Evidence map›Paper›PMID 42249801›Full record

Trial reportOncotarget2026

A randomized double-blind placebo-controlled phase I/II clinical trial of a human papillomavirus therapeutic vaccine, PepCan, for reducing head and neck squamous cell carcinoma recurrence.

Emily Bivens, Omar Atiq, Teresa Evans, Milan Bimali, Ginger Brown, Jasmine Crane, Nadia Darwish, Jennifer L Faulkner, Rangaswamy Govindarajan, Aaron Johnson and 12 more

Abstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Oncotarget, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

22 authors.

Emily Bivens
Omar Atiq
Teresa Evans
Milan Bimali
Ginger Brown
Jasmine Crane
Nadia Darwish
Jennifer L Faulkner
Rangaswamy Govindarajan
Aaron Johnson
Alongkorn Kurilung
Oxana Lazarenko
Yong-Chen William Lu
Keanna Marsh
Mauricio Moreno
Intawat Nookaew
Michael Robeson
Jumin Sunde
David Ussery
Emre Vural
Mindy Wilman
Mayumi Nakagawa

Funding

Expanding Translational Research in ArkansasUL1TR003107 · NCATS · UNIV OF ARKANSAS FOR MED SCIS · PI JAMES, LAURA P · 2019 to 2023
$21.6M
Understanding and Enhancing T-Cell Responses to High Risk Human Papillomaviruses-RenewalR01CA143130 · NCI · UNIV OF ARKANSAS FOR MED SCIS · PI NAKAGAWA, MAYUMI · 2010 to 2025
$10.0M
NCATS NIH HHS UL1 TR003107NCI NIH HHS R01 CA143130
6 · The paper itself

Abstract

Copyright: © 2026 Bivens et al. This is an open access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

objectivesThe main goals were to assess safety and efficacy (i.e., recurrence reduction).

resultsSeventeen patients were enrolled. The most common adverse events were grades 1 and 2 injection site reactions, and they occurred more frequently in the PepCan group (p < 0.0001). Two patients had allergic reactions (grade 2 and grade 3), at the 6th vaccination, which were considered to be a dose-limiting toxicity. No serious adverse events were reported. In the intention-to-treat analyses, 45% (5/11) had non-recurrence in the PepCan group while 80% (4/5) had non-recurrence in the placebo group (p = not significant). Those who received PepCan and experienced non-recurrence showed a trend of having higher new peripheral T cell immune responses to human papillomavirus type 16 E6 (p = 0.05). Pre-vaccination T helper type 1 cells were higher in the PepCan non-recurrence group compared to the PepCan recurrence group (p = 0.01).

methodsPepCan consists of four human papillomavirus type16 E6 peptides and a Candida skin testing reagent. Patients with head and neck squamous cell carcinoma who had no evidence of disease after standard of care treatments were randomized at 3:1 to PepCan versus placebo (saline). Seven intradermal injections were given followed with two observational visits. Safety was assessed using CTCAE version 5, and efficacy was assessed based on not having recurrence within 2 years. In addition, immune responses and oral and gut microbiome were assessed.

conclusionsPepCan was well tolerated. PepCan does not seem to be effective in reducing recurrence; however, the results are inconclusive given the small patient numbers.

Indexed as

Cancer VaccinesCarcinoma, Squamous CellHead and Neck NeoplasmsNeoplasm Recurrence, LocalPapillomavirus InfectionsPapillomavirus VaccinesAdultAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedSquamous Cell Carcinoma of Head and NeckTreatment OutcomeCancer VaccinesPapillomavirus Vaccinesadjuvantclinical trialhead and neck cancerhuman papillomavirustherapeutic vaccine

Identifiers

PMID42249801
PMCPMC13249280

What OpenQuestion holds

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LicenceCC BY
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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.