Question_and_Answer__W81XWH16T0375.docx

QUESTION and ANSWER to Solicitation W81XWH-16-T-0375

QUESTIONS

General:

1. The solicitation indicates that it is an unrestricted procurement. Can you please confirm that Not-for-Profit organizations are eligible to apply?

ANSWER: The requirement is unrestricted.

2. Is there a cost ceiling for individual Phases and/or the whole project?

ANSWER: No cost Ceiling, except for travel CLIN.

3. On page 7, item 9-Travel, it indicates “none”. However, the PWS indicates that video files will not leave USAMRIID and must be reviewed onsite. This therefore requires travel to Fort Detrick. Please clarify.

ANSWER: Yes, the video files will not leave USAMRIID, must be reviewed onsite, and this will require travel to Fort Detrick.

4. Within the background section of the PWS, there are 16 numbered references, but none of the actual citations are provided. Is a list of these citations available?

ANSWER: The Background was lifted from the original Statement of Objectives and the reference numbering starts at reference #4:

4. Luciani K, et al. Am J Trop Med Hyg, 14-0845.

5. Ethier M, et al. Med Health R I, 95(7):227-9.

6. Harvala H, et al. J Med Virol, 81(2):305-8.

7. Hirsch MS, et al. N Engl J Med, 359(3):294-303.

8. Lury KM, et al. Emerg Radiol, 11(1):46-8.

9. Deresiewicz RL, et al. N Engl J Med, 336(26):1867-74.

10. Badar Z, et al. Ped Inf Dis, 6:66-71.

11. Wendell L, et al. Neuro Care, 19:111-115.

12. Morse RP, et al. Ped Neuro, 8:473-475.

13. Silverman MA, et al. EID, 19:194-201.

14. Anderson BA, et al. Can Med Assoc J, 131:186-188.

15. Delfraro A, et al. EID, 17:952-954.

16. Ehrenkranz NJ, et al. Annu Rev Med, 25:9-14.

Specific:

5. During the sources sought request, we were informed that data were collected using DSI implants with Notocord Hem software. 2x EEG channels each subject (C3-O1; C4-O2).

Can you please confirm that this is correct? Which model # DSI implant was used? What file format were data saved in? Were any other sensor data collected (accelerometer, temperature, EKG)? Were video data collected using the same system and time-locked?

ANSWER: Yes, this is correct. Two DSI M01 implants will be used; one for each EEG channel. The original file format will be NSS, although, we plan to convert these files to EDF so they can be analyzed using NeuroScore or other applicable software. One DSI M11will be used for blood pressure, temperature and ECG. All three will have accelerometer. These data can be provided as well. The video data will be collected on a separate system but the systems will be time-synchronized.

6. For on-site review of video data to complement interpretation of EEG, is the Notocord Hem software all that is available or is NeuroScore also available on-site at USAMRIID?

ANSWER: NeuroScore can be made available.

7. For Task I, the PWS indicates that analyses will include characterization of paroxysmal and ictal activity. Is the presence of isolated inter-ictal spikes considered to be paroxysmal activity in this context? Validation of interictal spikes requires a level of detailed analyses that is substantially beyond that which can be used to identify seizures.

ANSWER: See answers to Question 4.

8. Can you provide information on which alphavirus animals were exposed to, the administration route, and dosage? Was the protocol sufficient to induce what appear to be clinical seizures? Can anything be said about the general quality of the data, especially with respect to artifacts? EEG identification of seizures is very straight forward and easily achieved with commercially available analysis packages. However, more subtle finding like qEEG changes in alpha or delta power require careful review of data for artifacts something more challenging in software like NeuroScore. Pre-processing of data in EEGLAB or other products may be critical depending on the quality of the data.

ANSWER: Animals have not yet been exposed, so we cannot provide any comment on the general quality of the data. The plan is to expose the animals to either eastern (EEEV), western (WEEV), or Venezuelan equine encephalitis viruses (VEEV) by the aerosol route. With EEEV and WEEV, we expect to see clinical seizures in at least some of the animals. With VEEV, we do not expect to see clinical seizures. The purpose of this contract is to have the EEG analyzed with enough detail to characterize the animal model and to compare the findings to the human literature.

9. Please clarify how many animals will be used in Phase III.

ANSWER: This purpose of this Phase is to have additional analysis on any NHPs from Phase 1 and 2 that survive beyond the 15 days allotted in Phase 1 and 2. So, this is not a specific number of NHPs

10. Can USAMRIID provide any information about the clinical status of animals post-infection? In particular, did they show evidence of clinical seizures, how many days did these last, and how frequent were they on a daily basis?

ANSWER: Animals have not yet been exposed, so we cannot provide any comment on the animals that will provide these data. The plan is to expose the animals to either eastern (EEEV), western (WEEV), or Venezuelan equine encephalitis viruses (VEEV) by the aerosol route. With EEEV and WEEV, we expect to see clinical seizures in at least some of the animals. With VEEV, we do not expect to see clinical seizures. In general, the clinical neurological course of disease is fairly short (1 - 3 days) for EEEV and WEEV infections.