Human Vaccines & Immunotherapeutics (Jun 2018)

Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial

  • Innocent Valéa,
  • Samuel Adjei,
  • Effua Usuf,
  • Ousmane Traore,
  • Daniel Ansong,
  • Halidou Tinto,
  • Harry Owusu Boateng,
  • Amanda Leach,
  • Athanase Mwinessobaonfou Some,
  • Patrick Buabeng,
  • Johan Vekemans,
  • Louis Arnaud Nana,
  • Amos Kotey,
  • Pascale Vandoolaeghe,
  • Florence Ouedraogo,
  • David Sambian,
  • Marc Lievens,
  • Marc Christian Tahita,
  • Theresa Rettig,
  • Erik Jongert,
  • Palpouguini Lompo,
  • Ali Idriss,
  • Dorota Borys,
  • Sayouba Ouedraogo,
  • Frank Prempeh,
  • Md Ahsan Habib,
  • Lode Schuerman,
  • Hermann Sorgho,
  • Tsiri Agbenyega

DOI
https://doi.org/10.1080/21645515.2018.1442996
Journal volume & issue
Vol. 14, no. 6
pp. 1489 – 1500

Abstract

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The RTS,S/AS01 malaria vaccine (Mosquirix) reduces the incidence of Plasmodium falciparum malaria and is intended for routine administration to infants in Sub-Saharan Africa. We evaluated the immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix) and human rotavirus vaccine (HRV; Rotarix) when co-administered with RTS,S/AS01 (www.clinicaltrials.gov NCT01345240) in African infants. 705 healthy infants aged 8–12 weeks were randomized to receive three doses of either RTS,S/AS01 or licensed hepatitis B (HBV; Engerix B) vaccine (control) co-administered with diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type-b-conjugate vaccine (DTaP/Hib) and trivalent oral poliovirus vaccine at 8–12-16 weeks of age, because DTaP/Hib was not indicated before 8 weeks of age. The vaccination schedule can still be considered broadly applicable because it was within the age range recommended for EPI vaccination. PHiD-CV or HRV were either administered together with the study vaccines, or after a 2-week interval. Booster doses of PHiD-CV and DTaP/Hib were administered at age 18 months. Non-inferiority of anti-HBV surface antigen antibody seroprotection rates following co-administration with RTS,S/AS01 was demonstrated compared to the control group (primary objective). Pre-specified non-inferiority criteria were reached for PHiD-CV (for 9/10 vaccine serotypes), HRV, and aP antigens co-administered with RTS,S/AS01 as compared to HBV co-administration (secondary objectives). RTS,S/AS01 induced a response to circumsporozoite protein in all groups. Pain and low grade fever were reported more frequently in the PHiD-CV group co-administered with RTS,S/AS01 than PHiD-CV co-administered with HBV. No serious adverse events were considered to be vaccine-related. RTS,S/AS01 co-administered with pediatric vaccines had an acceptable safety profile. Immune responses to RTS,S/AS01 and to co-administered PHiD-CV, pertussis antigens and HRV were satisfactory.

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