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Primary and booster vaccination with DTPw-HB/Hib pentavalent vaccine in Costa Rican children who had received a birth dose of hepatitis B vaccine  [cached]
Faingezicht Idis,Avila-Aguerro Maria Luisa,Cervantes Yolanda,Fourneau Marc
Revista Panamericana de Salud Pública , 2002,
Abstract: Objective. The DTPw-HB/Hib pentavalent combination vaccine has been developed following recommendations of the World Health Organization for the introduction of hepatitis B (HB) and Haemophilus influenzae type b (Hib) vaccines into routine childhood vaccination programs. The objectives of this study were to: 1) analyze the immunogenicity and the reactogenicity of the DTPw-HB/Hib pentavalent combination vaccine in comparison to separate injections of DTPw-HB and Hib vaccines as primary vaccination in a group of children who had received a dose of HB vaccine at birth and 2) in the second year of life to assess the antibody persistence as well as the response to a DTPw-HB/Hib or DTPw/Hib booster. Methods. In the first part of the study (primary-vaccination stage), conducted in 1998-1999, we analyzed the immunogenicity and reactogenicity of the DTPw-HB/Hib combination vaccine in comparison to separate injections of DTPw-HB and Hib vaccines as primary vaccination at 2, 4, and 6 months of age in 207 Costa Rican children who had received a dose of HB vaccine at birth. Later, in the booster-vaccination stage of the study, in 1999-2000, in a subset of the children (69 toddlers, now 15-18 months old), antibody persistence was measured, and response to a DTPw-HB/Hib or DTPw/Hib booster was also assessed. Results. In both primary-vaccination groups, at least 97.5% of the infants reached protective levels of antibodies (seropositivity) against the antigens employed in the vaccines. The DTPw-HB/Hib pentavalent combination vaccine did not result in more local reactions than did the DTPw-HB vaccine alone, and, in terms of general reactions, there was no clinically significant difference between the combination or separate injections, and with the pentavalent vaccine having the benefit of needing one less injection. Nine months after the third dose of the primary-vaccination course, antibody persistence was similar in both groups, with over 93% of children still having protective/seropositive titers for Hib, HB, and tetanus and about 50% for diphtheria and Bordetella pertussis. At 15 months of age, virtually all the toddlers responded with a strong boost response to all the vaccine antigens, whether they received the DTPw-HB/Hib pentavalent vaccine or the DTPw/Hib vaccine as a booster. Both booster regimens were equally well tolerated, indicating that up to five doses of the HB vaccine can be given without impact on safety. Conclusions. Our study confirms that the DTPw-HB/Hib pentavalent vaccine is highly immunogenic as a primary vaccination in children who received an
Primary and booster vaccination with DTPw-HB/Hib pentavalent vaccine in Costa Rican children who had received a birth dose of hepatitis B vaccine
Faingezicht,Idis; Avila-Aguerro,Maria Luisa; Cervantes,Yolanda; Fourneau,Marc; Clemens,Sue Ann Costa;
Revista Panamericana de Salud Pública , 2002, DOI: 10.1590/S1020-49892002001000005
Abstract: objective. the dtpw-hb/hib pentavalent combination vaccine has been developed following recommendations of the world health organization for the introduction of hepatitis b (hb) and haemophilus influenzae type b (hib) vaccines into routine childhood vaccination programs. the objectives of this study were to: 1) analyze the immunogenicity and the reactogenicity of the dtpw-hb/hib pentavalent combination vaccine in comparison to separate injections of dtpw-hb and hib vaccines as primary vaccination in a group of children who had received a dose of hb vaccine at birth and 2) in the second year of life to assess the antibody persistence as well as the response to a dtpw-hb/hib or dtpw/hib booster. methods. in the first part of the study (primary-vaccination stage), conducted in 1998-1999, we analyzed the immunogenicity and reactogenicity of the dtpw-hb/hib combination vaccine in comparison to separate injections of dtpw-hb and hib vaccines as primary vaccination at 2, 4, and 6 months of age in 207 costa rican children who had received a dose of hb vaccine at birth. later, in the booster-vaccination stage of the study, in 1999-2000, in a subset of the children (69 toddlers, now 15-18 months old), antibody persistence was measured, and response to a dtpw-hb/hib or dtpw/hib booster was also assessed. results. in both primary-vaccination groups, at least 97.5% of the infants reached protective levels of antibodies (seropositivity) against the antigens employed in the vaccines. the dtpw-hb/hib pentavalent combination vaccine did not result in more local reactions than did the dtpw-hb vaccine alone, and, in terms of general reactions, there was no clinically significant difference between the combination or separate injections, and with the pentavalent vaccine having the benefit of needing one less injection. nine months after the third dose of the primary-vaccination course, antibody persistence was similar in both groups, with over 93% of children still having protective/se
A fully liquid DTPw-HepB-Hib combination vaccine for booster vaccination of toddlers in El Salvador
Suárez,Eduardo; Asturias,Edwin J.; Hilbert,Anne Katrin; Herzog,Christian; Aeberhard,Ursula; Spyr,Christian;
Revista Panamericana de Salud Pública , 2010, DOI: 10.1590/S1020-49892010000200005
Abstract: objectives:to compare the safety and immunogenicity of a booster dose of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis b-haemophilus influenzae type b (dtpw-hepb-hib) vaccine to the separate administration of commercially available dtpw and hib vaccines in healthy toddlers. methods:an open-label, randomized, parallel-group, phase iii study conducted at six centers in san salvador, el salvador, during february-june 2006. toddlers (15-24 months of age) were eligible to participate if they had received primary immunization at 2, 4, and 6 months of age with a commercial dtpw-hepb/hib vaccine requiring reconstitution. participants received either one booster dose of dtpw-hepb-hib fully liquid vaccine or dtpw and hib vaccines administered separately. blood samples were taken immediately prior to and at 1 month post-vaccination. for a 5-day period following vaccination, solicited adverse events were collected in subject diaries and assessed. results:the combined dtpw-hepb-hib fully liquid vaccine was non-inferior to the separately administered dtpw and hib vaccines, in terms of seroprotection/seroconversion rates for all antigens evaluated. the combination vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. the geometric mean concentrations (gmcs) of all antibodies in the dtpw-hepb-hib group exceeded the seroprotection/seroconversion thresholds by very large margins, although for some antigens they were somewhat lower than the corresponding titers in the comparator group. with the combination vaccine, considerably fewer solicited local and systemic adverse events, such as fever and irritability, were reported than with the comparator vaccines. conclusions:this study demonstrates that the fully liquid combined dtpw-hepb-hib vaccine is highly immunogenic and has a favorable safety profile when given as a booster vaccination to toddlers who have received a primary vaccination course with
Hepatitis B antibody titers in Indonesian adolescents who received the primary hepatitis B vaccine during infancy
Hartono Gunardi,Adra Firmansyah,Sri Rezeki S Harun,Sudigdo Sastroasmoro
Paediatrica Indonesiana , 2013,
Abstract: Background Hepatitis B (HB) has been classified as moderate-to-highly endemic in Indonesia. HB vaccination, the most effective method to prevent HB viral transmission, induces protective antibodies against HB surface antigen (anti-HBs). However, these antibodies decline in titer over time. Studies on the duration of protection and the prevalence of non-responders in Indonesian adolescents have been limited.Objectives To determine anti-HBs titers in 15-17-year old Indonesian adolescents given primary HB vaccine during infancy and the prevalence of non-responders after a HB vaccine booster dosage.Methods This cross-sectional study was performed from February to September 2008 on adolescents aged 15-17 years in three senior high schools in Jakarta who received complete primary HB vaccines during infancy, based on parents’ recall. Investigations included HB vaccination history, anthropometric measurements, and blood tests for anti-HBs before and 4-6 weeks after a booster dose of HB vaccine.Results Of 94 subjects, 35 had protective anti-HBs and 59 had undetectable anti-HBs. A booster dose was administered to 58 of the non-protected subjects, of which 33 showed anamnestic responses. However, 25 subjects failed to generate protective anti-HBs. Taking into consideration the adolescents with protective anti-HBs before and after the booster dose, serologic protection was demonstrated in 73%. Non-responder prevalence was 27%. The high prevalence of non-responders may indicate bias of parents’ recall.Conclusion Protective anti-HBbs is detected in less than half of Indonesian adolescents given primary HB vaccine during infancy. Following booster dosage, anamnestic responses are noted in one-third of subjects. The prevalence of non-responders is 27%, but confirmation with further study is needed.
Monoarthropathy or Polyarthritis in Adolescent Japanese Girls Who Received Immunization with the Human Papillomavirus Vaccine  [PDF]
Ryuta Abe, Tomomi Kinoshita, Akiyo Hineno, Shu-ichi Ikeda
Case Reports in Clinical Medicine (CRCM) , 2016, DOI: 10.4236/crcm.2016.53020
Abstract: Joint pain or arthralgia is a common complaint among girls who have received immunization with the human papillomavirus (HPV) vaccine, but the pathogenesis of this disorder has not been completely understood. We report 2 cases of joint lesions after HPV vaccination. In one case, a 13-year-old patient showed transient arthropathy in the right wrist joint after the first dose of Gardasil® administered in her left shoulder. In the other case, an 18-year-old patient had migrating joint pain with redness and swelling after the third dose of Cervarix®. Her serum C-reactive protein and anti-MMP-3 levels were slightly elevated, but no autoantibodies, including rheumatoid factor and anti-CCP antibody, were detected. Although various nonsteroidal anti-inflammatory drugs produced no relief, small doses of both tacrolimus and prednisolone were highly effective for her polyarthritis. The development of reactive joint lesions after HPV vaccination was noteworthy.
Acute diarrhoea in a community cohort of children who received an oral rotavirus vaccine in Northeast Brazil
Vieira, Sarah Cristina Fontes;Gurgel, Ricardo Queiroz;Kirby, Andrew;Barreto, Isis Pinheiro;Souza, Liane Desiderio de;Oliveira, Oderlan Carvalho;Correia, Jailson de Barros;Dove, Winifred;Cunliffe, Nigel A;Cuevas, Luis E;
Memórias do Instituto Oswaldo Cruz , 2011, DOI: 10.1590/S0074-02762011000300012
Abstract: rotavirus is an important cause of childhood diarrhoea. a monovalent rotavirus vaccine (rotarix?) was introduced into the immunization program of brazil in 2006. in this study, we describe the incidence and burden of disease of rotavirus diarrhoea in two cohorts of children (vaccinated and unvaccinated). we followed two groups of 250 children under one year old, who were enrolled in december 2006 from a low-income residential area in northeast brazil. the children were monitored every two weeks for two years. stool samples from children with diarrhoea were examined for the presence of rotavirus. rotaviruses were genotyped using real time-polymerase chain reaction. the mean numbers of all-cause diarrhoea episodes/child (adjusted for age) in the first year were 0.87 and 0.84, in vaccinated and unvaccinated children, respectively. during the second year, the number of episodes/child decreased to 0.52 and 0.42. only 16 (4.9%) of 330 stool samples were rotavirus-positive (10 vaccinated and 6 unvaccinated children) and only p[4]g2 rotaviruses were identified. all-cause diarrhoea episodes were more severe in unvaccinated children in the first year of age (p < 0.05), while vaccinated children had more severe episodes 18 months after vaccination. rotavirus diarrhoea incidence was very low in both groups.
Economic evaluation of delivering Haemophilus influenzae type b vaccine in routine immunization services in Kenya
Akumu,Angela Oloo; English,Mike; Scott,J Anthony G; Griffiths,Ulla K;
Bulletin of the World Health Organization , 2007, DOI: 10.1590/S0042-96862007000700008
Abstract: objective: haemophilus influenzae type b (hib) vaccine was introduced into routine immunization services in kenya in 2001. we aimed to estimate the cost-effectiveness of hib vaccine delivery. methods: a model was developed to follow the kenyan 2004 birth cohort until death, with and without hib vaccine. incidence of invasive hib disease was estimated at kilifi district hospital and in the surrounding demographic surveillance system in coastal kenya. national hib disease incidence was estimated by adjusting incidence observed by passive hospital surveillance using assumptions about access to care. case fatality rates were also assumed dependent on access to care. a price of us$ 3.65 per dose of pentavalent diphtheria-tetanus-pertussis-hep b-hib vaccine was used. multivariate monte carlo simulations were performed in order to assess the impact on the cost-effectiveness ratios of uncertainty in parameter values. findings: the introduction of hib vaccine reduced the estimated incidence of hib meningitis per 100 000 children aged < 5 years from 71 to 8; of hib non-meningitic invasive disease from 61 to 7; and of non-bacteraemic hib pneumonia from 296 to 34. the costs per discounted disability adjusted life year (daly) and per discounted death averted were us$ 38 (95% confidence interval, ci: 26-63) and us$ 1197 (95% ci: 814-2021) respectively. most of the uncertainty in the results was due to uncertain access to care parameters. the break-even pentavalent vaccine price - where incremental hib vaccination costs equal treatment costs averted from hib disease - was us$ 1.82 per dose. conclusion: hib vaccine is a highly cost-effective intervention in kenya. it would be cost-saving if the vaccine price was below half of its present level.
A new DTPw-HB/Hib combination vaccine for primary and booster vaccination of infants in Latin America
Tregnaghi,Miguel; López,Pio; Rocha,Crisanta; Rivera,Luis; David,Marie-Pierre; Rüttimann,Ricardo; Schuerman,Lode;
Revista Panamericana de Salud Pública , 2006, DOI: 10.1590/S1020-49892006000300006
Abstract: objectives: in 1998 the world health organization (who) recommended the inclusion of haemophilus influenza type b (hib) conjugate vaccines in infant immunization programs, whenever in accordance with national priorities. glaxosmithkline biologicals has developed a new pentavalent combined diphtheria-tetanus-whole cell pertussis-hepatitis b/hib (dtpwhb/hib) vaccine containing 5 μg of polyribosylribitol phosphate (prp), and we assessed the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with this new vaccine compared with a reference regimen consisting of the licensed dtpw-hb (tritanrix) and hib (hiberix) vaccines given as simultaneous concomitant injections. methods: we performed a randomized, double-blind study from september 1998 to august 1999 to establish the immunogenicity and reactogenicity of primary and booster vaccination of healthy children with the new pentavalent combined dtpw-hb/hib vaccine given as a single injection, compared with the reference regimen. results: both vaccination regimens elicited excellent immune responses, with all subjects in both groups achieving seroprotective anti-prp antibody concentrations of > 0.15 μg/ml one month after primary vaccination. the combined dtpw-hb/hib vaccine was non-inferior to the licensed vaccines in terms of seroprotection/seropositivity/vaccine response rates for all antigen components. persistence of antibodies against all study vaccine antigens up to the time of booster vaccination was comparable between groups, and a marked increase of all antibody concentrations was observed after the booster dose. both vaccine regimens were similar in terms of their overall reactogenicity profiles. conclusions: our results indicate that the new dtpw-hb/hib pentavalent combination vaccine provides an efficient and reliable way of implementing who recommendations for controlling hepatitis b and hib infections on a worldwide basis.
Immunogenicity, reactogenicity and consistency of production of a Brazilian combined vaccine against diphtheria, tetanus, pertussis and Haemophilus influenzae type b
Martins, Reinaldo de Menezes;Camacho, Luiz Antonio Bastos;Marcovistz, Rugimar;Noronha, Tatiana Guimar?es de;Maia, Maria de Lourdes Sousa;Santos, Eliane Matos dos;Barbosa, Glayse Glayde;Silva, Andrea Marques Vieira da;Souza, Patricia Cristina Neves Feliciano de;Lemos, Maria Cristina Ferreira;Homma, Akira;
Memórias do Instituto Oswaldo Cruz , 2008, DOI: 10.1590/S0074-02762008000700014
Abstract: a randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-haemophilus influenzae type b vaccine entirely produced in brazil by bio-manguinhos and instituto butantan (dtp/hib-bm) was undertaken. the reference vaccine had the same dtp vaccine but the hib component was produced using purified materials supplied by glaxosmithkline (dtp/hib-gsk), which is registered and has supplied the brazilian national immunization program for over more than five years. one thousand infants were recruited for the study and received vaccinations at two, four and six months of age. with respect to immunogenicity, the vaccination protocol was followed in 95.6% and 98.4% of infants in the dtp/hib-bm and dtp/hib-gsk groups, respectively. for the hib component of the study, there was 100% seroprotection (>0.15 μg/ml) with all three lots of dtp/hib-bm and dtp/hib-gsk. the geometric mean titer (gmt) was 9.3 μg/ml, 10.3 μg/ml and 10.3 μg/ml for lots 1, 2 and 3 of dtp/hib-bm, respectively, and the gmt was 11.3 g/ml for dtp/hib-gsk. for diphtheria, tetanus and pertussis, seroprotection was 99.7%, 100% and 99.9%, respectively, for dtp/hib-bm, three lots altogether and 99.2%, 100% and 100% for dtp/hib-gsk. gmts were similar across all lots and vaccines. adverse events rates were comparable among the vaccine groups. the brazilian dtp/hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.
Invazive Haemophilus influenzae Infections in Two Children who Vaccinated with Haemophilus influenzae type b Vaccine  [cached]
?a?lar ?dek,Halil ?zdemir,An?l Tap?s?z,Ergin ?ift?i
Cocuk Enfeksiyon Dergisi , 2010,
Abstract: Haemophilus influenzae type b (Hib) causes invasive infectious diseases such as meningitis, bacteremia and pneumonia. Invasive Hib infections occur mostly in children under five years old, but in the first 6-12 months of their life they are at greatest risk for the disease. After the introduction of conjugate Hib vaccines, the incidence of invasive Hib infections has decreased. There are still some cases of invasive Hib disease immunization with conjugate Hib vaccine. There is no evidence that non-type b infections have increased in frequency, but some cases have been reported. Patients with immune deficiency syndromes can also have invasive Hib infections because of inadequate antibody responses. Here, we present two cases with invasive Hib infections immunization with conjugate Hib vaccines.
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