SPECIAL NOTICE
Q -- Asymptomatic Reactivation Of Varicella Virus Following Stressful Life Events
- Notice Date
- 8/30/2005
- Notice Type
- Special Notice
- NAICS
- 622110
— General Medical and Surgical Hospitals
- Contracting Office
- Department of Health and Human Services, Center for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, GA, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 0000hcj3-2005-23656
- Response Due
- 9/7/2005
- Archive Date
- 9/7/2005
- Description
- The Centers for Disease Control and Prevention intends to issue a sole source purchase order to the University of Colorado Health Sciences Center, Fitzsimmons Building 500, Aurora, Colorado 80045-0500 to do the following: BACKGROUND: Following primary infection with varicella zoster virus (VZV), the virus establishes a permanent, latent infection within ganglia. VZV can reactivate clinically years later to cause herpes zoster (HZ). Ten to 20% of persons develop HZ during life (~700,000 cases annually); risks are greatest among the elderly and the immunosuppressed. HZ can cause post-herpetic neuralgia, a chronic, often incapacitating condition with no fully effective treatment. The burden of HZ is high and is increasing as the ?baby boom? cohort ages. The factors leading to development of HZ are not known: virtually all adults are infected with VZV, yet only a minority develop HZ. In order to develop prevention strategies, the correlates of protection against HZ is an area of active research. Clearly, immunity can protect against the development of HZ, but the mechanisms by which immunity is boosted in some persons and not others is not known. Some researchers believe that asymptomatic reactivation of VZV occurs, and that this reactivation then ?internally boost? specific HZ immunity, thereby protecting against subsequent HZ. This phenomenon might similarly boost varicella vaccine mediated immunity and thereby reduce the risk of vaccine failure (Krause P, et al. Nature Med 2000; 6:451?454). Others reject this hypothesis, speculating instead that a key mode of protection against HZ and against vaccine failure is from ?external boosting? of immunity by exposure to persons with varicella occurring in the general population (Hope-Simpson RE. Proc R Soc Med 1965;58:9?2). Of course, both mechanisms may also be at play. Currently, neither of these hypotheses has been convincingly validated, but the debate has taken on significance because of the growing burden of HZ. Also, if exposure to varicella in the population is the primary determinant to maintenance of specific immunity to HZ, reduction in circulation of VZV due to introduction of varicella vaccination could cause a decline in anti-HZ protection and increase the risk of HZ, and it might reduce protection against primary infection with varicella among vaccinees. On the other hand, if asymptomatic reactivation occurs, subsequent internal boosting could over-ride the impacts of varicella exposure on HZ risk and on duration of vaccine-mediated immunity. A recent study used 2 PCR techniques to test for presence of VZV in saliva specimens from 8 asymptomatic astronauts before, during and after space flight lasting 10-13 days. The astronauts? saliva was sampled every 1-2 days during a 1 month period beginning 8 months prior to flight, throughout flight, and during the first 15 days after flight. Whereas VZV shedding was detected in just 1 of 112 saliva samples collected prior to flight, during and after flight, shedding was detected in 61 of 200 total specimens, including specimens from all 8 astronauts, and from almost all sampling times (Mehta SK, et al. J Med Virol 2004;72:174?17). Results of the 2 PCR techniques were discordant, and varied from by day during and after flight in unpredictable ways. The affect of this viral shedding on immunity was not reported, and it was not possible to identify immunologic or other predictors of shedding since shedding occurred for all 8 astronauts. Asymptomatic shedding of VZV in saliva is indicative of reactivation, providing a mechanism for internal boosting. The results of this study were therefore intriguing, but their implications unclear: was shedding by astronauts just a ?space curiosity? or might it occur in response to more common provocations? If so, is asymptomatic reactivation a point on the clinical spectrum of HZ, or is it qualitatively different from HZ? Does reactivation boost specific immunity and thereby prevent subsequent HZ, and if so can researchers take advantage of the phenomenon to determine the immunologic correlates of protection against HZ? Finally, does reactivation of vaccine-strain VZV also occur, and might this also boost immunity, making vaccine-mediated immunity to VZV more durable? STATEMENT OF WORK: It is proposed to conduct a pilot study to test for VZV shedding among groups of persons undergoing various provocations: 1) to confirm a report that asymptomatic reactivation of VZV occurs (as indicated by shedding in saliva), and to extend those findings to persons undergoing common physiologic stressors so that its implications can be investigated in follow up studies; 2) to determine whether asymptomatic shedding of vaccine-strain VZV also occurs; 3) to determine whether there is an association between baseline levels of humoral and cell-mediated immunity to VZV and shedding. The Contractor shall furnish all labor, equipment, and material necessary for the purpose of conducting a study to test for VZV shedding among groups of persons undergoing various provocations; make various determinations as defined in the tasks and provide a written report of the findings. Co-PI?s will identify site coordinators who will be responsible for the following activities: 1. Enrollment of the following subjects, using proper informed consent as described in protocol: a. At least 8 adults 61 through 70 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective open-heart cardiac surgery at least 2 weeks after enrollment b. At least 8 adults 61 through 70 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective orthopedic hip replacement surgery at least 2 weeks after enrollment. c. At least 8 adults 61 through 70 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective intra-abdominal laparoscopic surgery at least 2 weeks after enrollment. d. At least 8 adults 61 through 70 years of age unambiguously reporting a history of varicella who are planning to participate in a road race or marathon of 10 kilometers (?6.2 miles) at least 2 weeks after enrollment. e. At least 8 adults 41 through 50 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective open-heart cardiac surgery at least 2 weeks after enrollment f. At least 8 adults 41 through 50 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective orthopedic hip replacement surgery at least 2 weeks after enrollment. g. At least 8 adults 41 through 50 years of age unambiguously reporting a history of varicella who are scheduled to undergo any variant of elective intra-abdominal laparoscopic surgery at least 2 weeks after enrollment. h. At least 8 adults 41 through 50 years of age unambiguously reporting a history of varicella who are planning to participate in a road race or marathon of ?10 kilometers (?6.2 miles) at least 2 weeks after enrollment. i. At least 8 children 7 through 16 years of age with documentation of a history of varicella vaccination and with no history of prior or subsequent chickenpox who are scheduled to undergo any variant of elective corrective orthopedic spinal surgery at least 2 weeks after enrollment. j. At least 8 children 7 through 16 years of age with documentation of a history of varicella vaccination and with no history of prior or subsequent chickenpox who are scheduled to undergo any variant of elective laparoscopic intra-abdominal surgery at least 2 weeks after enrollment. k. At least 8 children 7 through 16 years of age with documentation of a history of varicella vaccination and with no history of prior or subsequent chickenpox who are scheduled to undergo elective tonsillectomy at least 2 weeks after enrollment. l. At least 8 children 7 through 16 years of age with documentation of a history of varicella vaccination and with no history of prior or subsequent chickenpox who are planning to participate in a road race or marathon of ?10 kilometers (6.2 miles) at least 2 weeks after enrollment. 2. Administration of a data collection instrument (about 2-3 pages in length) for all these ?96 subjects, with elements of instrument developed by CDC. 3. Using safe, sterile technique, venipuncture to obtain ~8cc whole blood specimen from all ?96 subjects 10-14 days before the surgery or race. a. Collect ~4cc of the whole blood in an anti-coagulated (green-top) tube, label the tube with the proper identification number, and store at 40 C until shipment to CDC. b. Collect ~4 cc of the whole blood in a serum separator (red-top) tube. Within 4 hours of collection of this blood specimen in the red-top tube, the clotted blood will be centrifuged at 1,000-1,300g for 10-15 minutes and the serum transferred into screw-cap tubes (screw-cap tubes provided by CDC) by Pasteur pipette, the tubes labeled with the proper identification number, and stored at 40 C until shipment to CDC. 4. Collection of saliva samples using OroSure? sponge kits (including OroSure? sponges and tubes, provided by CDC) at the following 5 time periods: 10-14 days before the surgery or race, within 4 hours before the surgery or race, within 8 hours after the surgery or race is complete, 2 days after the surgery or race is complete, and 1 week after the surgery or race is complete. Saliva specimens will be labeled with the proper identification number, and stored at -200 C (e.g., at home freezer temperature) until shipment to CDC. Note, collection and storage of some or all of the saliva specimens using OroSure sponge kits can be conducted by subjects themselves so long as they are properly trained regarding collection and labeling of specimens, understand the techniques, have the facilities (e.g., a functioning home freezer) to properly store the specimens, and can be relied upon to conduct all these steps correctly. 5. Ship data collection instrument along with whole blood, serum, and saliva samples from all ?96 subjects to CDC in Atlanta at 40 C (i.e., on ice or using ice-packs) using proper shipping procedures for biological materials; for each subject, the data collection instrument and all whole blood, serum and saliva samples should be shipped within 1 week after collection of the final saliva sample (i.e., the sample collected 1 week after surgery or the race). Data collection instrument (about 2-3 pages in length) shall be furnished for each of the 96 subjects. PERIOD OF PERFORMANCE: Shall last 6 months, commencing with the date of contract award. DELIVERABLES: Contractor shall provide completed data collection instruments, whole blood, serum and saliva samples for 96 subjects, all collected, labeled, stored and shipped appropriately and in a timely manner as described above. MINIMUM QUALIFICATIONS: 1. The contractor should be a large medical center with surgical departments having sufficient patient volume to provide a high likelihood for enrollment of all required surgical subjects during a 4 month period, and the center should be able to provide data to demonstrate such patient volume for all categories of surgical patients in the study. Specifically, the medical center should provide recent retrospective hospital data relating to volume of elective open-heart cardiac surgery, elective orthopedic hip replacement surgery, and elective intra-abdominal laparoscopic surgery. Roughly, to meet these volume criteria, the medical center should conduct ?5 such procedures weekly for adults, and ?2 such procedures weekly for children, unless they can provide other assurance that they can recruit the necessary number of patients during a 4 month study period. 2. The contractor should be located in a community with active road runners clubs and with sufficient number of road races (i.e., jogging races, marathons) per calendar year, and with sufficient participation, to provide a high likelihood for enrollment of all required runners intending 10 mile road races during a 4 month period. The contractor should be able to provide documentation of an active road race calendar. 3. The contractor should be able to provide examples of relevant past clinical research involving recruitment of patients for clinical studies. CDC believes that this requirement is met by only one provider. This procurement will be processed under the authority of FAR 6.302-1 and 6.302-2. Only one responsible source and no other sources will satisfy agency requirements. Interested persons may identify their interest and capability to respond to this requirement. Hoever, information received may be considered solely for informational purposes only. This procurement is not set-aside for small business. For contractual question please contact Linda M. Young at 770-488-2655 or at lml3@cdc.gov.
- Place of Performance
- Address: Atlanta, Georgia
- Zip Code: 30341
- Country: United States
- Zip Code: 30341
- Record
- SN00882381-W 20050901/050830211801 (fbodaily.com)
- Source
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