Evidence map›Paper›PMID 37731485›Full record

ArticleFrontiers in immunology2023

Immunological correlates of protection afforded by PHV02 live, attenuated recombinant vesicular stomatitis virus vector vaccine against Nipah virus disease.

Thomas P Monath, Richard Nichols, Friederike Feldmann, Amanda Griffin, Elaine Haddock, Julie Callison, Kimberly Meade-White, Atsushi Okumura, Jamie Lovaglio, Patrick W Hanley and 4 more

Registry-linked trialAbstract read
In one paragraph

Article in Frontiers in immunology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06221813 (A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing 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.

NCT06221813 phase1completednot on this mapstarted 2024, after this paper: background citation

A Phase 1b Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of a Prime-Boost Regimen of Three Dose Levels of PHV02, a Nipah Virus Vaccine Candidate (rVSV-ΔG-EBOV GP-NiVG) in Healthy Adults

TypeinterventionalSponsorPublic Health Vaccines LLCRan2024 to 2024Enrolled120ConditionsNipah Virus InfectionArmsPHV02, Lactated Ringer's
3 · Its place in the literature

Who cites it

22 citing papers in PubMed.

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  18. Article
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  20. Vaccine adjuvants for infectious disease in the clinic.Bioengineering & translational medicine · 2024
    Review
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

14 authors.

Thomas P MonathCrozet Biopharma LLC, Lexington, MA, United States.
Richard NicholsPublic Health Vaccines Inc., Cambridge, MA, United States.
Friederike FeldmannRocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Amanda GriffinLaboratory of Virology, Division of Intramural Studies, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Elaine HaddockLaboratory of Virology, Division of Intramural Studies, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Julie CallisonLaboratory of Virology, Division of Intramural Studies, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Kimberly Meade-WhiteLaboratory of Virology, Division of Intramural Studies, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Atsushi OkumuraLaboratory of Virology, Division of Intramural Studies, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Jamie LovaglioRocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Patrick W HanleyRocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Chad S ClancyRocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Carl ShaiaRocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Hamilton, MT, United States.
Wasima RidaBiostatistics Consultant, Arlington, VA, United States.
Joan FuscoPublic Health Vaccines Inc., Cambridge, MA, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Introduction: Immune correlates of protection afforded by PHV02, a recombinant vesicular stomatitis (rVSV) vector vaccine against Nipah virus (NiV) disease, were investigated in the African green monkey (AGM) model. Neutralizing antibody to NiV has been proposed as the principal mediator of protection against future NiV infection. Methods: Two approaches were used to determine the correlation between neutralizing antibody levels and outcomes following a severe (1,000 median lethal doses) intranasal/intratracheal (IN/IT) challenge with NiV (Bangladesh): (1) reduction in vaccine dose given 28 days before challenge and (2) challenge during the early phase of the antibody response to the vaccine. Results: Reduction in vaccine dose to very low levels led to primary vaccine failure rather than a sub-protective level of antibody. All AGMs vaccinated with the nominal clinical dose (2 × 10 Discussion and conclusion: It was concluded that PHV02 vaccine elicited a rapid onset of protection and that any detectable level of neutralizing antibody was a functional immune correlate of survival.

Indexed as

Ebola VaccinesHemorrhagic Fever, EbolaHenipavirus InfectionsNipah VirusVesicular StomatitisAnimalsAntibodies, NeutralizingChlorocebus aethiopsAntibodies, NeutralizingEbola Vaccinesimmune correlateneutralizing antibodyNipah virusrecombinant VSVvaccine

Identifiers

PMID37731485
PMCPMC10507387

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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.