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Abstract
ABSTRACTDespite 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.
Highlights
Pertussis, known as whooping cough, is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis (B. pertussis)
It was estimated in 2008 that 16 million cases of pertussis occurred worldwide, and 195,000 children died from the disease, an incidence that owes to insufficient coverage or compliance in pediatric immunization,[11,12] as well as to resurgence in countries with high vaccination coverage: a high incidence of pertussis was observed in some developed countries (Australia, Portugal, United Kingdom, United States) that switched vaccination programs from vaccines that contained whole cell pertussis to acellular pertussis (aP).[13]
Reasons for premature study withdrawal were lost to follow-up (n D 7), withdrawal of consent (n D 5), and serious adverse event (SAE) (n D 1; participant from aP4 group withdrew herself after experiencing an SAE [premature labor] at day 364)
Summary
Known as whooping cough, is a highly contagious respiratory disease caused by the bacterium Bordetella pertussis (B. pertussis). All age groups are susceptible to pertussis; the most severe symptoms occur in infants and young children, in whom potentially fatal complications such as convulsions, bronchopneumonia and encephalopathy may occur.[1,2,3] Household exposure is considered to play an important role in the spread of the disease.[4,5,6] A previous study demonstrated that 35% to 55% of infant cases could be prevented if immunity to pertussis in parents was maintained or boosted. Health agencies in the United States and European Union recommend booster vaccine administration to adults in close contact with infants to reduce the risk of the disease.[14,15] As a result of resurgence and increased incidence
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