A phase 1, randomized, observer blind, antigen and adjuvant dosage finding clinical trial to evaluate the safety and immunogenicity of an adjuvanted, trivalent subunit influenza vaccine in adultsâ¯≥â¯65 years of age.
Vaccine
; 38(3): 578-587, 2020 01 16.
Article
em En
| MEDLINE
| ID: mdl-31679865
OBJECTIVE: To assess the safety and immunogenicity of the MF59®-adjuvanted trivalent influenza vaccine (aTIV; Fluad®) compared with modified aTIV formulations. METHODS: A total of 196 subjectsâ¯≥â¯65â¯years were randomized to receive7different formulations of vaccine containing a range of adjuvant and antigen dosesby single injection, or divided into two injections at a single time point. The primary study objective was to compare the serologic response of different formulations of aTIV containing increased amounts of adjuvant and antigen21â¯days after vaccination. Subjects were followed for immunogenicity and safety for one year. RESULTS: The highest immune response, as measured by hemagglutination inhibition (HI) assay, 3â¯weeks after vaccination was observed in subjects in Group 6 with GMT 382.2 (95% confidence interval [CI] 237.5 to 615.0), 552.3 (364.8 to 836.1), and 54.1 (36.9 to 79.4) against A/H1N1, A/H3N2, and B respectively. Rates of seroconversion were also generally highest in this treatment group: 75% (95% CI 55.1 to 89.3), 75% (55.1 to 89.3), and 42.9% (24.5 to 62.8), respectively, against A/H1N1, A/H3N2, and B strains. The highest incidence of solicited adverse events (AEs) was reported by subjects who received both the highest dosage of antigen in combination with the highest dosage of adjuvant at the same site: 67.9% and 57.1% in Groups 4 and 6, respectively. The majority of solicited AEs were mild to moderate in severity. The number of unsolicited AEs was similar across the different dosages. CONCLUSION: In this phase I trial of adultsâ¯≥â¯65â¯years of age who received increased adjuvant and antigen dosages relative to the licensed aTIV, increased dosage of MF59 resulted in increased immunogenicity against all 3 components of seasonal influenza vaccine. The increase in immunogenicity was accompanied by an increase in the incidence of local reactogenicity.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Polissorbatos
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Esqualeno
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Vacinas contra Influenza
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Adjuvantes Imunológicos
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Influenza Humana
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Imunogenicidade da Vacina
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Antígenos Virais
Tipo de estudo:
Clinical_trials
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Diagnostic_studies
Limite:
Aged
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Aged80
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Female
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Humans
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Male
País/Região como assunto:
Europa
Idioma:
En
Revista:
Vaccine
Ano de publicação:
2020
Tipo de documento:
Article