Evidence map›Paper›PMID 33852718›Full record

Trial reportThe Journal of infectious diseases2021

Topical Imiquimod Does Not Provide an Adjuvant Effect When Administered With Inactivated Influenza A/H5N1 Vaccine in Healthy Young Adults.

Hana M El Sahly, Robert L Atmar, Eli Sendra, Ashley Wegel, Wendy A Keitel

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Journal of infectious diseases, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03472976 (A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Inactivated Influenza A/H5N1 Vaccine Administered Intradermally With or Without Topical Aldara), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.1field-weighted citation impact, top 24% 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.

NCT03472976 phase1completednot on this map

A Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Inactivated Influenza A/H5N1 Vaccine Administered Intradermally With or Without Topical Aldara(R) in Healthy Young Adults

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2018 to 2019Enrolled50ConditionsAvian Influenza, Influenza ImmunisationArmsAqueous Cream B.P., Imiquimod, Influenza Virus Vaccine, Monovalent A/H5N1 A/Vietnam/1203/04
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 11 citations in OpenAlex.

  1. 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
  2. Vaccine and Treatment Evaluation Units: A Historical Perspective.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2025
    Article
  3. Review
  4. Article
  5. 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

5 authors at 2 institutions in 1 country.

Hana M El SahlyDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.ORCID 0000-0003-0489-0074
Robert L AtmarDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Eli SendraThe Emmes Company, Rockville, Maryland, USA.
Ashley WegelThe Emmes Company, Rockville, Maryland, USA.
Wendy A KeitelDepartment of Molecular Virology and Microbiology, Baylor College of Medicine, Houston, Texas, USA.
Baylor College of Medicine · USEmmes (United States) · US

Funding

NIAID NIH HHS HHSN272201300015CNIAID NIH HHS HHSN272201300015INIAID NIH HHS HHSN272201500002CNIH HHS HHSN272201300015I
6 · The paper itself

Abstract

backgroundSafe, effective, and easy to deploy adjuvants are needed for influenza prepandemic preparedness. Based on recent reports, we hypothesized that preapplication of topical imiquimod followed by intradermal (ID) vaccination with monovalent inactivated influenza A/H5N1 vaccine (MIV A/H5N1) results in improved serologic responses.

methodsWe randomized 50 healthy adults in a 1:1 ratio to receive topical imiquimod (group 1) or control cream (group 2) followed by ID injection of 9 µg of the hemagglutinin MIV A/H5N1 in 2 doses, 21 days apart. Subjects were followed for safety and serologic responses as measured by the hemagglutination inhibition (HAI) and microneutralization (MN) assays.

resultsSolicited and unsolicited adverse events were comparable between groups 1 and 2, and were mostly mild to moderate in severity. At 21 days after dose 2, the geometric mean titers (GMTs) of HAI antibodies against the vaccine strain were 16.2 and 24.3 in groups 1 and 2, respectively. The MN antibody GMTs were 9.3 and 10.7 in groups 1 and 2, respectively. There were no significant differences in antibody levels between groups at study time points.

conclusionsTopical imiquimod administration combined with ID MIV A/H5N1 was safe but did not result in improved serologic responses to the vaccine.Clinical Trials Registration. NCT03472976.

Indexed as

Influenza A Virus, H5N1 SubtypeInfluenza, HumanInfluenza VaccinesAdjuvants, ImmunologicAdjuvants, PharmaceuticAntibodies, ViralHemagglutination Inhibition TestsHemagglutininsHumansImiquimodVaccines, InactivatedYoung AdultAdjuvants, ImmunologicAdjuvants, PharmaceuticAntibodies, ViralHemagglutininsImiquimodInfluenza VaccinesVaccines, Inactivatedadjuvantinfluenzatopicalvaccine

Identifiers

PMID33852718
PMCPMC9633716
OpenAlexW3155799996

What OpenQuestion holds

Textmetadata
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.