Hanna Czajka

Children Hospital in Olsztyn, Allenstein, Warmian-Masurian Voivodeship, Poland

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Publications (15)21.58 Total impact

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    ABSTRACT: Polysorbate 80 (P80), a nonionic detergent used to solubilize proteins, is used in both oral and injectable medications including vaccines. Development studies with 13-valent pneumococcal conjugate vaccine (PCV13) demonstrated that adding P80 resulted in a more robust manufacturing process. Prior to adding P80 to the formulation of PCV13, we investigated the immunogenicity and safety of PCV13 with and without P80.
    The Pediatric Infectious Disease Journal 08/2014; · 3.57 Impact Factor
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    ABSTRACT: Combination vaccines offer protection against multiple diseases with fewer injections. This study evaluated the immunogenicity and safety of an investigational diphtheria, tetanus, acellular pertussis, hepatitis B, poliomyelitis, Haemophilus influenzae type b (Hib) and meningococcal serogroup C (MenC) heptavalent combination vaccine (heptavalent vaccine) given as 4 doses at 2, 3, 4 and 12-18 months of age. In this randomized, open, phase II study (NCT00970307/NCT01171989) conducted in Poland, 421 infants were enrolled to receive the heptavalent vaccine or licensed comparator vaccines. Immunogenicity against study vaccine antigens was measured prior to and 1 month after primary and booster vaccinations. Safety and reactogenicity of the vaccines were also evaluated. The primary noninferiority objectives of the MenC and Hib immune responses induced by the heptavalent vaccine versus comparator vaccines were reached after primary vaccination, but no statistical conclusion could be drawn after booster dose. One month after primary and booster vaccinations, ≥98.4% of the heptavalent vaccine recipients were seroprotected for MenC and Hib. Exploratory analyses indicated that the heptavalent vaccine induced higher postprimary vaccination antibody geometric mean concentrations against Hib, but lower postprimary and postbooster vaccinations geometric mean titers against MenC compared with the relevant comparator vaccines. The reactogenicity profiles of the vaccines were acceptable, although 1 infant vaccinated with the heptavalent vaccine experienced a serious adverse event (thrombocytopenia) considered possibly related to vaccination. The heptavalent vaccine was immunogenic and had a clinically acceptable safety profile when administered to infants and toddlers.
    The Pediatric Infectious Disease Journal 07/2013; 32(7):777-85. · 3.57 Impact Factor
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    ABSTRACT: patients treated with hematopoietic stem cell transplantation (HSCT) lose immune memory accumulated through a lifetime. They are at increased risk of developing infections with microorganisms such as Haemophilus influenza, Streptococcus pneumoniae and others for which vaccines are available. Therefore, all patients after HSCT should be routinely revaccinated. Systemic reimmunization after HSCT is a relatively neglected area especially in countries which have not national recommendations and there is lack of systemic regulations in health care system. the rate of immunization before transplantation and the persistence of vaccine-specific antibodies after HSCT was assessed. a group of38 children after stem cell transplantation (19 autologous, 19 allogeneic) was studied. only a few patients completed standard vaccination protocol before HSCT. At the median time of 29 (range: 6-67) months after autologous and 13 (range: 8-33) months after allogeneic HSCT, when the revaccination was commenced, the majority of children had concentration of antibody lower than the minimum protective thresholds. That was 82% for tetanus, 71% for Hib and varicella, 46% for HBV and 38% for diphtheria. all HSCT recipients should be routinely revaccinated to stimulate the immunity to the vaccine-preventable diseases.
    Przegla̧d epidemiologiczny 01/2012; 66(1):93-8.
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    ABSTRACT: On 24th February 24 and 24th March 2011 in Warsaw took place two meetings of the Polish Experts Group * under the common heading „New possibilities for the use of paediatric combined vaccines containing DTPa”. During both meetings the discussions focused on the results of clinical studies and practical experiences published until now in the literature, which are dealing with combined vaccines containing DTPa components. The large part of the discussed data was related to the use of penta- and hexavalent vaccines. The members of Expert Group presented their conference materials concerning a number of issues: safety and immunogenicity of combined vaccines, their use in paediatric risk groups, and current practice and vaccination schedules of combined vaccines included into prophylactic vaccination programmes of the European Union member countries. There were also discussions concerning problems associated with the use of these vaccines in the context of data influencing evidence based medicine, and based on critical evaluation of published data on experiences with combined vaccines containing DTPa. The presented below document was prepared as a consensus position of Expert Group members, after taking into consideration all the proposals and final acceptation of the participants at both meetings.
    Journal of Experimental Marine Biology and Ecology - J EXP MAR BIOL ECOL. 01/2011; 86(3):268-269.
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    ABSTRACT: The aim of the study was the evaluation of safety and efficacy of vaccination in children after stem cell transplantation. 21 patients, 1.4-22 (average 7.8) years old, 13 boys and 8 girls after autologous (11-52%) and allogeneic (10-48%) transplantation were included in the vaccination protocol. Indications for transplantation were: neoplastic disease--16, immunodeficiencies--3 and aplastic anaemia 2 cases. Time between transplantation and beginning of vaccination protocol was 0.8-4 (average 1.5) years. Vaccination protocol was constructed on the basis of the European Group for Blood and Marrow Transplantation indications. We have evaluated: (1) quality of recipient immune reconstitution and protection against common pathogens (2) immunogenicity of revaccination schedule; (3) safety of the vaccination programme. With the exception of one patient presenting with repeated fever, lymph node enlargement, muscle and joint pain, no important side effects were observed. Meningococcial meningitis developed in one patient who refused vaccination. The mean concentrations of antibodies in the plasma before and after vaccination were as follows: anti-diphteria (54; 2285), anti-tetanus (136; 3149) and anti-hepatitis B virus (anti-HBs: 24; 474) IU/ml. (1) Vaccination in patients after transplantation is efficient and well tolerated. (2) Significant increase of antibody level was detected. (3) Any delay in beginning the vaccination can result in life threatening complications.
    Medycyna wieku rozwojowego 01/2010; 14(1):42-52.
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    Journal of Experimental Marine Biology and Ecology - J EXP MAR BIOL ECOL. 01/2010; 85(3):243-250.
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    ABSTRACT: Children aged 11 to <24 months received 2 intranasal doses of live attenuated influenza vaccine (LAIV) or placebo, 35+/-7 days apart. Dose 1 was administered concomitantly with a combined measles, mumps, and rubella vaccine (Priorix). Seroresponses to measles and mumps were similar between groups. Compared with placebo, response rates to rubella in LAIV+Priorix recipients were statistically lower at a 15 IU/mL threshold (83.9% vs 78.0%) and the prespecified noninferiority criteria were not met. In a post hoc analysis using an alternate widely accepted threshold of 10 IU/mL, the noninferiority criteria were met (93.4% vs 89.8%). Concomitant administration with Priorix did not affect the overall influenza protection rate of LAIV (78.4% and 63.8% against antigenically similar influenza strains and any strain, respectively).
    Vaccine 12/2009; 28(6):1566-74. · 3.77 Impact Factor
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    ABSTRACT: The immunogenicity of the 10-valent pneumococcal nontypeable Haemophilus influenzae protein D-conjugate vaccine (PHiD-CV) was assessed and compared with the 7-valent pneumococcal conjugate vaccine (7vCRM). Healthy subjects (1650) were randomized to be vaccinated with 3 doses of PHiD-CV or 7vCRM (Prevenar/Prevnar) at 2-3-4 months of age and a fourth booster dose at 12-18 months. Serotype-specific pneumococcal responses (GlaxoSmithKline's ELISA with 22F-inhibition) and opsonophagocytic activity (OPA) were measured 1 month after primary and booster vaccinations. The primary objective to demonstrate noninferiority of PHiD-CV versus 7vCRM (in terms of percentage of subjects with antibody concentration >or=0.2 microg/mL) for at least 7 of the 10 vaccine serotypes was reached as noninferiority was demonstrated for 8 serotypes. Although, noninferiority could not be demonstrated for ELISA responses against serotypes 6B and 23F, a post-hoc analysis of the percentage of subjects with OPA titers >or=8 suggested noninferiority for the 7 serotypes common to both vaccines including 6B and 23F.Priming of the immune system against all vaccine serotypes was confirmed by robust increases in ELISA antibody levels ( approximately 6.0-17 fold) and OPA titers ( approximately 8-93 fold) after a fourth consecutive dose of PHiD-CV. PHiD-CV induces ELISA and functional OPA antibodies for all vaccine serotypes after primary vaccination and is noninferior to 7vCRM in terms of ELISA and/or OPA threshold responses. Effective priming is further indicated by robust booster responses.
    The Pediatric Infectious Disease Journal 05/2009; 28(4 Suppl):S66-76. · 3.57 Impact Factor
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    ABSTRACT: The aim of the study was to become familiar with parents' and Medical Health Care specialists knowledge and attitude towards vaccinations. The influence of information, provided to patients from various sources, on general opinion about immunization and its coverage within the last year were evaluated. Analysis of questionnaires about vaccinations performed among 151 parents and 180 Medical Health Care specialists. Medical Health Care specialists knowledge was considerably higher in comparison to questioned parents. Surprisingly enough, only approximately 90% of Medical Health Care workers knew about prophylaxis of Hib infections. A doctor is the main and the most reliable source of information for parents. Significant impact on parents' attitude to vaccinations is made not only by campaigns promoting vaccinations, but also by widespread opinions about their harmfulness. The doctor is the major source of reliable information about vaccinations for parents. Therefore, there is the need of continuous improvement of Medical Health Care specialists knowledge, but also the ability of successfully communicating it to parents.
    Przegla̧d lekarski 02/2009; 66(1-2):27-33.
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    ABSTRACT: Controversies on vaccinations refer to two fundamentally different areas. The public contestation refers first of all to the objective need, efficiencies and the safety of vaccinations. Results of reliable research and their metaanalyses published over the recent years confirmed none of claimed by antivaccinists dispraise including causalities among the vaccination and the autism, autoimmune or allergic diseases. The second area, wherein one observes disagreements on the subject of vaccinations, is discussions on of the efficiency of each vaccine, schemata of vaccinations, or else economic advantages from their usage. Result these discussions is the progress in the optimization of schemata, efficiencies and safeties of vaccinations. The more and more greater attention it goes at the standardization of the definition of events and the supervision over undesirable connected symptoms with the usage of vaccinations.
    Przegla̧d lekarski 02/2009; 66(1-2):65-71.
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    ABSTRACT: To study the immunogenicity and reactogenicity of a combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine (Hib-MenC-TT) when administered as a booster dose in combination with a measles, mumps and rubella vaccine (MMR). A phase 3 open randomised controlled trial. One centre in Oxford, UK and nine centres in Poland. 12-15-month-old healthy children. In the primary stage of the study 500 healthy 6-12-week-old infants were randomised in a 3:1 ratio to receive Hib-MenC-TT+DTPa-IPV or MenC-CRM197 vaccine+DTPa-IPV-Hib. In the booster stage, 476 participants (190 in the UK and 286 in Poland) were vaccinated with Hib-MenC-TT and MMR. The proportion of children with protective serum antibody levels against MenC and Hib 6 weeks following a Hib-MenC-TT booster dose. The co-primary objectives were met: the Hib-MenC-TT booster dose induced protective antibody titres in children vaccinated with Hib-MenC-TT+DTPa-IPV or MenC-CRM197+DTPa-IPV-Hib at 2, 3 and 4 months of age. 94.8% (lower limit of (LL) 95% CI 92.4) of participants had rSBA-MenC >or=1:128 and 100% (LL 95% CI 99.2) achieved anti-PRP concentrations >or=1.0 microg/ml. The percentage of toddlers with a post boost rSBA-MenC of 1:128 was significantly higher after priming with Hib-MenC-TT (97.7%) than after MenC-CRM197 (86%) (difference: 11.7%; 95% CI 6.2 to 19.4). The waning antibody titres against Hib and MenC following primary immunisation can be boosted to protective levels by administering the Hib-MenC-TT vaccine at 12-15 months of age, supporting the recent introduction of this vaccine in the UK immunisation schedule to sustain protection of children against Hib and MenC disease. NCT00258700. Study ID: 103974 (http://clinicaltrials.gov).
    Archives of Disease in Childhood 05/2008; 93(11):963-70. · 3.05 Impact Factor
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    ABSTRACT: The immunological system of premature newborns /preterm infants/ is a special challenge for specialists in infectious diseases prevention. The early beginning of immunization in this group is relevant to the necessity of the protection of the premature newborns, who have weaker immunity for infectious diseases than the group of infants born at term. But on the other hand there is justified fear for weaker protection and appearance of unexpected adverse events after immunization in this group of infants. In the review of medical literature covering these problems special attention was paid to the postimmunization response of premature newborns and to the antigens of the following diseases: tetanus, diphtheria, pertussis, poliomyelitis and pneumococci. Such factors as corticotherapy, blood transfusion or blood products may influence the immunization response. We also assessed the safety of immunisation for this group of high risk infants.
    Medycyna wieku rozwojowego 01/2008; 12(2 Pt 2):643-52.
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    ABSTRACT: We conducted a phase 3 randomized controlled trial looking at the immunogenicity and safety of a novel combined Haemophilus influenzae type b and Neisseria meningitidis serogroup C tetanus toxoid conjugate vaccine, Hib-MenC-TT in a 2-, 3-, and 4-month primary infant immunization schedule. SBA MenC titers > or =1:8 and anti-PRP concentrations > or =0.15 microg/mL were measured in 99.2% and 100%, respectively, of the infants receiving Hib-MenC-TT.
    The Pediatric Infectious Disease Journal 11/2007; 26(11):1057-9. · 3.57 Impact Factor
  • Hanna Czajka, Jacek Wysocki
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    ABSTRACT: The combined vaccine against diphtheria, tetanus and pertussis containing the whole cell component of pertussis (DPTw) is characterized by high effectiveness but is also one of the most reactogenic vaccines. Adverse events following this vaccine includes a hypotonic-hyporesponsive episode, however this episode is not well known to general practitioners and pediatricians, so the data about its incidence are not reliable. The aim of this study was to characterize the clinical features of HHE following DTPw vaccine, to estimate the ability to diagnose this syndrome by GPs and pediatricians and to assess the registration system of HHE in Poland. The studied group consisted of 49 children, patients of the Regional Consultation Polyclinic in Kraków in the years 1997-2002, in whom HHE was diagnosed. The following were analysed: sex and age, interval between vaccination and HHE, relationship to the number of DTPw doses, duration of HHE and, based on the referral, the diagnosis made by a GP. The average age of children at the moment of HHE was 3.4 months, but 46/49 children were under 6 months. The symptoms of HHE occurred after a few minutes to 48 hours after vaccination and in two children similar episodes were observed on the 6th day after vaccination, which is not consistent with the definition of HHE. Most often HHE was observed after the first (21/49) and the second (16/49) dose of DTPw. In two children HHE occurred twice, after two consecutive doses of DTPw. In four cases only GPs referring patients have diagnosed HHE. Thirty children from the studied group were further vaccinated against diphtheria, tetanus and pertussis. 61 doses of DTPa (a vaccine with acellular pertussis component) were used and in no case was the adverse event observed. Based on the results obtained it has been concluded that some difficulties are observed in the diagnosis of HHE made by GPs and pediatricians, therefore the number of HHE cases registered in Poland decreased. Hypotonic-hyporesponsive episode should be taken into consideration in differential diagnosis of the nervous system diseases. Therefore, it is extremely important to ask parents about the history of vaccinations in their children.
    Neurologia i neurochirurgia polska 02/2004; 38(1 Suppl 1):S17-24. · 0.49 Impact Factor
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    ABSTRACT: INTRODUCTION: The Paediatric Expert Group on the Immunization Programme was established in January 2007. It is an independent advisory body to the Minister of Health. The Expert Group consists of paediatricians from various sub-specialities. Most of them are members of the Polish Society of Vaccinology (Table I). The Group started their activities informally in 2005. The first project concerned changes in immunization against tuberculosis and prophylaxis of measles, mumps and rubella. The project was fully implemented in 2006. The changes initiated three years ago, gradually implemented in the Immunization Programme are a result of wide cooperation with the Ministry of Health, Department of Health Policy Chief Sanitory Inspector, as well as the Institute of Tuberculosis and Pulmonary Diseases. The aim of the Paediatric Expert Group on the Immunization Programme is to present a unified policy in matters related to vaccination, leading to rapid changes in the prophylaxis of infective diseases which are still a threat to the life and health of children.
    Medycyna wieku rozwojowego 12(2 Pt 2):713-9.