Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea-randomised trial

Hoan Jong Lee, Young June Choe, Young Jin Hong, Kyung Hyo Kim, Su Eun Park, Yun Kyung Kim, Chi Eun Oh, Hyunju Lee, Hyoyoung Song, Hans Bock, Daniela Casula, Chiranjiwi Bhusal, Ashwani Kumar Arora

Research output: Contribution to journalArticle

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Abstract

Background: Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents. Methods: 264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed. Results: One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs. Conclusions: Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).

Original languageEnglish
Pages (from-to)1180-1186
Number of pages7
JournalVaccine
Volume34
Issue number9
DOIs
Publication statusPublished - 2016 Feb 24

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Korea
Korean Peninsula
serotypes
Vaccines
immune response
vaccines
Safety
Enzyme-Linked Immunosorbent Assay
Antigens
Control Groups
Vaccination
Serogroup B Neisseria meningitidis
enzyme-linked immunosorbent assay
antigens
Glycoconjugates
dosage
vaccination
Meningitis
Neisseria meningitidis
Sepsis

Keywords

  • 4CMenB vaccine
  • Adolescents
  • Korea
  • Neisseria meningitidis
  • Serogroup B

ASJC Scopus subject areas

  • Molecular Medicine
  • Immunology and Microbiology(all)
  • veterinary(all)
  • Public Health, Environmental and Occupational Health
  • Infectious Diseases

Cite this

Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea-randomised trial. / Lee, Hoan Jong; Choe, Young June; Hong, Young Jin; Kim, Kyung Hyo; Park, Su Eun; Kim, Yun Kyung; Oh, Chi Eun; Lee, Hyunju; Song, Hyoyoung; Bock, Hans; Casula, Daniela; Bhusal, Chiranjiwi; Arora, Ashwani Kumar.

In: Vaccine, Vol. 34, No. 9, 24.02.2016, p. 1180-1186.

Research output: Contribution to journalArticle

Lee, HJ, Choe, YJ, Hong, YJ, Kim, KH, Park, SE, Kim, YK, Oh, CE, Lee, H, Song, H, Bock, H, Casula, D, Bhusal, C & Arora, AK 2016, 'Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea-randomised trial', Vaccine, vol. 34, no. 9, pp. 1180-1186. https://doi.org/10.1016/j.vaccine.2016.01.033
Lee, Hoan Jong ; Choe, Young June ; Hong, Young Jin ; Kim, Kyung Hyo ; Park, Su Eun ; Kim, Yun Kyung ; Oh, Chi Eun ; Lee, Hyunju ; Song, Hyoyoung ; Bock, Hans ; Casula, Daniela ; Bhusal, Chiranjiwi ; Arora, Ashwani Kumar. / Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine in healthy adolescents in Korea-randomised trial. In: Vaccine. 2016 ; Vol. 34, No. 9. pp. 1180-1186.
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AU - Choe, Young June

AU - Hong, Young Jin

AU - Kim, Kyung Hyo

AU - Park, Su Eun

AU - Kim, Yun Kyung

AU - Oh, Chi Eun

AU - Lee, Hyunju

AU - Song, Hyoyoung

AU - Bock, Hans

AU - Casula, Daniela

AU - Bhusal, Chiranjiwi

AU - Arora, Ashwani Kumar

PY - 2016/2/24

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N2 - Background: Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents. Methods: 264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed. Results: One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs. Conclusions: Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).

AB - Background: Neisseria meningitidis serogroup B is a significant cause of septicaemia and meningitis worldwide. This phase 3 randomised, controlled study assessed the immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine, 4CMenB, in healthy Korean adolescents. Methods: 264 adolescents (11-17 years old) were randomised to receive two doses, one month apart, of 4CMenB or control vaccines [placebo followed by one dose of a quadrivalent meningococcal ACWY glycoconjugate vaccine (MenACWY-CRM)]. Immunogenicity was evaluated by serum bactericidal assay with human complement (hSBA) against three serogroup B test strains specific for individual vaccine antigens (fHbp, NadA or PorA P1.4), and by enzyme-linked immunosorbent assay (ELISA) against the NHBA antigen. Solicited reactions and adverse events (AEs) were assessed. Results: One month post-second vaccination, 98%, 97%, and 97% of subjects in the 4CMenB group achieved hSBA titres ≥4 against the fHbp, NadA and PorA test strains, respectively, while percentages in the Control group were comparable to baseline (27%, 16%, and 17%, respectively). Geometric mean ELISA concentrations (GMCs) against NHBA increased 52-fold relative to baseline in the 4CMenB group, while there was no substantial increase in GMCs in the Control group (1.05-fold). Frequencies of solicited reactions after any vaccination were higher in the 4CMenB group than in the Control group, although most reactions were of short duration and mild to moderate intensity. There were no vaccine-related serious AEs. Conclusions: Two doses of 4CMenB induced robust immune responses against the vaccine antigens and were well tolerated, with no safety concerns identified, in Korean adolescents (NCT01973218).

KW - 4CMenB vaccine

KW - Adolescents

KW - Korea

KW - Neisseria meningitidis

KW - Serogroup B

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