EUROVAC: European vaccine effort against HIV/AIDS (cluster proposal, 3-2)

• Research unit: EU RFP
• Project number: 99.0471-3

Key words (English)

Vaccine; preventative; HIV;
Life Sciences; Medicine; Health; Safety; Scientific Research; Social Aspects

Alternative project number (English)

EU project number: QLK2-CT-1999-01321

Research programs (English)

EU-programme: 5. Frame Research Programme - 1.1.2 Control of infectious diseases

Short description (English)

See abstract

Further information (English)

Full name of research-institution/enterprise:
Centre hospitalier universitaire vaudois CHUV
Division d'immunologie et d'allergie
Laboratoire d'immunopathologie du SIDA

Partners and International Organizations (English)

Coordinator: CNRS, Lyon (F)

Abstract (English)

The main objective of project 3 in year 2 according to the revised workplan submitted in year 1 is to continue to work on the clinical trial protocol and participant information sheet.
January 2001 - Regulatory meeting to review the role of each partner in implementing the necessary approvals for clinical trials. Areas of concern identified:
(i) a Clinical Trial Agreement would need to be in place involving the partner responsible for the product(s), the clinical centres and the data management centre which defined responsibilities and ownership rights
(ii) Provision of indemnity was a critical responsibility and three areas were identified: product liability, on-protocol harm to participants, off-protocol harm (including negligence of practitioners)
(iii) Ownership of (a) the intellectual property right for each product and (b) the clinical trial data generated the research were the major items
As EuroVac is not a legal entity, the agreement would have to be coordinated by one of the academic institutions, and it was decided to ask Imperial College to do this.
It may be necessary to explore specific cover for any harm caused by product(s) that arise from the public sector eg MVA and DNA.
March, June 2001 - 3 further meetings to resolve the selection of products, and trial designs. Decision was taken to simplify regimens to a single agent, 2 doses (week 0 and 4) in first instance as human safety data are not available for any of the immunogens.
October 2001 - selection of NYVAC B& C for the first trial made. Providing the regulatory authorities approve the safety data from this trial, the second trial will proceed with NYVAC prime x 2 and recombinant protein boost x2 (a clade B vs clade C comparison).

References in databases (English)

Swiss Database: Euro-DB of the
State Secretariat for Education and Research
Hallwylstrasse 4
CH-3003 Berne, Switzerland
Tel. [phone]
Swiss Project-Number: 99.0471-3