Human Vaccines & Immunotherapeutics (Jun 2020)

Long-term immunogenicity and immune memory response to the hepatitis B antigen in the RTS,S/AS01E malaria vaccine in African children: a randomized trial

  • Innocent Valéa,
  • Samuel Adjei,
  • Effua Usuf,
  • Ousmane Traore,
  • Daniel Ansong,
  • Halidou Tinto,
  • Harry Owusu Boateng,
  • Athanase Mwinessobaonfou Some,
  • Patrick Buabeng,
  • Johan Vekemans,
  • Amos Kotey,
  • Pascale Vandoolaeghe,
  • Mark Cullinane,
  • Magali Traskine,
  • Florence Ouedraogo,
  • David Sambian,
  • Marc Lievens,
  • Marc Christian Tahita,
  • Erik Jongert,
  • Palpouguini Lompo,
  • Ali Idriss,
  • Dorota Borys,
  • Sayouba Ouedraogo,
  • Frank Prempeh,
  • Lode Schuerman,
  • Hermann Sorgho,
  • Tsiri Agbenyega

DOI
https://doi.org/10.1080/21645515.2019.1695457
Journal volume & issue
Vol. 16, no. 6
pp. 1464 – 1470

Abstract

Read online

RTS,S/AS01E malaria vaccine contains the hepatitis B virus surface antigen and may thus serve as a potential hepatitis B vaccine. To evaluate the impact of RTS,S/AS01E when implemented in the Expanded Program of Immunization, infants 8–12 weeks old were randomized to receive either RTS,S/AS01E or a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type b, trivalent oral poliovirus, pneumococcal non-typeable Haemophilus influenzae protein D conjugate and human rotavirus vaccine. Long-term persistence of antibodies against the circumsporozoite (CS) protein and hepatitis B surface antigen (HBsAg) were assessed, together with the immune memory response to the HB antigen following a booster dose of HepB vaccine. Subgroups receiving RTS,S or the HepB control vaccine were pooled into RTS,S groups and HepB groups, respectively. One month post-HepB booster vaccination, 100% of participants in the RTS,S groups and 98.3% in the control groups had anti-HBs antibody concentrations ≥10 mIU/mL with the geometric mean concentrations (GMCs) at 46634.7 mIU/mL (95% CI: 40561.3; 53617.6) and 9258.2 mIU/mL (95% CI: 6925.3; 12377.0), respectively. Forty-eight months post-primary vaccination anti-CS antibody GMCs ranged from 2.3 EU/mL to 2.7 EU/mL in the RTS,S groups compared to 1.1 EU/mL in the control groups. Hepatitis B priming with the RTS,S/AS01E vaccine was effective and resulted in a memory response to HBsAg as shown by the robust booster response following an additional dose of HepB vaccine. RTS,S/AS01E when co-administered with PHiD-CV, HRV and other childhood vaccines, had an acceptable safety profile.

Keywords