Evidence map›Paper›PMID 40839957›Full record

Trial reportGynecologic oncology2025

A randomized pilot study of HPV16 L2E7E6 fusion protein vaccination site post-treatment for HPV16+ cervical cancer.

Stéphanie Gaillard, Jade Alvarez, Tianbei Zhang, Hao Wang, Hua-Ling Tsai, Leslie Cope, Amy Deery, Vikrant Palande, Chi-Fen Lee, Amanda N Fader and 13 more

Registry-linked trialAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02405221 (A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients With History of HPV16 Associated Cervical Cancer), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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.

NCT02405221 phase1completednot on this map

A Pilot Clinical Trial Assessing the Safety and Feasibility of Intramuscular Administration of the TA-CIN Vaccine as Adjuvant Therapy for Patients With History of HPV16 Associated Cervical Cancer

TypeinterventionalSponsorSidney Kimmel Comprehensive Cancer Center at Johns HopkinsRan2019 to 2025Enrolled15ConditionsHPV16 Associated Cervical CancerArmsTA-CIN (arm), TA-CIN (thigh)
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Review
  3. 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

23 authors.

Stéphanie GaillardDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Gynecology/Obstetrics, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Jade AlvarezDepartment of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Tianbei ZhangDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins School of Medicine; Baltimore, MD, USA; Mark Foundation Center for Advanced Genomics and Imaging, Johns Hopkins University, Baltimore, MD, USA.
Hao WangDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Biostatistics, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Hua-Ling TsaiDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Biostatistics, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Leslie CopeDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Biostatistics, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Amy DeeryDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Vikrant PalandeDepartment of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Chi-Fen LeeDepartment of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Amanda N FaderDepartment of Gynecology/Obstetrics, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Warner K HuhDivision of Gynecologic Oncology, University of Alabama at Birmingham; Birmingham, AL, USA.
Rebecca C ArendDivision of Gynecologic Oncology, University of Alabama at Birmingham; Birmingham, AL, USA.
Margaret I LiangDivision of Gynecologic Oncology, University of Alabama at Birmingham; Birmingham, AL, USA.
J Michael StraughnDivision of Gynecologic Oncology, University of Alabama at Birmingham; Birmingham, AL, USA.
Russell VangDepartment of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Darin OstranderDepartment of Nephrology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Karen HornerDepartment of Nephrology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Li ZhangDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Dipika SinghDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Kellie N SmithDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Bloomberg∼Kimmel Institute for Cancer Immunotherapy, Johns Hopkins School of Medicine; Baltimore, MD, USA; Mark Foundation Center for Advanced Genomics and Imaging, Johns Hopkins University, Baltimore, MD, USA.
T C WuDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Gynecology/Obstetrics, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA.
Charles A LeathDivision of Gynecologic Oncology, University of Alabama at Birmingham; Birmingham, AL, USA.
Richard B S RodenDepartment of Oncology, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Gynecology/Obstetrics, Johns Hopkins School of Medicine; Baltimore, MD, USA; Department of Pathology, Johns Hopkins School of Medicine; Baltimore, MD, USA. Electronic address: roden@jhmi.edu.

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI WILLIAM George NELSON · 1985 to 2026
$208.6M
XRAY CRYSTALLOGRAPHYP30CA013148 · NCI · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI Robert S Welner · 1985 to 2026
$165.9M
Treatment of HIV- and HIV+ Patients with HPV16+ CIN2/3 Using pNGLV4a-hCRTE6E7L2 DNA vaccine administered intramuscularly via electroporationP50CA098252 · NCI · JOHNS HOPKINS UNIVERSITY · PI TZYY-CHOOU WU · 2003 to 2026
$53.5M
Development of Novel Spontaneous HPV Cervicovaginal Carcinoma Models for Cancer ImmunotherapyR01CA237067 · NCI · JOHNS HOPKINS UNIVERSITY · PI WU, TZYY-CHOOU · 2019 to 2023
$2.9M
NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA013148NCI NIH HHS P50 CA098252NCI NIH HHS R01 CA237067
6 · The paper itself

Abstract

objectiveSince anti-tumor immunity is enhanced by vaccination of mice adjacent to human papillomavirus type 16 (HPV16+) tumors, we examined whether HPV16 L2E7E6 fusion protein (TA-CIN) vaccination in the thigh of HPV16+ cervical cancer patients would be more immunogenic than their arm.

methodsHPV16+ cervical cancer (stage IB1-IVA) patients, who had completed standard-of-care treatment within the past year and absent evidence of disease (NED), were enrolled in a pilot study (NCT02405221). Participants were randomized 1:1 to receive three 100 μg TA-CIN monthly intramuscular immunizations either in the arm or thigh and followed for two years for safety (CTCAEv4.0), immune response, and recurrence.

resultsFifteen patients were enrolled (median age 44, range 35-83 years); one patient experienced a non-vaccine-related adverse event after one vaccination and withdrew. Treatment-related adverse events (n = 8) were grade 1, primarily at the injection site, and self-resolved. No recurrence was observed. TA-CIN-specific antibody titers tended to be higher in thigh-vaccinated patients. Bulk TCRseq revealed significant increases in expanded and de novo T cell clones following thigh-vaccination compared with the arm. No correlation with prior treatment modality was observed. E6-, E7-, and L2-specific TCR clones expanded, although L2-specific T cell responses were predominant. One month post-vaccination, scRNAseq revealed significant expansion of MAIT and cytotoxic CD8+ T cells, and both expanded and novel TCR clonotypes were identified in the latter.

conclusionsThigh or arm vaccination with TA-CIN was well tolerated, but the former elicited higher CD8 T cell and antibody responses in HPV16+ cervical cancer patients with NED after primary therapy.

Indexed as

Human papillomavirus 16Oncogene Proteins, ViralPapillomavirus InfectionsPapillomavirus VaccinesUterine Cervical NeoplasmsAdultAgedAged, 80 and overFemaleHumansMiddle AgedPilot ProjectsRecombinant Fusion ProteinsThighOncogene Proteins, ViralPapillomavirus VaccinesRecombinant Fusion ProteinsCervical cancerE6E7HPV16immunotherapyL2

Identifiers

PMID40839957
PMCPMC12404000

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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.