TY - JOUR
T1 - DTwP-HB-Hib
T2 - Antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old
AU - Gunardi, Hartono
AU - Rusmil, Kusnandi
AU - Fadlyana, Eddy
AU - Dhamayanti, Meita
AU - Sekartini, Rini
AU - Tarigan, Rodman
AU - Satari, Hindra Irawan
AU - Medise, Bernie Endyarni
AU - Sari, Rini Mulia
AU - Bachtiar, Novilia Sjafri
AU - Kartasasmita, Cissy B.
AU - Hadinegoro, Sri Rezeki S.
N1 - Publisher Copyright:
© 2018 The Author(s).
PY - 2018/5/28
Y1 - 2018/5/28
N2 - Background: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. Methods: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. Results: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P<0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. Conclusions: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination.
AB - Background: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. Methods: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. Results: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P<0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. Conclusions: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination.
KW - Booster dose
KW - Children
KW - DTwP-HB-Hib vaccine
KW - Immunogenicity
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=85047512227&partnerID=8YFLogxK
U2 - 10.1186/s12887-018-1143-6
DO - 10.1186/s12887-018-1143-6
M3 - Article
C2 - 29804542
AN - SCOPUS:85047512227
SN - 1471-2431
VL - 18
JO - BMC Pediatrics
JF - BMC Pediatrics
IS - 1
M1 - 177
ER -