Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years

• Published in: Clinical infectious diseases Vol. 61; no. suppl_5; pp. S521 - S530
• Main Authors: Diallo, Aldiouma, Sow, Samba O., Idoko, Olubukola T., Hirve, Siddhivinayak, Findlow, Helen, Preziosi, Marie-Pierre, Elie, Cheryl, Kulkarni, Prasad S., Parulekar, Varsha, Diarra, Bou, Haidara, Fadima Cheick, Diallo, Fatoumata, Tapia, Milagritos, Akinsola, Adebayo K., Adegbola, Richard A., Bavdekar, Ashish, Juvekar, Sanjay, Chaumont, Julie, Martellet, Lionel, Marchetti, Elisa, LaForce, Marc F., Plikaytis, Brian D., Enwere, Godwin C., Tang, Yuxiao, Borrow, Ray, Carlone, George, Viviani, Simonetta
• Format: Journal Article
• Language: English
• Published: United States Oxford University Press 15.11.2015
• Subjects: Adolescent; Adult; Africa; Animals; Antibodies, Bacterial - blood; Blood Bactericidal Activity; Child; Child, Preschool; Complement System Proteins; Drug dosages; Enzyme-Linked Immunosorbent Assay; Female; Follow-Up Studies; Healthy Volunteers; Humans; Immunization; Immunoglobulins; India; Male; Meningococcal Vaccines - administration & dosage; Meningococcal Vaccines - immunology; Rabbits; Safety; SEROLOGIC AND SAFETY STUDIES OF A GROUP A MENINGOCOCCAL CONJUGATE VACCINE; The Meningitis Vaccine Project: The Development, Licensure, , and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa; Time Factors; Vaccines; Young Adult; Africa; India; African meningitis belt; MenA conjugate vaccine; antibody persistence; India
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1093/cid/civ518

Background. Mass vaccination campaigns of the population aged 1–29 years with 1 dose of group A meningococcal (MenA) conjugate vaccine (PsA-TT, MenAfriVac) in African meningitis belt countries has resulted in the near-disappearance of MenA. The vaccine was tested in clinical trials in Africa and in India and found to be safe and highly immunogenic compared with the group A component of the licensed quadrivalent polysaccharide vaccine (PsACWY). Antibody persistence in Africa and in India was investigated. Methods. A total of 900 subjects aged 2–29 years were followed up for 4 years in Senegal, Mali, and The Gambia (study A). A total of 340 subjects aged 2–10 years were followed up for 1 year in India (study B). In study A, subjects were randomized in a 2:1 ratio, and in study B a 1:1 ratio to receive either PsA-TT or PsACWY. Immunogenicity was evaluated by measuring MenA serum bactericidal antibody (SBA) with rabbit complement and by a group A–specific immunoglobulin G (IgG) enzyme-linked immunosorbent assay. Results. In both studies, substantial SBA decay was observed at 6 months postvaccination in both vaccine groups, although more marked in the PsACWY group. At 1 year and 4 years (only for study A) postvaccination, SBA titers were relatively sustained in the PsA-TT group, whereas a slight increasing trend, more pronounced among the youngest, was observed in the participants aged <18 years in the PsACWY groups. The SBA titers were significantly higher in the PsA-TT group than in the PsACWY group at any time point, and the majority of subjects in the PsA-TT group had SBA titers ≥128 and group A–specific IgG concentrations ≥2 μg/mL at any point in time in both the African and Indian study populations. Conclusions. Four years after vaccination with a single dose of PsA-TT vaccine in Africa, most subjects are considered protected from MenA disease. Clinical Trials Registration. PsA-TT-003 (ISRCTN87739946); PsA-TT-003a (ISRCTN46335400).