Evidence map›Paper›PMID 29534736›Full record

Trial reportJournal for immunotherapy of cancer2018

Prime-boost vaccination targeting prostatic acid phosphatase (PAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) using Sipuleucel-T and a DNA vaccine.

Ellen Wargowski, Laura E Johnson, Jens C Eickhoff, Lauren Delmastro, Mary Jane Staab, Glenn Liu, Douglas G McNeel

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

Trial report in Journal for immunotherapy of cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01706458 (Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer), which is not on this map. Cited by 40 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 1 pooled it
2.0field-weighted citation impact, top 13% 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.

NCT01706458 phase2completednot on this map

Pilot Trial of Sipuleucel-T, With or Without pTVG-HP DNA Booster Vaccine, in Patients With Castrate-Resistant, Metastatic Prostate Cancer

TypeinterventionalSponsorUniversity of Wisconsin, MadisonRan2013 to 2020Enrolled18ConditionsProstate CancerArmssipuleucel-T, DNA Vaccine
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. Pooled it
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  8. Article
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  15. A comprehensive comparison of DNA and RNA vaccines.Advanced drug delivery reviews · 2024
    Review
  16. Review
  17. Review
  18. Review
  19. Therapeutic cancer vaccines: advancements, challenges, and prospects.Signal transduction and targeted therapy · 2023
    Review
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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 1 institution in 1 country.

Ellen WargowskiUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Laura E JohnsonUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Jens C EickhoffUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Lauren DelmastroUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Mary Jane StaabUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Glenn LiuUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA.
Douglas G McNeelUniversity of Wisconsin Carbone Cancer Center, 1111 Highland Avenue, Madison, WI, 53705, USA. dm3@medicine.wisc.edu.
University of Wisconsin Carbone Cancer Center · US

Funding

UW COMPREHENSIVE CANCER CENTER SUPPORTP30CA014520 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI Christian Capitini · 1985 to 2026
$142.6M
NCI NIH HHS P30 CA014520
6 · The paper itself

Abstract

backgroundProstatic acid phosphatase (PAP) is a prostate tumor antigen, and the target of the only FDA-approved anti-tumor vaccine, sipuleucel-T. We have previously reported in two clinical trials that a DNA vaccine encoding PAP (pTVG-HP) could elicit PAP-specific, Th1-biased T cells in patients with PSA-recurrent prostate cancer. In the current pilot trial we sought to evaluate whether this vaccine could augment PAP-specific immunity when used as a booster to immunization with sipuleucel-T in patients with metastatic, castration-resistant prostate cancer (mCRPC).

methodsEigthteen patients with mCRPC were randomized to receive sipuleucel-T alone or followed by intradermal immunization with pTVG-HP DNA vaccine. Patients were followed for time to progression, and immune monitoring was conducted at defined intervals.

resultsOverall, patients were followed for a median of 24 months. 11/18 patients completed treatments as per protocol. No treatment-associated events > grade 2 were observed. Th1-biased PAP-specific T-cell responses were detected in 11/18 individuals, and were not statistically different between study arms. Higher titer antibody responses to PAP were detectable in patients who received pTVG-HP booster immunizations. Median time to progression was less than 6 months and not statistically different between study arms. The median overall survival for all patients was 28 months.

conclusionsThese findings suggest that prime-boost vaccination can augment and diversify the type of immunity elicited with anti-tumor vaccination in terms of T-cell and humoral immunity. Future studies will explore DNA as priming immunization rather than a booster immunization.

trial registrationNCT01706458 .

Indexed as

Acid PhosphataseAgedAged, 80 and overAntigens, NeoplasmCancer VaccinesHumansMaleProstatic Neoplasms, Castration-ResistantTissue ExtractsVaccinationVaccines, DNAAcid PhosphataseAntigens, NeoplasmCancer Vaccinesprostatic acid phosphatasesipuleucel-TTissue ExtractsVaccines, DNAClinical trialDNA vaccineImmune monitoringProstate cancerProstatic acid phosphataseSipuleucel-T

Identifiers

PMID29534736
PMCPMC5850960
OpenAlexW2803449896

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.