PMID- 34787449
OWN - NLM
STAT- MEDLINE
DCOM- 20220211
LR  - 20220211
IS  - 2379-5042 (Electronic)
IS  - 2379-5042 (Linking)
VI  - 6
IP  - 6
DP  - 2021 Dec 22
TI  - Immunogenicity and Safety of Investigational MenABCWY Vaccine and of 4CMenB and 
      MenACWY Vaccines Administered Concomitantly or Alone: a Phase 2 Randomized Study 
      of Adolescents and Young Adults.
PG  - e0055321
LID - 10.1128/mSphere.00553-21 [doi]
LID - e00553-21
AB  - This phase 2, randomized, open-label study assessed the immunogenicity and safety 
      of an investigational meningococcal ABCWY vaccine (MenABCWY) that contains 
      components of licensed vaccines against meningococcal serogroup B (4CMenB) and 
      serogroups ACWY (MenACWY). A total of 500 healthy 10- to 25-year-old participants 
      were randomly assigned to one of five study groups in a 1:1:1:1:1 ratio. Four 
      groups received two doses 2 months apart of MenABCWY and 4CMenB plus MenACWY 
      administered concomitantly in the same arm (4CMenB+ACWY/S group) or different 
      arms (4CMenB+ACWY/D group) or 4CMenB administered alone. A fifth group received a 
      single MenACWY dose. Immunogenicity was determined by serum bactericidal assay 
      using human complement (hSBA). The study was powered to assess immunological 
      interference against pooled serogroup B test strains. One month after the second 
      vaccine dose, hSBA geometric mean titers (GMTs) (with 80% confidence intervals 
      [CI]) against pooled serogroup B strains were 31.84 (80% CI, 28.18 to 35.98), 
      38.48 (80% CI, 34.23 to 43.26), 40.08 (80% CI, 35.44 to 45.33), and 42.38 (80% 
      CI, 37.31 to 48.13) in the MenABCWY, 4CMenB+ACWY/S, 4CMenB+ACWY/D, and 4CMenB 
      groups, respectively. Immune responses (GMTs and 80% CIs) were lower for PorA and 
      NHBA serogroup B test strains in the MenABCWY group compared to the 4CMenB+ACWY/D 
      group and 4CMenB group. Evaluation of solicited and unsolicited adverse events 
      (AEs) identified no safety concerns for the MenABCWY vaccine. One serious AE 
      (syncope in the 4CMenB group) was considered related to vaccination. In 
      conclusion, there is no evidence of substantial immunological interference 
      between 4CMenB and MenACWY vaccine components against serogroup B. The safety and 
      tolerability profile of the investigational MenABCWY vaccine was acceptable. 
      (This study has been registered at ClinicalTrials.gov under registration no. 
      NCT03587207.) IMPORTANCE The bacterial species Neisseria meningitidis is a major 
      cause of meningitis, with six meningococcal groups (serogroups) causing most 
      cases. A licensed vaccine, MenACWY (Menveo), targets four of these meningococcal 
      serogroups, and another vaccine, 4CMenB (Bexsero), targets serogroup B. A 
      combined vaccine (MenABCWY) that targets all five serogroups is under development 
      to simplify the vaccination schedule. In a previous study, the immune response to 
      serogroup B was found to be overall higher in individuals who received 4CMenB 
      than in those who received an investigational MenABCWY vaccine. We investigated 
      this further by giving healthy adolescents and young adults the MenABCWY vaccine, 
      4CMenB plus MenACWY vaccine in the same or different arms, 4CMenB vaccine alone, 
      or MenACWY vaccine alone. Immunogenicity results for serogroup B across study 
      groups suggest no major interference between the MenB and MenACWY vaccine 
      components. This supports further development of the combined MenABCWY vaccine.
FAU - Beran, Jiri
AU  - Beran J
AD  - Vaccination and Travel Medicine Center, Hradec Kralove, Czech Republic.
AD  - Institute for Postgraduate Health Education, Prague, Czech Republic.
FAU - Drazan, Daniel
AU  - Drazan D
AD  - General practitioner, Jindrichuv Hradec, Czech Republic.
FAU - Enweonye, Igwebuike
AU  - Enweonye I
AD  - GSK, Amsterdam, The Netherlands.
FAU - Bhusal, Chiranjiwi
AU  - Bhusal C
AD  - GSK, Amsterdam, The Netherlands.
FAU - Toneatto, Daniela
AU  - Toneatto D
AUID- ORCID: 0000-0002-7661-4370
AD  - GSK, Siena, Italy.
LA  - eng
SI  - ClinicalTrials.gov/NCT03587207
PT  - Clinical Trial, Phase II
PT  - Comparative Study
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20211117
PL  - United States
TA  - mSphere
JT  - mSphere
JID - 101674533
RN  - 0 (4CMenB vaccine)
RN  - 0 (Drugs, Investigational)
RN  - 0 (MenACWY)
RN  - 0 (Meningococcal Vaccines)
RN  - 0 (Vaccines, Conjugate)
SB  - IM
MH  - Adolescent
MH  - Blood Bactericidal Activity
MH  - Child
MH  - Drug-Related Side Effects and Adverse Reactions/epidemiology/pathology
MH  - Drugs, Investigational/administration & dosage/*adverse effects
MH  - Female
MH  - Healthy Volunteers
MH  - Humans
MH  - Male
MH  - Meningococcal Vaccines/administration & dosage/*adverse effects/*immunology
MH  - Serogroup
MH  - Vaccines, Conjugate/administration & dosage/adverse effects/immunology
MH  - Young Adult
PMC - PMC8597725
OTO - NOTNLM
OT  - MenABCWY
OT  - Neisseria meningitidis
OT  - immunogenicity
OT  - investigational
EDAT- 2021/11/18 06:00
MHDA- 2022/02/12 06:00
PMCR- 2021/11/17
CRDT- 2021/11/17 12:15
PHST- 2021/11/18 06:00 [pubmed]
PHST- 2022/02/12 06:00 [medline]
PHST- 2021/11/17 12:15 [entrez]
PHST- 2021/11/17 00:00 [pmc-release]
AID - mSphere00553-21 [pii]
AID - msphere.00553-21 [pii]
AID - 10.1128/mSphere.00553-21 [doi]
PST - ppublish
SO  - mSphere. 2021 Dec 22;6(6):e0055321. doi: 10.1128/mSphere.00553-21. Epub 2021 Nov 
      17.