Evidence map›Paper›PMID 24607004›Full record

Trial reportVaccine2014

Phase II randomized, double-blinded comparison of a single high dose (5×10(8) TCID50) of modified vaccinia Ankara compared to a standard dose (1×10(8) TCID50) in healthy vaccinia-naïve individuals.

Sharon E Frey, Patricia L Winokur, Heather Hill, Johannes B Goll, Paul Chaplin, Robert B Belshe

Abstract readClinical Trial, Phase IIRandomized 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 26 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
26citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 25% 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

26 citing papers in PubMed, 1 synthesis or guideline pooled it, 37 citations in OpenAlex.

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  8. 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
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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

6 authors at 4 institutions in 2 countries.

Sharon E FreySaint Louis University Medical School, Department of Internal Medicine, United States. Electronic address: freyse@slu.edu.
Patricia L WinokurUniversity of Iowa and Iowa City VA Medical Center Health Care System, Department of Internal Medicine, United States.
Heather HillEMMES Corporation, Rockville, MD, United States.
Johannes B GollEMMES Corporation, Rockville, MD, United States.
Paul ChaplinBavarian Nordic GmbH, Martinsried, Germany.
Robert B BelsheSaint Louis University Medical School, Department of Internal Medicine, United States.
Emmes (United States) · USSaint Louis University · USBavarian Nordic (Germany) · DEIowa City VA Medical Center · US

Funding

NIAID NIH HHS HHSN272200800003CNIAID NIH HHS HHSN272200800008C
6 · The paper itself

Abstract

introductionReintroduction of Variola major as an agent of bioterrorism remains a concern. Time to seroconversion and plaque reduction neutralizing antibody titers (PRNT) of 1 or 2 standard doses (SD) were compared to a single high dose (HD) of modified vaccinia Ankara (MVA).

methodsNinety subjects were randomized 1:1 to receive 1 HD or 2 SD of MVA subcutaneously on Days 0 and 28 in a placebo-controlled trial. Serum was collected for PRNT and ELISA. Subjects were followed for safety for the entire study.

resultsThe HD was well-tolerated. Using Bavarian Nordic's ELISA, subjects in both groups achieved seroconversion by Study Day 15 (HD) and Day 28 (SD). Before second vaccination, the hazard rate of seroconverting for the HD group was 1.7 times the SD group with a median time for seroconversion of 14 days for both groups. The peak titer of one HD vaccine was superior to one dose of SD vaccine but inferior to the peak titer after the second dose of the SD vaccination regimen. Using Saint Louis University's PRNT, peak titers were 95.8 and 65.2 for the HD and SD groups, respectively, prior to second vaccination. Non-inferiority of the SD group was not established. The proportions of positives were 93.3% (42/45) and 82.2% (37/45) for the HD and SD groups, respectively. The peak titer after two standard doses was superior to that of the HD.

conclusionsHD MVA was safe and well-tolerated. While the hazard rate for seroconverting was significantly higher in the HD group before second dose, the effect was small as the median time to seroconversion was identical. When comparing PRNT, non-inferiority of one SD was not established and the peak titers were low for both groups. The HD peak response was inferior to the standard two-dose regimen response based on ELISA and PRNT.

Indexed as

AdolescentAdultAntibodies, NeutralizingAntibodies, ViralFemaleHumansMaleNeutralization TestsSmallpoxSmallpox VaccineViral Plaque AssayYoung AdultAntibodies, NeutralizingAntibodies, ViralSmallpox VaccineELISAIMVAMUNEMVAPlaque reduction neutralizing antibodySmallpoxVaccineVariola

Identifiers

PMID24607004
PMCPMC4106233
OpenAlexW2038391011

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.