Evidence map›Paper›PMID 41191941›Full record

Trial reportThe New England journal of medicine2025

Safety and Immunogenicity of an rVSV Lassa Fever Vaccine Candidate.

Elissa Malkin, Marija Zaric, Mark Kieh, Lindsey R Baden, David Fitz-Patrick, Arianna Marini, Heejin Yun, Peter Hayes, Rachel Bromell, Morolayo Ayorinde and 34 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IMulticenter Study
In one paragraph

Trial report in The New England journal of medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04794218 (A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath), which is not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing 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.

NCT04794218 phase1unknown statusnot on this map

A Phase 1 Randomized, Double-blinded, Placebo-controlled, Dose-escalation Clinical Trial to Evaluate the Safety and Immunogenicity of rVSV∆G-LASV-GPC Vaccine in Adults in Good General Heath

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2021 to 2024Enrolled114ConditionsLassa Fever, Lassa Virus InfectionArmsrVSV∆G-LASV-GPC, Placebo/Diluent
3 · Its place in the literature

Who cites it

16 citing papers in PubMed.

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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

44 authors.

Elissa MalkinVaccine Research Unit, George Washington University, Washington, DC.
Marija ZaricInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Mark KiehPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Lindsey R BadenBrigham and Women's Hospital, Boston.
David Fitz-PatrickEast-West Medical Research Institute, Honolulu.
Arianna MariniInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Heejin YunInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Peter HayesInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Rachel BromellInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Morolayo AyorindeInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Natalia FernandezInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.ORCID 0000-0002-4213-079X
Ruhani VarmaInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.ORCID 0009-0002-9722-1442
Faith SigeiInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Matthew WardInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Hema PindoliaInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Shayna SewellInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Fahimah AminiInternational AIDS Vaccine Initiative (IAVI) Human Immunology Laboratory, Imperial College London, London.
Julie BliePartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Barthalomew WilsonPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Patrick FaleyPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
John McCulloughPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Franklin TokpahPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Cecelia WissehPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Elvis TowalidPartnership for Research on Vaccines and Infectious Diseases in Liberia, Monrovia.
Swapnil HadawaleIAVI, New York.
Eddy SayeedIAVI, New York.
Devin HuntIAVI, New York.
Nahid KeshavarziIAVI, New York.
Burc BarinEmmes, Rockville, MD.
Irina Maljkovic BerryIntegrated Research Facility at Fort Detrick, Division of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Frederick, MD.
Christopher L ParksIAVI, New York.
Shobhna Gopal TruterIAVI, New York.
Kathleen WalkerIAVI, New York.
Johan VekemansIAVI, New York.
Jennifer LehrmanIAVI, New York.
Michelle EngelbrechtIAVI, New York.
Mariette MalherbeIAVI, New York.
Dagna LauferIAVI, New York.
Vincent PhiliponisIAVI, New York.
Elizabeth HiggsDivision of Clinical Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD.
Gaudensia MutuaIAVI, New York.
Patricia E FastIAVI, New York.
Swati B GuptaIAVI, New York.
rVSVΔG-LASV-GPC Study Group

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
NCI NIH HHS 75N91019D00024NIH HHS HHSN272201800013C
6 · The paper itself

Abstract

backgroundNo vaccine is currently available for Lassa fever, a viral hemorrhagic disease that is estimated to cause thousands of deaths each year in western Africa. A replication-competent recombinant vesicular stomatitis virus-vectored vaccine encoding a Lassa virus (LASV) glycoprotein complex, rVSVΔG-LASV-GPC, has been developed, but data on its safety and immunogenicity are limited.

methodsIn this phase 1, double-blind trial conducted in the United States and Liberia, we randomly assigned healthy adults (18 to 50 years of age) to receive rVSVΔG-LASV-GPC or placebo intramuscularly. Participants received a single vaccine dose of 2×10

resultsA total of 114 adults were enrolled. No serious vaccine-related adverse events were reported. The vaccine caused minimal local reactions and dose-dependent, mild-to-severe early-onset systemic reactogenicity events that were transient. No hearing loss was detected. All doses induced robust long-lasting cellular and humoral (binding and neutralizing) responses that cross-reacted against common LASV lineages. No infectious vaccine virus particles were found in plasma, urine, or saliva.

conclusionsThe rVSVΔG-LASV-GPC vaccine resulted in transient local and systemic reactogenicity events but no hearing loss or serious adverse events. The vaccine had immunogenicity over a wide dose range in healthy adults in the United States and Liberia. (Funded by the Coalition for Epidemic Preparedness Innovations and the National Institute of Allergy and Infectious Diseases; ClinicalTrials.gov number, NCT04794218; Pan African Clinical Trials Registry number, PACTR2021106625781067.).

Indexed as

Immunogenicity, VaccineLassa FeverLassa virusViral VaccinesAdolescentAdultAntibodies, NeutralizingAntibodies, ViralDouble-Blind MethodFemaleHealthy VolunteersHearing LossHumansImmunization, SecondaryInjections, IntramuscularLiberiaAntibodies, NeutralizingAntibodies, ViralVaccines, SyntheticViral Vaccines

Identifiers

PMID41191941
PMCPMC12614316

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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.