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

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-? (IFN-?) enzyme-linked immunosorbent spot (ELISpot) and Cr-release assays.

SUBMITTER: Rittig SM

PROVIDER: S-EPMC3098631 | biostudies-literature | 2011 May

REPOSITORIES: biostudies-literature

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

Rittig Susanne M SM Haentschel Maik M Weimer Katrin J KJ Heine Annkristin A Muller Martin R MR Brugger Wolfram W Horger Marius S MS Maksimovic Olga O Stenzl Arnulf A Hoerr Ingmar I Rammensee Hans-Georg HG Holderried Tobias A W TA Kanz Lothar L Pascolo Steve S Brossart Peter P

Molecular therapy : the journal of the American Society of Gene Therapy 20101228 5

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/ ...[more]

PMID: 21189474

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Project description:BackgroundThe Standing Committee on Vaccination recommends the seasonal influenza vaccination as a standard vaccination for individuals aged ≥ 60 years and as an indication vaccination independent of age. Empirical data on repeated vaccination are not available for Germany. The aim of this study was therefore to investigate the frequency and influencing factors of repeated vaccinations.MethodsWe conducted a longitudinal retrospective observational study with claims data from ≥ 60‑year-olds insured with the statutory health insurance AOK Plus in Thuringia between 2012 and 2018. The number of seasons with influenza vaccination was described and the association with various individual characteristics was analysed in a regression model.ResultsIncluded were 103,163 individuals with at least one influenza vaccination in the 2014/2015 season, of whom 75.3% had been vaccinated in ≥ 6 of 7 seasons. We found repeated vaccinations more frequently among nursing home residents (rate ratio (RR) 1.27), individuals with increased health risk due to underlying diseases (RR 1.21) and higher age groups (vs. 60-69 years: RR 1.17-1.25). With each additional year of participating in a disease management program, the number of vaccinations increased (RR 1.03). Women (RR 0.91), individuals with nursing care level 1 (vs. no nursing care level: RR 0.90) and people with a comorbidity (vs. no comorbidity: RR 0.97) were less likely to receive repeated vaccinations.DiscussionA large proportion of individuals aged ≥ 60 years who have been vaccinated against influenza once is likely to repeatedly receive vaccinations. In accordance with vaccination recommendations, nursing home residents and in particular individuals with an increased health risk are vaccinated repeatedly. General practitioners play a central role: non-acute patient contacts should be used to offer vaccinations, especially to women and individuals in need of care who are living at home.

Dataset Information

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

Publications

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

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