Evidence map›Paper›PMID 28750854›Full record

Trial reportVaccine2017

Tularemia vaccine: Safety, reactogenicity, "Take" skin reactions, and antibody responses following vaccination with a new lot of the Francisella tularensis live vaccine strain - A phase 2 randomized clinical Trial.

Mark J Mulligan, Jack T Stapleton, Wendy A Keitel, Sharon E Frey, Wilbur H Chen, Nadine Rouphael, Srilatha Edupuganti, Allison Beck, Patricia L Winokur, Hana M El Sahly and 10 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Vaccine, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01150695 (A Phase II, Multi-Center, Double-Blind, Randomized Trial Comparing the Safety and Immunogenicity of a Francisella Tularensis Live Vaccine Strain), which is not on this map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
1.2field-weighted citation impact, top 21% 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.

NCT01150695 phase2completednot on this map

A Phase II, Multi-Center, Double-Blind, Randomized Trial Comparing the Safety and Immunogenicity of a Francisella Tularensis Live Vaccine Strain (LVS) Vaccine Produced by DynPort Vaccine Company (DVC-LVS) to a LVS Vaccine in Use by the United States Army Medical Research Institute of Infectious Diseases (USAMRIID-LVS)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2010 to 2012Enrolled228ConditionsTularaemiaArmsPlacebo, Undiluted Francisella tularensis live attenuated vaccine
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 36 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
  4. Historical Advances in Clinical Trial Design and Expanding Representation as the New Frontier for Innovation.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  5. Emerging and Pandemic Pathogens: Lessons Learned From a Clinical Research Network.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Review
  6. From Yesterday to Tomorrow: How Vaccine Platforms Have Shaped the Vaccine and Treatment Evaluation Units.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  7. Article
  8. Review
  9. Review
  10. Article
  11. Deletion Mutants ofPathogens (Basel, Switzerland) · 2021
    Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. Article
  19. Article
  20. 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

20 authors at 7 institutions in 1 country.

Mark J MulliganThe Hope Clinic of the Emory Vaccine Center, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, 500 Irvin Court, Suite 200, Decatur, GA 30030, USA. Electronic address: mark.mulligan@emory.edu.
Jack T StapletonUniversity of Iowa, SW54-4, GH, 200 Hawkins Drive, Iowa City, IA 52242, USA.
Wendy A KeitelDepartments of Molecular Virology and Microbiology, and Medicine, Baylor College of Medicine, Houston, TX, BCM MS 280, One Baylor Plaza, Houston, TX 77030, USA.
Sharon E FreyDivision of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 South Grand Boulevard, DRC-8, St. Louis, MO 63104, USA.
Wilbur H ChenCenter for Vaccine Development, University of Maryland School of Medicine, 685 W. Baltimore St., Suite 480, Baltimore, MD 21201, USA.
Nadine RouphaelThe Hope Clinic of the Emory Vaccine Center, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, 500 Irvin Court, Suite 200, Decatur, GA 30030, USA.
Srilatha EdupugantiThe Hope Clinic of the Emory Vaccine Center, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, 500 Irvin Court, Suite 200, Decatur, GA 30030, USA.
Allison BeckThe Hope Clinic of the Emory Vaccine Center, Department of Medicine, Division of Infectious Diseases, Emory University School of Medicine, 500 Irvin Court, Suite 200, Decatur, GA 30030, USA.
Patricia L WinokurUniversity of Iowa, SW54-4, GH, 200 Hawkins Drive, Iowa City, IA 52242, USA.
Hana M El SahlyDepartments of Molecular Virology and Microbiology, and Medicine, Baylor College of Medicine, Houston, TX, BCM MS 280, One Baylor Plaza, Houston, TX 77030, USA.
Shital M PatelDepartments of Molecular Virology and Microbiology, and Medicine, Baylor College of Medicine, Houston, TX, BCM MS 280, One Baylor Plaza, Houston, TX 77030, USA.
Robert L AtmarDepartments of Molecular Virology and Microbiology, and Medicine, Baylor College of Medicine, Houston, TX, BCM MS 280, One Baylor Plaza, Houston, TX 77030, USA.
Irene GrahamDivision of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 South Grand Boulevard, DRC-8, St. Louis, MO 63104, USA.
Edwin AndersonDivision of Infectious Diseases, Allergy and Immunology, Saint Louis University School of Medicine, 1100 South Grand Boulevard, DRC-8, St. Louis, MO 63104, USA.
Samer S El-KamaryCenter for Vaccine Development, University of Maryland School of Medicine, 685 W. Baltimore St., Suite 480, Baltimore, MD 21201, USA.
Marcela F PasettiCenter for Vaccine Development, University of Maryland School of Medicine, 685 W. Baltimore St., Suite 480, Baltimore, MD 21201, USA.
Marcelo B SzteinCenter for Vaccine Development, University of Maryland School of Medicine, 685 W. Baltimore St., Suite 480, Baltimore, MD 21201, USA.
Heather HillThe Emmes Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, USA.
Johannes B GollThe Emmes Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, USA.
DMID 08-0006 Tularemia Vaccine Study Group
Baylor College of Medicine · USUniversity of Maryland, Baltimore · USEmory University · USSaint Louis University · USEmmes (United States) · USUniversity of Iowa · USHOPE Clinic · US

Funding

Atlanta Clinical and Translational Science Institute (ACTSI) RenewalUL1TR000454 · NCATS · EMORY UNIVERSITY · PI STEPHENS, DAVID S · 2012 to 2016
$25.8M
Clinical Research Career Development (RMI)K12RR023250 · NCRR · UNIVERSITY OF MARYLAND BALTIMORE · PI SHULDINER, ALAN R. · 2005 to 2009
$13.3M
The University of Iowa Clinical and Translational Science AwardU54TR001356 · NCATS · UNIVERSITY OF IOWA · PI WINOKUR, PATRICIA · 2015 to 2016
$7.1M
NCATS NIH HHS U54 TR001356NCATS NIH HHS UL1 TR000454NCRR NIH HHS K12 RR023250NIAID NIH HHS HHSN272200800001CNIAID NIH HHS HHSN272200800001GNIAID NIH HHS HHSN272200800001INIAID NIH HHS HHSN272200800001ONIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800005CNIAID NIH HHS HHSN272200800008CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS HHSN272201200001CNIAID NIH HHS HHSN272201200001GNIAID NIH HHS HHSN272201200003INIAID NIH HHS HHSN272201200031CNIAID NIH HHS HHSN272201300015CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201300018CNIAID NIH HHS HHSN272201300018INIAID NIH HHS HHSN272201300020INIAID NIH HHS HHSN272201300021CNIAID NIH HHS HHSN272201300021INIAID NIH HHS HHSN272201300022CNIAID NIH HHS HHSN272201300022I
6 · The paper itself

Abstract

backgroundTularemia is caused by Francisella tularensis, a gram-negative bacterium that has been weaponized as an aerosol. For protection of personnel conducting biodefense research, the United States Army required clinical evaluation of a new lot of tularemia live vaccine strain manufactured in accordance with Current Good Manufacturing Practices.

methodsA phase 2 randomized clinical trial compared the new lot (DVC-LVS) to the existing vaccine that has been in use for decades (USAMRIID-LVS). The vaccines were delivered by scarification to 228 participants. Safety, reactogenicity, take and/or antibody levels were assessed on days 0, 1, 2, 8, 14, 28, 56, and 180. PRINCIPAL

resultsBoth vaccines were safe and had acceptable reactogenicity profiles during six months of follow-up. There were no serious or grade 3 and 4 laboratory adverse events. Moderate systemic reactogenicity (mostly headache or feeling tired) was reported by ∼23% of participants receiving either vaccine. Injection site reactogenicity was mostly mild itchiness and pain. The frequencies of vaccine take skin reactions were 73% (95% CI, 64, 81) for DVC-LVS and 80% (95% CI, 71, 87) for USAMRIID-LVS. The 90% CI for the difference in proportions was -6.9% (-16.4, 2.6). The rates of seroconversion measured by microagglutination assay on days 28 or 56 were 94% (95% CI, 88, 98; n=98/104) for DVC-LVS and 94% (95% CI, 87, 97; n=103/110) for USAMRIID-LVS (p=1.00). Day 14 sera revealed more rapid seroconversion for DVC-LVS relative to USAMRIID-LVS: 82% (95% CI, 73, 89) versus 55% (95% CI, 45, 65), respectively (p<0.0001). MAJOR

conclusionsThe DVC-LVS vaccine had similar safety, reactogenicity, take and antibody responses compared to the older USAMRIID vaccine, and was superior for early (day 14) antibody production. Vaccination take was not a sensitive surrogate for seroconversion in a multi-center study where personnel at five research clinics performed assessments. ClinicalTrials.gov identifier NCT01150695.

Indexed as

AdolescentAdultAgglutination TestsAntibodies, BacterialBacterial VaccinesDouble-Blind MethodFemaleFrancisella tularensisHumansMaleMiddle AgedSeroconversionTularemiaVaccinationVaccines, AttenuatedYoung AdultAntibodies, BacterialBacterial VaccinesVaccines, AttenuatedBacterialFrancisella tularensisLVSTakeTularemiaVaccine

Identifiers

PMID28750854
PMCPMC5800773
OpenAlexW2736787461

What OpenQuestion holds

Textmetadata
LicenceTDM
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.