A Multi‐centre Trial of Pollen‐tyrosine Adsorbate

W, Palmer; Balacescu, A.

doi:10.1111/j.1398-9995.1977.tb02703.x

Cited by 13 publications

(7 citation statements)

References 9 publications

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“…Another 32 publications were excluded because no safety data was documented. This resulted in 43 studies 13–17,20,25–61 which were included in the safety analysis, with 6 DBPCTs, 6 randomized controlled trials (RCTs), 6 controlled trials (CTs), and 25 non‐controlled studies. For the subgroup analysis of children/adolescents 15,17,25,26,28–31,33,35–38,40,42,44–46,49,51,54–60 and asthmatic patients, 13,14,16,27,29,30,32,34,35,37,38,40–44,47,49–57,61 27 publications were identified and included, respectively.…”

Section: Resultsmentioning

confidence: 99%

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

Becker

Zieglmayer

Cantó

et al. 2021

Clinical & Translational All

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Background The World Allergy Organization and the European Academy of Allergy and Clinical Immunology recommend to perform product‐specific meta‐analyses for allergen‐specific immunotherapies because of the high degree of heterogeneity between individual products. This meta‐analysis evaluates the efficacy and safety of Glutaraldehyde‐modified and MCT® (MicroCrystalline Tyrosine)‐adsorbed allergoids (MATA). Methods The databases MEDLINE, LILACS, embase, LIVIVO, Web of Science and Google (Scholar) were searched for publications on MATA up to June 2019. Primary endpoint was the combined symptom and medication score (CSMS). Secondary endpoints were single scores, immunogenicity and improvement of allergic condition. Secondary safety endpoints were the occurrence of side effects. A random effects model was applied with (standardized) mean differences ([S]MDs) including confidence intervals (CI). Heterogeneity was analyzed using the I2 index and publication bias using Egger's test and Funnel plots. Subgroups were analyzed regarding age and asthma status. Results Eight randomized double‐blind placebo‐controlled trials were selected for efficacy and 43 publications for safety analysis. In total, 4531 patients were included in this analysis including eight studies containing data on children and adolescents. AIT with MATA significantly reduced allergic symptoms and medication use with a SMD for CSMS of −0.8 (CI: −1.24, −0.36) in comparison to placebo. Heterogeneity was moderate between the studies. The total symptom score (−1.2 [CI: −2.11, −0.29]) and the total medication score (−2.2 [CI: −3.65, −0.74]) were also significantly reduced after MATA treatment. Patient's condition improved significantly after treatment with MATA, with an odds ratio of 3.05 (CI: 1.90, 4.90) when compared to placebo. The proportion of patients, who developed side effects was 38% (CI: 19%, 57%). No serious side effects occurred. Safety in the subgroups of asthmatic patients, children and adolescents did not differ from the overall patient population. Conclusions This meta‐analysis reveals a large body of evidence from publications investigating MATA. MATA significantly improved allergic symptoms and reduced the use of anti‐allergic medication in comparison to placebo, with an excellent safety profile. Especially for children and asthmatic patients, the use of MATAs can be considered as safe, because the safety profiles in these groups did not differ from the total patient population.

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Section: Resultsmentioning

confidence: 99%

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

Becker

Zieglmayer

Cantó

et al. 2021

Clinical & Translational All

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“…Clinical use of these vaccines (e.g. as Pollinex ® ) has shown a safe and efficacious profile over many years of human use (Bonifazi et al, 1991;Drachenberg et al, 2002;Ko et al, 1987;Metzger et al, 1981;Muehlethaler et al, 1990;Palmer and Balacescu, 1977;Verstraeten and Wheeler, 1978). A further recent addition to some of the Pollinex ® vaccines has been the immunostimulatory adjuvant MPL ® (to encourage a skew in a Th1-like direction) whose safety and efficacy has been well documented elsewhere (e.g.…”

Section: Discussionmentioning

confidence: 99%

“…However such responses, as found with ragweed allergoid-containing vaccines, resolved rapidly, even after multiple injections and showed no evidence of a progressive nature. Clinical use of MATA vaccines has shown some evidence of local reactions (including swelling and/or erythema and itch) (Miller, 1976;Miller et al, 1976;Palmer and Balacescu, 1977;Verstraeten and Wheeler, 1978;Drachenberg et al, 2001;. Several tolerability studies indicate that local injection reactions are comparable to other commonly used vaccine depot systems such as aluminium adsorbed extracts (Bonifazi et al, 1991;Drachenberg et al, 2003;Muehlethaler et al, 1990;Symington et al, 1977).…”

Section: Discussionmentioning

confidence: 99%

“…An array of data are available to show the safe and efficacious use of MATAs using grass pollen (including ragweed) extracts (e.g. Bonifazi et al, 1991;Drachenberg et al, 2001;Ko et al, 1987;Muehlethaler et al, 1990;Palmer and Balacescu, 1977). Indeed, a recent study with Pollinex ® Quattro Ragweed, using a four-injection course, has demonstrated the vaccine to be well tolerated and to significantly reduce allergy symptoms (www.…”

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confidence: 99%

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Pollinex^® Quattro Ragweed: safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL^®) for the treatment of ragweed pollen allergy

Baldrick

Richardson

Woroniecki

et al. 2007

J of Applied Toxicology

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A novel allergy vaccine (Pollinex Quattro Ragweed) has been developed for the prevention or relief of allergic symptoms caused by pollen from Ambrosia spp. (ragweed). An extract from the pollen (chemically modified by glutaraldehyde) is 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 and comprised reference to preclinical data available for the marketed non-MPL adjuvanted form of the ragweed vaccine (Pollinex R) and a new repeat dose toxicity study in the rat. Studies with Pollinex R comprised single dose subcutaneous toxicity studies in mice and rats, repeat dose (10 injections over 20 days) parenteral toxicity studies in rats and dogs, an in vitro gene mutation assay along with single and multiple injection local tolerance studies in rats and dogs. The repeat dose subcutaneous toxicity study with Pollinex Quattro Ragweed involved seven injections over 3 weeks (which was more aggressive than the four weekly doses used in the clinic) with dose levels of up to 0.5 ml per animal used. Overall, the product showed no toxicological findings of significance at levels greatly in excess of those proposed for clinical use. As is a feature with vaccination, some dose site irritation was seen.

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“…Gingerols, particularly 4-shogaol and 8-dehydrogingerdione, are likely inhibitors of inflammation (Funk et al, 2005;Grzanna et al, 2005), as well as polyphenolics like shikimic acid (Pajonk et al, 2006). The amino acid tyrosine has been shown to absorb specific allergens released by mast cells (Palmer et al, 1977) and the presence of DL-methyl-m-tyrosine in the nettle extract likely reduces the load of endogenous allergens such as histamine and Prostaglandin D 2 in the body. Coumarin derivatives such as 4-methyl-7ethoxycoumarin and osthole are also likely contributors to the anti-inflammatory and anti-allergy components of nettle (Liu et al, 1998;Matsuda et al, 2002).…”

Section: Inhibition Of Mast Cell Tryptasementioning

confidence: 99%

Nettle extract (Urtica dioica) affects key receptors and enzymes associated with allergic rhinitis

Roschek

Fink

McMichael

et al. 2009

Phytotherapy Research

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A nettle (Urtica dioica) extract shows in vitro inhibition of several key inflammatory events that cause the symptoms of seasonal allergies. These include the antagonist and negative agonist activity against the Histamine-1 (H(1)) receptor and the inhibition of mast cell tryptase preventing degranulation and release of a host of pro-inflammatory mediators that cause the symptoms of hay fevers. The nettle extract also inhibits prostaglandin formation through inhibition of Cyclooxygenase-1 (COX-1), Cyclooxygenase-2 (COX-2), and Hematopoietic Prostaglandin D(2) synthase (HPGDS), central enzymes in pro-inflammatory pathways. The IC(50) value for histamine receptor antagonist activity was 251 (+/-13) microg mL(-1) and for the histamine receptor negative agonist activity was 193 (+/-71) microg mL(-1). The IC(50) values for inhibition of mast cell tryptase was 172 (+/-28) microg mL(-1), for COX-1 was 160 (+/-47) microg mL(-1), for COX-2 was 275 (+/-9) microg mL(-1), and for HPGDS was 295 (+/-51) microg mL(-1). Through the use of DART TOF-MS, which yields exact masses and relative abundances of compounds present in complex mixtures, bioactives have been identified in nettle that contribute to the inhibition of pro-inflammatory pathways related to allergic rhinitis. These results provide for the first time, a mechanistic understanding of the role of nettle extracts in reducing allergic and other inflammatory responses in vitro.

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A Multi‐centre Trial of Pollen‐tyrosine Adsorbate

Cited by 13 publications

References 9 publications

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

Pollinex^® Quattro Ragweed: safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL^®) for the treatment of ragweed pollen allergy

Nettle extract (Urtica dioica) affects key receptors and enzymes associated with allergic rhinitis

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A Multi‐centre Trial of Pollen‐tyrosine Adsorbate

Cited by 13 publications

References 9 publications

A meta‐analysis on allergen‐specific immunotherapy using MCT® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

A meta‐analysis on allergen‐specific immunotherapy using MCT® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

Pollinex® Quattro Ragweed: safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL®) for the treatment of ragweed pollen allergy

Nettle extract (Urtica dioica) affects key receptors and enzymes associated with allergic rhinitis

Contact Info

Product

Resources

About

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

A meta‐analysis on allergen‐specific immunotherapy using MCT^® (MicroCrystalline Tyrosine)‐adsorbed allergoids in pollen allergic patients suffering from allergic rhinoconjunctivitis

Pollinex^® Quattro Ragweed: safety evaluation of a new allergy vaccine adjuvanted with monophosphoryl lipid A (MPL^®) for the treatment of ragweed pollen allergy