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

ABSTRACT: WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine.A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose.Of 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ?0.15 and ?1.0 ?g/ml. Anti-diphtheria and anti-tetanus concentration ?0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ?0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure.The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles.NCT01986335 - October 30(th) 2013.

SUBMITTER: Rusmil K

PROVIDER: S-EPMC4684926 | biostudies-literature | 2015 Dec

REPOSITORIES: biostudies-literature

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

Rusmil Kusnandi K Gunardi Hartono H Fadlyana Eddy E Soedjatmiko Dhamayanti Meita M Sekartini Rini R Satari Hindra Irawan HI Risan Nelly Amalia NA Prasetio Dwi D Tarigan Rodman R Garheni Reni R Milanti Mia M Hadinegoro Sri Rezeki SR Tanuwidjaja Suganda S Bachtiar Novilia Sjafri NS Sari Rini Mulia RM

BMC pediatrics 20151219

<h4>Background</h4>WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine.<h4>Methods</h4>A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakart ...[more]

PMID: 26686508

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Project description:BackgroundCombination vaccines improve coverage, compliance and effectively introduce new antigens to mass vaccination programmes. This was a phase III, observer-blind, randomized study of GSK Biologicals diphtheria-tetanus-whole cell pertussis vaccine combined with hepatitis B and Haemophilus influenzae type b vaccines, containing a reduced amount of polyribosyl-ribitol-phosphate (PRP) and a DTPw component manufactured at a different site (DTPw-HBV/Hib2.5 [Kft]). The primary aim of this study was to demonstrate that DTPw-HBV/Hib2.5 [Kft] was not inferior to the licensed DTPw-HBV/Hib (Tritanrix(tm)-HepB/Hiberix(tm)) vaccine or the DTPw-HBV/Hib2.5 vaccine, also containing a reduced amount of PRP, with respect to the immune response to the PRP antigen, when administered to healthy infants, according to the Expanded Programme for Immunization (EPI) schedule at 6, 10 and 14 weeks of age.Methods299 healthy infants were randomised to receive either DTPw-HBV/Hib2.5 [Kft] DTPw-HBV/Hib2.5 or DTPw-HBV/Hib according to the 6-10-14 week EPI schedule. Blood samples were analysed prior to the first dose of study vaccine and one month after the third vaccine dose for the analysis of immune responses. Solicited local and general symptoms such as pain, redness and swelling at the injection site and drowsiness and fever, unsolicited symptoms (defined as any additional adverse event) and serious adverse events (SAEs) were recorded up to 20 weeks of age.ResultsOne month after the third vaccine dose, 100% of subjects receiving DTPw-HBV/Hib2.5 [Kft] or DTPw-HBV/Hib and 98.8% of subjects receiving DTPw-HBV/Hib2.5 vaccine had seroprotective levels of anti-PRP antibodies (defined as anti-PRP antibody concentration ≥0.15 μg/ml). Seroprotective antibody concentrations were attained in over 98.9% of subjects for diphtheria, tetanus and hepatitis B. The vaccine response rate to pertussis antigen was at least 97.8% in each group. Overall, the DTPw-HBV/Hib2.5 [Kft] vaccine was well tolerated in healthy infants; no SAEs were reported in any group.ConclusionsThe DTPw-HBV/Hib2.5 [Kft] vaccine was immunogenic and well-tolerated when administered according to the EPI schedule to Indian infants.Trial registrationhttp://www.clinicaltrials.gov NCT00473668.

Project description:BackgroundIn 1986, the Government of Mali launched its Expanded Program on Immunization (EPI) with the goal of vaccinating, within five years, 80% of all children under the age of five against six target diseases: diphtheria, tetanus, pertussis, poliomyelitis, tuberculosis, and measles. The Demographic and Health Survey carried out in 2001 revealed that, in Kita Circle, in the Kayes region, only 13% of children aged 12 to 23 months had received all the EPI vaccinations. A priority program was implemented in 2003 by the Regional Health Department in Kayes to improve EPI immunization coverage in this area.MethodsA cross-sectional survey using Henderson's method (following the method used by the Demographic and Health Surveys) was carried out in July 2006 to determine the level of vaccination coverage among children aged 12 to 23 months in Kita Circle, after implementation of the priority program. Both vaccination cards and mothers' declarations (in cases where the mother cannot make the declaration, it is made by the person responsible for the child) were used to determine coverage.ResultsAccording to the vaccination cards, 59.9% [CI 95% (54.7-64.8)] of the children were fully vaccinated, while according to the mothers' declarations the rate was 74.1% [CI 95% (69.3-78.4)]. The drop-out rate between DTCP1 and DTCP3 was 5.5%, according to the vaccination cards. The rate of immunization coverage was higher among children whose mothers had received the anti-tetanus vaccine [OR = 2.1, CI 95% (1.44-3.28)]. However, our study found no difference associated with parents' knowledge about EPI diseases, distance from the health centre, or socio-economic status. Lack of information was one reason given for children not being vaccinated against the six EPI diseases.ConclusionThree years after the implementation of the priority program (which included decentralization, the active search for missing children, and deployment of health personnel, material and financial resources), our evaluation of the vaccination coverage rates shows that there is improvement in the EPI immunization coverage rate in Kita Circle. The design of our study did not, however, enable us to determine the extent to which different aspects of the program contributed to this increase in coverage. Efforts should nevertheless be continued, in order to reach the goal of 80% immunization coverage. ABSTRACT IN FRENCH: See the full article online for a translation of this abstract in French.

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

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

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