Priming by a novel universal influenza vaccine (Multimeric-001)-a gateway for improving immune response in the elderly population
| Autor: | Tanya M. Gottlieb, Svetlana Bruzil, Dimitry Shaikevich, Inna Volokhov, Tamar Ben-Yedidia, Kirsten Y. Haima, Yoseph Caraco, Sagit Ziv-Sefer, Ester Abramov, Jacob Atsmon |
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| Rok vydání: | 2014 |
| Předmět: |
Male
Influenza vaccine T-Lymphocytes Priming (immunology) Placebo Antibodies Viral Immune system Adjuvants Immunologic Influenza Human Medicine Humans Seroconversion Aged Aged 80 and over Immunity Cellular Vaccines Synthetic General Veterinary General Immunology and Microbiology biology business.industry Public Health Environmental and Occupational Health Antibody titer Hemagglutination Inhibition Tests Immunity Humoral Vaccination Infectious Diseases Influenza Vaccines Immunology Vaccines Subunit biology.protein Molecular Medicine Female Antibody business |
| Zdroj: | Vaccine. 32(44) |
| ISSN: | 1873-2518 |
| Popis: | Background A new vaccine, “Multimeric-001” (M-001) has been recently developed, containing conserved, common linear influenza epitopes that activate both cellular and humoral arms of the immune system against a wide variety of influenza A and B strains. Apart from its direct action, M-001 is an attractive candidate for priming immune responses to seasonal influenza vaccine for the elderly population. The current clinical study was designed to assess M-001's standalone and priming action in participants over 65 years old. Evaluation of standalone action is based on induction of cell mediated immunity (CMI), since M-001 alone does not induce hemagglutinin inhibition (HAI) antibodies. Methods This was a two-center, randomized, placebo-controlled study. 120 participants were randomized 1:1:1:1 into four groups to receive either two sequential non-adjuvanted or a single non-adjuvanted or a single adjuvanted intramuscular injection of 500 mcg M-001 (treatment), or one placebo (saline) injection, before receiving the trivalent inactivated influenza vaccine (TIV). Due to visual differences between placebo and treatment the study was partially blinded. HAI was evaluated at baseline and 3 weeks after standard TIV vaccination as a measure of M-001's efficacy. CMI responses were evaluated in a subset (10/group) of the participants. Participants were monitored for safety throughout the study. Results Overall the treatment was well-tolerated and safe, though sample sizes allowed only limited statistical analysis. M-001 priming resulted in enhanced seroconversion towards all three TIV strains, compared to priming with placebo. Significant elevation of influenza-specific CMI was observed following immunization with M-001 alone. Conclusions The standalone and priming actions of M-001 were demonstrated in elderly participants despite the limitations of small population size and pre-existing HAI antibody titers in some participants. As a standalone vaccine, M-001 induced significant CMI to multiple strains and as a primer, M-001 enhanced HAI responses. Larger scale studies are warranted. ClinicalTrials.gov registry number NCT01419925 . |
| Databáze: | OpenAIRE |
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