Evidence map›Paper›PMID 32000810›Full record

ArticleJournal of translational medicine2020

Safety, tolerability and immunogenicity of V934/V935 hTERT vaccination in cancer patients with selected solid tumors: a phase I study.

Luigi Aurisicchio, Arthur Fridman, David Mauro, Rose Sheloditna, Alberto Chiappori, Ansuman Bagchi, Gennaro Ciliberto

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase I
In one paragraph

Article in Journal of translational medicine, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00753415 (A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors), which is not on this map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.4field-weighted citation impact, top 8% 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.

NCT00753415 phase1completednot on this map

A Phase I Investigation of the Safety, Tolerability and Immunogenicity of V934/V935 hTERT Vaccination in Cancer Patients With Selected Solid Tumors

TypeinterventionalSponsorMerck Sharp & Dohme LLCRan2008 to 2011Enrolled37ConditionsNon-Small Cell Lung Carcinoma, Breast Cancer, Melanoma, Upper GI Tract CarcinomaArmsV935, V934-EP
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 26 citations in OpenAlex.

  1. Review
  2. Review
  3. Transcriptomic analysis of the immune response toMolecular therapy. Nucleic acids · 2025
    Article
  4. Review
  5. Review
  6. A comprehensive comparison of DNA and RNA vaccines.Advanced drug delivery reviews · 2024
    Review
  7. Review
  8. Review
  9. Review
  10. Article
  11. The Role of Telomerase in Breast Cancer's Response to Therapy.International journal of molecular sciences · 2022
    Review
  12. Article
  13. Telomeres and Cancer.Life (Basel, Switzerland) · 2021
    Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Article
  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

7 authors at 3 institutions in 2 countries.

Luigi AurisicchioTakis Biotech, Rome, Italy.
Arthur FridmanMerck & Co., Inc., Kenilworth, NJ, USA.
David MauroPrelude Therapeutics, Wilmington, DE, USA.
Rose SheloditnaCelgene Corporation, Summit, NJ, USA.
Alberto ChiapporiDepartment of Thoracic Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL, USA.
Ansuman BagchiMerck & Co., Inc., Kenilworth, NJ, USA.
Gennaro CilibertoScientific Directorate, Regina Elena National Cancer Institute, IRCCS, Rome, Italy. gennaro.ciliberto@ifo.gov.it.
Merck & Co., Inc., Rahway, NJ, USA (United States) · USIstituti di Ricovero e Cura a Carattere Scientifico · ITMoffitt Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHuman telomerase reverse transcriptase (hTERT) is an antigen that may represent a target for a novel anti-cancer strategy. A pilot, phase I study tested the safety and feasibility of a prime-boost immunization regimen based on V935, an adenoviral type 6 vector vaccine expressing a modified version of hTERT, administered alone or in combination with V934, a DNA plasmid that also expresses the same antigen and is delivered using the electroporation injection technique.

methodsTreatments: Group #1 received two doses (low-dose: 0.5 × 10

resultsIn total, 37 patients affected by solid tumors (prostate cancer in 38%) were enrolled. The safety profile of different regimens was good and comparable across groups, with no severe adverse events, dose-limiting toxicities or treatment discontinuations. As expected, the most common adverse events were local reactions. A significant increase in ELISPOT responses against hTERT peptide pool 2 was observed (p < 0.01), while no evidence of boosting was observed for peptide pools 1 and 3. This was also evident for group #1 and #2 separately. In patients with prostate cancer, there was a significant increase in ELISPOT response against hTERT peptide pool 2 following immunization (p < 0.01), regardless of previous therapy, immunosuppressing agents, or adenoviral type 6 titers at screening.

conclusionOur results suggest the safety and feasibility of V934/V935 hTERT vaccination in cancer patients with solid tumors Trial Registration Name of the registry: ClinicalTrial.gov Trial registration number: NCT00753415 Date of registration: 16 September 2008 Retrospectively registered URL of trial registry record: https://clinicaltrials.gov/ct2/results?cond=&term=NCT00753415&cntry=&state=&city=&dist=.

Indexed as

NeoplasmsViral VaccinesAdenoviridaeGenetic VectorsHumansMaleVaccinationViral VaccinesAdenovirusCancer vaccinationElectroporationhTERTPrime-boost immunization

Identifiers

PMID32000810
PMCPMC6993365
OpenAlexW3006147225

What OpenQuestion holds

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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.