Health Protection Agency, Centre for Emergency Preparedness and Response, Porton Down, United Kingdom

The Health Protection Agency's role is to provide an integrated approach to protecting UK public health through the provision of support and advice to the NHS, local authorities, emergency services, other Arms Length Bodies, the Department of Health and the Devolved Administrations. HPA's Centre for Emergency Preparedness and Response (CEPR) based at Porton Down, UK, is focused on applied microbiological research and emergency response. This includes developing healthcare interventions for small and medium volume biopharmaceuticals either independently or in partnership with commercial and non commercial bodies to phase III before "spinning out" for commercialisation. Key specialisms at HPA-CEPR include vaccine research under high containment (dangerous pathogens) and preclinical toxicology. Coupled with our research programmes HPA-CEPR has the capability to assess vaccines for efficacy and other parameters using immunological assays and in vivo models within our accredited facilities. HPA-CEPR manages macaque breeding colonies for both cynomolgus and rhesus based on the Porton site. Both colonies are B-virus free and of fully defined health status.

Programme areas include:

• The development and testing of new public health vaccines

• Exploitation of the natural pharmacological properties of molecules to generate novel medicines

• Prion pathogens (BSE & CJD)

• Biosafety and biodefence research & testing

• Evaluation of diagnostic kits

• External Quality Assessment services

• Molecular identification and bioinformation services

As a partner of TRANSVAC, HPA-CEPR will offer access to their immunocompromised rhesus macaques models for evaluation of the immunogenicity and clinical profile of vaccines. The experienced staff from HPA will carry out all standard procedures and animal care e.g. regular clinical observations and blood sampling and a detailed post-mortem examination of the animals.

The support that will be offered will be access to specific animal studies and all the costs associated with their conduct. These include purchase of the animals and all associated animal husbandry and procedures for taking samples at ACDP containment levels 2 and 3. Analysis of samples within ACDP containment level 2 and 3 laboratories by an experienced HPA scientist, specifically the evaluation of the immune status of the study subjects, is included, as is the provision of a final outline report and access to all raw data. Additionally the opportunity exists for the User to work with the HPA to evaluate vaccine-specific immune responses in immunocopromised animals.

On-site access

In the event that specialised techniques required for the evaluation of the test vaccine cannot be transferred to HPA staff, the User may acquire on-site access to the laboratories of the HPA at specific time points for testing.

Modalities of access

Organisation short name: HPA-CEPR

Unit of access: The Unit of access is defined as one vaccine tested in immunocompromised rhesus macaques with a maximum of eight animals included.

Quantity of access available: 1 vaccine tested in immunocompromised rhesus macaques with a maximum of 8 animals included.

Timelines: Study duration = 34 weeks.

Overview of access provided between January 2011 (1st call) and October 2011 (4th call):
Min. quantity of access to be provided: 1
Estimated number of users/User groups: 1-3
Estimated number of projects: 1-3
Access already provided: 0
Access still available: 1

Last call submission date scheduled for: April 2012 (Call number: 6)

Input – sample requirements:

The User will be responsible for the timely delivery of test substances (and reagents (e.g. antigens) when it applies).

Output – deliverables to User:

The deliverables are raw study data describing:

• Any adverse clinical effects of the vaccine

• Any pathological effects of the vaccine, including exacerbation of the SIV infection, accumulation of the vaccine in any organs

• Effects of the immunosuppression on immune response to the vaccine. The vaccine-induced responses measured will be selected in collaboration with the User as those appropriate to the vaccine under test that can be performed within the set study budget. Additional monitoring can be arranged if additional costs are met by the User.

Contact

Ann Rawkins

ann [dot] rawkins [at] hpa [dot] org [dot] uk