A phase I, randomized, controlled, dose-ranging study of investigational acellular pertussis (aP) and reduced tetanus-diphtheria-acellular pertussis (TdaP) booster vaccines in adults.
Hum Vaccin Immunother
; 14(1): 45-58, 2018 01 02.
Article
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| MEDLINE
| ID: mdl-29172945
ABSTRACT
Despite high vaccination coverage worldwide, pertussis has re-emerged in many countries. This randomized, controlled, observer-blind phase I study and extension study in Belgium (March 2012-June 2015) assessed safety and immunogenicity of investigational acellular pertussis vaccines containing genetically detoxified pertussis toxin (PT) (NCT01529645; NCT02382913). 420 healthy adults (average age 26.8 ± 5.5 years, 60% female) were randomized to 1 of 10 vaccine groups 3 investigational aP vaccines (containing pertussis antigens PT, filamentous hemagglutinin [FHA] and pertactin [PRN] at different dosages), 6 investigational TdaP (additionally containing tetanus toxoid [TT] and diphtheria toxoid [DT]), and 1 TdaP comparator containing chemically inactivated PT. Antibody responses were evaluated on days 1, 8, 30, 180, 365, and approximately 3 years post-booster vaccination. Cell-mediated immune responses and PT neutralization were evaluated in a subset of participants in pre-selected groups. Local and systemic adverse events (AEs), and unsolicited AEs were collected through day 7 and 30, respectively; serious AEs and AEs leading to study withdrawal were collected through day 365 post-vaccination. Antibody responses against pertussis antigens peaked at day 30 post-vaccination and then declined but remained above baseline level at approximately 3 years post-vaccination. Responses to FHA and PRN were correlated to antigen dose. Antibody responses specific to PT, toxin neutralization activity and persistence induced by investigational formulations were similar or significantly higher than the licensed vaccine, despite lower PT doses. Of 15 serious AEs, none were considered vaccination-related; 1 led to study withdrawal (premature labor, day 364; aP4 group). This study confirmed the potential benefits of genetically detoxified PT antigen. All investigational study formulations were well tolerated.
Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Vacuna contra la Tos Ferina
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Tos Ferina
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Inmunización Secundaria
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Vacunación
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Vacunas contra Difteria, Tétanos y Tos Ferina Acelular
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Toxina del Pertussis
Tipo de estudio:
Clinical_trials
Límite:
Adult
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Female
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Humans
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Male
País/Región como asunto:
Europa
Idioma:
En
Revista:
Hum Vaccin Immunother
Año:
2018
Tipo del documento:
Article
País de afiliación:
Bélgica