Evidence map›Paper›PMID 35809371›Full record

Trial reportEBioMedicine2022

Safety and immunogenicity of intramuscular, single-dose V590 (rVSV-SARS-CoV-2 Vaccine) in healthy adults: Results from a phase 1 randomised, double-blind, placebo-controlled, dose-ranging trial.

Jonathan A Robbins, Dereck Tait, Qinlei Huang, Sheri Dubey, Tami Crumley, Josee Cote, Julie Luk, Jeffrey R Sachs, Kathryn Rutkowski, Harriet Park and 15 more

Open access · goldAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in EBioMedicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.4field-weighted citation impact, top 9% 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

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 24 citations in OpenAlex.

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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

25 authors at 5 institutions in 1 country.

Jonathan A RobbinsMerck & Co., Inc., Rahway, New Jersey, USA. Electronic address: jonathan.robbins@merck.com.
Dereck TaitThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USA.
Qinlei HuangMerck & Co., Inc., Rahway, New Jersey, USA.
Sheri DubeyMerck & Co., Inc., Rahway, New Jersey, USA.
Tami CrumleyMerck & Co., Inc., Rahway, New Jersey, USA.
Josee CoteMerck & Co., Inc., Rahway, New Jersey, USA.
Julie LukMerck & Co., Inc., Rahway, New Jersey, USA.
Jeffrey R SachsMerck & Co., Inc., Rahway, New Jersey, USA.
Kathryn RutkowskiThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USA.
Harriet ParkThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USA.
Robert SchwabCelerion, Lincoln, Nebraska, USA.
William Joseph HowittBio-Kinetic Clinical Applications (QPS), Missouri, USA.
Juan Carlos RondonClinical Pharmacology of Miami, Florida, USA.
Martha Hernandez-IllasQPS Miami Research Associates, Florida, USA.
Terry O'ReillyCelerion, Lincoln, Nebraska, USA.
William SmithAlliance for Multispecialty Research, LLC, Knoxville, Tennessee, USA.
Jakub SimonMerck & Co., Inc., Rahway, New Jersey, USA.
Cathy HardaloMerck & Co., Inc., Rahway, New Jersey, USA.
Xuemei ZhaoMerck & Co., Inc., Rahway, New Jersey, USA.
Richard WnekMerck & Co., Inc., Rahway, New Jersey, USA.
Alethea CopeThe International AIDS Vaccine Initiative, Inc. (IAVI), New York, USA.
Eseng LaiMerck & Co., Inc., Rahway, New Jersey, USA.
Paula AnnunziatoMerck & Co., Inc., Rahway, New Jersey, USA.
Dalya GurisMerck & Co., Inc., Rahway, New Jersey, USA.
S Aubrey StochMerck & Co., Inc., Rahway, New Jersey, USA.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USInternational AIDS Vaccine Initiative · USCelerion (United States) · USAlliance for Multispecialty Research (United States) · USClinical Pharmacology of Miami · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundVaccines against COVID-19 are needed to overcome challenges associated with mitigating the global pandemic. We report the safety and immunogenicity of V590, a live recombinant vesicular stomatitis virus-based COVID-19 vaccine candidate.

methodsIn this placebo-controlled, double-blind, three-part phase 1 study, healthy adults were randomised to receive a single intramuscular dose of vaccine or placebo. In Part 1, younger (18-54 years) and, in Part 2, older (≥55 years) adults seronegative for SARS-CoV-2 nucleocapsid received one of four V590 dose levels (5.00 × 10

findings232 participants were randomised and 219 completed the study. In seronegative participants, anti-SARS-CoV-2 spike-specific antibody responses to V590 were low and comparable to placebo across the lower dose levels. At the highest dose level (5.55 × 10

interpretationV590 was generally well-tolerated. However, Day 28 anti-SARS-Cov-2 spike-specific antibody responses in seronegative participants following a single intramuscular administration of V590 were not sufficient to warrant continued development.

fundingThe study was funded by Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

Indexed as

COVID-19COVID-19 VaccinesAdultAntibodies, ViralDouble-Blind MethodHumansPandemicsSARS-CoV-2VaccinesAntibodies, ViralCOVID-19 VaccinesVaccinesCOVID-19SARS-CoV-2V590VaccineVesicular stomatitis virus (VSV)

Identifiers

PMID35809371
PMCPMC9259069
OpenAlexW4284989952

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.