Antibody persistence up to 5 y after vaccination with a quadrivalent meningococcal ACWY-tetanus toxoid conjugate vaccine in adolescents.
Long-term protection against meningococcal disease relies on antibody persistence after vaccination. We report antibody persistence up to 5 y after vaccination in adolescents who received a single dose of either meningococcal serogroups A, C, W, Y tetanus toxoid conjugate vaccine (MenACWY-TT, Pfizer) or MenACWY polysaccharide vaccine (MenPS, GSK Vaccines) at the age of 11-17 y in the randomized controlled primary study NCT00464815. In this phase III, open, controlled, multi-center persistence follow-up study conducted in India and the Philippines (NCT00974363), antibody persistence was evaluated by a serum bactericidal antibody assay using rabbit complement (rSBA) yearly, up to year 5 after vaccination. Serious adverse events (SAEs) related to study participation were recorded. Five years after a single dose of MenACWY-TT, the percentage of participants (N = 236) with rSBA titers ≥1:8 was 97.5% for serogroup A, 88.6% for serogroup C, 86.0% for serogroup W and 96.6% for serogroup Y. The percentages in the MenPS group (N = 86) were 93.0%, 87.1%, 34.9% and 66.3%, respectively. Exploratory analysis indicated a higher percentage of subjects with rSBA titers ≥1:8 for serogroups W and Y, and higher rSBA geometric mean antibody titers for serogroups A, W and Y in the MenACWY-TT group than the MenPS group at each time point (years 3, 4 and 5). No differences between groups were observed for serogroup C. No SAEs related to study participation were reported. In conclusion, the results of this follow-up study indicate that antibodies persisted up to 5 y after a single dose of MenACWY-TT in adolescents.
a Clinical Research Division , Research Institute for Tropical Medicine , Alabang, Muntinlupa City , Philippines.
Beatriz P
BP
Quiambao
b K.E.M Hospital, Sardar Moodliar Road , Pune , Maharashtra , India.
Ashish
A
Bavdekar
c Department of Pediatrics , Maulana Azad Medical College (MAMC), and Associated Lok Nayak Hospital , New Delhi , India.
Anand Prakash
AP
Dubey
d Chacha Nehru Hospital , Indore , India.
Hemant
H
Jain
e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
Devayani
D
Kolhe
e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
Véronique
V
Bianco
e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
Jacqueline M
JM
Miller
e GSK Vaccines, Bangalore, India; Wavre, Belgium; and King of Prussia , PA , USA.
Marie
M
Van der Wielen
D000293:Adolescent; D000818:Animals; D000907:Antibodies, Bacterial / Q000097:blood*; D001770:Blood Bactericidal Activity; D002648:Child; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007194:India; D008297:Male; D022401:Meningococcal Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D010679:Philippines; D011817:Rabbits; D013997:Time Factors; D055815:Young Adult
D000907:Antibodies, Bacterial; D022401:Meningococcal Vaccines
Neisseria meningitidis; adolescents; antibody persistence; conjugate vaccine; quadrivalent meningococcal vaccine