Evidence map›Paper›PMID 25239484›Full record

Trial reportVaccine2014

Immunogenicity and safety of four different dosing regimens of anthrax vaccine adsorbed for post-exposure prophylaxis for anthrax in adults.

David I Bernstein, Lisa Jackson, Shital M Patel, Hana M El Sahly, Paul Spearman, Nadine Rouphael, Thomas L Rudge, Heather Hill, Johannes B Goll

Abstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Vaccine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
0.9field-weighted citation impact, top 28% 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

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

  1. Use of Anthrax Vaccine in the United States: Recommendations of the Advisory Committee on Immunization Practices, 2019.MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports · 2019
    Guideline
  2. Trial
  3. Trial
  4. Future Goals and Long-term Vision of the Infectious Diseases Clinical Research Consortium/Vaccine and Treatment Evaluation Unit Network.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. Subcutaneous vaccine administration - an outmoded practice.Human vaccines & immunotherapeutics · 2021
    Review
  8. Article
  9. Article
  10. 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

9 authors at 7 institutions in 1 country.

David I BernsteinCincinnati Children's Hospital Medical Center, University of Cincinnati, 3333 Burnet Ave., Cincinnati, OH 45229, USA. Electronic address: david.bernstein@cchmc.org.
Lisa JacksonGroup Health Research Institute, Group Health Cooperative, Seattle, WA, USA.
Shital M PatelBaylor College of Medicine, Houston, TX, USA.
Hana M El SahlyBaylor College of Medicine, Houston, TX, USA.
Paul SpearmanEmory University School of Medicine, Atlanta, GA, USA.
Nadine RouphaelHope Clinic of the Emory Vaccine Center, Atlanta, GA, USA.
Thomas L RudgeBattelle Memorial Institute, Columbus, OH, USA.
Heather HillThe EMMES Corporation, Rockville, MD, USA.
Johannes B GollThe EMMES Corporation, Rockville, MD, USA.
Baylor College of Medicine · USEmmes (United States) · USBattelle · USCincinnati Children's Hospital Medical Center · USEmory University · USGroup Health Cooperative · USHOPE Clinic · US

Funding

NIAID NIH HHS HHSN272200800002CNIAID NIH HHS HHSN272200800004CNIAID NIH HHS HHSN272200800005CNIAID NIH HHS HHSN272200800006CNIAID NIH HHS HHSN272200800013CNIAID NIH HHS N01 AI080006PHS HHS HHSN272200800013
6 · The paper itself

Abstract

backgroundStrategies to implement post exposure prophylaxis (PEP) in case of an anthrax bioterror event are needed. To increase the number of doses of vaccine available we evaluated reducing the amount of vaccine administered at each of the vaccinations, and reducing the number of doses administered.

methodsHealthy male and non-pregnant female subjects between the ages of 18 and 65 were enrolled and randomized 1:1:1:1 to one of four study arms to receive 0.5 mL (standard dose) of vaccine subcutaneously (SQ) at: (A) days 0, 14; (B) days 0 and 28; (C) days 0, 14, and 28; or (D) 0.25 mL at days 0, 14, and 28. A booster was provided on day 180. Safety was assessed after each dose. Blood was obtained on days 0, 7, 14, 21, 28, 35, 42, 49, 56, 63, 70, 84, 100, 180, and 201 and both Toxin Neutralizing antibody and anti-PA IgG antibody measured.

resultsAlmost all subjects developed some local reactions with 46-64% reported to be of moderate severity and 3.3% severe during the primary series. Vaccine groups that included a day 14 dose induced a ≥ 4 fold antibody rise in more subjects on days 21, 28, and 35 than the arm without a day 14 dose. However, schedules with a full day 28 dose induced higher peak levels of antibody that persisted longer. The half dose regimen did not induce antibody as well as the full dose study arms.

conclusionDepending on the extent of the outbreak, effectiveness of antibiotics and availability of vaccine, the full dose 0, 28 or 0, 14, 28 schedules may have advantages.

Indexed as

Post-Exposure ProphylaxisAdolescentAdultAgedAnthraxAnthrax VaccinesAntibodies, BacterialAntibodies, NeutralizingFemaleHumansImmunization ScheduleImmunization, SecondaryImmunoglobulin GMaleMiddle AgedYoung AdultAnthrax VaccinesAntibodies, BacterialAntibodies, NeutralizingImmunoglobulin GAnthraxPost exposure prophylaxisVaccine

Identifiers

PMID25239484
PMCPMC4250293
OpenAlexW1987814950

What OpenQuestion holds

Textmetadata
LicenceTDM
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.