Description of service

BPRC will provide access to adult, MHC-typed macaques for immunogenicity/adjuvanticity evaluation for typical immunogenicity studies of up to 26 weeks and up to containment level BSL3. The service includes baseline assessments and post-vaccination follow-up by biosample collection (up to 12 time points in total) and banking for at least up to 2 years after the study, as well as standard humoral and/or cellular immunology tests. Users may suggest specific assays for selected time points. These may include but are not limited to vaccine specific and advanced multi-label flow cytometric analyses. A typical immunisation protocol might contain up to three (prime-boost) immunisation events. The access and services include applications for regulatory and/or ethical approval (by European and Dutch law), optimisation of study design and the summary of results in a study report. Additional study objectives, such as challenge or advanced immunological assessments (imaging, flow cytometry, etc.) and the addition of more animal units, may be negotiated and offered under institutional access rules.

 

1.Vaccine Immunogenicity Evaluation in NHP

BPRC.EF.VIE (vaccine immunogenicity evaluation)

For the evaluation of immunogenicity (and tolerability) of vaccine candidates in it's experimental facilities (EF), BPRC - as partner of TRANSVAC - offers access to non-human primate (NHP) models, ic. Macaca mulatta (rhesus) and Macaca fascicularis (cynomolgus). Users (read: applicants) can be supported by BPRC in the design and preparation of experiments and are encouraged to contact BPRC prior to application for service. BPRC will require background information from the user/applicant on the vaccine candidate(s) to enable BPRC to obtain any relevant legal approvals/permits, including an independent ethical review, all according to Dutch law, EC Directives, and prior to start of the study. A detailed Study Plan will be agreed between the applicant and BPRC and become an integral part of a collaborative research agreement, also prior to start of study.

While details of study design can vary and are adaptable upon specific request, a typical immunogenicity evaluation as meant here, is in principle based on vaccine delivery and ≤3 months monitoring time, with relevant biosample collection at specific time points for the assessment of the anticipated host (immune) response by a primary and a secondary readout.

For the evaluation of vaccine-induced host (immune) responses BPRC has self-sufficient, MHC- and KIR gene-typed colonies of the respective Macaca spp., rooms for experimental housing and handling of animals up to bio-safety level 3, and several operational laboratories for immunology, flow and/or spectral cytometry, in vitro imaging, hematology and clinical chemistry, microbiology, and molecular biology.

BPRC will be responsible for the execution of the in vivo phase of the study, and all animal handlings will be conducted by qualified personnel only. BPRC will perform assays according to the Study Plan, in collaboration with the user. Any surplus of biosamples or specific specimens can be provided to the applicant (at receiver's expense) or kept in BPRC's biobank for future research purposes depending on the agreement with the applicant and on the discretion of BPRC. Study results will be collected and provided in a full written Study Report to the user.

 

2. Vaccine Efficacy Evaluation in NHP

BPRC.EF.VEE

For evaluation of the protective efficacy of vaccine candidates in its experimental facilities (EF), BPRC - as partner of TRANSVAC - offers access to non-human primate (NHP) models, ic. Macaca mulatta (rhesus) and Macaca fascicularis (cynomolgus). Several viral, bacterial and parasitic infection models are up and running.

While the duration of an infectious challenge experiment is adaptable upon specific request, the setup will also depend on the nature of the infectious agent required for challenge. A typical efficacy evaluation as meant here is based on prior vaccination and a follow up for efficacy readout after infectious challenge of ≤3 months.

For more background on BPRC's specific capacities and modi operandi, see under its infrastructure service BPRC.EF.VIE, vaccine immunogenicity evaluation.

 

3. Pathogen-Host Interaction (PHI) Studies in NHP

BPRC.EF.PHI

For pathogen-host interaction studies in its experimental facilities (EF), relevant to research and development (R&D) efforts towards vaccines for emerging diseases and/or pathogen variants, including the definition of new efficacy evaluation models, BPRC - as partner of TRANSVAC - offers access to non-human primate (NHP) models, ic. Macaca mulatta (rhesus) and Macaca fascicularis (cynomolgus).

While the duration of an experiment can vary and will depend on the nature of the infectious agent under investigation, a typical PHI study as meant here is based on a 3 months study protocol for the in vivo part of the experiment.

For more background on BPRC's specific capacities and modi operandi, see under its infrastructure service BPRC.EF.VIE, vaccine immunogenicity evaluation.

 

4. Vaccine Research & Discovery in NHP

BPRC.EF.VRD

To support vaccine research and discovery in general and for more exploratory approaches into host (immune) response characteristics in its experimental facilities (EF), BPRC - as partner of TRANSVAC - offers access to non-human primate (NHP) models, ic. Macaca mulatta (rhesus) and Macaca fascicularis (cynomolgus). The investigational approaches can be targeted towards (but must not be limited to) antigen discovery, global host response analysis (OMICs approaches), in-depth immune response analysis (e.g. germinal centre response; hematopoietic precursor analysis), or immune correlate/biomarker identification/validation studies.

While the duration and nature of an experiment can vary and will depend on the investigational questions and targets, a typical vaccine research & discovery study as meant here is based on a 3-months study protocol for the in vivo part of the experiment.

For more background on BPRC's specific capacities and modi operandi, see under its infrastructure service BPRC.EF.VIE, vaccine immunogenicity evaluation.

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Applicants are encouraged to contact the Lead Scientist before submitting the request for access to this service.

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BPRC also provides access to rhesus and cynomolgus macaque models of COVID-19 to test both therapeutic and prophylactic vaccines.