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PubMed2006

Monoid sublingual immunotherapy.

Sublingual monoid immunotherapy with monomeric allergoids has been largely used in Europe in the last few years. An open trial of allergoid in tablets has been done in rhinitic patients allergic to house dust mites, grass pollens and Parietaria with clear improvement in clinics and drug consumption scores. In a second phase a double blind placebo controlled trial of grass pollens allergoids have been done in hay fever patients with significant decrease on the scores of rhinorrea, sneezing and conjunctivitis nasal steroid consumption and clinical score after serial nasal challenges. Monomeric allergoids are an efficace and safe immunotherapy in allergic rhinitis.

Administration, Sublingual↗
PubMed2005

Characterization of modified allergen extracts by in vitro beta-hexosaminidase release from rat basophils.

BACKGROUND: To date, there is no well-established test available that can be used to measure functional properties of modified allergens (allergoids). Due to the cross-linking process, the IgE-binding capacity of the allergens, normally necessary for their characterization, is lost. The aim of this study was to test whether the rat basophilic leukaemia (RBL) cell assay (beta-hexosaminidase release by rat basophils upon allergen stimulation) can be adopted to characterize allergoids and to evaluate the assay for testing allergoids and native allergens as well. METHODS: Mice were immunized with native and modified Phleumpratense extracts in the presence of alum. Their sera were used to sensitize RBL-2H3 cells and measure basophil stimulation induced by different allergen extracts in the presence or absence of various additives. RESULTS: Sera containing specific IgE against both extract formulations were obtained. Native as well as modified extracts induced dose-dependent beta-hexosaminidase release from RBL cells. Both extracts were used to evaluate the characteristics of the assay, which showed high precision. Storage conditions were chosen to enhance extract degradation, which could be read directly from the altered stimulatory capacity of the extracts. Additives turned out to have diverse effects on the assay, whereas phenol had no measurable effect, alum had an inhibitory effect and glycerol elevated basophil activation. CONCLUSIONS: For the first time, a reliable, precise in vitro assay is available that is able to directly measure the properties of modified allergen extracts after their production process. The test is well evaluated and its advantages and limitations are discussed in this report.

Allergoids↗
PubMedDate not supplied

Specific immunotherapy [correction of immunotheraphy] of allergic diseases: a three years perspective observational study.

In order evaluate the long-term benefit of Specific ImmunoTherapy (SIT), administered either subcutaneously or sublingually, in comparison with drug therapy, in terms of efficacy, tolerability and patients' adherence to the treatment, a three year perspective, observational study was carried out over tree years in a rather large number of allergic subjects. One hundred and ten patients of both sex (50F, 60M; age: 22.4 - 35.5 years) were admitted. Sixty of them were rhinitics, some with concomitant mild intermittent asthma or conjunctivitis; 43 had a persistent asthma, often with concomitant rhinitis. Seven had urticaria. Sixty patients were treated with the allergoid sublingual SIT (in tablets) plus drugs on demand, 19 with the subcutaneous SIT (depot, aluminium hydroxide subcutaneous SIT) and 31 with the pharmacological therapy alone, mainly nasal steroids and antihistamines. The treatment efficacy, evaluated after 36 months, by symptoms and drug consumption reduction, was statistically better in the group assigned to the allergoid sublingual SIT than in the other two groups. This was the case also for the tolerability, the patient's compliance and the physicians' and patients' opinion. The present findings, obtained by a non-randomized study, show that the allergoid sublingual SIT was very appreciated by both patients and physicians for the good effectiveness and the high degree of safety guaranteed, in addition to its simplicity of use.

Adult↗
PubMed1987

[Use of isoelectric focusing for assessing the composition of pollen allergens].

The preparations of allergens and allergoids obtained from ragweed, timothy and wormwood pollen, as well as the preparations of allergens from birch and orchard grass pollen differing in the method of their production, have been studied with the use of analytical isoelectric focusing in a thin gel layer. The composition of the preparations of allergoids differs from that of the allergenic preparations from the pollen of the same plant species by the decreased content of protein components detected in this investigation. The main proteins contained in the preparations of allergoids are distributed in the zone of pH 3.5-4.5. Differences in the composition of different batches of the same allergens, manifested by variations in some protein bands or by their absence, have been noted. Protein components with the isoelectric point in the alkaline zone have been detected only in the preparations of ragweed pollen allergens.

Allergens↗
PubMed2004

Biological characterization of glutaraldehyde-modified Parietaria judaica pollen extracts.

BACKGROUND: Allergoids are widely used in specific immunotherapy (SIT) for the treatment of IgE-mediated allergic diseases, but all techniques for standardization of conventional allergic extracts may not be appropriate for standardization of a glutaraldehyde (GA)-modified extract because of the unique characteristics of these extracts. OBJECTIVE: To assess an accurate methodology for standardization of chemically modified extracts. METHODS: GA-modified extracts from Parietaria judaica pollen were purified by diafiltration. Biochemical properties were investigated by determination of amino groups, chromatography, and SDS-PAGE. The IgE-binding activity was determined by skin prick test, enzyme allergosorbent test inhibition, basophil activation, and histamine release tests. Peripheral blood mononuclear cells (PBMCs) from P. judaica pollen-allergic subjects were stimulated with either native or allergoid extracts, and proliferation was measured. RESULTS: Biochemical data indicated a high degree of allergen polymerization resulting in extract components higher than 100 kDa. IgE-binding activity, both in vivo and in vitro, was reduced by more than 99.8%. Both allergen and allergoid induced PBMC proliferation and synthesis of blocking IgG antibodies at similar rates. Moreover, no evidence of introduction of new determinants by chemical modification was found. CONCLUSIONS: The preparation of GA-modified extracts by diafiltration is faster and more reliable than previous chromatographic methods. These modified extracts have drastically reduced their allergenicity while maintaining their immunogenicity, and therefore they can be used in safer and shortened schedules of SIT.

Adolescent↗
PubMedDate not supplied

Safety and tolerability of ultra-Rush (20 minutes) sublingual immunotherapy in patients with allergic rhinitis and/or asthma.

BACKGROUND: The safety and good tolerability of sublingual immunotherapy (SLIT) has already been proved in allergic patients, but only one study has investigated the occurrence of immediate adverse reactions in allergic patients after a 2-hour ultra-rush regimen of SLIT performed with a chemically modified extract (sublingual monomeric allergoid, Lais, Lofarma S.p.A., Milan). The objective of the present study was to evaluate the occurrence of immediate adverse reactions in allergic patients after a very fast (20 minutes) ultra-rush regimen of sublingual allergoid SLIT. METHODS AND RESULTS: We studied 105 patients: 28 children (20 male, mean age 13.3 +/- 2.1 yr) and 77 adults (29 male, mean age 34.7 +/- 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9%) had a mild local symptom (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued. CONCLUSIONS: These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.

Administration, Sublingual↗
PubMedDate not supplied

Safety and tolerability of ultra-rush (20 minutes) sublingual immunotherapy in patients with allergic rhinitis and/or asthma.

BACKGROUND: The safety and good tolerability of sublingual immunotherapy (SLIT) has already been proved in allergic patients, but only one study has investigated the occurrence of immediate adverse reactions in allergic patients after a 2-hour ultra-rush regimen of SLIT performed with a chemically modified extract (sublingual monomeric allergoid, Lais, Lofarma S.p.A., Milan). The objective of the present study was to evaluate the occurrence of immediate adverse reactions in allergic patients after a very fast (20 minutes) ultra-rush regimen of sublingual allergoid SLIT. METHODS AND RESULTS: We studied 105 patients: 28 children (20 male, mean age 13.3 +/- 2.1 yr) and 77 adults (29 male, mean age 34.7 +/- 9.9 years) with a history of intermittent/persistent rhinitis or intermittent/mild persistent asthma due to House Dust Mite (n = 56), Parietaria (n = 34) and Timothy-grass (n = 15) The build-up ultra-rush phase involved the administration, every five minutes, of increasing doses of the sublingual allergoid SLIT. All patients tolerated the treatment very well. Only one patient out of 105 (0.9%) had a mild local symptoms (gastric pirosis) that occurred 30 minutes after the last initial dose and spontaneously disappeared as the treatment was continued. CONCLUSIONS: These data show the excellent safety and tolerability profile of an ultra-rush SLIT regimen performed with a chemically modified extract, even when high doses were administered through an extremely short induction phase (20 minutes), thus confirming the previously reported results.

Administration, Sublingual↗
PubMedDate not supplied

IgG4 levels in relation to Olea europaea immunotherapy.

We determined olive pollen-specific IgG4 levels in 100 patients, 39 of whom had been subjected to no immunotherapy (IT) for Olea (31 allergic and 8 nonallergic individuals) and 61 of whom had been administered IT as extracts, including Olea pollen (29 extracts in BUs, 24 allergenic extracts polymerized with glutaraldehyde:Allergoid and 8 extracts standardized in PNUs). IgG4 levels were correlated to the clinical picture, type of extract and average cumulative dose (ACD). We found average IgG4 levels of 0.80 +/- 0.74, 8.60 +/- 13.07 (p < 0.01) and 1.42 +/- 2.5 micrograms/ml (n.s.) for the untreated group and those treated with BU and Allergoid, respectively. The difference between the IT-BU-treated and IT-Allergoid-treated patients was significant at p < 0.01. On the other hand, we found no significant differences among the average IgG4 levels of the three groups in relation to age or sex. The group of asthmatic patients treated with BU extracts had average IgG4 levels of 16 +/- 17.34 micrograms/ml, while those of the rhinoconjunctivitic, non-asthmatic group were 5.05 +/- 6.149 micrograms/ml, with p < 0.05 (Student's "t" test). Thus, patients treated with extracts polymerized with glutaraldehyde had IgG4 levels that were similar to those of the patients subjected to no IT. Also, the group treated with IT extracts standardized in BUs had increased IgG4 levels that were correlated with the cumulative dose, particularly in asthmatic patients.

Adolescent↗
PubMed1991

Contrast media for angiography: physicochemical properties, pharmacokinetics and biocompatibility.

Contrast agents are used as diagnostic molecules for the visualization of the vascular system. Despite their rapid pharmacokinetic distribution, and their excretion within a few minutes, their injection is associated with clinical symptoms of relative bioincompatibility. Allergoid reactions and disturbances of the hemostatic system represent the main fields of biological investigations. Due to the extent of clinical and experimental works the ubiquitous interactions between these molecules and cellular and/or protein systems have emerged. The development of a new family of low osmolality ionic or non-ionic contrast molecules had decreased the incidence of minor reactions, but did not modify the frequency of severe accidents and even led to the emergence of new iatrogenic syndromes. Despite extensive laboratory investigations there are still no predictive criteria nor any specific therapeutic prevention of these allergoid reactions. The suggested future line of investigation concerns the physicochemical interaction of CM and targeted biological systems which may allow the analysis and predictivity of these interactions at the molecular level.

Angiography↗
PubMed1977

Hyposensitization of patients with allergic rhinitis by intranasal administration of chemically modified grass pollen allergen. A pilot study.

In a pilot study, five adult patients with allergic rhinitis due to grass pollen underwent local intranasal hyposensitization with a chemically modified grass pollen extract--a so-called allergoid. Local hyposensitization during a pre-seasonal period resulted in an increased serum level of timothy-specific IgE antibodies in all patients, indicating that the allergoid had immunogenic properties. In four of the patients the clinical effect during the grass pollen season was judged satisfactory. Pre- and post-seasonal provocation test in these four patients also showed a reduction of the nasal sensitivity during this period. All patients tolerated the treatment well without any marked side effects. These promising preliminary results motivate further investigation into this form of therapy.

Administration, Intranasal↗
PubMedDate not supplied

Comparison of the efficacy and safety of two preseasonal regimens of glutaraldehyde modified, tyrosine-adsorbed parietaria pollen extract over a period of three years in monosensitive patients.

The purpose of this study was to evaluate the clinical efficacy over a period of three years (1988-90) of two preseasonal dosage regimens of a Parietaria allergoid (Bencard Tyrosine Parietaria) in patients who were only sensitive to this pollen. Fifty patients were included (14 men and 36 women, age: mean, 28 years; range, 14-47 years). Twenty five patients (group A) were treated each january with the basic course of Bencard Tyrosine Parietaria. This consisted of injecting subcutaneously 0.5 ml from each of three vials, with one week between each injection. A further injection using the vial with the highest dose was given one week later. Each january and february, twenty five patients (group B) were treated with the basic course of Bencard Tyrosine Parietaria, repeating the last dose five times, with one week between each injection. Immunotherapy with a tyrosine-adsorbed Parietaria judaica allergoid is an effective method for mitigating nasal (p < 0.0001), bronchial (p < 0.005), conjunctival (p < 0.001) and palatal itching symptoms (p < 0.0001) in patients who are sensitive to this pollen. Sensitivity to Parietaria pollen, as verified by skin test and nasal challenge, decreased during immunotherapy (p < 0.001). Histamine release by peripheral blood basophils decreased during the course of the study, falling from 43.5 ng/ml to 12.3 ng/ml in group A and from 42.9 ng/ml to 10.0 ng/ml in group B; during the second and third years, IgG levels were increased one and four months after starting treatment with the extract, while this was not the case after ten months; IgE levels were also increased. Finally, overall tolerance to this immunotherapy product was good in almost all patients.

Adolescent↗
PubMed1977

[Anaphylactoid reactions following administration of plasma substitutes in man. Prevention of this side-effect of haemaccel by premedication with H1- and H2-receptor antagonists (author's transl)].

In a randomized controlled single blind trial in 50 volunteers the problem was investigated whether a combination of dimethpyrindene (0.1 mg/kg b.w.) and cimetidine (10 mg/kg b.w.) could prevent anaphylactoid or allergoid reactions following Haemaccel infusion. In the control group 6 anaphylactoid and 9 allergoid reactions were observed, in the H1 + H2-group, however, none of those reactions occured. No single wheal could be detected. It is considered appropriate to recommend the general use premedication of an H1 + H2-blocker before all anaesthetics and operations. This mainly depends on further clinical trials with the antihistaminic drugs concerning their side-effects under various conditions.

Anaphylaxis↗
PubMed1987

Preliminary experimental and clinical results with inactivated allergens conjugated to the Corynebacterium granulosum-derived immunomodulator P40.

Allergoids have been used successfully for immunotherapy of allergic disorders. It has appeared to us that the effect of allergoids could be potentiated by their coupling to an immunomodulator. In the present study we show that a conjugate made up of the coupling of ovalbumin through glutaraldehyde action to the C. granulosum-derived immunomodulator P40 is completely devoid of antigenicity and of cross-reactivity with ovalbumin. This conjugate was found to significantly inhibit mast cell degranulation. It also proved to be capable of protecting against the lethal systemic anaphylactic shock sensitized mice. Immunotherapy was performed in patients hypersensitive to either the pollen of Dactylis glomerata or to the house dustmite allergens using the conjugates made of the specific allergens and of the P40. Clinical improvement was observed in a significant percentage of the patients subjected to immunotherapy. Administration of the conjugates did not result in untoward reactions in any of the patients.

Allergens↗
PubMed1980

Incidence and mechanisms of adverse reactions to polypeptides in man and dog.

Adverse reactions (pseudoallergic = anaphylactoid (severe) and allergoid (slight)) to polygeline (Haemaccel) are caused by histamine release. The mechanism by which other polypeptides produce these reactions is unfortunately hitherto unknown. "Purification" of Haemaccel led to a drug which was free from anaphylactoid reactions in a controlled clinical trial. Clinically insignificant allergoid reactions to polygeline (restricted to the skin) could be prevented by premedication with H1 + H2-receptor antagonists.

Anaphylaxis↗
PubMed1978

[New possibilities of hyposensitization with pollen-l-tyrosine complexes (author's transl)].

The so far most comprehensive individual study into the clinical findings in the hyposensitization therapy with pollen-L-tyrosine complexes in 253 pollinosis patients, who were first subjected to a hyposensitization therapy, permitted a comprehensive evaluation of the indication possibilities of these preparations (Pollagen, Tyrosin-Allergoid; in other countries available as Pollinex, Polvac, Bencard-Polen). The success of this hyposensitization, which may be reduced to three injections, can be immunologically established and is only slightly smaller than in the case of a specific desensitization over a period of 5--6 months preseasonally. The therapy is indicated first and foremost in patients who either have a moderate or medium-degree sensitization to grass pollens or who come to a medical examination only briefly before the pollen season. The addition of rye pollens obviously gives the preparation Tyrosin-Allergoid an advantage over the mixture of pure grass pollens as used in Pollagen. Rye pollens are responsible for the highest pollen concentrations and thus for the most severe complaints of pollinosis patients. A considerable increase in the therapeutic success, approximately 20%, can be achieved on the basis of a therapy modification, presented here for the first time: The patient is treated preseasonally with a specific desensitization vaccine and immediately before the pollen season he is additionally vaccinated with tyrosine-adsorbed pollen allergens as a kind of booster vaccination.

Adult↗
PubMedDate not supplied

Safety evaluation of a new allergy vaccine containing the adjuvant monophosphoryl lipid A (MPL) for the treatment of grass pollen allergy.

A novel allergy vaccine (Pollinex Quattro) has been developed for the prevention or relief of allergic symptoms caused by a variety of pollens. Within this range, the grass pollen allergy vaccine contains extracts of 12 grass pollens and rye cereal (all chemically modified by glutaraldehyde) that are adsorbed onto L-tyrosine with addition of the immunostimulatory adjuvant monophosphoryl lipid A (MPL). A specific preclinical safety testing strategy was developed to support clinical use, comprising single-dose toxicity, repeat-dose toxicity and local tolerance studies. Dose levels of up to 0.5 ml per animal (mouse) and up to 1.0 ml per animal (rat and rabbit) were used with vaccines containing 2000 or 12 000 standardized units (SU) ml(-1) of grass pollen allergoids, 50 micro g ml(-1) of MPL adjuvant and 20 mg ml(-1) of tyrosine. Overall, the product showed no toxicological findings of significance at levels greatly in excess of those proposed for clinical use. A not unexpected, but relatively minor, immunostimulatory effect was seen following repeated dosing (once weekly for 3 weeks) at 1.0 ml per rat.

Adjuvants, Immunologic↗
PubMed1980

H1 + H2-receptor antagonists for premedication in anaesthesia and surgery: a critical view based on randomized clinical trials with Haemaccel and various antiallergic drugs.

Histamine release by drugs used in anaesthesia and surgery has been often demonstrated in human volunteers, but only occassionally in patients. Three questions arose from these studies. (1) Is the incidence of histamine release high in patients during routine anaesthesia and surgery? (2) Can the clinical effects of histamine release in man be prevented by H1 + H2-receptor antagonists? (3) Are there any side-effects of such a premedication? These problems were investigated in patients and volunteers by randomized controlled clinical trials using only one of the histamine-liberating drugs in man, the plasma substitute Haemaccel. This drug was chosen because it causes a reproducible histamine release in man and because its mechanism of action in man is largely known. (1) Out of 600 orthopaedic patients 30 (5%) showed anaphylactoid reactions following Haemaccel infusion. 26 of these had a histamine release of more than 1 ng histamine/ml plasma. Using predictive values this gives an efficiency of the test by nearly 98%. (2) In volunteers the combination of an H1-plus H2-receptor antagonist (dimethypyrindene and cimetidine) completely prevented the clinical effects of histamine release by Haemaccel (9 allergoid and anaphylactoid reactions in the control group, none in the H1 + H2-group). The incidence of histamine release, however, remained unchanged. (3) The premedication was found to release histamine itself. Cimetidine was effective when given alone but especially in combination with chlorpheniramine (4 events out of 7 applications). The clinical side-effects of these premedication were mild since apparently the free histamine was largely blocked at the receptor sites. It is concluded that premedication with a combination of H1- and H2-receptor antagonists is indicated due to the high incidence of histamine release during anaesthesia and surgery induced by various drugs and treatments. Such premedication is effective but associated with mild side-effects. For this reason more extended clinical trials with dimethpyrindene plus cimetidine in patients are necessary before this premedication can be generally recommended.

Adolescent↗
PubMed1985

Modified forms of allergen immunotherapy.

There have been many attempts to modify allergens and thus to improve upon conventional immunotherapy, which has been proved effective but has several drawbacks. These include the risk of systemic reactions and the time and cost involved. The modifications have taken three major approaches. One approach, to impede allergen release from the site of deposition, has met with limited success. An example is alum precipitation, which has modestly reduced the number of injections and incidence of systemic reactions. A second approach, to suppress specific IgE production and to induce specific tolerance, has not been successful in man. The third approach, to reduce allergenicity while retaining immunogenicity of allergens, has been the most successful and appears to have the most promise. One example is polymerized allergens, which have been shown to be safe, efficacious, and immunogenic in multiple clinical trials. Other examples include allergoids and glutaraldehyde-treated, tyrosine-adsorbed allergens.

Allergens↗