BACKGROUND: Group B streptococcus (GBS) is a leading cause of sepsis and meningitis in early infancy. Substantial data demonstrate that women with higher levels of circulating antibody against the capsular polysaccharide (CPS) deliver infants at reduced risk of GBS infection, which serves as the basis for vaccine design. This study evaluates two different dosages, two injection schedules and three formulations of an investigational trivalent (serotypes Ia, Ib and III) CRM197-glycoconjugate GBS vaccine in healthy, non-pregnant women. METHODS:678 healthy non-pregnant women received one or two injections of one of two dosages (5/5/5 μg or 20/20/20 μg) of the investigational vaccine, formulated with or without aluminum hydroxide (Enrollment Group 1), or with full or half dosages of MF59(®) (Enrollment Group 2); or a placebo (Enrollment Groups 1 and 2). Geometric mean serotype-specific antibody concentrations (GMCs) at Days 61 (Enrollment Group 1) and 361 (both Groups) were analyzed to select a formulation suitable for pregnant or non-pregnant women, respectively. Solicited adverse reactions were recorded up to Day 7 and adverse events (AEs) were recorded throughout the study. RESULTS: Rates of reported AEs were similar across all groups. Higher rates of local reactogenicity were seen in adjuvanted vaccine groups compared with non-adjuvanted vaccine (or placebo) groups. All vaccine groups elicited higher GMCs than placebo; differences between treatments were not statistically significant, indicating no additional potential benefit of higher antigen content, addition of adjuvant, or a second dose. CONCLUSIONS: All GBS vaccine formulations induced a persistent antibody response and showed similar immunogenicity profiles (NCT01150123).
RCT Entities:
BACKGROUND:Group B streptococcus (GBS) is a leading cause of sepsis and meningitis in early infancy. Substantial data demonstrate that women with higher levels of circulating antibody against the capsular polysaccharide (CPS) deliver infants at reduced risk of GBS infection, which serves as the basis for vaccine design. This study evaluates two different dosages, two injection schedules and three formulations of an investigational trivalent (serotypes Ia, Ib and III) CRM197-glycoconjugate GBS vaccine in healthy, non-pregnant women. METHODS: 678 healthy non-pregnant women received one or two injections of one of two dosages (5/5/5 μg or 20/20/20 μg) of the investigational vaccine, formulated with or without aluminum hydroxide (Enrollment Group 1), or with full or half dosages of MF59(®) (Enrollment Group 2); or a placebo (Enrollment Groups 1 and 2). Geometric mean serotype-specific antibody concentrations (GMCs) at Days 61 (Enrollment Group 1) and 361 (both Groups) were analyzed to select a formulation suitable for pregnant or non-pregnant women, respectively. Solicited adverse reactions were recorded up to Day 7 and adverse events (AEs) were recorded throughout the study. RESULTS: Rates of reported AEs were similar across all groups. Higher rates of local reactogenicity were seen in adjuvanted vaccine groups compared with non-adjuvanted vaccine (or placebo) groups. All vaccine groups elicited higher GMCs than placebo; differences between treatments were not statistically significant, indicating no additional potential benefit of higher antigen content, addition of adjuvant, or a second dose. CONCLUSIONS: All GBS vaccine formulations induced a persistent antibody response and showed similar immunogenicity profiles (NCT01150123).
Authors: Bonnie Phillips; Koen K A Van Rompay; Jennifer Rodriguez-Nieves; Clarisse Lorin; Marguerite Koutsoukos; Mark Tomai; Christopher B Fox; Josh Eudailey; Maria Dennis; S Munir Alam; Michael Hudgens; Genevieve Fouda; Justin Pollara; Anthony Moody; Xiaoying Shen; Guido Ferrari; Sallie Permar; Kristina De Paris Journal: J Virol Date: 2018-09-26 Impact factor: 5.103
Authors: Sonwabile Dzanibe; Gaurav Kwatra; Peter V Adrian; Sheila Z Kimaro-Mlacha; Clare L Cutland; Shabir A Madhi Journal: Sci Rep Date: 2017-11-28 Impact factor: 4.379