LIVIVO - The Search Portal for Life Sciences

zur deutschen Oberfläche wechseln
Advanced search

Search results

Result 1 - 2 of total 2

Search options

  1. Article: [Conduct vaccines clinical trials and optimize the immunization strategies].

    Yin, Z D

    Zhonghua yu fang yi xue za zhi [Chinese journal of preventive medicine

    2020  Volume 54, Issue 9, Page(s) 915–917

    Abstract: ... which reported the main results of pre-license clinical trials and post-marketing evaluation of various vaccines ... the actual effectiveness and safety in the general population through phase Ⅳ clinical trials and optimize ... and phase Ⅰ, Ⅱ, Ⅲ clinical trials mainly focused on the assessment of the vaccine's safety ...

    Abstract Development of an effective vaccine requires a long and complicated process. Preclinical studies and phase Ⅰ, Ⅱ, Ⅲ clinical trials mainly focused on the assessment of the vaccine's safety (tolerability), immunogenicity and efficacy before license. After license, it is necessary to further evaluate the actual effectiveness and safety in the general population through phase Ⅳ clinical trials and optimize the immunization strategies with the disease's epidemiology data. In this special issue, published several articles, which reported the main results of pre-license clinical trials and post-marketing evaluation of various vaccines, it was extremely useful to support vaccine licensing and market use. We encourage the continuous clinical studies and post-marketing evaluation of vaccines, including the novel corona virus-19 vaccines, to provide technical support for the population use, under the situation of COVID-19 pandemic.
    MeSH term(s) COVID-19 ; COVID-19 Vaccines ; Clinical Trials as Topic/organization & administration ; Coronavirus Infections/epidemiology ; Coronavirus Infections/prevention & control ; Humans ; Immunization/methods ; Pandemics/prevention & control ; Pneumonia, Viral/epidemiology ; Pneumonia, Viral/prevention & control ; Vaccines ; Viral Vaccines
    Chemical Substances COVID-19 Vaccines ; Vaccines ; Viral Vaccines
    Keywords covid19
    Language Chinese
    Publishing date 2020-09-07
    Publishing country China
    Document type Introductory Journal Article
    ZDB-ID 604575-3
    ISSN 0253-9624
    ISSN 0253-9624
    DOI 10.3760/cma.j.cn112150-20200803-01084
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    In stock of ZB MED Cologne/Königswinter

    Zs.B 2487: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
    bis Jg. 2021: Bestellungen von Artikeln über das Online-Bestellformular
    ab Jg. 2022: Lesesaal (EG)

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

  2. Article ; Online: A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network.

    Neuhann, Julia M / Stemler, Jannik / Carcas, Antonio / Frías-Iniesta, Jesús / Bethe, Ullrich / Heringer, Sarah / Tischmann, Lea / Zarrouk, Marouan / Cüppers, Arnd / König, Franz / Posch, Martin / Cornely, Oliver A

    Trials

    2022  Volume 23, Issue 1, Page(s) 865

    Abstract: ... with potent vaccines and research should focus on optimal vaccination schedules. In addition ... of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population ... humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be ...

    Abstract Background: In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual's medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.
    Methods/design: EU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.
    Discussion: The EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.
    Trial registration: ClinicalTrials.gov NCT05160766 . Registered on 16 December 2021.
    Protocol version: V06_0: 27 July 2022.
    MeSH term(s) Adult ; Aged ; Antibodies, Neutralizing ; Antibodies, Viral ; BNT162 Vaccine ; Biological Specimen Banks ; COVID-19/prevention & control ; COVID-19 Vaccines/adverse effects ; Clinical Trials, Phase II as Topic ; Humans ; Pandemics/prevention & control ; Randomized Controlled Trials as Topic ; SARS-CoV-2 ; Vaccines
    Chemical Substances Antibodies, Neutralizing ; Antibodies, Viral ; COVID-19 Vaccines ; Vaccines ; BNT162 Vaccine (N38TVC63NU)
    Language English
    Publishing date 2022-10-08
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2040523-6
    ISSN 1745-6215 ; 1468-6694 ; 1745-6215
    ISSN (online) 1745-6215
    ISSN 1468-6694 ; 1745-6215
    DOI 10.1186/s13063-022-06791-y
    Database MEDical Literature Analysis and Retrieval System OnLINE

    More links

    Kategorien

    Order via subito

    This service is chargeable due to the Delivery terms set by subito. Orders including an article and supplementary material will be classified as separate orders. In these cases, fees will be demanded for each order.

To top