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

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...

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Autores principales: Diallo, Aldiouma, Sow, Samba O., Idoko, Olubukola T., Hirve, Siddhivinayak, Findlow, Helen, Preziosi, Marie-Pierre, Elie, Cheryl, Kulkarni, Prasad S., Parulekar, Varsha, Diarra, Bou, Cheick Haidara, Fadima, 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
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639491/
https://www.ncbi.nlm.nih.gov/pubmed/26553684
http://dx.doi.org/10.1093/cid/civ518
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author Diallo, Aldiouma
Sow, Samba O.
Idoko, Olubukola T.
Hirve, Siddhivinayak
Findlow, Helen
Preziosi, Marie-Pierre
Elie, Cheryl
Kulkarni, Prasad S.
Parulekar, Varsha
Diarra, Bou
Cheick Haidara, Fadima
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
author_facet Diallo, Aldiouma
Sow, Samba O.
Idoko, Olubukola T.
Hirve, Siddhivinayak
Findlow, Helen
Preziosi, Marie-Pierre
Elie, Cheryl
Kulkarni, Prasad S.
Parulekar, Varsha
Diarra, Bou
Cheick Haidara, Fadima
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
author_sort Diallo, Aldiouma
collection PubMed
description 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).
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spelling pubmed-46394912015-11-12 Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years Diallo, Aldiouma Sow, Samba O. Idoko, Olubukola T. Hirve, Siddhivinayak Findlow, Helen Preziosi, Marie-Pierre Elie, Cheryl Kulkarni, Prasad S. Parulekar, Varsha Diarra, Bou Cheick Haidara, Fadima 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 Clin Infect Dis The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa 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). Oxford University Press 2015-11-15 2015-11-09 /pmc/articles/PMC4639491/ /pubmed/26553684 http://dx.doi.org/10.1093/cid/civ518 Text en © The Author 2015. Published by Oxford University Press on behalf of the Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa
Diallo, Aldiouma
Sow, Samba O.
Idoko, Olubukola T.
Hirve, Siddhivinayak
Findlow, Helen
Preziosi, Marie-Pierre
Elie, Cheryl
Kulkarni, Prasad S.
Parulekar, Varsha
Diarra, Bou
Cheick Haidara, Fadima
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
Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title_full Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title_fullStr Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title_full_unstemmed Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title_short Antibody Persistence at 1 and 4 Years Following a Single Dose of MenAfriVac or Quadrivalent Polysaccharide Vaccine in Healthy Subjects Aged 2–29 Years
title_sort antibody persistence at 1 and 4 years following a single dose of menafrivac or quadrivalent polysaccharide vaccine in healthy subjects aged 2–29 years
topic The Meningitis Vaccine Project: The Development, Licensure, Introduction, and Impact of a New Group a Meningococcal Conjugate Vaccine for Africa
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4639491/
https://www.ncbi.nlm.nih.gov/pubmed/26553684
http://dx.doi.org/10.1093/cid/civ518
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