Evidence map›Paper›PMID 21189474›Full record

Trial reportMolecular therapy : the journal of the American Society of Gene Therapy2011

Intradermal vaccinations with RNA coding for TAA generate CD8+ and CD4+ immune responses and induce clinical benefit in vaccinated patients.

Susanne M Rittig, Maik Haentschel, Katrin J Weimer, Annkristin Heine, Martin R Muller, Wolfram Brugger, Marius S Horger, Olga Maksimovic, Arnulf Stenzl, Ingmar Hoerr and 5 more

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Molecular therapy : the journal of the American Society of Gene Therapy, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 113 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
113citing papers in PubMed, 2 pooled it
5.1field-weighted citation impact, top 4% 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.

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

113 citing papers in PubMed, 2 syntheses or guidelines pooled it, 219 citations in OpenAlex.

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  14. Research progress of MUC1 in genitourinary cancers.Cellular & molecular biology letters · 2024
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53 more citing papers are in PubMed but not listed here.

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

15 authors at 5 institutions in 2 countries.

Susanne M RittigDepartment of Hematology, Oncology, Rheumatology and Immunology, Eberhard-Karls-University of Tuebingen, Tuebingen, Germany.
Maik Haentschel
Katrin J Weimer
Annkristin Heine
Martin R Muller
Wolfram Brugger
Marius S Horger
Olga Maksimovic
Arnulf Stenzl
Ingmar Hoerr
Hans-Georg Rammensee
Tobias A W Holderried
Lothar Kanz
Steve Pascolo
Peter Brossart
University of Tübingen · DEUniversity of Bonn · DECureVac (Germany) · DENephrologisches Zentrum Villingen-Schwenningen · DEUniversity of Zurich · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The aim of this phase I/II nonrandomized trial was to assess feasibility, safety as well as immunological and clinical responses of a mRNA-based vaccination in patients with stage IV renal cell cancer using granulocyte-macrophage colony stimulating factor (GM-CSF) as adjuvant. Intradermal injections of in vitro transcribed naked mRNA, which was generated using plasmids coding for the tumor-associated antigens mucin 1(MUC1), carcinoembryonic (CEA), human epidermal growth factor receptor 2 (Her-2/neu), telomerase, survivin, and melanoma-associated antigen 1 (MAGE-A1) were performed in 30 enrolled patients. In the first 14 patients (cohort A) vaccinations were administered on days 0, 14, 28, and 42 (20 µg/antigen) while in the consecutive 16 patients (cohort B) an intensified protocol consisting of injections at days 0-3, 7-10, 28, and 42 (50 µg/antigen) was used. In both cohorts, after this induction period, vaccinations were repeated monthly until tumor progression analyzed by Response Evaluation Criteria In Solid Tumors criteria (RECIST). Vaccinations were well tolerated with no severe side effects and induced clinical responses [six stable diseases (SD) and one partial response in cohort A and nine SD in cohort B]. In cohort A, 35.7% survived 4 years (median survival 24 months) compared to 31.25% in cohort B (median survival 29 months). Induction of CD4(+) and CD8(+) T cell responses was shown for several tumor-associated antigens (TAA) using interferon-γ (IFN-γ) enzyme-linked immunosorbent spot (ELISpot) and Cr-release assays.

Indexed as

Adjuvants, ImmunologicAgedAntigens, NeoplasmCancer VaccinesCarcinoma, Renal CellCD4-Positive T-LymphocytesCD8-Positive T-LymphocytesEnzyme-Linked Immunosorbent AssayFemaleGenetic TherapyGranulocyte-Macrophage Colony-Stimulating FactorHumansMaleMiddle AgedRNA, MessengerAdjuvants, ImmunologicAntigens, NeoplasmCancer VaccinesGranulocyte-Macrophage Colony-Stimulating FactorRNA, Messenger

Identifiers

PMID21189474
PMCPMC3098631
OpenAlexW1971201276

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.