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Revista Cubana de Hematología, Inmunología y Hemoterapia

versión On-line ISSN 1561-2996


RAMIREZ,GONZALEZ, Wendy et al. Immunogenicity and protective efficacy of variants of a novel PROLINEM DS anti-allergic vaccine. Rev Cubana Hematol Inmunol Hemoter [online]. 2023, vol.39  Epub 01-Mayo-2023. ISSN 1561-2996.


The second generation anti allergic vaccine named PROLINEM DS is based on allergens from D. siboney house dust mite and a combination adjuvant containing PL and Alum. Allergen adsorption is relevant both safety and clinical efficacy in alum-adsorbed vaccines. Negative influence of phosphate ions on allergen adsorption was demonstrated in previous researches.


To evaluate immunogenicity and protective efficacy of four variants obtained within design space of PROLINEM DS vaccine.


Four variants were differentiated from each other by both phosphate and alum contents. Balb/c mice were administered with 3 doses by subcutaneous route. Further, mice were subjected to allergen aerosol challenge.


Specific IgG1 and IgG2a antibodies were induced by four vaccine variants. It was correlated with pro inflammatory cytokines balance Th1/Th2 both in lungs and lymphatic nodes. Formulation with lower PBS and Alum levels showed the highest IgG/IgE ratio at the end of vaccination schedule. This ratio shows in one variable the balance between potentially blocking and effector components. Mice injected with lower level of Alum showed a reduction of granuloma size in the site of vaccine administration.


Decrease both alum and phosphate contents were a pharmaceutical improvement for antiallergic vaccines formulation. Safety and efficacy in this vaccine are crucial for future human clinical trials.

Palabras clave : allergy immunotherapy; combination adjuvant; dust mite; design space; immunogenicity.

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