Molecular adjuvant and vaccine
Inventors
ALCOLEA ALCOLEA, Pedro José • ALONSO AYALA, Ana María • Larraga Rodríguez De Vera, Vincente Emilio
Assignees
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Publication Number
US-10568960-B2
Publication Date
2020-02-25
Expiration Date
Abstract
The invention relates to the fields of vaccines and vaccine adjuvants, and generally relates to polynucleotide adjuvants, polynucleotide vaccines and vaccine compositions. More specifically, the invention relates to said polynucleotides and vaccine compositions for use in inducing or enhancing a prophylactic or therapeutic immune response in a mammalian subject. Furthermore, it relates to said polynucleotides and vaccine compositions for use in the prophylactic or therapeutic treatment of an infectious disease, such as in the prophylactic or therapeutic treatment of leishmaniasis.
Core Innovation
The described invention provides a molecular adjuvant based on an E. coli fabI-derived nucleic acid, where the nucleic acid sequence is SEQ ID NO: 1 and the encoded polypeptide is SEQ ID NO: 2. The molecular adjuvant is used as a DNA vaccine adjuvant, and the fabI sequence is described in connection with CpG-containing sequence activity for acting as a molecular adjuvant.
The invention further relates to nucleic acid vaccine constructs that co-deliver the fabI-derived fragment with a Leishmania infantum LACK antigen gene. In particular, the described constructs include vectors/plasmids that co-deliver the fabI fragment together with the LACK gene, including the pPAL-LACK plasmid and related plasmid embodiments.
The described rationale contrasts homologous prime-boost and heterologous prime-boost approaches in the context of the fabI-based molecular adjuvant and LACK antigen delivery. The disclosure describes comparative results indicating an improved Th1-associated cytokine profile, including IFN-gamma with reduced IL-10 patterns, and reduced parasite burden in dogs vaccinated with pPAL-LACK compared with controls and a commercial product, supporting increased protective efficacy while avoiding the need for viral vectors.
Claims Coverage
The provided independent claims cover three inventive features centered on paired nucleic acid sequences in plasmid and vaccine contexts, and on antibody production by immunization.
Plasmid nucleic acids for protecting against leishmaniasis
A method for protecting a canine or human subject from leishmaniasis by administering to the subject a plasmid comprising the nucleic acid sequence of SEQ ID NO: 3 and the nucleic acid sequence of SEQ ID NO: 5.
Vaccine with paired plasmid nucleic acids
A vaccine for protecting a canine or human subject from leishmaniasis comprising a pharmaceutically acceptable carrier, additive or excipient and a plasmid with the nucleic acid sequence of SEQ ID NO: 3 and the nucleic acid sequence of SEQ ID NO: 5.
Immunization with paired polynucleotide sequences to produce antibodies
A method for producing antibodies by immunizing a canine or human subject with a polynucleotide sequence comprising the nucleic acid of SEQ ID NO: 3 and the nucleic acid of SEQ ID NO: 5, or a pharmaceutical composition comprising the same.
Protection and vaccination rely on administering or formulating a plasmid containing both SEQ ID NO: 3 and SEQ ID NO: 5, and antibody production is obtained by immunizing with a polynucleotide or pharmaceutical composition that includes the same paired nucleic acids.
Stated Advantages
Increased protective efficacy against leishmaniasis as supported by reduced parasite burden compared with controls and a commercial product.
Improved Th1-associated cytokine profile, including IFN-gamma with reduced IL-10 patterns.
Eliminates the need for viral vectors.
Documented Applications
Prophylactic/therapeutic immunization for infectious diseases, preferably leishmaniasis, including canine leishmaniasis using the described DNA vaccine adjuvant constructs.
Passive immunization via antibodies generated after immunization using the described polynucleotide/DNA vaccine approach.
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