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infections. It induces the formation of IL-2, tumour necrosis fac- tor, and interferon alpha and gamma (Bizzini et al., 1992). In clinical trials, P40 was claimed to be efficacious in the treatment of recurrent infections of the respiratory and genito-urinary tracts. Allergens coupled to P40 have been said to be instrumental in desensitising allergic patients without any side effects. infections. It induces the formation of IL-2, tumour necrosis fac- which might be shared with other organic polymers acting as tor, and interferon alpha and gamma (Bizzini et al., 1992). In immunostimulators. It has been used in experimental vaccines clinical trials, P40 was claimed to be efficacious in the treatment since 1987 (Asa et al., 2000) and it was used in the experimental of recurrent infections of the respiratory and genito-urinary tracts. vaccines given to a great number of the participants in the Gulf Allergens coupled to P40 have been said to be instrumental in War. These included those who were not deployed but received desensitising allergic patients without any side effects. the same vaccines as those who were deployed. The adjuvant activity of non-ionic block copolymer surfactants - Lipopolysaccharide (LPS) was demonstrated when given with 2% squalene-in-water emul- LPS is an adjuvant for both humoral and cell-mediated sion. However, this adjuvant contributed to the cascade of reac- immunity. It augments the immune response to both protein and tions called "Gulf War syndrome", documented in the soldiers polysaccharide antigens. It is too toxic and pyrogenic, even in involved in the Gulf War. The symptoms they developed includ- minute doses, to be used as an adjuvant in humans. ed arthritis, fibromyalgia, lymphadenopathy, rashes, photosensi- tive rashes, malar rashes, chronic fatigue, chronic headaches, - Mycobacterium and its components abnormal body hair loss, non-healing skin lesions, aphthous Interestingly, Mycobacterium and its components, as originally ulcers, dizziness, weakness, memory loss, seizures, mood formulated, were too toxic to be used as adjuvants in humans. changes, neuropsychiatric problems, anti-thyroid effects, anaemia, However, the efforts to detoxify them resulted in the development elevated ESR (erythrocyte sedimentation rate), systemic lupus of N-acetyl muramyl-L-alanyl-D-isoglutamine, or muramyl erythematosus, multiple sclerosis, ALS (amyotrophic lateral scle- dipeptide (MDP). When given without antigen, it increased non- rosis), Raynaud's phenomenon, Sjérgren's syndrome, chronic diar- specific resistance against infections with bacteria, fungi, para- thoea, night sweats and low-grade fevers. sites, viruses, and even against certain tumours (McLaughlin et This long list of reactions shows just how much damage is done al., 1980). However, MDPs are potent pyrogens (maybe that's by vaccines, particularly when potentiated by powerful "immuno- why they may be effective against certain tumours—my com- enhancers" such as squalene and other adjuvants. Interestingly, ment) and their action is not completely understood; hence they vaccinators as a rule consider such problems as mysterious and/or are not acceptable for use in humans. coincidental with vaccines. Since the administration of a multi- tude of vaccines to the participants = Cholera Toxin (and prospective participants) in the A major drawback with cholera Gulf War is well-documented (in fact, toxin as a mucosal adjuvant is its . . . veterans claim they were given many intrinsic toxicity. This long list of reactions shows more than were even recorded), this just how much damage is done list of observed reactions further Liposomes . F incriminates the vaccines as causing Liposomes are particles made up by vaccines, particularly when such problems. of concentric lipid membranes con- i taining phospholipids and other potentiated by powerful lipids in a bilayer configuration sepa- "immuno-enhancers" such as rated by aqueous compartments. squalene and other adjuvants. Editor's Note: They have been used parenterally in Due to space constraints, we are people as carriers of biologically unable to publish the references active substances (Gregoriadis, for Part 1 of Dr Scheibner's article 1976) and considered safe. until next issue. If any readers urgently require a copy of these references, please contact Immunostimulating complexes (ISCOMs) your nearest NEXUS office. TOON As NANT 4 al 1N00. NAB 100N. T As Continued in the next issue... - Lipopolysaccharide (LPS) LPS is an adjuvant for both humoral and cell-mediated immunity. It augments the immune response to both protein and polysaccharide antigens. It is too toxic and pyrogenic, even in minute doses, to be used as an adjuvant in humans. - Mycobacterium and its components Interestingly, Mycobacterium and its components, as originally formulated, were too toxic to be used as adjuvants in humans. However, the efforts to detoxify them resulted in the development of N-acetyl muramyl-L-alanyl-D-isoglutamine, or muramy] dipeptide (MDP). When given without antigen, it increased non- specific resistance against infections with bacteria, fungi, para- sites, viruses, and even against certain tumours (McLaughlin et al., 1980). However, MDPs are potent pyrogens (maybe that's why they may be effective against certain tumours—my com- ment) and their action is not completely understood; hence they are not acceptable for use in humans. just how much damage is done by vaccines, particularly when potentiated by powerful “immuno-enhancers" such as Immunostimulating complexes (ISCOMs) ISCOMs (DeVries et al., 1988; Morein et al., 1990; Lovgren et al., 1991) represent an interesting approach to stimulation of the humoral and cell-mediated immune response towards amphipathic antigens. It is a relatively stable but non-covalently-bound com- plex of saponin adjuvant Quil-A, cholesterol and amphipathic antigen in a molar ratio of approximately 1:1:1. The spectrum of viral capsid antigens and non-viral amphipathic antigens of rele- vance for human vaccination, incorporated into ISCOMs, com- prises influenza, measles, rabies, gp340 from EB-virus, gp120 from HIV, Plasmodium falciparum and Trypanosoma cruzi. ISCOMs have been shown to induce cytotoxic T-lymphocytes (CTL). Following oral administration, some types of CTLs were found in mesenteric lymph nodes and in the spleen, and specific IgA response could be induced. ISCOMs have only been used in veterinary vaccines, partly due to their haemolytic activity and some local reactions all reflecting the detergent activity of the Quil-A molecule. About the Author: Viera Scheibner, PhD, is a retired principal research scientist with a doctorate in natural sciences. During her distin- guished career, she published three books and some 90 sci- entific papers in refereed scientific journals. Since the mid-1980s when she helped develop the Cotwatch breathing monitor for babies at risk of cot death (sudden infant death syndrome, or SIDS), Dr Scheibner has done extensive research into vaccines and vaccinations. In 1993 she published Vaccination: The Medical Assault on the Immune System, and in mid-2000 followed up with Behavioural Problems in Childhood: Link to Vaccination (see review, 7/05). Dr Scheibner regularly conducts lectures, attends confer- ences and debates, is often asked by lawyers to provide expert reports for vaccine-damage court cases. Her previous articles for NEXUS covered the SIDS/vaccines link (2/05), the brain-eating bugs/vaccines connection (3/03), and the shaken baby syndrome/vaccination controversy (5/05). Other Adjuvants: Squalene Squalene is an organic polymer with some antigenic epitopes 40 - NEXUS This long list of reactions shows Continued in the next issue... squalene and other adjuvants. DECEMBER 2000 — JANUARY 2001