Evidence map›Paper›PMID 26319063›Full record

SynthesisVaccine2015

Sex difference in immune response to vaccination: A participant-level meta-analysis of randomized trials of IMVAMUNE smallpox vaccine.

Jesse D Troy, Heather R Hill, Marian G Ewell, Sharon E Frey

Abstract readMeta-Analysis
PubMed Full text at PMC Publisher
In one paragraph

Synthesis in Vaccine, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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.

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

21 citing papers in PubMed.

  1. Trial
  2. Trial
  3. Article
  4. 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
  5. Review
  6. Article
  7. Review
  8. Article
  9. Review
  10. Sex-Differential and Non-specific Effects of Vaccines Over the Life Course.Current topics in microbiology and immunology · 2023
    Review
  11. Cytokine profiling in pulmonary arterial hypertension: the role of redox homeostasis and sex.Translational research : the journal of laboratory and clinical medicine · 2022
    Article
  12. Article
  13. Review
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Article
  20. Article
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

4 authors.

Jesse D TroyThe EMMES Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, United States. Electronic address: jesse.troy@duke.edu.
Heather R HillThe EMMES Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, United States. Electronic address: hhill@emmes.com.
Marian G EwellThe EMMES Corporation, 401 North Washington Street, Suite 700, Rockville, MD 20850, United States. Electronic address: mewell@emmes.com.
Sharon E FreySaint Louis University School of Medicine, Department of Internal Medicine, Edward A. Doisy Research Center, 1100 S. Grand Bld., Saint Louis, MO 63104, United States. Electronic address: freyse@slu.edu.

Funding

NIAID NIH HHS HHSN272201300021INIAID NIH HHS HHSN27220130021INIAID NIH HHS HHSN272201500002CPHS HHS HEALTHHHSN272201500002C
6 · The paper itself

Abstract

introductionPrevious research shows immune response to vaccination differs by sex but this has not been explored for IMVAMUNE, a replication-deficient smallpox vaccine developed in response to the potential for bioterrorism using smallpox.

methodsWe conducted a participant-level meta-analysis (N=275, 136 men, 139 women) of 3 randomized trials of IMVAMUNE conducted at 13 centers in the US through a federally-funded extramural research program. Studies were eligible for inclusion if they tested the standard dose (1×10(8)TCID₅₀/mL on Days 0 and 28) of liquid formulation IMVAMUNE, were completed at the time of our search, and enrolled healthy vaccinia-naïve participants. Models of the peak log₂ ELISA and PRNT titers post-second vaccination were constructed for each study with sex as a covariate. Results from these models were combined into random effects meta-analyses of the sex difference in response to IMVAMUNE. We then compared this approach with fixed effects models using the combined participant level data.

resultsIn each study the mean peak log₂ ELISA titer was higher in men than women but no single study demonstrated a statistically significant difference. Combination of the adjusted study-specific estimates into the random effects model showed a higher mean peak log₂-titer in men compared with women (absolute difference [men-women]: 0.32, 95% CI: 0.02-0.60). Fixed effects models controlling for study showed a similar result (log₂ ELISA titer, men-women: 0.34, 95% CI: 0.04-0.63). This equates to a geometric mean peak titer that is approximately 27% higher in men than women (95% CI: 3-55%). Peak log₂ PRNT titers were also higher (although not significantly) in men (men-women: 0.14, 95% CI: -0.30 to 0.58).

conclusionOur results show statistically significant differences in response to IMVAMUNE comparing healthy, vaccinia-naïve men with women and suggest that sex should be considered in further development and deployment of IMVAMUNE and other MVA-based vaccines.

Indexed as

ImmunityVaccinationAntibodies, ViralEnzyme-Linked Immunosorbent AssayFemaleHumansMaleRandomized Controlled Trials as TopicSex FactorsSmallpoxSmallpox VaccineAntibodies, ViralSmallpox VaccineImvamuneMeta-analysisMVA vaccineSmallpoxVaccinesVaccinia virus

Identifiers

PMID26319063
PMCPMC4581981

What OpenQuestion holds

Textmetadata
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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.