Evidence map›Paper›PMID 20350191›Full record

Trial reportThe Journal of infectious diseases2010

Safety and immunogenicity of modified vaccinia Ankara (ACAM3000): effect of dose and route of administration.

Marissa B Wilck, Michael S Seaman, Lindsey R Baden, Stephen R Walsh, Lauren E Grandpre, Colleen Devoy, Ayush Giri, Jane A Kleinjan, Lizanne C Noble, Kristen E Stevenson and 2 more

Erratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of infectious diseases, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT00133575 (ACAM 3000 MVA), which is not on this map. Cited by 49 papers.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed
3.0field-weighted citation impact, top 8% 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.

NCT00133575 phase1 / phase2completednot on this map

ACAM 3000 MVA (Acambis Modified Vaccinia Ankara) Immunization Followed by Dryvax® Vaccination of Healthy Vaccinia-Naïve Adults: A Phase I/II, Placebo-Controlled Study of the Effects of Dose and Route of Administration of MVA on Safety, Reactogenicity and Immunogenicity, Followed by Dryvax® Immunization to Assess Effects of MVA Vaccination on Dryvax® Takes

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2005 to 2008Enrolled72ConditionsSmallpoxArmsMVA Smallpox Vaccine, Placebo, Live vaccinia virus vaccine
3 · Its place in the literature

Who cites it

49 citing papers in PubMed, 74 citations in OpenAlex.

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  16. A Review of Mpox Outbreak and Public Health Response in Spain.Risk management and healthcare policy · 2024
    Review
  17. Review
  18. Article
  19. Article
  20. Monkeypox: epidemiology, pathogenesis, treatment and prevention.Signal transduction and targeted therapy · 2022
    Review
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

12 authors at 4 institutions in 1 country.

Marissa B WilckDivision of Infectious Diseases, Brigham and Women's Hospital, Boston, Massachusetts, USA.
Michael S Seaman
Lindsey R Baden
Stephen R Walsh
Lauren E Grandpre
Colleen Devoy
Ayush Giri
Jane A Kleinjan
Lizanne C Noble
Kristen E Stevenson
Haesook T Kim
Raphael Dolin
Brigham and Women's Hospital · USBeth Israel Deaconess Medical Center · USDana-Farber Cancer Institute · USHarvard University · US

Funding

Treatments for Nipah Virus InfectionU54AI057159 · NIAID · HARVARD UNIVERSITY (MEDICAL SCHOOL) · PI KASPER, DENNIS L. · 2003 to 2013
$113.7M
Research Resource Technical Development ComponentU19AI057330 · NIAID · DANA-FARBER CANCER INSTITUTE · PI REINHERZ, ELLIS L · 2003 to 2009
$19.5M
NIAID NIH HHS U19 AI057330NIAID NIH HHS U19 AI057330)NIAID NIH HHS U54 AI057159
6 · The paper itself

Abstract

backgroundWe conducted a clinical trial of the safety and immunogenicity of modified vaccinia Ankara (MVA) to examine the effects of dose and route of administration.

methodsSeventy-two healthy, vaccinia virus-naive subjects received 1 of 6 regimens of MVA (ACAM3000) or placebo consisting of 2 administrations given 1 month apart.

resultsMVA was generally well tolerated at all dose levels and by all routes. More pronounced local reactogenicity was seen with the intradermal and subcutaneous routes than with intramuscular administration. Binding antibodies to whole virus and neutralizing antibodies to the intracellular mature virion and extracellular enveloped virion forms of vaccinia virus were elicited by all routes of MVA administration and were greater for the higher dose by each route. Similar levels of neutralizing antibodies were seen at a 10-fold-lower dose given intradermally (1 x 10(7) median tissue culture infective doses [TCID(50)]), compared with responses after 1 x 10(8) TCID(50) given intramuscularly or subcutaneously. T cell immune responses to vaccinia virus were detected by an interferon gamma enzyme-linked immunospot assay but had no clear relationship to dose or route.

conclusionsThese data suggest that intradermal immunization with MVA provides a dose-sparing effect by eliciting antibody responses similar in magnitude and kinetics to those elicited by the intramuscular or subcutaneous routes but at a 10-fold-lower dose.

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralAntibody FormationDose-Response Relationship, ImmunologicDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleHumansInjections, IntradermalInjections, IntramuscularInjections, SubcutaneousMaleSmallpox VaccineVaccines, AttenuatedAntibodies, NeutralizingAntibodies, ViralSmallpox VaccineVaccines, Attenuated

Identifiers

PMID20350191
PMCPMC3016847
OpenAlexW2023217157

What OpenQuestion holds

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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.