PMID- 29804542
OWN - NLM
STAT- MEDLINE
DCOM- 20190318
LR  - 20190318
IS  - 1471-2431 (Electronic)
IS  - 1471-2431 (Linking)
VI  - 18
IP  - 1
DP  - 2018 May 28
TI  - DTwP-HB-Hib: antibody persistence after a primary series, immune response and 
      safety after a booster dose in children 18-24 months old.
PG  - 177
LID - 10.1186/s12887-018-1143-6 [doi]
LID - 177
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(R)) 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. TRIAL REGISTRATION: NCT02095314 
      (retrospectively registered, March 24, 2014).
FAU - Gunardi, Hartono
AU  - Gunardi H
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia. 
      hartono@ikafkui.net.
FAU - Rusmil, Kusnandi
AU  - Rusmil K
AD  - Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan 
      Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
FAU - Fadlyana, Eddy
AU  - Fadlyana E
AD  - Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan 
      Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
FAU - Soedjatmiko
AU  - Soedjatmiko
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
FAU - Dhamayanti, Meita
AU  - Dhamayanti M
AD  - Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan 
      Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
FAU - Sekartini, Rini
AU  - Sekartini R
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
FAU - Tarigan, Rodman
AU  - Tarigan R
AD  - Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan 
      Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
FAU - Satari, Hindra Irawan
AU  - Satari HI
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
FAU - Medise, Bernie Endyarni
AU  - Medise BE
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
FAU - Sari, Rini Mulia
AU  - Sari RM
AD  - PT Bio Farma, Jl. Pasteur No 28, Bandung, Jawa Barat, Indonesia.
FAU - Bachtiar, Novilia Sjafri
AU  - Bachtiar NS
AD  - PT Bio Farma, Jl. Pasteur No 28, Bandung, Jawa Barat, Indonesia.
FAU - Kartasasmita, Cissy B
AU  - Kartasasmita CB
AD  - Department of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan 
      Sadikin Hospital, Jl. Pasteur No 38, Bandung, 40161, Indonesia.
FAU - Hadinegoro, Sri Rezeki S
AU  - Hadinegoro SRS
AD  - Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto 
      Mangunkusumo Hospital, Jl. Diponegoro No 71, Jakarta, 10430, Indonesia.
LA  - eng
SI  - ClinicalTrials.gov/NCT02095314
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20180528
PL  - England
TA  - BMC Pediatr
JT  - BMC pediatrics
JID - 100967804
RN  - 0 (Diphtheria-Tetanus-Pertussis Vaccine)
RN  - 0 (DtwP-HepB-Hib vaccine)
RN  - 0 (Haemophilus Vaccines)
RN  - 0 (Hepatitis B Vaccines)
SB  - IM
MH  - Antibody Formation/*immunology
MH  - Child
MH  - Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage/adverse 
      effects/*immunology
MH  - Edema/etiology
MH  - Female
MH  - Fever/etiology
MH  - Follow-Up Studies
MH  - Haemophilus Vaccines/administration & dosage/adverse effects/*immunology
MH  - Hepatitis B Vaccines/administration & dosage/adverse effects/*immunology
MH  - Humans
MH  - *Immunization, Secondary/adverse effects
MH  - Infant
MH  - Male
MH  - Prospective Studies
MH  - *Vaccination/adverse effects
PMC - PMC5971417
OTO - NOTNLM
OT  - Booster dose
OT  - Children
OT  - DTwP-HB-Hib vaccine
OT  - Immunogenicity
OT  - Safety
COIS- ETHICS APPROVAL AND CONSENT TO PARTICIPATE: This trial has been approved by 
      Health Research Ethics Committee Faculty of Medicine Universitas Padjajaran 
      Bandung (418/UN6.C2.1.2/KEPK/PPN/2013) and The Ethics Committee of the Faculty of 
      Medicine, University of Indonesia (735/H2.F1/ETIK/2013). A written form of 
      informed consent was obtained from every child's parent or legal guardian before 
      the recruitment. COMPETING INTERESTS: Hartono Gunardi, Kusnandi Rusmil, Eddy 
      Fadlyana, Soedjatmiko, Meita Dhamayanti, Rini Sekartini, Rodman Tarigan, Hindra 
      Irawan Satari, Bernie Endyarni Medise, Cissy B Kartasasmita, Sri Rezeki S 
      Hadinegoro, received grant support through their institutions. Rini Mulia Sari 
      and Novilia Sjafri Bachtiar were employees of PT Bio Farma at the time of the 
      conduct of this study and manuscript preparation. PUBLISHER'S NOTE: Springer 
      Nature remains neutral with regard to jurisdictional claims in published maps and 
      institutional affiliations.
EDAT- 2018/05/29 06:00
MHDA- 2019/03/19 06:00
PMCR- 2018/05/28
CRDT- 2018/05/29 06:00
PHST- 2017/07/11 00:00 [received]
PHST- 2018/05/03 00:00 [accepted]
PHST- 2018/05/29 06:00 [entrez]
PHST- 2018/05/29 06:00 [pubmed]
PHST- 2019/03/19 06:00 [medline]
PHST- 2018/05/28 00:00 [pmc-release]
AID - 10.1186/s12887-018-1143-6 [pii]
AID - 1143 [pii]
AID - 10.1186/s12887-018-1143-6 [doi]
PST - epublish
SO  - BMC Pediatr. 2018 May 28;18(1):177. doi: 10.1186/s12887-018-1143-6.