TY - JOUR
T1 - Immunogenicity and safety of an investigational quadrivalent meningococcal conjugate vaccine administered as a booster dose in children vaccinated against meningococcal disease 3 years earlier as toddlers
T2 - A Phase III, open-label, multi-center study
AU - Piazza, Franco M.
AU - Virta, Miia
AU - Paassilta, Marita
AU - Ukkonen, Benita
AU - Ahonen, Anitta
AU - Esteves-Jaramillo, Alejandra
AU - Forsten, Aino
AU - Seppä, Ilkka
AU - Ding, Jian
AU - Neveu, David
AU - Jordanov, Emilia
AU - Dhingra, Mandeep S.
N1 - Funding Information:
The authors would like to thank all participants who volunteered to take part in the study, all study investigators and the staff at the Vaccine Evaluation Unit, Public Health England. The authors also wish to acknowledge and thank the Sanofi Pasteur study team especially Corinne Chalus, Hnin Phyu, Isabelle Lacroix and Jennifer Kinsley for their support during the conduct of this study. Editorial assistance with the preparation of the manuscript was provided by Sam Hijazi PhD and Juliette Gray PhD, of inScience Communications, Springer Healthcare Ltd, UK, and was funded by Sanofi Pasteur.
Publisher Copyright:
© 2021 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2022
Y1 - 2022
N2 - Booster doses of meningococcal conjugate vaccines induce long-term protection against invasive meningococcal disease. We evaluated the immunogenicity and safety of a booster dose of MenACYW-TT in pre-school children who were primed 3 years earlier with MenACYW-TT or MCV4-TT (Nimenrix®). In this Phase III, open-label, multi-center study (NCT03476135), children (4–5 years old), who received a primary dose of MenACYW-TT or MCV4-TT as toddlers in a previous study, received a booster dose of MenACYW-TT. Titers of antibody against meningococcal serogroups A, C, W and Y were measured by serum bactericidal assay using human (hSBA) and baby rabbit (rSBA) complement in samples collected before (D0) and 30 days after (D30) booster vaccination. Safety was assessed over the 30-day study period. Ninety-one participants received the booster dose. In both study groups, hSBA titers increased from D0 to D30; serogroup C titers [95% confidence interval] were higher in the MenACYW-TT-primed vs MCV4-TT-primed group at D0 (106 [73.2, 153] vs 11.7 [7.03, 19.4], respectively) and D30 (5894 [4325, 8031] vs 1592 [1165, 2174], respectively); rSBA results were similar. Nearly all participants achieved ≥1:8 hSBA and rSBA titers at D30, which were higher or comparable to those observed post-primary dose, suggesting rapid booster responses. At D0, all hSBA and rSBA titers were higher than those observed pre-primary dose, suggesting persistence of immunogenicity. The MenACYW-TT booster dose was well-tolerated and had similar safety outcomes across study groups. These findings suggest that MenACYW-TT elicits robust booster responses in children primed 3 years earlier with MenACYW-TT or MCV4-TT.
AB - Booster doses of meningococcal conjugate vaccines induce long-term protection against invasive meningococcal disease. We evaluated the immunogenicity and safety of a booster dose of MenACYW-TT in pre-school children who were primed 3 years earlier with MenACYW-TT or MCV4-TT (Nimenrix®). In this Phase III, open-label, multi-center study (NCT03476135), children (4–5 years old), who received a primary dose of MenACYW-TT or MCV4-TT as toddlers in a previous study, received a booster dose of MenACYW-TT. Titers of antibody against meningococcal serogroups A, C, W and Y were measured by serum bactericidal assay using human (hSBA) and baby rabbit (rSBA) complement in samples collected before (D0) and 30 days after (D30) booster vaccination. Safety was assessed over the 30-day study period. Ninety-one participants received the booster dose. In both study groups, hSBA titers increased from D0 to D30; serogroup C titers [95% confidence interval] were higher in the MenACYW-TT-primed vs MCV4-TT-primed group at D0 (106 [73.2, 153] vs 11.7 [7.03, 19.4], respectively) and D30 (5894 [4325, 8031] vs 1592 [1165, 2174], respectively); rSBA results were similar. Nearly all participants achieved ≥1:8 hSBA and rSBA titers at D30, which were higher or comparable to those observed post-primary dose, suggesting rapid booster responses. At D0, all hSBA and rSBA titers were higher than those observed pre-primary dose, suggesting persistence of immunogenicity. The MenACYW-TT booster dose was well-tolerated and had similar safety outcomes across study groups. These findings suggest that MenACYW-TT elicits robust booster responses in children primed 3 years earlier with MenACYW-TT or MCV4-TT.
KW - booster
KW - MenACYW-TT
KW - Meningococcal
KW - pre-school children
KW - quadrivalent meningococcal conjugate vaccine
U2 - 10.1080/21645515.2021.1902701
DO - 10.1080/21645515.2021.1902701
M3 - Article
AN - SCOPUS:85107490389
SN - 2164-5515
VL - 18
JO - HUMAN VACCINES & IMMUNOTHERAPEUTICS
JF - HUMAN VACCINES & IMMUNOTHERAPEUTICS
IS - 1
ER -
