Evidence map›Paper›PMID 38478705›Full record

Trial reportThe Journal of infectious diseases2024

Safety and Immunogenicity of a Messenger RNA-Based Cytomegalovirus Vaccine in Healthy Adults: Results From a Phase 1 Randomized Clinical Trial.

Carlos Fierro, Daniel Brune, Marian Shaw, Howard Schwartz, Conor Knightly, Jiang Lin, Andrea Carfi, Andrew Natenshon, Shiva Kalidindi, Caroline Reuter and 2 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03382405 (A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults), which is not on this map. Cited by 34 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 2 pooled it
19.7field-weighted citation impact, top 1% 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.

NCT03382405 phase1completednot on this map

A Phase 1, Randomized, Observer-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Cytomegalovirus Vaccines mRNA-1647 and mRNA-1443 When Administered to Healthy Adults

TypeinterventionalSponsorModernaTX, Inc.Ran2017 to 2020Enrolled181ConditionsCytomegalovirus InfectionArmsmRNA-1647, mRNA-1443, Placebo
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 2 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  5. Towards mRNA therapeutics 2.0.Nature reviews. Drug discovery · 2026
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  17. Immunology of RNA-based vaccines: The critical interplay between inflammation and expression.Molecular therapy : the journal of the American Society of Gene Therapy · 2025
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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 at 5 institutions in 1 country.

Carlos FierroJohnson County Clin-Trials, Department of Clinical Safety & Risk Management, Lenexa, Kansas.
Daniel BruneOptimal Research, LLC, Peoria, Illinois.
Marian ShawAdvanced Clinical Research, Meridian, Idaho.
Howard SchwartzResearch Centers of America, LLC, Hollywood, Florida.
Conor KnightlyModerna, Inc, Department of Clinical Development Operations, Cambridge, Massachusetts.
Jiang LinModerna, Inc, Department of Biostatistics, Cambridge, Massachusetts.
Andrea CarfiModerna, Inc, Department of Research and Development, Cambridge, Massachusetts.
Andrew NatenshonModerna, Inc, Department of Infectious Disease Development, Cambridge, Massachusetts.
Shiva KalidindiModerna, Inc, Department of Statistical Programming, Cambridge, Massachusetts.
Caroline ReuterJohnson County Clin-Trials, Department of Clinical Safety & Risk Management, Lenexa, Kansas.
Jacqueline MillerModerna, Inc, Department of Infectious Diseases, Cambridge, Massachusetts.
Lori PantherModerna, Inc, Department of Infectious Diseases, Cambridge, Massachusetts.
Moderna Therapeutics (United States) · USJohnson County Clin-Trials (United States) · USCancer Treatment Centers of America · USMeridian Clinical Research · USOptimal Solutions (United States) · US

Funding

Moderna, Inc
6 · The paper itself

Abstract

backgroundThis phase 1 trial evaluated the safety, reactogenicity, and immunogenicity of mRNA-1647, a messenger RNA (mRNA)-based cytomegalovirus (CMV) vaccine, in CMV-seronegative and -seropositive adults.

methodsParticipants were randomly assigned to receive 30, 90, 180, or 300 µg of mRNA-1647 or placebo on a 0-, 2-, and 6-month schedule and followed for 12 months after the last dose.

resultsA total of 154 (80 CMV-seronegative and 74 CMV-seropositive) participants were enrolled; 118 participants were randomized to mRNA-1647 and 36 to placebo. Mean (standard deviation) age was 32.5 (8.6) and 35.1 (8.9) years in the placebo and mRNA-1647 groups, respectively, in phase B (63% and 64% female) and 42.5 (6.2) and 33.3 (8.7) years, respectively, in phase C (2% and 16% female). No deaths, related serious adverse events, or adverse events of special interest were reported. Most adverse reactions were grade ≤2 severity. Increased neutralizing antibody, binding antibody, and antigen-specific cell-mediated responses were observed across mRNA-1647 treatment groups, regardless of CMV serostatus.

conclusionsThis phase 1, first-in-human trial demonstrated that mRNA-1647 has an acceptable safety profile in adults and elicits humoral and cellular immune responses. Clinical Trials Registration.  NCT03382405.

Indexed as

Antibodies, ViralCytomegalovirusCytomegalovirus InfectionsCytomegalovirus VaccinesRNA, MessengerAdultAntibodies, NeutralizingDouble-Blind MethodFemaleHealthy VolunteersHumansImmunogenicity, VaccineMaleMiddle AgedYoung AdultAntibodies, NeutralizingAntibodies, ViralCytomegalovirus VaccinesRNA, MessengercCMVCMVcongenital cytomegaloviruscytomegalovirusviral vaccine

Identifiers

PMID38478705
PMCPMC11420795
OpenAlexW4392745103

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.