C. DeVinci & G. Pizza, S. Orsola-Malpighi Hospital, Bologna, Italy; HH Fudenberg, NeuroImmuno Therapeutics Research Foundation, Spartanburg, SC; G Krueger, Institut fuer Pathologie, Universitaet zu Koeln, Koeln, Germany; PH Levine, NCI/NIH, Rockville, MD; D. Viza, Laboratoire Immunobiologie, URA 1294 CNRS, Faculté de Médecine, Paris, France.

Clinical efficacy of Transfer Factor (TF) specific for many viral infections including HSV, CMV, and EBV, has been well documented. Furthermore, several studies imply a viral implication in the pathogenesis of Chronic Fatigue Immune Dysregulation Syndrome (CFIDS) against EBV, CMV, HHV-6, herpes simplex I and II to treat 21 CFIDS patients. The purpose of the study was to determine whether TF to these viruses, one or another of which has been claimed to be the cause of CFIDS, would cause dramatic clinical improvement. All TF preparations were tested for potency by LIF and were adjusted to the same potency. TF specific for Rubella was not used. Both TF and placebo TF were taken orally with a dose averaging 10 potency units each day.

Twelve of the 21 patients receiving these TF's had a clinical response; whereas, two patients failed to respond while receiving lactose placebo. No adverse effects from TF administration were observed. Serial serum samples to assay for antibodies to EBV and HHV-6 were collected for laboratory investigation. It is noteworthy that one patient, who improved under specific TF, relapsed when she received placebo. Three others on a double blind cross-over study using specific and non-specific TF did not respond to non-specific TF but did respond to the antigen-specific TF's listed above. Presumably, in those who did not respond to the TF described above, the disease was related to other micro-organisms (e.g., rubella, Borrelia burgdorferi). Indeed, three non-responders had significant clinical improvement using TF prepared from the cells of household contacts but not from TF from the cells of normal non-household contacts. These results demonstrate the benefits of multi-valent TF in patients with CFIDS. This demonstrates the potential benefit and complete safety of orally administered TF. A larger double-blind placebo cross-over study restricted to anti-EBV and anti-HHV-6 TF has been initiated.