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EU-COVAT-1 Aged

AcronymISRCTNEudraCTNCT (clinicaltrials.gov)DRKS
EU-COVAT-1 Aged2021-004526-29

A Multinational, Phase 2, Randomised, Adaptive Protocol to Evaluate Immunogenicity and Reactogenicity of Different COVID‐19 Vaccines Administration in Older Adults (≥75) Already Vaccinated Against SARS‐CoV‐2 (EU‐COVAT‐1 Aged)

Status: Active

Purpose / Objectives

Primary Outcome

To evaluate immune response against wild‐type SARS‐CoV‐2 of different
booster strategies in elderly subjects (≥75 years old) already fully vaccinated
against SARS‐CoV‐2.

Secondary Outcomes

  •  To compare the humoral immune response against wild‐type SARS‐CoV‐2
    between treatment arms within each cohort following 3rd vaccination dose
    in elderly individuals (≥75 years) already vaccinated against SARS‐CoV‐2.
  • To compare the humoral immune response against wild‐type SARS‐CoV‐2
    between cohorts following 3rd vaccination dose in elderly individuals (≥75
    years) already vaccinated against SARS‐CoV‐2.
  • To evaluate immune response against variants of concern of SARS‐CoV‐2 of
    different booster strategies in elderly individuals (≥75 years) already fully
    vaccinated against SARS‐CoV‐2.
  •  To assess the CD4+ and CD8+ T cell response of different booster strategies
    in elderly individuals (≥75 years) already vaccinated against SARS‐CoV‐2.
  •  To evaluate the long‐term humoral immune response of different booster
    strategies in individuals already fully vaccinated against SARS‐CoV‐2.

Diagnosis

Target population

Age

75-99

Inclusion criteria

  •  Already fully vaccinated adults with BioNTech, Moderna or Astra Zeneca vaccines (same vaccine product for 1st and 2nd dose) not more than 9 ± 3 months since the second vaccine dose at time of enrolment for planned 3rd vaccine dose in the trial. Vaccination status should be documented.
  •  Elderly (≥75 years old).
  •  No contra‐indication against any of the vaccine products in the trial.
  • Written informed consent from subject has been obtained.

Exclusion criteria

  •  Primary vaccination performed with two different vaccine products as 1st and 2nd vaccinationdoses (heterologous vaccination scheme).
  • Subjects with any significant or uncontrolled disease posing a risk due to vaccination as judged by the investigator.
  •  Compromised immune status.
  • Participation in other interventional trials.
  •  Subjects unable to report solicited adverse events.
  •  Subject with any contraindications to the vaccines in the trial at randomisation. A list ofcontraindications as listed the Summary of medicinal Product Characteristics, SmPC, the Fachinformation in Germany) or the Investigator’s Brochure, if appropriate.
  •  Use of drugs with significant interaction with the investigational product according to the SmPC or similar documents.
  • Diseases or findings that may have a significant effect on the target variables and which may therefore mask or inhibit the therapeutic effect under investigation.
  • Persons with any kind of dependency on the principal investigator or employed by the sponsor or principal investigator.
  • Legally incapictated persons.
  •  Persons held in an institution by legal or official order.

Study design

  • Phase II
  • Multicenter
  • Six-arm
  • Single-blind
  • Randomized

Intervention

mRNA‐based booster strategies following different prime boost
vaccination strategies.

Documents (password protected)

Responsibilities in overall study

Universität zu Köln

  • Tel. +49 (0)221 478 0

Sponsor representative

Univ.-Prof. Dr. med. Oliver A. Cornely

National Coordinating Investigator

Univ.-Prof. Dr. med. Oliver A. Cornely

Project management

Infektiologie II

Dr. rer. medic. Sarah Heringer
Dr. Lea Tischmann
Dr. med. Ullrich Bethe
Yasmin Habibullah

ZKS Köln

Arnd Cüppers
Dipl.oec.troph. Gundula Palmbach

Monitoring

ZKS Köln

Margarete Wicharz
Dr. Sascha Behr

Data management

ZKS Köln

Dr. rer. nat. Frank Scheckenbach
Irene Grünwald

Database development

ZKS Köln

Andrea Pfeiffer

SAE management

ZKS Köln

Hedyeh Haddadi
Dr. rer. nat. Valeria Facchinetti
Jochen Büchs
Kerstin Eggers
Dip.-Biol. Anna Sherman