Assessment of the Tolerability and Safety in Humans of a New Adjuvanted Anti-allergic Therapeutic Vaccine.
Sunday, March 4, 2018
South Hall A2 (Convention Center)
Mary C. Reyes Zamora, MSc, Raul L Castro Almarales, MSc, Maytee Mateo Morejon, MSc, Wendy Ramirez González, MSc, Damaris Torralba Averoff, Mercedes Ronquillo Diaz, MSc, Alina C González Paredes, Maria A Tamayo Gutierrez, Mirta Álvarez Castelló, MSc, Jose S. Rodriguez Canosa, MSc, Oliver Perez, PhD, Alexis Labrada Rosado, PhD

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).


An open, non-randomized Phase I Clinical Trial was conducted in 20 adult asthmatic patients sensitized to Dermatophagoides siboney. The vaccine was administered subcutaneously, in a dose-escalation scheme with three effective doses with a two week interval. It was determined the maximum tolerated dose without the occurrence of systemic allergic reactions. The safety of the treatment was assessed through adverse reactions and clinical, spirometric and laboratory parameters. Immunogenicity was determined through skin tests and immunological tests.


There were 46 adverse events, all categorized as expected, locals, non-severe and 95.65% of them were immediate allergic reactions. However, as the dose increased, the percentage of allergic reactions decreased, with no change in their intensity, indicating increased tolerability. Skin reactivity to D.siboney decreased significantly (p = 0.001) at 84 days.


The scheme of only three effective doses was very well tolerated, with a satisfactory safety profile. The results obtained are considered valid, reliable and support the application of phase II clinical trials.