Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine.
Vaccine
; 37(9): 1209-1218, 2019 02 21.
Article
in En
| MEDLINE
| ID: mdl-30691980
ABSTRACT
BACKGROUND:
Data on duration of protection against invasive meningococcal disease post-vaccination with the recombinant, 4-component, meningococcal serogroup B vaccine (4CMenB) are limited. We evaluated bactericidal activity persistence in adolescents/young adults up to 7.5â¯years post-primary vaccination with 4CMenB, and response to a booster dose compared with vaccine-naïve controls.METHODS:
This open-label, multicenter study (NCT02446743) enrolled 15-24â¯year-old-previously vaccinated participants from Canada, Australia (group Primed_4y) 4â¯years post-priming with 4CMenB (2 doses; 0,1-month schedule), and Chile (Primed_7.5y) 7.5â¯years after priming with 4CMenB (2 doses; 0,1/0,2/0,6-month schedule) and vaccine-naïve participants of similar age (Naïve_4y and Naïve_7.5y groups). Primed participants received a booster dose; vaccine-naïve participants received 2 catch-up doses of 4CMenB, 1â¯month apart. We evaluated antibody persistence and immune responses using hSBA in terms of geometric mean titers and percentages of participants with hSBA titers ≥4, the kinetics of bactericidal activity post-booster (previously vaccinated) or post-2 doses (vaccine-naïve), and safety.RESULTS:
Antibody levels declined at 4 (Primed_4y) and 7.5 (Primed_7.5y) years post-primary vaccination, but remained higher than in vaccine-naïve participants at baseline (≤44% vs ≤â¯13% [fHbp]; ≤84% vs ≤â¯24% [NadA]; ≤29% vs ≤â¯14% [PorA]) for all vaccine antigens except NHBA (≤81% vs ≤â¯79%). One month post-booster and post-second dose, 93-100% of primed and 79-100% of vaccine-naïve participants had hSBA titers ≥4 for all antigens. Kinetics of the antibody response were similar across groups with an early robust response observed 7â¯days post-booster/second dose. No vaccine-related serious adverse event was reported.CONCLUSION:
For all antigens except NHBA, a higher proportion of primed participants had hSBA titers ≥4, at 4 and 7.5â¯years post-vaccination, compared with vaccine-naïve participants. A more robust immune response after booster compared to a first dose in vaccine-naïve individuals, showed effective priming in an adolescent/young adult population. No safety or new reactogenicity issues were identified.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Immunization, Secondary
/
Meningococcal Vaccines
/
Immunogenicity, Vaccine
/
Meningococcal Infections
/
Antibodies, Bacterial
Type of study:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Male
Country/Region as subject:
America do norte
/
America do sul
/
Chile
/
Oceania
Language:
En
Journal:
Vaccine
Year:
2019
Document type:
Article
Affiliation country:
Australia
Publication country:
HOLANDA
/
HOLLAND
/
NETHERLANDS
/
NL
/
PAISES BAJOS
/
THE NETHERLANDS