Key points
- Investigators can request samples from the North American pertussis controlled human infection model (pertussis CHIM) platform.
- CDC will only consider requests for samples for proposals that have funding.
- To submit a request for samples, follow the steps described below.
Processing requests
To submit a request for samples from the pertussis CHIM, follow the steps described below. To ensure the appropriateness of samples for your study, please review the following prior to making a request:
Application process
Only proposals with funding will be considered. Investigators who are awaiting a funding decision at the time of the request may reserve the samples for up to 3 months, depending on
- Type of sample
- Amount available in CDC's central biorepository
The cost of obtaining samples and associated research datasets is determined based on the requesting institution's designation (e.g., for-profit vs. non-profit) and the type of sample requested.
Please note that the entire process may take up to 6 months to complete.
Step 1: Submit initial request
- Investigator submits a request form via the
- CDC staff will determine availability of samples and check suitability for the research project based on the information provided. This may require asking the investigator for more information.
Step 2: Submit research proposal once it's determined that the samples requested are available
- Investigator will provide the following required documentation:
- Investigator CV
- Research plan (study protocol)
- Investigator institution IRB approval or waiver letter
- CDC staff will review for completeness.
Step 3: Review and approve proposal
- Research proposals will be reviewed by a scientific review panel to evaluate
- Appropriateness of the samples for the proposed research
- Whether the samples requested are a limited resource
- Value of the research in advancing pertussis knowledge gaps and/or generating data that can be used to develop/license new pertussis vaccines
- Compliance with human subjects regulations
- Qualifications of the investigator
- Submitters will need to clearly indicate how the science will be of the highest quality and focused on public health action.
Step 4: Execute human Materials Transfer Agreement (hMTA)
- CDC Technology Transfer Office staff will work with Investigator to draft and execute the appropriate agreements.
Step 5: Transfer specimens
- CDC staff will coordinate with the investigator to ship samples.
Step 6: Transfer data and documentation
- De-identified study metadata are made available to the investigator as secure transfers through the website. CDC will notify the requestor when the transfer link is activated.
- A README documentation file containing the following will be included:
- Brief description of the study
- Listing of files provided (including data dictionary)
- Description of system requirements
- Frequency distribution for selected key variables
Sample collection schedule by challenge dose
The table below details the number of participants per dose. Please note that the sample collection schedule was optimized during the dose escalation phase; thus, schedules may vary slightly. Click on the schedule version links to get exact collection dates per cohort.
Study Phase | # Participants | Dose | Schedule |
---|---|---|---|
Dose Escalation | 6 | 10^4 CFU | V9 |
Dose Escalation | 5 | 10^5 CFU | V9.1 |
Dose Escalation | 5 | 5 x 10^5 CFU | V9.1 |
Dose Escalation | 6 | 10^6 CFU | V9.1 |
Dose Escalation | 6 | 5 x 10^6 CFU | V9.2 |
Dose Escalation | 12 | 10^7 CFU (HID) | V9.2 |
Dose Confirmation | 10 | 10^7 CFU | V9.4 |
Dose Confirmation | 10 | 5 x 10^7 CFU | V9.4 |
Dose Confirmation | 4 | 5 x 10^6 CFU | V9.4 |
Sub-study | 10 | 10^8 CFU | V9.4 |
*HID = human infective dose; CFU = colony forming unit
Sample processing and storage conditions
Sample type | Collection tube | Additives, if applicable | Long-term storage container | Long-term storage temperature |
---|---|---|---|---|
Serum | 10 mL BD Vacutainer® Venous Blood Collection™ Silicone-coated (Red top) | NA | Screwcap cryovials, 2 mL | -80°C |
Plasma | 10 mL BD Vacutainer® Sodium Heparin tubes (Green top) | NA | Screwcap cryovials, 2 mL | -80°C |
Nasopharyngeal aspirates | NPAK NPA kit (Syringe and catheter system) | Dulbecco’s Phosphate buffered saline with Casamino acids | Screwcap cryovials, 2 mL | -80°C |
Nasal washes | Sterile container (e.g., urine collection cup) | Saline used for nasal wash process | Screwcap cryovials, 2 mL | -80°C |
Saliva | NEST dry saliva collection kit, 5 mL, Thomas Scientific | Neat or with Zymo Research DNA/RNA Shield | NEST tube, 5 mL | -80°C |
Whole blood | 2.5 mL BD PAXgene® Blood RNA collection tubes (Clear top) | NA | 2.5 mL BD PAXgene® Blood RNA collection tubes (Clear top) | -80°C |
PBMCs* | 10 mL BD Vacutainer® Sodium Heparin tubes (Green top) | NA | Screwcap cryovials, 2 mL | LN2 |
* Peripheral blood mononuclear cells