Roman Prymula | Charles University, Prague (original) (raw)
Papers by Roman Prymula
Expert Review of Vaccines, 2014
Travel medicine and infectious disease
Coinfection by HIV and syphilis has become a growing problem due to the re-appearance of unsafe s... more Coinfection by HIV and syphilis has become a growing problem due to the re-appearance of unsafe sexual practices in the era of potent anti-retroviral drugs. We describe a repeated import of syphilis by a couple of men-who-have-sex-with-men from Thailand to Czech Republic likely due to non-adherence of the patients to physician recommendations. Such cases can become foci for dissemination of once locally rare infections and present a danger for the community.
Vaccine, 2015
The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Au... more The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age. We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12-15 or 24-26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination. High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups. Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants.
Vaccine, Jan 18, 2008
This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive... more This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, ...
Rubella is a contagious viral disease with few complications except when contracted by pregnant w... more Rubella is a contagious viral disease with few complications except when contracted by pregnant women. Rubella infection in pregnancy can result in miscarriage, stillbirth or an infant born with congenital rubella syndrome (CRS) which comprises deafness, heart disease, cataracts and other permanent congenital manifestations. Clinical diagnosis of rubella is difficult due to overlapping symptoms with many other diseases and confirmation of rubella is not possible without laboratory testing.
Human vaccines & immunotherapeutics, 2014
The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and... more The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability, we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and 12 months of age concomitantly with routine infant vaccines: DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol; a third group received MenC vaccine. Immune responses to 4CMenB were not decreased by the use of paracetam...
Vaccine, 2009
Acute otitis media (AOM), one of the most common childhood diseases, is associated with a substan... more Acute otitis media (AOM), one of the most common childhood diseases, is associated with a substantial medical, social and economic burden. Non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae are the two main causes of bacterial OM. The 7-valent pneumococcal CRM 197 -conjugate vaccine (7vCRM, Prevnar TM /Prevenar TM , Wyeth) demonstrated efficacy against AOM caused by vaccine pneumococcal serotypes. Protection against overall AOM was also observed with an 11-valent pneumococcal protein D-conjugate vaccine (11Pn-PD) in the Pneumococcal Otitis Efficacy Trial (POET). Following POET, an optimized 10-valent pneumococcal non-typeable H. influenzae protein D-conjugate vaccine (PHiD-CV; Synflorix TM , GlaxoSmithKline Biologicals) was developed. This vaccine includes serotypes 1, 5, and 7F, in addition to those already included in 7vCRM, and was recently licensed in Europe for active immunization against invasive disease and AOM caused by S. pneumoniae in infants and children from 6 weeks up to 2 years of age. The use of protein D as carrier protein permits avoidance of possible interferences known to occur with some conjugate vaccines, and has the added potential benefit of providing protection against NTHi. This review seeks to highlight the recent advances in the field of OM vaccination, with a focus on data regarding the recently licensed PHiD-CV.
Pediatria Polska, 2012
ABSTRACT Wraz z postępującym starzeniem się populacji europejskiej prawdopodobnie będzie następow... more ABSTRACT Wraz z postępującym starzeniem się populacji europejskiej prawdopodobnie będzie następował stały wzrost zachorowalności i zwiększenie nakładów finansowych na leczenie w populacji osób dorosłych. Tendencje te czynią zasadne przeprowadzenie przeglądu i rewizji możliwych strategii profilaktycznych, jakimi są szczepienia. Z uwagi na niedobór skoordynowanych programów szczepień u dorosłych istotny problem stanowi wdrażanie tej formy immunizacji w populacji dorosłych. W krajach Europy Zachodniej zaczęto uwzględniać konieczność rozszerzenia szczepień w tej grupie demograficznej. Problem ten w Europie Środkowej pozostaje słabo poznany i wciąż niedostatecznie opisany. W niniejszym artykule podsumowano dostępne dane, których analiza wskazuje na konieczność rozszerzenia kalendarza szczepień dorosłych w grupie krajów Europy Środkowej, należących do Stowarzyszenia Świadomej Postawy wobec Szczepień CEVAG (Central European Vaccination Awareness Group) (Bułgaria, Chorwacja, Czechy, Estonia, Węgry, Łotwa, Litwa, Rumunia, Słowacja, Słowenia i Turcja). Grupa CEVAG zaleca wdrożenie kalendarza szczepień dorosłych, który powinien obejmować szczepienia przeciwko chorobom o największej śmiertelności i zachorowalności w tej populacji. Kalendarz ten powinien być indywidualizowany w stosunku do indywidualnych potrzeb i priorytetów krajowych.As Europe's population ages, disease morbidity and treatment costs in the adult population are likely to rise substantially, making this a pertinent time to review and revise preventive strategies such as vaccination. Vaccine uptake remains a problem for adults and there is a lack of coordinated programmes for vaccination of adults. Countries in Western Europe have begun to identify the need to increase adult vaccination, but the situation in Central European countries remains poorly identified and inadequately described. This paper summarises the evidence to support the development of an adult vaccination calendar in the Central European Vaccination Awareness Group (CEVAG) member countries (Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Romania, Slovakia, Slovenia and Turkey). CEVAG recommends the introduction of an adult vaccination calendar, which should include vaccination against diseases that represent a large burden in adults in terms of mortality and morbidity. This calendar could be modified to meet the priorities of individual countries.
The Lancet, 2014
Rates of varicella have decreased substantially in countries implementing routine varicella vacci... more Rates of varicella have decreased substantially in countries implementing routine varicella vaccination. Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine (MMRV). We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV. This study was done in ten European countries with endemic varicella. Healthy children aged 12-22 months were randomised (3:3:1 ratio, by computer-generated randomisation list, with block size seven) to receive 42 days apart (1) two doses of MMRV (MMRV group), or (2) MMR at dose one and monovalent varicella vaccine at dose two (MMR+V group), or (3) two doses of MMR (MMR group; control). Participants and their parents or guardians, individuals involved in assessment of any outcome, and sponsor staff involved in review or analysis of data were masked to treatment assignment. The primary efficacy endpoint was occurrence of confirmed varicella (by detection of varicella zoster virus DNA or epidemiological link) from 42 days after the second vaccine dose to the end of the first phase of the trial. Cases were graded for severity. Efficacy analyses were per protocol. Safety analyses included all participants who received at least one vaccine dose. This trial is registered with ClinicalTrials.gov, number NCT00226499. Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. In the efficacy cohort of 5285 children, the mean duration of follow-up in the MMRV group was 36 months (SD 8·8), in the MMR+V group was 36 months (8·5) and in the MMR group was 35 months (8·9). Varicella cases were confirmed for 37 participants in the MMRV group (two moderate to severe), 243 in the MMR+V group, and 201 in the MMR group. Second cases occurred for three participants (all in the MMR+V group). Varicella cases were moderate to severe for two participants in the MMRV group, 37 in the MMR+V group (one being a second case that followed a mild first case); and 117 in the MMR group. Efficacy of two-dose MMRV against all varicella was 94·9% (97·5% CI 92·4-96·6), and against moderate to severe varicella was 99·5% (97·5-99·9). Efficacy of one-dose varicella vaccine against all varicella was 65·4% (57·2-72·1), and against moderate to severe varicella (post hoc) was 90·7% (85·9-93·9). The most common adverse event in all groups was injection-site redness (up to 25% of participants). Within 15 days after dose one, 57·4% (95% CI 53·9-60·9) of participants in the MMRV group reported fever of 38°C or more, by contrast with 44·5% (41·0-48·1) with MMR+V, and 39·8% (33·8-46·1) with MMR. Eight serious adverse events were deemed related to vaccination (three MMRV, four MMR+V, one MMR). All resolved within the study period. These results support the implementation of two-dose varicella vaccination on a short course, to ensure optimum protection from all forms of varicella disease. GlaxoSmithKline Vaccines.
Vaccine, 2009
Following primary and booster vaccination with an 11-valent pneumococcall protein D conjugate vac... more Following primary and booster vaccination with an 11-valent pneumococcall protein D conjugate vaccine there was a 42.8% (95% CI: −16.7 to 71.9, ns) reduction in the carriage of Streptococcus pneumoniae vaccine serotypes and a 42.6% (95% CI: 1.3-66.6) reduction in the carriage of Haemophilus influenzae identified by standard microbiological techniques. When PCR and immunoblot assays were used to further improve specificity of non-typeable H. influenzae strain identification, carriage of H. influenzae was still reduced with 38.6% (95% CI: −6.3 to 64.6, ns). Reduction of acute otitis media (AOM) episodes preceded the impact on carriage. These data provide further support of the functional role of the protein D immunity.
Vaccine, 2007
Primary vaccination with pneumococcal protein D conjugate vaccine in the first year of life induc... more Primary vaccination with pneumococcal protein D conjugate vaccine in the first year of life induced clear ELISA and OPA responses, which varied considerably for the different serotypes. Antibody levels declined following primary vaccination but were restored (except for serotype 3) to above post-primary levels by booster vaccination in the second year of life. Antibody levels declined when measured in the fourth year of life, although remaining higher than in the non-immunized children. For some serotypes, antibody levels did not decline indicating exposure to pneumococci or cross-reacting bacteria. Development of natural immunity to several serotypes was evident from the increase in opsonophagocytic activity in the control group between booster and plain polysaccharide vaccination. Vigorous and rapid OPA and ELISA responses were elicited to all vaccine serotypes including serotype 3 following administration of plain polysaccharide vaccine in both the conjugate and control groups, being higher in the conjugate group (Study ID: 104083/NCT00169507).
Travel Medicine and Infectious Disease, 2014
Coinfection by HIV and syphilis has become a growing problem due to the reappearance of unsafe se... more Coinfection by HIV and syphilis has become a growing problem due to the reappearance of unsafe sexual practices in the era of potent anti-retroviral drugs. We describe a repeated import of syphilis by a couple of men-who-have-sex-with-men from Thailand to Czech Republic likely due to non-adherence of the patients to physician recommendations. Such cases can become foci for dissemination of once locally rare infections and present a danger for the community. ª
Ticks and Tick-borne Diseases, 2012
The Lancet, 2009
Background Although fever is part of the normal infl ammatory process after immunisation, prophyl... more Background Although fever is part of the normal infl ammatory process after immunisation, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion. We assessed the eff ect of prophylactic administration of paracetamol at vaccination on infant febrile reaction rates and vaccine responses.
Indoor and Built Environment, 2006
Contamination of the air by fungi at the Transplant Intensive Care Unit (ICU) of the University H... more Contamination of the air by fungi at the Transplant Intensive Care Unit (ICU) of the University Hospital in Hradec Králové was investigated in 2004. Air samples were taken from the patient's breathing zone in the single rooms, in the room used for drug preparation and from the air outside the hospital building. Air was sampled with Biotest RCS Plus air sampler and material collected on the yeasts and mould strips prepared with Rosa Bengal Streptomycin Agar. The majority of the air samples (64%) from the Transplant ICU were free of fungi. Only Cladosporium spp., Penicillium spp. and Mucor spp. were found though rarely with the load ranging from 2 to 26 CFU·m Ϫ3 . No isolates of the opportunistic pathogen Aspergillus fumigatus strain were detected in the single rooms. In contrast, two outdoor samples were positive for this opportunistic mould.
Clinical Otolaryngology, 2006
BMC Infectious Diseases, 2010
Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are ... more Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are licensed. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on the introduction of HPV vaccines in central Europe. Eight countries currently have medical representatives on CEVAG: the Czech
Advances in Therapy, 2012
Intanza(®)/IDflu(®) (Sanofi Pasteur SA, Lyon, France), a split-virion, trivalent influenza vaccin... more Intanza(®)/IDflu(®) (Sanofi Pasteur SA, Lyon, France), a split-virion, trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available in adults 18-59 years of age (9 μg) and ≥60 years of age (15 μg) as of the 2010/2011 northern hemisphere influenza season. This study assessed the acceptability of intradermal vaccination with Intanza/IDflu in routine clinical practice in adult vaccinees and their vaccine prescribers. Vaccine prescribers and adults who had elected to be vaccinated with Intanza/IDflu during the 2010/2011 northern hemisphere influenza season were recruited to complete surveys about their opinions of influenza vaccination and their acceptance of the intradermal vaccination. Czech subjects 18-59 years of age were vaccinated with the 9 μg formulation and those ≥60 years of age with the 15 μg formulation of Intanza/IDflu. All Turkish subjects were vaccinated with the 9 μg formulation, as Intanza/IDflu 15 μg was not available in Turkey at the time the survey was conducted. One thousand and twelve vaccinees and 28 vaccine prescribers in the Czech Republic, and 249 vaccinees and 15 vaccine prescribers in Turkey completed questionnaires. Overall, 96.1% of vaccinees were satisfied or very satisfied with Intanza/IDflu. The main reason for satisfaction was that the injection was considered minimally painful. Most (93.9%) vaccinees reported that they would prefer to receive the same vaccination next year. Furthermore, 95.3% of vaccine prescribers were satisfied or very satisfied with the intradermal vaccine, and 82.6% preferred intradermal over intramuscular vaccination. Intradermal vaccination for seasonal influenza using Intanza/IDflu is well accepted by adult vaccinees and vaccine prescribers. By providing an additional, well-accepted method, Intanza/IDflu might help increase seasonal influenza vaccination rates in adults.
Expert Review of Vaccines, 2014
Travel medicine and infectious disease
Coinfection by HIV and syphilis has become a growing problem due to the re-appearance of unsafe s... more Coinfection by HIV and syphilis has become a growing problem due to the re-appearance of unsafe sexual practices in the era of potent anti-retroviral drugs. We describe a repeated import of syphilis by a couple of men-who-have-sex-with-men from Thailand to Czech Republic likely due to non-adherence of the patients to physician recommendations. Such cases can become foci for dissemination of once locally rare infections and present a danger for the community.
Vaccine, 2015
The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Au... more The multicomponent, recombinant serogroup B vaccine, 4CMenB, is approved in Europe, Canada and Australia from two months of age. We investigated persistence to booster doses at 12 months of age following infant vaccination, and immune response to catch-up vaccination of toddlers and children up to two years of age. We assessed persistence of immune responses after one year in participants vaccinated as infants, and responses to two doses at 12-15 or 24-26 months of age in vaccine-naïve children, as serum bactericidal activity with human complement (hSBA) against indicator strains for four vaccine antigens. Adverse events were recorded after each vaccination. High antibody titers were induced against all four 4CMenB components following booster vaccination in infant-primed toddlers and after two doses in previously unvaccinated toddlers or two-year-olds. Antibodies waned over 12 months, particularly those against NZ OMV. Systemic reactogenicity in toddlers was lower than in infants, and lower again in vaccine-naïve two-year-olds. Local reactogenicity was common in all groups. Four infant or two toddler 4CMenB vaccinations elicit immune responses believed to be protective for the first two years of life, which can be boosted. Reactogenicity is lower in toddlers than in infants.
Vaccine, Jan 18, 2008
This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive... more This randomized (1:1), double-blind, multicenter study, included 4,968 healthy infants to receive either the 11-valent pneumococcal protein D (PD)-conjugate study vaccine or the hepatitis A vaccine (HAV) (control) at 3, 4, 5, and 12-15 months of age. The three-dose primary course of both vaccines was co-administered with combined hexavalent DTPa-HBV-IPV/Hib vaccine. The pneumococcal PD-conjugate study vaccine did not impact the immune response of co-administered hexavalent vaccine and the control HAV vaccine induced seropositivity (antibodies >or=15 mIU/mL) in all infants. The incidence of solicited symptoms was higher with the 11-valent pneumococcal PD-conjugate study vaccine, yet similar to that induced by concomitant DTPa-HBV-IPV/Hib vaccine. Overall, the reactogenicity and safety profile of the 11-valent pneumococcal PD-conjugate vaccine when co-administered with the hexavalent DTPa-HBV-IPV/Hib vaccine, as well as the immunogenicity of the co-administered hexavalent vaccine, ...
Rubella is a contagious viral disease with few complications except when contracted by pregnant w... more Rubella is a contagious viral disease with few complications except when contracted by pregnant women. Rubella infection in pregnancy can result in miscarriage, stillbirth or an infant born with congenital rubella syndrome (CRS) which comprises deafness, heart disease, cataracts and other permanent congenital manifestations. Clinical diagnosis of rubella is difficult due to overlapping symptoms with many other diseases and confirmation of rubella is not possible without laboratory testing.
Human vaccines & immunotherapeutics, 2014
The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and... more The novel meningococcal serogroup B vaccine (4CMenB, Bexsero(®)), recently approved in Europe and Australia, may soon be included in routine infant immunization schedules, subject to guidance from national or regional recommending bodies. In the development of 4CMenB and consistent with other newly introduced vaccines, clinical studies have shown concomitant administration with routine infant vaccines induces an incremental increase in some reactions, including fever. As this may hinder acceptability, we examined the impact of prophylactic paracetamol on the occurrence of fever and other solicited reactions, as well as the immune responses to study vaccines, in a prospectively designed study. 4CMenB was administered as a 4-dose series at 2, 3, 4, and 12 months of age concomitantly with routine infant vaccines: DTaP-HBV-IPV/Hib and PCV7, with or without prophylactic paracetamol; a third group received MenC vaccine. Immune responses to 4CMenB were not decreased by the use of paracetam...
Vaccine, 2009
Acute otitis media (AOM), one of the most common childhood diseases, is associated with a substan... more Acute otitis media (AOM), one of the most common childhood diseases, is associated with a substantial medical, social and economic burden. Non-typeable Haemophilus influenzae (NTHi) and Streptococcus pneumoniae are the two main causes of bacterial OM. The 7-valent pneumococcal CRM 197 -conjugate vaccine (7vCRM, Prevnar TM /Prevenar TM , Wyeth) demonstrated efficacy against AOM caused by vaccine pneumococcal serotypes. Protection against overall AOM was also observed with an 11-valent pneumococcal protein D-conjugate vaccine (11Pn-PD) in the Pneumococcal Otitis Efficacy Trial (POET). Following POET, an optimized 10-valent pneumococcal non-typeable H. influenzae protein D-conjugate vaccine (PHiD-CV; Synflorix TM , GlaxoSmithKline Biologicals) was developed. This vaccine includes serotypes 1, 5, and 7F, in addition to those already included in 7vCRM, and was recently licensed in Europe for active immunization against invasive disease and AOM caused by S. pneumoniae in infants and children from 6 weeks up to 2 years of age. The use of protein D as carrier protein permits avoidance of possible interferences known to occur with some conjugate vaccines, and has the added potential benefit of providing protection against NTHi. This review seeks to highlight the recent advances in the field of OM vaccination, with a focus on data regarding the recently licensed PHiD-CV.
Pediatria Polska, 2012
ABSTRACT Wraz z postępującym starzeniem się populacji europejskiej prawdopodobnie będzie następow... more ABSTRACT Wraz z postępującym starzeniem się populacji europejskiej prawdopodobnie będzie następował stały wzrost zachorowalności i zwiększenie nakładów finansowych na leczenie w populacji osób dorosłych. Tendencje te czynią zasadne przeprowadzenie przeglądu i rewizji możliwych strategii profilaktycznych, jakimi są szczepienia. Z uwagi na niedobór skoordynowanych programów szczepień u dorosłych istotny problem stanowi wdrażanie tej formy immunizacji w populacji dorosłych. W krajach Europy Zachodniej zaczęto uwzględniać konieczność rozszerzenia szczepień w tej grupie demograficznej. Problem ten w Europie Środkowej pozostaje słabo poznany i wciąż niedostatecznie opisany. W niniejszym artykule podsumowano dostępne dane, których analiza wskazuje na konieczność rozszerzenia kalendarza szczepień dorosłych w grupie krajów Europy Środkowej, należących do Stowarzyszenia Świadomej Postawy wobec Szczepień CEVAG (Central European Vaccination Awareness Group) (Bułgaria, Chorwacja, Czechy, Estonia, Węgry, Łotwa, Litwa, Rumunia, Słowacja, Słowenia i Turcja). Grupa CEVAG zaleca wdrożenie kalendarza szczepień dorosłych, który powinien obejmować szczepienia przeciwko chorobom o największej śmiertelności i zachorowalności w tej populacji. Kalendarz ten powinien być indywidualizowany w stosunku do indywidualnych potrzeb i priorytetów krajowych.As Europe's population ages, disease morbidity and treatment costs in the adult population are likely to rise substantially, making this a pertinent time to review and revise preventive strategies such as vaccination. Vaccine uptake remains a problem for adults and there is a lack of coordinated programmes for vaccination of adults. Countries in Western Europe have begun to identify the need to increase adult vaccination, but the situation in Central European countries remains poorly identified and inadequately described. This paper summarises the evidence to support the development of an adult vaccination calendar in the Central European Vaccination Awareness Group (CEVAG) member countries (Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Romania, Slovakia, Slovenia and Turkey). CEVAG recommends the introduction of an adult vaccination calendar, which should include vaccination against diseases that represent a large burden in adults in terms of mortality and morbidity. This calendar could be modified to meet the priorities of individual countries.
The Lancet, 2014
Rates of varicella have decreased substantially in countries implementing routine varicella vacci... more Rates of varicella have decreased substantially in countries implementing routine varicella vaccination. Immunisation is possible with monovalent varicella vaccine or a combined measles-mumps-rubella-varicella vaccine (MMRV). We assessed protection against varicella in naive children administered one dose of varicella vaccine or two doses of MMRV. This study was done in ten European countries with endemic varicella. Healthy children aged 12-22 months were randomised (3:3:1 ratio, by computer-generated randomisation list, with block size seven) to receive 42 days apart (1) two doses of MMRV (MMRV group), or (2) MMR at dose one and monovalent varicella vaccine at dose two (MMR+V group), or (3) two doses of MMR (MMR group; control). Participants and their parents or guardians, individuals involved in assessment of any outcome, and sponsor staff involved in review or analysis of data were masked to treatment assignment. The primary efficacy endpoint was occurrence of confirmed varicella (by detection of varicella zoster virus DNA or epidemiological link) from 42 days after the second vaccine dose to the end of the first phase of the trial. Cases were graded for severity. Efficacy analyses were per protocol. Safety analyses included all participants who received at least one vaccine dose. This trial is registered with ClinicalTrials.gov, number NCT00226499. Between Sept 1, 2005, and May 10, 2006, 5803 children (mean age 14·2 months, SD 2·5) were vaccinated. In the efficacy cohort of 5285 children, the mean duration of follow-up in the MMRV group was 36 months (SD 8·8), in the MMR+V group was 36 months (8·5) and in the MMR group was 35 months (8·9). Varicella cases were confirmed for 37 participants in the MMRV group (two moderate to severe), 243 in the MMR+V group, and 201 in the MMR group. Second cases occurred for three participants (all in the MMR+V group). Varicella cases were moderate to severe for two participants in the MMRV group, 37 in the MMR+V group (one being a second case that followed a mild first case); and 117 in the MMR group. Efficacy of two-dose MMRV against all varicella was 94·9% (97·5% CI 92·4-96·6), and against moderate to severe varicella was 99·5% (97·5-99·9). Efficacy of one-dose varicella vaccine against all varicella was 65·4% (57·2-72·1), and against moderate to severe varicella (post hoc) was 90·7% (85·9-93·9). The most common adverse event in all groups was injection-site redness (up to 25% of participants). Within 15 days after dose one, 57·4% (95% CI 53·9-60·9) of participants in the MMRV group reported fever of 38°C or more, by contrast with 44·5% (41·0-48·1) with MMR+V, and 39·8% (33·8-46·1) with MMR. Eight serious adverse events were deemed related to vaccination (three MMRV, four MMR+V, one MMR). All resolved within the study period. These results support the implementation of two-dose varicella vaccination on a short course, to ensure optimum protection from all forms of varicella disease. GlaxoSmithKline Vaccines.
Vaccine, 2009
Following primary and booster vaccination with an 11-valent pneumococcall protein D conjugate vac... more Following primary and booster vaccination with an 11-valent pneumococcall protein D conjugate vaccine there was a 42.8% (95% CI: −16.7 to 71.9, ns) reduction in the carriage of Streptococcus pneumoniae vaccine serotypes and a 42.6% (95% CI: 1.3-66.6) reduction in the carriage of Haemophilus influenzae identified by standard microbiological techniques. When PCR and immunoblot assays were used to further improve specificity of non-typeable H. influenzae strain identification, carriage of H. influenzae was still reduced with 38.6% (95% CI: −6.3 to 64.6, ns). Reduction of acute otitis media (AOM) episodes preceded the impact on carriage. These data provide further support of the functional role of the protein D immunity.
Vaccine, 2007
Primary vaccination with pneumococcal protein D conjugate vaccine in the first year of life induc... more Primary vaccination with pneumococcal protein D conjugate vaccine in the first year of life induced clear ELISA and OPA responses, which varied considerably for the different serotypes. Antibody levels declined following primary vaccination but were restored (except for serotype 3) to above post-primary levels by booster vaccination in the second year of life. Antibody levels declined when measured in the fourth year of life, although remaining higher than in the non-immunized children. For some serotypes, antibody levels did not decline indicating exposure to pneumococci or cross-reacting bacteria. Development of natural immunity to several serotypes was evident from the increase in opsonophagocytic activity in the control group between booster and plain polysaccharide vaccination. Vigorous and rapid OPA and ELISA responses were elicited to all vaccine serotypes including serotype 3 following administration of plain polysaccharide vaccine in both the conjugate and control groups, being higher in the conjugate group (Study ID: 104083/NCT00169507).
Travel Medicine and Infectious Disease, 2014
Coinfection by HIV and syphilis has become a growing problem due to the reappearance of unsafe se... more Coinfection by HIV and syphilis has become a growing problem due to the reappearance of unsafe sexual practices in the era of potent anti-retroviral drugs. We describe a repeated import of syphilis by a couple of men-who-have-sex-with-men from Thailand to Czech Republic likely due to non-adherence of the patients to physician recommendations. Such cases can become foci for dissemination of once locally rare infections and present a danger for the community. ª
Ticks and Tick-borne Diseases, 2012
The Lancet, 2009
Background Although fever is part of the normal infl ammatory process after immunisation, prophyl... more Background Although fever is part of the normal infl ammatory process after immunisation, prophylactic antipyretic drugs are sometimes recommended to allay concerns of high fever and febrile convulsion. We assessed the eff ect of prophylactic administration of paracetamol at vaccination on infant febrile reaction rates and vaccine responses.
Indoor and Built Environment, 2006
Contamination of the air by fungi at the Transplant Intensive Care Unit (ICU) of the University H... more Contamination of the air by fungi at the Transplant Intensive Care Unit (ICU) of the University Hospital in Hradec Králové was investigated in 2004. Air samples were taken from the patient's breathing zone in the single rooms, in the room used for drug preparation and from the air outside the hospital building. Air was sampled with Biotest RCS Plus air sampler and material collected on the yeasts and mould strips prepared with Rosa Bengal Streptomycin Agar. The majority of the air samples (64%) from the Transplant ICU were free of fungi. Only Cladosporium spp., Penicillium spp. and Mucor spp. were found though rarely with the load ranging from 2 to 26 CFU·m Ϫ3 . No isolates of the opportunistic pathogen Aspergillus fumigatus strain were detected in the single rooms. In contrast, two outdoor samples were positive for this opportunistic mould.
Clinical Otolaryngology, 2006
BMC Infectious Diseases, 2010
Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are ... more Vaccines against human papillomavirus (HPV), the primary causative agent in cervical cancer, are licensed. This paper contains the Central European Vaccination Advisory Group (CEVAG) guidance statement on the introduction of HPV vaccines in central Europe. Eight countries currently have medical representatives on CEVAG: the Czech
Advances in Therapy, 2012
Intanza(®)/IDflu(®) (Sanofi Pasteur SA, Lyon, France), a split-virion, trivalent influenza vaccin... more Intanza(®)/IDflu(®) (Sanofi Pasteur SA, Lyon, France), a split-virion, trivalent influenza vaccine delivered by intradermal injection with a microinjection system, became available in adults 18-59 years of age (9 μg) and ≥60 years of age (15 μg) as of the 2010/2011 northern hemisphere influenza season. This study assessed the acceptability of intradermal vaccination with Intanza/IDflu in routine clinical practice in adult vaccinees and their vaccine prescribers. Vaccine prescribers and adults who had elected to be vaccinated with Intanza/IDflu during the 2010/2011 northern hemisphere influenza season were recruited to complete surveys about their opinions of influenza vaccination and their acceptance of the intradermal vaccination. Czech subjects 18-59 years of age were vaccinated with the 9 μg formulation and those ≥60 years of age with the 15 μg formulation of Intanza/IDflu. All Turkish subjects were vaccinated with the 9 μg formulation, as Intanza/IDflu 15 μg was not available in Turkey at the time the survey was conducted. One thousand and twelve vaccinees and 28 vaccine prescribers in the Czech Republic, and 249 vaccinees and 15 vaccine prescribers in Turkey completed questionnaires. Overall, 96.1% of vaccinees were satisfied or very satisfied with Intanza/IDflu. The main reason for satisfaction was that the injection was considered minimally painful. Most (93.9%) vaccinees reported that they would prefer to receive the same vaccination next year. Furthermore, 95.3% of vaccine prescribers were satisfied or very satisfied with the intradermal vaccine, and 82.6% preferred intradermal over intramuscular vaccination. Intradermal vaccination for seasonal influenza using Intanza/IDflu is well accepted by adult vaccinees and vaccine prescribers. By providing an additional, well-accepted method, Intanza/IDflu might help increase seasonal influenza vaccination rates in adults.