Sponsor: Medicago R&D Inc. Version 4.
0
Protocol #: CP-PRO-CoVLP-021 Phase III 1-Jun-2021
PPD Study Code: SYNH0016
PPD LABORATORIES COLLECTION FLOW CHART
(Collect blood tubes in order listed below-top to bottom)
Period 1 Period 2 Cross-over
Centrifugation Speed
Visit V1 V2 V3 V4 V5 V1C V2C V3C V4C V5 C Draw Tube Invert Time Elapsed (minutes) Post
and Time Storage
Cap Color Blood Volume of Collection / Prior to Transfer Ship to PPD Laboratories Shipping
UNS Ship to 3PL Condition at Shipping Frequency Special Instructions
*Shade may vary Draw Tube (mL) Centrifugation Device Central Lab Condition
Time Point Day 0 Day 21 Day 42 Day 201 Day 386 Day 0 Day 21 Day 42 Day 201 Day 386 per region
Site
(minutes)
Test
Clot at least for 30-60 minutes
Anti-Sars-Cov-2 Coll Separate serum within
4mL 1500 g at RT ~2mL serum into Frozen -20C Frozen on Dry
(Kit type Ax) 1 1 1 1 5-10x 60 minutes of collection PPD Weekly
Red Top for 10 min 5mL Transfer Vial or below Ice
Store within 1 hour after
centrifugation
Daily:
For sites WITHOUT
Clot at least for 30-60 minutes
~1mL serum into CAPABILITY TO FREEZE at
Separate serum within
Sero Nab 10mL 1500 g at RT each 2mL Cryo Vial Frozen on Dry -70C Primary and Back-up aliquots
(Kit type Nx)
1 1 1 1 1 5-10x 60 minutes of collection x4 PPD Frozen -70C
Red Top for 10 min (1 Primary and Ice Weekly: should not be shipped together
Store within 1 hour after
3 Back-up) For sites WITH CAPABILITY
centrifugation
TO FREEZE at
-70C
PLEASE SHIP PRIMARY SAMPLES
Clot at least for 30-60 minutes TO NEXELIS AND BACKUP
~0.5mL serum into
Separate serum within SAMPLES TO MEDICAGO
Sero Elisa Nab 10mL 1500 g at RT each 2mL Cryo Vial Frozen on Dry Monthly - See shipping
1 1 1 1 1 1 1 1 1 1 1 5-10x 60 minutes of collection x7 Nexelis / Medicago Frozen -70C Shipping Schedule must be
(Kit type Sx) Red Top for 10 min (3 Primary and Ice schedule
Store within 1 hour after followed
4 Back-up)
centrifugation LABELS PROVIDED BY
Only applicable for MEDICAGO
CMI Subset
Immunogenicity
5 x 8mL
PBMC Cell Preparation See instructions in the Caprion procedure Liquid Frozen on Dry Monthly - See shipping
1 1 1 1 1 1 1 1 1 1 1 See instructions in the Caprion procedure manual x7 Refer to Caprion lab manual
(Kit type PBMCx) Tube (CPT) manual Nitrogen Ice schedule
Na Citrate
Covid19 Swab PPD LABEL See instructions in the Viroclinic procedure manual
Frozen on Dry
1 NP swab Frozen -70C Daily
Primary Ice
Clinic Collected
(USE KIT TYPE
SWAB FOR PPD
LABELS)
Covid19 Swab PPD LABEL See instructions in the Viroclinic procedure manual
Frozen on Dry
1 NP swab Frozen -70C Daily
Backup Ice
For sites without capability to
freeze at -70C, affix a PPD label
(included in PPD kits).
DO NOT COVER the label for
ViroClinics.
SHIP swabs to PPD
Covid19 Swab PPD LABEL Frozen on Dry
1 NP swab See instructions in the Viroclinic procedure manual Frozen -70C Weekly
Primary Ice
Self-Collected
(USE KIT TYPE
SWAB HOME FOR
PPD LABELS)
Covid19 Swab PPD LABEL See instructions in the Viroclinic procedure manual
Frozen on Dry
1 NP swab Frozen -70C Weekly
Backup Ice
Blood Volume (mL) 14 N/A 10 N/A 4 14 N/A 10 N/A N/A N/A
Estimated Total Blood Volume PERIOD 1 (mL) = 28
Blood Volume (mL) Does not include unscheduled visit.
50 50 50 50 50 50 50 50 50 50 N/A
CMI Subset 'Estimated Total Blood Volume PERIOD 2 (mL) = 24
Does not include unscheduled visit.
A3 'Estimated Total Blood Volume (mL) CMI SUBSET = 250
A
N1 A2
A4
N4
N2 Does not include unscheduled visit.
N PBMC1 N3 S7 S9 S10 PBMC5
Collection Kits PBMC2 PBMC3 PBMC4 S8
PBMC S1 S6 PBMC7 PBMC9 PBMC10 S5
S2 S3 S4 PBMC8
S PBMC6 SWAB
SWAB HOME
PLEASE SHIP SAMPLES DIRECTLY TO THIRD PARTY LABS
FOR SITES WITHOUT CAPABILITY TO FREEZE at -70C - SHIP SWABS to PPD as instructed
Labels are provided by PPD for Anti-Sars-Cov-2 Coll and Sero Nab and samples must be registered into Preclarus.
For CMI Subset, Medicago is only providing labels for Sero Elisa NAB and not the PBMC. Labels for PBMC have to be resistant to nitrogen and are a special labels that sites routinely have.
Samples are not registered into Preclarus.
PPD Laboratories Central Lab Hot Line
US: 1-800-323-2996 or 1-859-781-8877;
[email protected] EU: +32 2 725 2127 or +32 2 416 4300;
[email protected] Singapore: +65 65946210;
[email protected] GCL-PM-0093jr02, Effective Date: 13NOV2020
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