Evidence map›Paper›PMID 33121346›Full record

Trial reportHuman vaccines & immunotherapeutics2021

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults.

Antonios O Aliprantis, Christine A Shaw, Paul Griffin, Nicholas Farinola, Radha A Railkar, Xin Cao, Wen Liu, Jeffrey R Sachs, Christine J Swenson, Heather Lee and 8 more

Open access · bronzeAbstract readClinical Trial, Phase IRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Human vaccines & immunotherapeutics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 86 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
86citing papers in PubMed, 4 pooled it
11.2field-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.

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

86 citing papers in PubMed, 4 syntheses or guidelines pooled it, 146 citations in OpenAlex.

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  3. Vaccines for the common cold.The Cochrane database of systematic reviews · 2022
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26 more citing papers are in PubMed but not listed here.

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

18 authors at 4 institutions in 3 countries.

Antonios O AliprantisMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0002-8744-2535
Christine A ShawModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-0471-206X
Paul GriffinQPharm, Herston, Australia.ORCID 0000-0002-1656-421X
Nicholas FarinolaCMAX, Adelaide, Australia.ORCID 0000-0002-9855-6984
Radha A RailkarMerck & Co., Inc., Kenilworth, NJ, USA.
Xin CaoMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0002-7633-845X
Wen LiuMerck & Co., Inc., Kenilworth, NJ, USA.
Jeffrey R SachsMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0001-5725-558X
Christine J SwensonModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-4693-2597
Heather LeeModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-7310-341X
Kara S CoxMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0002-5798-2944
Daniel S SpellmanMerck & Co., Inc., Kenilworth, NJ, USA.
Colleen J WinsteadMerck & Co., Inc., Kenilworth, NJ, USA.
Igor SmolenovModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-7075-9827
Eseng LaiMerck & Co., Inc., Kenilworth, NJ, USA.
Tal ZaksModerna, Inc., Cambridge, MA, USA.
Amy S EspesethMerck & Co., Inc., Kenilworth, NJ, USA.ORCID 0000-0003-2213-909X
Lori PantherModerna, Inc., Cambridge, MA, USA.ORCID 0000-0002-8223-9167
Merck & Co., Inc., Rahway, NJ, USA (United States) · USModerna Therapeutics (United States) · USCenter For Medicare Advocacy · USThe University of Queensland · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Respiratory Syncytial Virus (RSV) causes lower respiratory tract infections that can be severe and sometimes fatal. The risk for severe RSV infection is highest in infants and older adults. A safe and effective RSV vaccine for older adults represents a serious unmet medical need due to higher morbidity and mortality in this age group. In this randomized, partially double-blind, placebo-controlled, phase 1 dose-escalation study, we evaluated the safety, tolerability and immunogenicity of an investigational messenger ribonucleic acid (mRNA) vaccine encoding the RSV fusion protein (F) stabilized in the prefusion conformation. The study was conducted in healthy younger adults (ages ≥18 and ≤49 years) and healthy older adults (ages ≥60 and ≤79 years). Participants received mRNA-1777 (V171) or placebo as a single intramuscular dose. For each dose level, three sentinel participants were administered open-label mRNA-1777 (V171). Seventy-two younger adults were randomized and administered 25, 100, or 200 µg mRNA-1777 (V171) or placebo, and 107 older adults were randomized and administered 25, 100, 200 or 300 µg mRNA-1777 (V171) or placebo. Primary objectives were safety and tolerability and secondary objectives included humoral and cell-mediated immunogenicity. All dose levels of mRNA-1777 (V171) were generally well tolerated and no serious adverse events related to the vaccine were reported. Immunization with mRNA-1777 (V171) elicited a humoral immune response as measured by increases in RSV neutralizing antibody titers, serum antibody titers to RSV prefusion F protein, D25 competing antibody titers to RSV prefusion F protein, and cell-mediated immune responses to RSV-F peptides.

Indexed as

Respiratory Syncytial Virus, HumanRespiratory Syncytial Virus InfectionsRespiratory Syncytial Virus VaccinesAgedAntibodies, NeutralizingAntibodies, ViralHumansImmunogenicity, VaccineMiddle AgedRNA, MessengerViral Fusion ProteinsAntibodies, NeutralizingAntibodies, ViralRespiratory Syncytial Virus VaccinesRNA, MessengerViral Fusion Proteinsprefusion FRespiratory Syncytial VirusRSVvaccinevaccine safety and immunogenicity

Identifiers

PMID33121346
PMCPMC8078688
OpenAlexW3096720517

What OpenQuestion holds

Textmetadata
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.