Abstract
Introduction
The SHIVBB plays a very important role in translational research. The success of translational research depends on access to high-quality biospecimens from biobanks such as SHIVBB. Over time, the function of the SHIVBB will become crucial for the development of appropriate diagnostics and therapies for all HIV-infected individuals.
The SHIVBB has collected longitudinal blood and tissue samples from patients with HIV infection. The samples have been divided into various cohorts of patients: i) patients that have not received treatments (CoRIS); ii) long term non-progressor (LTNP) patients; iii) elite controller or elite suppressor patients; iv) rapid progressor patients (RP); v) patients with acute or recent infection; vi) lymphocyte non-regenerator patients; vii) HIV-infected patients with liver transplant (OLT-HIV); viii) HIV-HCV co-infected patients; ix) children and adolescents infected via vertical transmission (CoRISpe); x) healthy controls.
Once the samples are deposited in the SHIVBB, they are processed for components (blood, serum, plasma, solid or liquid tissue, DNA, pellet cells and peripheral blood mononuclear cells (PBMC)) that are then cryopreserved in the SHIVBB. Strict compliance to ethical norms are guaranteed in all of the procedures.
The SHIVBB applies standard operating procedures (SOPs) for different types of specimens required for the preservation of viability, functionality, structural integrity, and stability. The SOPs ensure specimens are linked to their corresponding follow-up samples and associated datasets, and ensures the safe keeping of the material stored. Also, the SHIVBB maintains a quality management system (QMS), UNE-EN-ISO 9001:2000 that covers the full spectrum of the HIV BioBank's operations from March 2008 to 2009, and UNE-EN-ISO 9001:2008 that has been covering the full spectrum of the HIV BioBank's operations since March 2009. Some of the main goals of the SHIVBB are to identify the researchers' needs, to assist them with their study planning and proposal submissions, and to update SOPs and coordinate the circulation of manuscripts to the scientific committee and researchers.
Researchers (academic or industrial) wishing to perform a research project with the SHIVBB samples must complete a document application form, which is available on the SHIVBB website: (http://immunolab-hiv.org/web/main/biobanco.html) and Red RIS website: (http://www.retic-ris.net/). Before completing the form, a research project must be approved by the Ethics and Clinical Research Committee. Then, an application form is reviewed by the SHIVBB's Scientific Committee. A successful applicant does not need to obtain any other permission to use and store the SHIVBB samples. Researchers are required to sign a sample release application, confirm that all samples have been used at the end of the approval period, and provide raw experimental data back to the SHIVBB.
The SHIVBB does not charge any fee for providing samples to any research groups apart from the cost of transporting the samples under optimal conditions to assure their arrival in the best condition at the laboratory where they are to be used.
At present, the SHIVBB has more than 168,000 aliquots containing different types of samples from more than 9,100 HIV infected patients. We need a high number of samples to recognize individual characteristics of HIV infection in specific patients. The excellent traceability of the samples of the distinct HIV cohorts gives researchers the opportunity to study subgroups of HIV-patients which are well characterized in distinct stages of the disease and to correctly follow the evolution of the infection in a group of individuals over a long period of time. Furthermore, the large quantity of samples available in the SHIVBB enables researchers to conduct studies with higher scientific and statistical significance. A manager of the sample resource, as well as others involved in the decision on the access to the samples in the SHIVBB, is merely the caretaker of the samples and must act in the best interest of the donors.
The SHIVBB was established to offer important support to global research in the area of HIV infection. Its success is measured not only in publications, but also in technical and scientific advances achieved through the use of these samples.
Web: http://immunolab-hiv.org/web/main/biobanco.html and http://www.retic-ris.net/
E-mail:
Contact: M a Angeles Muñoz Fernández, SHIVBB Director
• Human immunodeficiency virus: 8,000 HIV infected adults and 1100 vertically HIV infected children o Followed longitudinally : 3,900 patients with follow up o Coinfected HIV-Hepatitis C: 556 patients o Uninfected healthy controls: 325 subjects
• Cohort of adults (CoRIS): 14,257 • Cohort of Long Term Non-Progressors (LTNP): 571 • Cohort of Elite Controllers or Elite Suppressors: 980 • Cohort of Rapid Progressors (RP): 388 • Cohort of Acute or Recent Infection: 145 • Cohort of Lymphocyte Non-regenerators: 98 • Cohort of HIV –HCV co-infection: 1,580 • Cohort of vertically HIV infected children and adolescents (coRISpe): 11,036
Instituto de Salud Carlos III: Red Temática de Investigación Cooperativa Sanitaria ISCIII RETIC RD06/0006/0035 and RD12-0017-0037 Fundación para la investigación y prevención del SIDA en España (FIPSE) Grupo de Estudio en Sida (GESIDA)
Institutional core budget: 0% Grants: 85% Other: 15%
% cases with DNA: 95.67% % cases with plasmas/serum: 92.85% % cases with live lymphocytes: 83.71% % cases with cell pellets: 66.67%
Number of ongoing ethical permissions for studies: 38 research studies and 2 clinical trials
Approximate numbers of samples released: 17,199 aliquots from 4,470 donors
Publications in the past year (based on biobank and users): 46
Special cohorts, such as LTNP, RP, Elite Controllers, Acute infection, LNR, and vertically HIV infected children and adolescents. Those with complete longitudinal sets of samples from the different cohorts of HIV patients with full clinical details, polymorphism data, viral sequence data, and HLA types.
1. Insecure funding.
2. Data storage/manipulation (clinical data combined with gene array data).
3. Efficient quality control of all samples stored in SHIVBB
We would obtain further technical assistance and a data manager to collate/analyze the amount of information that has been accrued on the cohorts of HIV infected patients. We would increase the storage capacity of the biobank and would increase novel techniques (production of monoclonal antibodies, T-cell immortalization of specific HIV-cohorts, envelops of different HIV isolates, etc.), consequently, we would increase personnel. We would prepare the biobank for future research issues.