Malaria_Amendment_2-20-15.pdf

NIAID-LMIV-NIHAO2015023

Amendment 2

2-20-2015

In the proposal, the offeror will demonstrate capability for providing fresh and/or frozen samples. Based on their written material, the review panel will determine if they meet the criteria for doing one or both. The offeror is only required to submit one proposal.

1. To submit a proposal, offerors must meet the shipment criteria for either fresh specimens, cryopreserved PBMCs, or both. Proposals may be submitted for processing, storage, and shipment of only cryopreserved PBMCs, only fresh specimens or both. It is up to the offeror to determine if the delivery criteria from Attachment 3, Statement of Work, shown below can be met. NIH does expect to conduct some studies that will not require fresh specimens requiring close physical proximity.

Attachment 3: Base Contract Statement of Work, Operation of a Facility for Testing of Malaria Vaccines in Adult Human Subjects, NIHAO2015023

3) GENERAL TASK ORDER REQUIREMENTS

The following requirements shall apply to each Task Order:

2. The contractor shall be responsible for initial processing, temporary storage, and shipment of samples to the LMIV per protocols provided by LMIV for evaluation of immunological outcomes (to include at a minimum serum or plasma for assessment of antibody levels, and peripheral blood mononuclear cells [PBMCs] for the assessment of cellular responses). In a typical trial of thirty volunteers, ten samples will be collected over an 18-month period per volunteer. These will be stored in multiple aliquots. The contractor will need to provide secure storage in a monitored – 70oC or lower, freezer with a documented inventory control for samples to be assayed by the contractor and will need to provide similar temporary storage and arrange for periodic shipment of samples to the LMIV. The contractor will provide facilities for separation, cryopreservation and storage of lymphocytes from whole blood prior to shipping to the LMIV. Fresh PBMCs may also need to be transported to LMIV, depending on the assays to be conducted in each protocol. Apheresis may be required to obtain large volume serum or plasma, or higher numbers of PBMCs, as per study protocols.

Depending on the study requirements (fresh versus cryopreserved sample), the Contractor is required to deliver specimens as described below to LMIV at 5640 Fishers Lane, Rockville, MD 20852:

a. Fresh specimens – delivered within two hours of initial processing and before 2

P.M. Eastern Time (ET) on the day of collection. Certain assays require fresh samples to maintain validity. Initial processing includes a period that is not to exceed a maximum of four (4) hours for sample collection and shipping preparation, and must occur on the same day of the Contracting Officer Representative (COR) requested delivery date or

b. Cryopreserved PBMCs – delivered between 8 A.M and 4 P.M. ET on the next business day after the COR request date.

2. It should also be noted that if an offeror is only able to deliver either fresh or Cryopreserved specimens not both there is a rating deduction 5 points as indicated in the solicitation starting on page 106, under Section M, Criterion 3: Facilities, Equipment, and Other Resources

NIAID-LMIV-NIHAO2015023

Amendment 2

2-20-2015

B. Ability to ensure delivery of fresh specimens according to protocol requirements (human PBMCs) to LMIV in Rockville, MD within two hours of initial processing.(5)

C. Ability to deliver cryopreserved PBMCs to LMIV by 4:00pm EST on the next business day after the COR's request. (5)

3. The attached Excel worksheet is intended to help you prepare your cost proposal. Complete the worksheet as applicable; a copy must be included with your proposal submittal.

QUESTIONS:

4. In Appendix A-1 (which corresponds to Task Area B), the Study Days are incorrect. The hotel phase should be listed as Study Days 162-175 and post-Malarone follow up should be listed as Study Days 176-178, correct? The ‘Days post vaccination’ and the ‘Number of visits’ are correct.

Answer: The study days for this design are not incorrect. No update is needed.

5. For Task Areas B and C, are RT-PCR assays intended to be run concurrently with the blood smear testing or at the conclusion of the trial? Based on Appendix A-1 and C-1, we are currently planning for paired blood smears and RT-PCR performed on a daily basis and reported on the same day as collection.

Answer: The plan for paired blood smears and RT-PCR performed on a daily basis and reported on the same day as collection is correct.

6. Can we exclude CVs/Resumes and/or the Bibliography from the Technical Proposal page limit?

Answer: CVs/Resumes and/or the Bibliography will be included with the Technical Proposal page limit.