CIVICs 19-0025 Repository
Research type
Research Study
Full title
Collaborative Influenza Vaccine Innovations Centers (CIVICs) Repository Protocol
IRAS ID
293561
Contact name
Christopher Chiu
Contact email
Sponsor organisation
Imperial College London
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
5 years, 7 months, 15 days
Research summary
The repository will include biological samples collected from subjects enrolled in CIVICs clinical studies including but not limited to Phase I, Phase I/II, Phase II, and Human Challenge trials, screening protocols and influenza related clinical studies supporting the development of improved influenza vaccines. Primary study protocols and informed consent forms will be approved by the respective site IRBs or via the single IRB approach for multi-site trials. Separate informed consent with a unique informed consent form will be obtained from subjects enrolled in active CIVICs protocols to give permissions for their biological specimens to be included in this repository. Biological specimens will include the following: 1) specimens collected specifically for the purpose of conducting secondary research; 2) residual biological specimens collected for the conduct of primary research as specified in the primary research protocol; and 3) when available and as deemed appropriate by the investigative team, residual biological specimens collected for the purposes of clinical care of the subject. The types of biological specimens to be obtained include but are not limited to the following: blood (serum, plasma, peripheral blood mononuclear cells), nasal/nasopharyngeal swab, nasal wash, pharyngeal swab, bronchial alveolar lavage fluid, respiratory mucosal specimens, lymph node aspirate, and bone marrow biopsy. Additional informed consent will be obtained as part of the consent process for this protocol for genetic testing to be done on biologic samples and for storage of genetic data in the NIH data repository for sharing with other researchers. The CIVICs repository will be maintained at Duke Human Vaccine Institute Accessioning Unit and Repository in the US until September 15, 2026.
REC name
London - Fulham Research Ethics Committee
REC reference
21/LO/0726
Date of REC Opinion
30 Nov 2021
REC opinion
Further Information Favourable Opinion