The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

Rusmil, Kusnandi; Gunardi, Hartono; Fadlyana, Eddy; Soedjatmiko,; Dhamayanti, Meita; Sekartini, Rini; Satari, Hindra Irawan; Risan, Nelly Amalia; Prasetio, Dwi; Tarigan, Rodman; Garheni, Reni; Milanti, Mia; Hadinegoro, Sri Rezeki; Tanuwidjaja, Suganda; Bachtıar, Novilia Sjafri; Sari, Rini Mulia

doi:10.1186/s12887-015-0525-2

Cited by 18 publications

(30 citation statements)

References 19 publications

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“…Ketiga fase menunjukkan bahwa vaksin ini aman dan imunogenik untuk diberikan pada bayi sebagai dosis primer. [6][7][8] Pembuatan vaksin kombinasi ini sangat membantu, karena bila vaksin Hib diberikan secara terpisah dengan DTwP/HB, berarti akan terjadi pemberian dua suntikan sekaligus akan tidak nyaman pada bayi serta biaya yang diperlukan menjadilebih mahal. Reaksi lokal dan sistemik dicatat pada kartu harian pada 30 menit, 72 jam, hingga 28 hari setelah imunisasi.…”

Section: Pendahuluanunclassified

Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia

Sundoro¹,

Rusmil²,

Sitaresmi³

et al. 2017

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Section: Pendahuluanunclassified

Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia

Sundoro¹,

Rusmil²,

Sitaresmi³

et al. 2017

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“…Thus, poor vaccine immunogenicity and effectiveness have been observed for both killed-and live-oral vaccines targeting bacterial and viral pathogens. The same does not appear to be true of parenterally administered vaccines [19,20].In addition to geographic variation, oral vaccine immunogenicity can vary by season and age at administration. OPV is less immunogenic when given during warm, humid months [21,22], while Rotarix was shown to have lower immunogenicity during the cool, dry season in Zambia [23].…”

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confidence: 99%

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

et al. 2017

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Oral vaccines are less immunogenic when given to infants in low-income compared with high-income countries, limiting their potential public health impact. Here, we review factors that might contribute to this phenomenon, including transplacental antibodies, breastfeeding, histo blood group antigens, enteric pathogens, malnutrition, microbiota dysbiosis and environmental enteropathy. We highlight several clear risk factors for vaccine failure, such as the inhibitory effect of enteroviruses on oral poliovirus vaccine. We also highlight the ambiguous and at times contradictory nature of the available evidence, which undoubtedly reflects the complex and interconnected nature of the factors involved. Mechanisms responsible for diminished immunogenicity may be specific to each oral vaccine. Interventions aiming to improve vaccine performance may need to reflect the diversity of these mechanisms. Enteric pathogens are a substantial threat to public health. This threat takes many forms, from the toxin-producing bacteria (e.g., Vibrio cholerae) and flagellated protozoa (e.g., Giardia lamblia) that colonize the mucosal surface of the small intestine to the enteroviruses that are capable of spreading via the bloodstream to the CNS, causing acute flaccid paralysis (e.g., poliovirus). Each year, enteric pathogens cause hundreds of millions of cases of diarrhea and approximately 800,000 deaths, the vast majority of which occur among children in low-income countries [1]. The most common causes of childhood diarrheal morbidity include rotavirus, Cryptosporidium, enterotoxigenic Escherichia coli and Shigella [2].Vaccines against enteric pathogens are important tools for mitigating this disease burden. Oral vaccines offer several distinct benefits compared with parenteral vaccines. They can be produced in large quantities at relatively low cost, are easy to administer and have the capacity to induce local immunity in the intestinal mucosa, thereby protecting vaccinated individuals against subsequent infection and -by blocking onward transmission -enhancing herd immunity [3,4]. Currently licensed oral vaccines include live-attenuated poliovirus vaccines containing one, two or three serotypes, live-attenuated rotavirus vaccines (Rotarix R , RotaTeq R , Lanzhou lamb rotavirus vaccine [China only] and Rotavac R [India only]), live-attenuated cholera vaccine (CVD 103-HgR or Vaxchora TM ), inactivated cholera vaccines (Dukoral R and Shanchol R ) and live-attenuated typhoid vaccine (Ty21a). Other oral vaccines are in development, including those against Shigella, enterotoxigenic E. coli, Campylobacter and Clostridium difficile, as well as several novel rotavirus vaccine candidates (including the human neonatal vaccine RV3-BB [5] and an oral bovine pentavalent vaccine [6]).Yet oral vaccines have an Achilles' heel -their immunogenicity and efficacy is impaired in low-income countries that experience the greatest burden of enteric disease (Box 1). For example, Rotarix has a 1-year protective efficacy against severe rotavirus-associated gas...

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“…Meskipun berdasarkan literatur didapatkan efek simpang DTwP lebih besar dari DTaP, tetapi pada penelitian yang dilakukan di Jakarta dan Bandung pada 600 bayi usia 6-11 minggu didapatkan hasil yang cukup aman dan tidak ditemukan KIPI serius seperti ensefalopati, kejadian hipotonik/hiporesponsif maupun kejang. 16 KIPI yang terbanyak adalah bengkak ringan (25%) yang akan sembuh tanpa pengobatan dan demam ringan (20%). Dengan pemberian DTwP risiko infeksi pertusis menjadi lebih rendah dan jangka waktu perlindungan lebih lama dibandingkan dengan pemberian DTaP.…”

Section: Pembahasaanunclassified

Perbandingan Efektivitas dan Keamanan Vaksin Pertusis Aselular dan Whole-cell

Tjahjowargo

Gunardi

2017

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Latar belakang. Imunisasi merupakan upaya pencegahan terbaik terhadap berbagai penyakit infeksi. Vaksin difteri, tetanus, pertusis whole-cell (DTwP) dapat menimbulkan kejadian ikutan pasca imunisasi (KIPI) yang mengkhawatirkan orangtua. Vaksin difteri, tetanus, pertusis aselular (DTaP) memiliki KIPI lebih ringan, tetapi diduga kurang efektif. Tujuan. Mengetahui efektivitas vaksin DTaP dibandingkan dengan vaksin DTwP. Metode. Penelusuran literatur elektronik PubMed dan Cochrane dengan kata kunci "DTaP/acellular pertussis", "DTwP/whole-cell pertussis", "children", "pertussis", "vaccine" and "safety/efficacy/effectiveness" dalam 10 tahun terakhir (2006 -2016). Hasil. Terdapat dua studi meta-analisis yang membandingkan efektivitas pemberian imunisasi DTwP dan DTaP serta satu studi kasus terkontrol yang membandingkan efek perlindungan jangka panjang pemberian imunisasi DTaP dengan DTwP. Efektivitas vaksin pertusis aselular berkisar 74% (IK95%, 51-86%) -97% (IK95%, 91-99%). Efektivitas vaksin pertusis whole-cell sebesar 94% (IK95%, 88-97%; p<0,0001). Estimasi effect size vaksin pertusis aseluer untuk melindungi terhadap penyakit pertusis sesuai kriteria WHO adalah sebesar 84% (IK95%, 81-87%); sedangkan untuk vaksin pertusis whole cell adalah 94% (IK95%, 88-97% Evidence base case report Comparison of Effectiveness and Safety between Acellular Pertussis and Whole-cell Pertussis VaccineSendy Tjahjowargo, Hartono Gunardi Background. Immunization is the best way to prevent various vaccine-preventable diseases. Diphtheria, tetanus and pertussis wholecell vaccine (DTwP) may cause serious adverse events following immunization. Diphtheria, tetanus and acellular pertussis vaccine has milder adverse effect but presumed to be less effective. Objective. To compare effectiveness of DTwP and DTaP vaccine. Method. Literature search using PubMed and Cochrane electronic database with keywords "DTaP/acellular pertussis", "DTwP/ whole-cell pertussis", "children", "pertussis", "vaccine" and "safety/efficacy/effectiveness" in the last 10 years (2006 -2016).Result. There were two meta-analysis comparing DTwP and DTaP vaccine effectiveness and one case-control study comparing the longterm protection after DTwP and DTaP vaccine. Acellular pertussis vaccine was 74 % (95% CI, 51-86%) -97% (95% CI, 91-99%) effectiveness (95% CI, 91-99%) and whole-cell pertussis vaccine was 94% effectiveness (95% CI, 88-97%). Effect size estimation of acellular pertussis vaccine to protect against pertussis disease according to WHO definition, was 84% (95% CI, 81-87%); for whole cell pertussis vaccine, the effect size was 94% (95% CI, 88-97%). DTaP had milder and less frequent adverse events than DTwP. Conclusion. DTaP and DTwP vaccine has comparable effectiveness. DTwP vaccine has better effect size for pertussis protection and long-term protection compared to DTaP vaccine. Vaccine DTaP has milder and less frequent adverse events. Sari Pediatri 2017;18(5):403-8

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The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule

Cited by 18 publications

References 19 publications

Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia

Profil Keamanan setelah Pemberian Dosis Primer Vaksin Pentabio® pada Bayi di Indonesia

Causes of Impaired Oral Vaccine Efficacy in Developing Countries

Perbandingan Efektivitas dan Keamanan Vaksin Pertusis Aselular dan Whole-cell

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