Safety and immunogenicity of an investigational quadrivalent meningococcal CRM(197) conjugate vaccine, MenACWY-CRM, compared with licensed vaccines in adults in Latin America.
BACKGROUND
This study compared the investigational quadrivalent meningococcal CRM₁₉₇ conjugate vaccine, MenACWY-CRM, with licensed quadrivalent polysaccharide (MPSV4) and conjugate (MenACWY-D) meningococcal vaccines.


METHODS
In this phase III multicenter study, 2505 adults (aged 19-55 years) were randomized to receive either MenACWY-CRM or MenACWY-D, and 326 adults (aged 56-65 years) were randomized to receive either MenACWY-CRM or MPSV4. Sera obtained pre-vaccination and at 1-month post-vaccination were tested for serogroup-specific serum bactericidal activity using human complement (hSBA) for immunogenicity non-inferiority and superiority analyses.


RESULTS
The vaccines in all groups were well tolerated. In the 19-55 years age group, post-vaccination geometric mean titers (GMTs) were consistently higher for MenACWY-CRM than for MenACWY-D for all four serogroups. MenACWY-CRM was non-inferior to MenACWY-D for all serogroups, and superior for serogroup Y. In the 56-65 years age group, post-vaccination GMTs were 1.2- to 5.4-fold higher for MenACWY-CRM than for MPSV4 for the four serogroups.


CONCLUSIONS
MenACWY-CRM is well tolerated and immunogenic in adults aged 19-65 years, with at least non-inferior immunogenicity compared with the currently licensed meningococcal vaccines.
Stamboulian
D
D
Fundación Centro de Estudios Infectológicos (FUNCEI), French 3085 (C1425AWK), Buenos Aires, Argentina. dstamb@funcei.org.ar
Lopardo
G
G
Lopez
P
P
Cortes-Barbosa
C
C
Valencia
A
A
Bedell
L
L
Karsten
A
A
Dull
P M
PM
D000328:Adult; D001118:Argentina; D003105:Colombia; D005260:Female; D006801:Humans; D008297:Male; D022401:Meningococcal Vaccines / Q000009:adverse effects* / Q000276:immunology*; D008875:Middle Aged; D018074:Vaccines, Conjugate / Q000009:adverse effects* / Q000276:immunology*
C556088:MenACWY-CRM vaccine; C568160:MenACWY-D vaccine; D022401:Meningococcal Vaccines; D018074:Vaccines, Conjugate