DCVC Immunological Analysis Unit Assay/Model Request

DCVC Immunological Analysis Unit Assay/Model Request

The goals of the DCVC Immunological Analyses Unit (IMAU; CIVICS A - Objective 3) are to centrally support iterative, pre-clinical, immunological characterization of immune responses, ensure consistent quality of immune monitoring assays performed across all DCVC discovery labs, and to facilitate data transfer to DMID-mandated databases and systems. The unit is based in the Duke Regional Biocontainment Laboratory (RBL), a division of the Duke Human Vaccine Institute, but also draws expertise from a number of other labs/cores at Duke and collaborating institutions.

Please use your institutional email address to complete this form.

If you have any questions or problems completing this form please contact Jacquelyn DuVall (jacquelyn.duvall@duke.edu)

Requestor Name:*

(First Last)

Requestor Email Address:*

Laboratory Contact Name

(if different from requestor)

Laboratory Contact Email Address:

(if different from requestor)

DCVC Vaccine Design and Discovery Team:*

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Other:*

CIVICS Project Code*

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CIVICS Product code(s)

Required for SDMCC data management.

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Short description of study/experiment:*

Menu of Services

Animal Study (Immunogenicity/ Challenge)

Routine Immunogenicity Screen
Confirmatory Immunogenicity Testing
Influenza virus challenge (includes experimental vaccination)

Humoral Response Monitoring

Simplex HA Binding (ELISA)
Multiplex HA Binding (Luminex)
NA ELLA
HAI
Microneutralization
ADCC/ADCP/ADNP (human, mouse)
Fc-gamma Binding

Cellular Response Monitoring

Routine Surface Phenotyping
Phenotyping with In Vitro Stimulation and Intracellular Staining
Cell Sorting

Biomarker/ Metabolite Profiling

Cytokine/Chemokine Profiling

BCR/TCR Repertoire

BCR Repertoire (cells)
BCR Repertoire (serum/plasma)
TCR Repertoire (cells)

Virus Stock Propagation and QC

Services Requested

The Immunological Analysis Unit provides five categories of discovery/exploratory immune assessments for mice, ferrets and humans. Please complete a separate request for each service type.

Service Requested:*

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CIVICs component being supported by virus produced:*

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What influenza strain do you need propagated?*

Please provide full strain name including type and subtype/lineage. Ex: A/California/07/2009 (H1N1)

Seed Stock Source?

Duke RBL Virology may not have your virus isolate in stock. Can you suggest a repository or collaborator that has the virus?

What type of animal study?*

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Clinical indication for the vaccine product being tested

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Do you have a draft TPP (Target Product Profile)?*

If Yes, please upload below If No, contact DCVC Program Management for support in developing a TPP

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Species/Strain:*

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Species/Strain Other:

Preferred Sex:*

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Number of Animals per Group:*

Please use multiples of 5 for mice and 2 for ferrets for immunogenicity-only studies. If doing challenge studies, use multiples of 4 for mice and 2 for ferrets.

What immunogens will be used?

From which Influenza strain is the immunogen derived?*

(ex: H3N2 A/Texas/71/2017)

Immunogen use details:*

Please provide source, dose, units, storage requirements, and method of formulation/diluent. TBD not an acceptable response

Adjuvant:*

Please provide name, source, dose and method of formulation with immunogen.

Requested route(s) of delivery:*

Select all that may apply

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Date vaccine material will be available*

Please provide the date sufficient quantity of the experimental product(s) are available for this requested animal study. Please note the material must be pharmaceutical grade or documented low/no endotoxin. Upload documentation below. If you need Endotoxin Testing Contact Heather Lynch.

Requested immunization / sampling schedule:*

Please specify schedule of vaccination (ex: prime/boost 14 days apart). TBD not an acceptable response.

Influenza challenge strain:*

Please Note: an LD50 dose study will be needed for ferret challenge with additional strains not specifically listed below.

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Primary Research Hypothesis

Statistical Methods Being Used

Statistician Name

Statistician email

Would you like Duke CIVICS Biostatistics Unit to review study plan?*

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Endpoint measures*

In addition to required humane endpoint monitoring, are there any additional samples and/or monitoring you would like for this mouse or ferret study?

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Assay(s) requested--Humoral Response Monitoring:*

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Assay(s) requested--Cellular Response Monitoring*

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Assay(s) requested--Biomarker Profiling*

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Assay(s) requested--BCR/TCR Repetoire*

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Are these samples from an Animal Study performed at the Duke Immunological Analysis Unit/RBL?*

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Animal Study Number (DCVC or RAMU):*

To help connect endpoint assay requests to originating animal study, please provide the animal study's DCVC or RAMU number.

HA strains to be tested

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Influenza strain to be tested

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Samples derived from:*

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Samples/Specimens are:*

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Date samples will be available:*

Estimated total number of samples:*

Please provide details of assay(s) you are interested in having us perform.

(optional)

File Upload*

**We may not be able to assign your request without a sample manifest.

Attach/upload to the Service Request a Sample Manifest form in addition to any relevant protocol, study plan, experimental design, Draft Target Product Profile etc. relevant to this request. Please download the sample manifest template from the link below. https://shared-resources.dhvi.duke.edu/sites/shared-resources.dhvi.duke.edu/files/Duke%20CIVICS%20IMAU%20sample%20submission_v2.xlsx

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