Long-term immunogenicity and immune memory response to the hepatitis B antigen in the RTS,S/AS01Emalaria vaccine in African children: a randomized trial

Autor: Valéa, Innocent, Adjei, Samuel, Usuf, Effua, Traore, Ousmane, Ansong, Daniel, Tinto, Halidou, Owusu Boateng, Harry, Some, Athanase Mwinessobaonfou, Buabeng, Patrick, Vekemans, Johan, Kotey, Amos, Vandoolaeghe, Pascale, Cullinane, Mark, Traskine, Magali, Ouedraogo, Florence, Sambian, David, Lievens, Marc, Tahita, Marc Christian, Jongert, Erik, Lompo, Palpouguini, Idriss, Ali, Borys, Dorota, Ouedraogo, Sayouba, Prempeh, Frank, Schuerman, Lode, Sorgho, Hermann, Agbenyega, Tsiri
Zdroj: Human Vaccines & Immunotherapeutics; June 2020, Vol. 16 Issue: 6 p1464-1470, 7p
Abstrakt: ABSTRACTRTS,S/AS01Emalaria 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/AS01Ewhen implemented in the Expanded Program of Immunization, infants 8–12 weeks old were randomized to receive either RTS,S/AS01Eor a licensed hepatitis B control vaccine (HepB), both co-administered with various combinations of the following childhood vaccines: diphtheria-tetanus-acellular pertussis-Haemophilus influenzaetype b, trivalent oral poliovirus, pneumococcal non-typeable Haemophilus influenzaeprotein 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/AS01Evaccine 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.
Databáze: Supplemental Index