Notice of Availability of Clinical Specimens from CFS Patients and Controls

Notice Number: NOT-AI-13-005

Release Date: October 9, 2012

National Institute of Allergy and Infectious Diseases (NIAID)

This Notice from the National Institute of Allergy and Infectious Diseases (NIAID) is to announce the availability of clinical specimens for chronic fatigue syndrome (CFS) research from Dr. W. Ian Lipkin, Columbia University, the Principal Investigator of an NIAID-supported study. Dr. Lipkin and colleagues recently completed a clinical study titled XMRV and MLV in Chronic Fatigue Syndrome to determine the strength of association between CFS and xenotropic murine leukemia virus-related virus (XMRV), MLV (murine leukemia viruses) and/or related retroviruses. The study enrolled 152 cases and 148 matched controls who each had a single blood draw and consented to future use of leftover clinical specimens. The following clinical samples are available from this study: 20 0.5 ml aliquots of plasma thawed once, 5 1.0 ml never-thawed plasma for proteomic or other studies that require fresh-frozen, never-thawed plasma and 6 3.0 ml aliquots of never-thawed cells from each enrollee.

The samples are de-identified and therefore do not meet the definition of human subjects research. Enrollees have consented to future use and the samples are accompanied with a code so that many characteristics can be matched with each. Inclusion requirements for cases were:

1. Established diagnosis of CFS

2. Meet both 1994 Fukuda and Canadian case definitions

3. Unable to work due to illness

4. Report viral-like prodrome

5. Report >/= 2 of the following (SF-36 criteria): vitality <35, social functioning subscale <62.5, role-physical subscale <50

6. Be between 18 and 70 years of age at time of informed consent

7. Ineligible if pregnant, <3 months postpartum or lactating.

Control subjects were matched on geographical region, race, sex and age (+/- 5 yrs). Approximately equivalent numbers of case/control pairs were recruited from Boston, MA; New York City, NY; Miami, FL; Salt Lake City, UT; Incline Village, NV; and Stanford, CA. All CFS patients and matched controls completed several detailed study instruments covering symptoms, past medical history, level of function, quality and intensity of their fatigue, medications, sleep patterns, mood and pain. In addition, the clinician's assessment of subject's physical state and severity of illness via a standardized physical exam form and the Karnofsky scale were also captured. Samples were analyzed for blood chemistries and serologic tests were completed for HIV and syphilis.

For more detail on the original study see: http://mbio.asm.org/content/3/5/e00266-12

Alter HJ, et al. 2012. A multicenter blinded analysis indicates no association between chronic fatigue syndrome/myalgic encephalomyelitis and either xenotropic murine leukemia virus-related virus or polytropic murine leukemia virus. mBio 3(5):e00266-12. doi:10.1128/mBio.00266-12.

Dr. Lipkin and the NIAID consider these samples from validated cases and well-matched controls to be an extremely valuable resource that may lead to significant advances in the understanding of the etiology and/or pathogenesis of CFS. Accordingly, our intent is to make these specimens available to the CFS research community. However, there are no set-aside funds associated with these samples. We believe that the NIH peer review process offers the fairest means to decide who should have access to these samples. To this end, we encourage the submission of new grant applications to the NIH that involve the use of some of these specimens as part/all of a research plan on some aspect of CFS. Applications will undergo normal referral and review processes. Samples will be provided to investigators who receive a funding commitment from any NIH Institute or Center for a new CFS research project utilizing some of these samples. Specimens will be shipped to the Principal Investigator(s) following the establishment of an MTA with Columbia University. Please note that these samples will be provided to funded investigators on a first come, first served basis, based on the outcome of the NIH peer review process, as noted above. Note that the intent is to encourage exploration of a variety of approaches and therefore the goal is to share specimens with multiple CFS investigators. Applicants should include a justification of the type and quantity of samples requested. This plan will be in effect until the samples have all been assigned; notifications as to changes in availability will be made via updates to this notice.

Possible funding opportunities that can be used to pursue these samples include, but are not limited to:

• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, and Treatment (R01)
• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: Etiology, Diagnosis, Pathophysiology, and Treatment (R21)
• Research Project Grant (R01)
• NIH Exploratory/Developmental Research Grant Program (R21)

The usual grant application submission dates apply; refer to the announcements for guidance.

Please direct all inquiries to:

Eun-Chung Park, Ph.D.
Program Officer, Virology Branch
DMID, NIAID, NIH
Telephone: 240-627-3322
Email: epark@niaid.nih.gov