1 T helper (Th1)-biased profile at day 43 and day 209 compared with placebo. S-protein-specific CD8+ T-cell responses were less frequently detected in children <5 years and undetectable in those <2 years. Compared with placebo, mRNA-1273 induced higher frequencies of S-specific polyfunctional CD4+ T cells at day 43; frequencies declined but remained detectable at day 209. Correlation between Th1 CD4+ responses and neutralizing antibodies was observed across age groups following mRNA-1273 vaccination.

conclusionsThe 2-dose mRNA-1273 primary series elicited robust and durable (≥ 6 months) Th1-biased CD4+ T-cell responses in children aged 6 months to 11 years. CD8+ T-cell responses varied by age. Clinical Trials Registration. NCT04796896.

Indexed as

2019-nCoV Vaccine mRNA-1273COVID-19Immunity, CellularSARS-CoV-2Antibodies, NeutralizingAntibodies, ViralCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesChildChild, PreschoolFemaleHumansInfantMaleSpike Glycoprotein, CoronavirusVaccination2019-nCoV Vaccine mRNA-1273Antibodies, NeutralizingAntibodies, ViralSpike Glycoprotein, Coronavirusspike protein, SARS-CoV-2COVID-19pediatricSARS-CoV-2T cellsvaccine

Identifiers

PMID40119775
PMCPMC12128075

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

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.