TY - JOUR
T1 - Immunogenicity, Reactogenicity, and Safety of a Pentavalent Meningococcal ABCWY Vaccine in Adolescents and Young Adults Who Had Previously Received a Meningococcal ACWY Vaccine
T2 - A Phase 3, Randomized Controlled Clinical Study
AU - BOOST Study Group
AU - Nolan, Terry
AU - Bhusal, Chiranjiwi
AU - Hoberman, Alejandro
AU - Llapur, Conrado J.
AU - Voloshyna, Olga
AU - Fink, Ezekiel
AU - Gentile, Angela
AU - Wallace, Garry
AU - Richmond, Peter C.
AU - Domachowske, Joseph B.
AU - Mzolo, Thembile
AU - Lattanzi, Maria
AU - Toneatto, Daniela
AU - Akinsola, Adebayo
AU - Ampajwala, Madhavi
AU - Arya, Mark
AU - Bartlett, Andrew
AU - Batra, Divya
AU - Bloch, Mark Theo
AU - Bordon, Jose
AU - Byars, William
AU - Carr, Jeremy Peter James
AU - Ceballos, Ana
AU - De Looze, Ferdinandus
AU - Deluca, Mercedes
AU - Domachowske, Joseph
AU - Farjo, Rand
AU - Gilsoul, Jennifer
AU - Gunner, Elizabeth Anne
AU - Gupta, Anil K.
AU - Hong, Matthew
AU - Kasarjian, Julie
AU - Llapur, Conrado Juan
AU - Mann, Darvy
AU - Marc, Gonzalo Perez
AU - Matherne, Paul G.
AU - Mitchell, Gretchen
AU - Obed, Mora Nair
AU - Oä§mahony, John
AU - Richmond, Peter
AU - Riera, Fernando Oscar
AU - Rok, Walter
AU - Saravolatz, Louis
AU - Silas, Peter
AU - Soto, Adriana Elvira
AU - Sullivan, Katherine
AU - Surber, Joseph
AU - Teijeiro, Ricardo Augusto
AU - Tiong, Florence
AU - Wadia, Ushma
N1 - Publisher Copyright:
© 2024 GSK Plc.
PY - 2025/4/15
Y1 - 2025/4/15
N2 - Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases. Methods: In this phase 3 study, healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages of participants with hSBA titers greater than or equal to the lower limit of quantitation (≥LLOQ) against serogroups ACWY and vaccine antigen-specific serogroup B (MenB) indicator strains. Results: Noninferiority of MenABCWY versus MenACWY-CRM was demonstrated following each MenABCWY dose. Percentages of participants with hSBA titers ≥LLOQ for serogroups ACWY were 97.9%-98.9% and 99.5%-100% following 1 and 2 MenABCWY doses, respectively, and 96.8%-99.0% following 1 MenACWY-CRM dose. After 2 MenABCWY doses, 75.6%-96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well tolerated in MenACWY-primed individuals, with a favorable safety profile. Conclusions: Immune responses against serogroups ACWY following 1 and 2 doses of investigational MenABCWY vaccine are noninferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after 2 MenABCWY doses administered 6 months apart. Clinical Trials Registration.
AB - Background: A MenABCWY vaccine containing 4CMenB and MenACWY-CRM vaccine components has been developed to protect against the 5 meningococcal serogroups that cause most invasive disease cases. Methods: In this phase 3 study, healthy participants aged 15-25 years, who had received MenACWY vaccination ≥4 years previously, were randomized (1:1) to receive 2 MenABCWY doses 6 months apart or 1 MenACWY-CRM dose. Primary objectives were to demonstrate the noninferiority of MenABCWY 1 month postvaccination versus MenACWY-CRM, with a lower limit of 2-sided 95% confidence interval above -10% for group differences in 4-fold rise in human serum bactericidal antibody (hSBA) titers against serogroups ACWY, and to evaluate reactogenicity and safety. Secondary endpoints included percentages of participants with hSBA titers greater than or equal to the lower limit of quantitation (≥LLOQ) against serogroups ACWY and vaccine antigen-specific serogroup B (MenB) indicator strains. Results: Noninferiority of MenABCWY versus MenACWY-CRM was demonstrated following each MenABCWY dose. Percentages of participants with hSBA titers ≥LLOQ for serogroups ACWY were 97.9%-98.9% and 99.5%-100% following 1 and 2 MenABCWY doses, respectively, and 96.8%-99.0% following 1 MenACWY-CRM dose. After 2 MenABCWY doses, 75.6%-96.3% of participants had hSBA titers ≥LLOQ against MenB indicator strains. The MenABCWY vaccine was well tolerated in MenACWY-primed individuals, with a favorable safety profile. Conclusions: Immune responses against serogroups ACWY following 1 and 2 doses of investigational MenABCWY vaccine are noninferior to those following MenACWY-CRM in MenACWY-primed adolescents and young adults. Robust immune responses were observed against MenB indicator strains after 2 MenABCWY doses administered 6 months apart. Clinical Trials Registration.
KW - MenABCWY
KW - MenACWY
KW - immunogenicity
KW - primed
KW - safety
UR - http://www.scopus.com/inward/record.url?scp=105004286341&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=105004286341&partnerID=8YFLogxK
U2 - 10.1093/cid/ciae622
DO - 10.1093/cid/ciae622
M3 - Article
C2 - 39722560
AN - SCOPUS:105004286341
SN - 1058-4838
VL - 80
SP - 752
EP - 760
JO - Clinical Infectious Diseases
JF - Clinical Infectious Diseases
IS - 4
ER -