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NeutNet
HIV/AIDS
Framework programme: 6
Call: 2
Project number:
LSSP-CT-2004-012190
EC contribution: € 299,000
Duration: 27 months
Type: SSA
Starting date: 1 January 2005
Graphic element Standardisation of HIV Neutralisation Assays to be Used in Vaccine Research and Clinical Trials
Keywords: HIV; neutralising antibody; standardisation

Summary:

The relevance of neutralising antibodies in protection against HIV infection and disease remains to be elucidated. Numerous in vitro neutralisation assays have been developed, each one with different variables and endpoints. NeutNet, a group of 14 participants from all over the world, proposes to coordinate activities aimed at standardising methods for the measurement of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines. NeutNet will organise an initial study with the most relevant neutralisation methods and a panel of well-characterised and common reagents, to define appropriate reference controls for neutralisation assays. The data from this study will serve as the basis for a subsequent study with polyclonal serologic reagents to gain an understanding of the prerequisites to measure accurately and reproducibly HIV-1 functional antibodies for HIV protection and pathogenesis. A workshop, jointly organised with World Health Organization (WHO)/Joint United Nations Programme on HIV/AIDS (UNAIDS), will provide a venue to discuss the results of the actions of NeutNet with a larger body of researchers in the field and share the information at a global level. The results of NeutNet will benefit HIV vaccine research and clinical trials, making it possible to compare all vaccine efforts throughout Europe and beyond.

Background:

While antibodies are known to play an important role in protection against viral diseases, such as polio, hepatitis, measles, and influenza, the relevance of neutralising antibodies (NAb) in HIV-1 protection and pathogenesis remains to be further defined. Production of an antibody response with a broad neutralising activity against primary isolates of multiple HIV-1 subtypes continues to be a desired characteristic for candidate HIV vaccines. To support the evaluation of phase I, II, and III human vaccine trials testing new HIV immunogens, it will be important to standardise as far as possible and practicable, and apply high-throughput, sensitive, specific and reproducible HIV neutralisation assays. In this proposal, a group of 11 laboratories, performing a range of different techniques to measure neutralising antibodies, will proceed with the coordination of an international collaborative study.

Aim:

The primary aim of this project is to coordinate activities aimed at standardising methods for the measurement of neutralising antibodies to HIV-1 for use in human clinical trials of candidate AIDS vaccines and in HIV research.

The specific objectives of this proposal are:

  1. to develop and centralise the necessary reagents to undertake the study, to provide for their maintenance at the project repository
  2. to prepare a draft protocol and guidelines for the study
  3. to organise an initial study to compare different neutralisation methods using a number of well-known monoclonal antibodies against a panel of well-characterised viruses
  4. to define the methods for data analysis and statistical comparisons of assay results from the different participants
  5. to organise a subsequent study to compare polyclonal serologic reagents, and to define the best conditions to determine neutralising activity
  6. to define the needs of the scientific community involved in both preventive and therapeutic HIV/AIDS vaccine trials for neutralisation standards, and to prepare candidate materials for evaluation
  7. to organise a meeting in collaboration with WHO/UNAIDS to discuss the results of the actions listed above and share the information with a larger body of researchers in this field.

Expected results:

  • Collection of reagents and materials for the studies
  • Development of a questionnaire for the collection of information about reagents
  • Definition of the statistical significance of the different methods
  • Definition of standards for neutralisation assays
  • Organisation of NeutNet - WHO/UNAIDS workshop
  • Dissemination of SOPs and workshop proceedings

Potential applications:

The results of NeutNet will benefit European HIV vaccine research and clinical HIV vaccine trials in that it will provide standardised HIV neutralisation assay(s) and, ultimately, neutralisation standards. This will make it possible to compare all vaccine efforts throughout Europe and beyond. In a global perspective, the structure of NeutNet allows for the global use of standardised neutralisation assay(s).

Coordinator:

Gabriella Scarlatti
Viral Evolution and Transmission Unit
DIBIT - San Raffaele Scientific Institute
Via Olgettina 58
20132 Milan
Italy
Tel: +39 02 2643 2821
Fax: +39 02 2643 4905
E-mail: scarlatti.gabriella@hsr.it
Website: http://www.sanraffaele.org

Partners:

Principal
Scientific
Participants
Official Address Other Information
2Eva Maria FENYODepartment of Medical Microbiology, ­Dermatology and Infection
Lund University
Sölvegatan 23
SE-223 62 Lund
Sweden
Tel:
+46 46 173275 or 173241 secr.
Fax: +46 46 176033
E-mail:
Eva_Maria.Fenyo@mmb.lu.se
Website: http://www.infek.lu.se
3Harvey HOLMESDivision of Retrovirology
National Institute for Biological Standards and Control (NIBSC)
Blanche Lane
South Mimms
UK-EN6 3QG Potters Bar
United Kingdom
Tel: +44 1707 654753
Fax: +44 1707 649865
E-mail: hholmes@nibsc.ac.uk
Website: http://www.nibsc.ac.uk/
4Christiane MOOGResearch Unit INSERM
ULP U544 ‘Pahtogénie des infections virales persistantes’
Institut de Virologie
3, rue Koberle
FR-67000 Strasbourg
France
Tel: +33 3 90 24 37 42
Fax: +33 3 90 24 37 23
E-mail:
c.moog@viro-ulp.u-strasbg.fr
Website: http://ulp.u-strasbg.fr
5Quentin SATTENTAUThe Sir William Dunn School of Pathology
University of Oxford
South Parks Road
UK-OX1 3RE Oxford
United Kingdom
Tel: +44 1865 275511
Fax: +44 1865 275515
E-mail:
quentin.sattentau@pathology.ox.ac.uk
Website: http://www.ox.ac.uk
6Lynn MORRISAIDS Virus Research Unit
National Institute for Communicable ­Dis­eases
1 Modderfontein Road
Sandringham
Johannesburg
South Africa
Tel: +27 11 386 6332
Fax: +27 11 386 6453
E-mail: lynnm@nicd.ac.za
Website: http://www.niv.ac.za
7Ruengpung SUTTHENTNHRBC
Department of Microbiology
Faculty of Medicine
Siriraj Hospital
Mahidol University
2 Pran-nok Road
Bangkok 10700
Thailand
Tel: +66 2 866 2576
Fax: +66 2 411 3921
E-mail: sirst@mahidol.ac.th
Website: http://www.nhrbc.org
8Vera BONGERTZLab AIDS & Imunologia Molecular
Dpto Imunologia / IOC / FIOCRUZ
Pav Leônidas Deane, sala 413
Av Brasil 4365
21045-900 Rio de Janeiro, RJ
Brazil
Tel: +55 21 3865 8130
Fax: +55 21 2290 4110
E-mail: bongertz@ioc.fiocruz.br
Website: http://www.fiocruz.br
9Vicky POLONISDivision of Retrovirology
Walter Reed Army Institute of Research
13 Taft Court Suite 200
Rockville, MD 20850
United States of America
Tel: +1 301 251 8308
Fax: +1 301 762 4177
E-mail: vpolonis@hivresearch.org
Website: http://www.hjf.org
10Terri WRINViroLogic, Inc.
270 East Grand Ave.
South San Francisco, CA 94080
United States of America
Tel: +1 650 866 7427
Fax: +1 650 742 0993
E-mail: twrin@virologic.com
11Susan ZOLLA-PAZNERNYU School of Medicine
c/o VA Hospital
 Room 18124N
423 East 23rd Street
New York, NY 10010
United States of America
Tel: +1 212 951 3211
Fax: +1 212 951 6321
E-mail:
zollas01@endeavor.med.nyu.edu
Website: http://www.med.nyu.edu
12David C. MONTEFIORIDepartment of Surgery
SORF Bldg., LaSalle
 St. Ext., Rm 130
Duke University Medical Center
Durham, NC 27710
United States of America
Tel: +1 919 684 5278
Fax: +1 919 684 4288
E-mail: monte@acpub.duke.edu
Website: http://www.edu.edu
13Saladin OSMANOVWHO-UNAIDS HIV Vaccine Initiative (HVI)
Initiative for Vaccine Research (IVR)
Health Technology and Pharmaceuticals (HTP)
World Health Organisation (WHO)
20 Avenue Appia
CH-1211 Geneva 27
Switzerland
Tel: +41 22 791 4393
Fax: +41 22 791 4865
E-mail: osmanovs@who.ch
Website:
http://www.who.int/ vaccine_research/diseases/hiv/en/

 
 
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