The aim of this work was to review the 20-years Cuban experience developing House Dust Mite AIT for asthma Methods Standardized allergen extracts were developed for the well-known species ...Dermatophagoides pteronyssinus and for the tropical species D.siboney and Blomia tropicalis. Sublingual route has shown similar efficacy as compared to injection, with less systemic side-effects and no life-threatening reactions Conclusions AIT with standardized HDM allergens has shown to be, not only a clinically advantageous treatment, but also an approach able to be extended into a public healthcare system.
Rationale A nasal allergen provocation test (NAPT) is performed to confirm the diagnosis of allergic rhinitis to house dust mite, in the situation of discrepancy between the symptoms and the results ...of skin prick test (SPT) and/or serum specific immunoglobulin E. In Cuba, sensitization to house dust mites (Dermatophagoides pteronyssinus (Dp), Dermatophagoides siboney and Blomia tropicalis) is a major cause of allergic rhinitis. Conclusions Nasal allergen provocation test with the Dermatophagoides pteronyssinus is effective and safety by the diagnosis of allergic rhinitis to this mite.
Nasal provocation test (NPT) is indicated to confirm the diagnosis of allergic rhinitis to house dust mites. Methods An open, non-randomized, controlled clinical trial was carried out in 50 patients ...with allergic rhinitis sensitized to D. siboney mite and 50 non-allergicsubjects.
Rationale Allergen-specific immunotherapy is the only method of treating allergic asthma with long-term effectiveness and potentially, able to change the disease course. The development of a new ...therapeutic vaccine for allergic asthma associated to mite sensitization and effective with few administrations would be a very advantageous alternative.
The proteoliposome (PL) of Neisseria meningitidis serogroup B has been reported as a safe and potent vaccine adjuvant, inducing a T
H
1-skewed response. The present study describes a pre-clinical ...safety evaluation of an allergy therapeutic vaccine candidate based on purified allergens from Dermatophagoides siboney house dust mite and PL as adjuvant, both components adsorbed onto aluminum hydroxide gel. Two separate studies of acute toxicity evaluation were performed in mice and rabbits, and two repeat-dose studies were conducted in non-sensitized and allergen-sensitized Balb/c mice, respectively. The study in sensitized mice intends to model a therapeutic setting. Aerosolized allergen challenge was used in both settings to model natural respiratory exposure. In the therapeutic setting, mice were administered with three doses containing 2 μg allergen at weekly intervals subcutaneous route and subsequently challenged with aerosolized allergen for 6 consecutive days. Parameters of general toxicity effects were assessed via measures of behavior, body weight, food and water consumption, and macroscopic evaluation of organs. Histological examination of organs and the injection site was performed. Potential immunotoxicity effects at the systemic level were assessed by blood eosinophil counting and serum allergen specific IgE by ELISA The vaccine did not produce general or functional toxic effects of significance, at a dose up to 100 μg allergen per kg body weight. An expected local reaction at the injection site was observed, which could be attributed mostly to the immunological effect of aluminum hydroxide. The models implemented here suggest an acceptable safety profile of this vaccine for testing in clinical trials of allergy immunotherapy.
Rationale Novel therapeutic vaccines for allergic asthma, based on House Dust Mite allergens, effective with fewer administration would be a very advantageous alternative over conventional allergy ...vaccines and would allow a greater extension of the immunotherapy approach, reducing the consumption of symptomatic medications. In Cuba and other Caribbean countries the species Dermatophagoides siboney is very relevant as a cause of respiratory allergy.The objective of this research was to perform the first evaluation in humans of the tolerability and safety of a D. siboney allergen vaccine, adjuvanted with Neisseria meningitidis B proteoliposome (PROLINEM-DS).
The proteoliposomes and cochleates are used as adjuvants for vaccines since they are potent immune stimulators. However, the hyper stimulation of the immune system provoked by adjuvants can cause ...immune-toxicological side effects. The present study was carried out to evaluate the toxic and immuno-toxicological effects of new adjuvants for anti-meningococci vaccines based on neo-proteoliposomes (nPL) and neo-cochleates (nCh), in Balb/c mice that were administered doses of 15 g each, over periods of 14 days through intramuscular route and three inoculations with the same doses through intranasal route, every 7 days. The Scanning and Transmission Electron Microscopy showed that the nPL and nCh had nanometric dimensions and their normal peculiar forms. The experimental formulations did not provoke general toxic effects in the tested animals, which tended to the progressive normal growing of this species, that did not statistically differ from the control ones. The studies of pathologic anatomy in inoculation organs and sites did not reveal modifications that can indicate toxicity and there was no sign of hepatic damage. The structural observations found in the spleen and lymphatic nodes showed the physiological development of the immune response, which was normal in all cases showing the restitution of the stimulation signs. The relative weight values of the spleen were within the standard range. These results showed that the nPL and nCh elaborated as adjuvants for vaccines did not show any evident induction of general toxic or particular immune-toxicologicl effects.
The development of effective vaccines against neglected diseases, especially those associated with poverty and social deprivation, is urgently needed. Modern vaccine technologies and a better ...understanding of the immune response have provided scientists with the tools for rational and safer design of subunit vaccines. Often, however, subunit vaccines do not elicit strong immune responses, highlighting the need to incorporate better adjuvants; this step therefore becomes a key factor for vaccine development. In this review we outline some key features of modern vaccinology that are linked with the development of better adjuvants. In line with the increased desire to obtain novel adjuvants for future vaccines, the Finlay Adjuvant Platform offers a novel approach for the development of new and effective adjuvants. The Finlay Adjuvants (AFs), AFPL (proteoliposome), and AFCo (cochleate), were initially designed for parenteral and mucosal applications, and constitute potent adjuvants for the induction of Th1 responses against several antigens. This review summarizes the status of the Finlay technology in producing promising adjuvants for unsolved-vaccine diseases including mucosal approaches and therapeutic vaccines. Ideas related to adjuvant classification, adjuvant selection, and their possible influence on innate recognition via multiple toll-like receptors are also discussed.
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