DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old
Abstract 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 serie...
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| Format: | Article |
| Language: | English |
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BMC
2018-05-01
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| Series: | BMC Pediatrics |
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| Online Access: | http://link.springer.com/article/10.1186/s12887-018-1143-6 |
| _version_ | 1819043537458561024 |
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| author | Hartono Gunardi Kusnandi Rusmil Eddy Fadlyana Soedjatmiko Meita Dhamayanti Rini Sekartini Rodman Tarigan Hindra Irawan Satari Bernie Endyarni Medise Rini Mulia Sari Novilia Sjafri Bachtiar Cissy B. Kartasasmita Sri Rezeki S. Hadinegoro |
| author_facet | Hartono Gunardi Kusnandi Rusmil Eddy Fadlyana Soedjatmiko Meita Dhamayanti Rini Sekartini Rodman Tarigan Hindra Irawan Satari Bernie Endyarni Medise Rini Mulia Sari Novilia Sjafri Bachtiar Cissy B. Kartasasmita Sri Rezeki S. Hadinegoro |
| author_sort | Hartono Gunardi |
| collection | DOAJ |
| description | Abstract 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. Trial registration NCT02095314 (retrospectively registered, March 24, 2014). |
| first_indexed | 2024-12-21T09:58:22Z |
| format | Article |
| id | doaj.art-ee0bf177dfc64b4db09e272da42c096f |
| institution | Directory Open Access Journal |
| issn | 1471-2431 |
| language | English |
| last_indexed | 2024-12-21T09:58:22Z |
| publishDate | 2018-05-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pediatrics |
| spelling | doaj.art-ee0bf177dfc64b4db09e272da42c096f2022-12-21T19:08:01ZengBMCBMC Pediatrics1471-24312018-05-011811810.1186/s12887-018-1143-6DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months oldHartono Gunardi0Kusnandi Rusmil1Eddy Fadlyana2Soedjatmiko3Meita Dhamayanti4Rini Sekartini5Rodman Tarigan6Hindra Irawan Satari7Bernie Endyarni Medise8Rini Mulia Sari9Novilia Sjafri Bachtiar10Cissy B. Kartasasmita11Sri Rezeki S. Hadinegoro12Department of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalDepartment of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin HospitalDepartment of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin HospitalDepartment of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalDepartment of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin HospitalDepartment of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalDepartment of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin HospitalDepartment of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalDepartment of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalPT Bio FarmaPT Bio FarmaDepartment of Child Health, Faculty of Medicine, Padjadjaran University/Dr. Hasan Sadikin HospitalDepartment of Child Health, Faculty of Medicine, Universitas Indonesia/Dr. Cipto Mangunkusumo HospitalAbstract 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. Trial registration NCT02095314 (retrospectively registered, March 24, 2014).http://link.springer.com/article/10.1186/s12887-018-1143-6Booster doseDTwP-HB-Hib vaccineImmunogenicitySafetyChildren |
| spellingShingle | Hartono Gunardi Kusnandi Rusmil Eddy Fadlyana Soedjatmiko Meita Dhamayanti Rini Sekartini Rodman Tarigan Hindra Irawan Satari Bernie Endyarni Medise Rini Mulia Sari Novilia Sjafri Bachtiar Cissy B. Kartasasmita Sri Rezeki S. Hadinegoro DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old BMC Pediatrics Booster dose DTwP-HB-Hib vaccine Immunogenicity Safety Children |
| title | DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old |
| title_full | DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old |
| title_fullStr | DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old |
| title_full_unstemmed | DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old |
| title_short | DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18–24 months old |
| title_sort | dtwp hb hib antibody persistence after a primary series immune response and safety after a booster dose in children 18 24 months old |
| topic | Booster dose DTwP-HB-Hib vaccine Immunogenicity Safety Children |
| url | http://link.springer.com/article/10.1186/s12887-018-1143-6 |
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