INTRODUCTION: Vaccination with formulations containing pneumococcal protein antigens such as pneumolysin toxoid (dPly) and histidine-triad protein D (PhtD) may extend serotype-related protection of pneumococcal conjugate vaccines (PCVs) against Streptococcus pneumoniae. METHODS: This phase II, multi-center, observer-blind trial conducted in Europe (NCT01204658) assessed 2 investigational vaccines containing 10 serotype-specific polysaccharide conjugates of PHiD-CV and either 10 or 30µg of dPly and PhtD each. Infants randomized 1:1:1:1 received 4 doses of PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV, or 13-valent PCV (PCV13), co-administered with DTPa-HBV-IPV/Hib, at ages ∼2, 3, 4 and 12-15months. Occurrences of fever >40.0°C following primary vaccination with PHiD-CV/dPly/PhtD vaccines compared to PHiD-CV (non-inferiority objective), dose superiority, safety and immunogenicity were assessed. RESULTS: 575 children received primary vaccination, and 564 booster vaccination. The non-inferiority objective was met; no fever >40.0°C causally related to vaccination was reported during primary vaccination. Incidence of adverse events appeared similar between the 3 PHiD-CV groups. Serious adverse events were reported in 13, 9, 21 (1 related to vaccination), and 17 children in the PHiD-CV/dPly/PhtD-10, PHiD-CV/dPly/PhtD-30, PHiD-CV, and PCV13 groups, respectively. PHiD-CV/dPly/PhtD-30 was superior to PHiD-CV/dPly/PhtD-10 in terms of post-dose 3 anti-Ply and Anti-PhtD antibody levels. Anti-Ply and anti-PhtD antibody levels were higher in both PHiD-CV/dPly/PhtD groups than in controls and increased from post-primary to post-booster timepoint. Post-primary and booster vaccination, for each PHiD-CV serotype, ≥98.5% of participants in PHiD-CV/dPly/PhtD groups had antibody concentrations ≥ 0.2μg/mL, except for 6B (≥72.3%) and 23F (≥82.7%) post-primary vaccination. Similar results were observed in the PHiD-CV group. Immune responses to protein D and DTPa-HBV-IPV/Hib were within similar ranges for the 3 PHiD-CV groups. CONCLUSION: Both PHiD-CV/dPly/PhtD formulations co-administered with DTPa-HBV-IPV/Hib in infants were well-tolerated and immunogenic for dPly and PhtD antigens, while immune responses to serotype-specific, protein D and co-administered antigens did not appear altered in comparison to PHiD-CV group.

• Klíčová slova
• Immunogenicity, Infants, PHiD-CV vaccination, PhtD, Pneumococcal protein, Reactogenicity, dPly,
• MeSH
• bakteriální proteiny imunologie   MeSH
• horečka etiologie   MeSH
• imunogenicita vakcíny * MeSH
• kojenec MeSH
• kombinované vakcíny imunologie   MeSH
• lidé MeSH
• pneumokokové infekce prevence a kontrola   MeSH
• pneumokokové vakcíny aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• protilátky bakteriální krev   MeSH
• sekundární imunizace MeSH
• séroskupina MeSH
• Streptococcus pneumoniae chemie   imunologie   MeSH
• streptolysiny imunologie   MeSH
• vakcinace MeSH
• vakcíny konjugované imunologie   MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• bakteriální proteiny MeSH
• kombinované vakcíny MeSH
• PHiD-CV vaccine MeSH Prohlížeč
• plY protein, Streptococcus pneumoniae MeSH Prohlížeč
• pneumokokové vakcíny MeSH
• protilátky bakteriální MeSH
• streptolysiny MeSH
• vakcíny konjugované MeSH

Influenza is a very serious disease, which causes thousands of deaths all over the world every year. As there is so far no sufficiently effective causal therapy of influenza the main function of vaccination lies in prevention. Influenza is a major problem especially in collective facilities. Therefore, great emphasis is laid in the Czech Republic Army on the vaccination of military groups and on the evaluation of reactogenicity and immunogenicity of the vaccines used. The specific aim of the clinical trial was to evaluate the reactogenicity and immunogenicity of two inactivated split influenza vaccines Fluarix and Vaxigrip in healthy adult volunteers aged 18-60 years with stress on military groups. The study was designed as an open clinical trial with 2 groups each of 100 volunteers in one centre. Randomisation was not conducted so that each group received only the vaccine specified beforehand. Both the inactivated split vaccines evaluated, Vaxigrip and Fluarix are highly immunogenic both against declared and other antigenic variants of influenza. The study has demonstrated a favourable trend in the preparation of influenza vaccines towards a marked reduction of general solicited symptoms as compared with previous years. Despite minute differences in immunogenicity and reactogenicity, the vaccines are generally speaking comparable, and in healthy individuals aged 18-60 years they induce a sufficient protection against the onset and development of influenza. The results of our open clinical trial (without randomisation) have again proved that both manufacturers produce vaccines of a high European standard.

• MeSH
• chřipka lidská prevence a kontrola   MeSH
• dospělí MeSH
• inaktivované vakcíny krev   imunologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• ozbrojené síly MeSH
• referenční hodnoty MeSH
• vakcíny proti chřipce krev   imunologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• Geografické názvy
• Česká republika MeSH
• Názvy látek
• inaktivované vakcíny MeSH
• vakcíny proti chřipce MeSH

Whole-cell pertussis (wP) vaccines introduced in the 1940s led to a dramatic reduction of pertussis incidence and are still widely used in low- and middle-income countries (LMICs) worldwide. The reactogenicity of wP vaccines resulted in reduced public acceptance, which drove the development and introduction of acellular pertussis (aP) vaccines in high-income countries in the 1990s. Increased incidence of pertussis disease has been observed in high-income countries following the introduction of aP vaccines despite near universal rates of pediatric vaccination. These increases are attributed to the reduced protection against colonization, carriage, and transmission as well as reduced duration of immunity conferred by aP vaccines relative to the wP vaccines they replaced. A reduced reactogenicity whole-cell pertussis (RRwP) vaccine was recently developed with the goal of achieving the same protection as conferred by wP vaccination but with an improved safety profile, which may benefit countries in which wP vaccines are still in routine use. In this study, we tested the RRwP vaccine in a baboon model of pertussis infection. We found that the RRwP vaccine induced comparable cellular and humoral immune responses and comparable protection following challenge relative to the wP vaccine, while significantly reducing injection-site reactogenicity.IMPORTANCEThe World Health Organization (WHO) recommended in 2015 that countries administering wP vaccines in their national vaccine programs should continue to do so, and that switching to aP vaccines for primary infant immunization should only be considered if periodic booster vaccinations and/or maternal immunization could be assured and sustained in their national immunization schedules (WHO, Vaccine 34:1423-1425, 2016, https://doi.org/10.1016/j.vaccine.2015.10.136). Due to the considerably higher cost of aP vaccines and the larger number of doses required, most LMICs continue to use wP vaccines. The development and introduction of a wP vaccine that induces fewer adverse events without sacrificing protection would significantly benefit countries in which wP vaccines are still in routine use. The results of this study indicate this desirable goal may be achievable.

• Klíčová slova
• baboon model, pertussis, whole cell vaccines,
• MeSH
• Bordetella pertussis imunologie   MeSH
• modely nemocí na zvířatech MeSH
• Papio * imunologie   MeSH
• pertuse * prevence a kontrola   imunologie   MeSH
• pertusová vakcína * imunologie   aplikace a dávkování   MeSH
• protilátky bakteriální krev   MeSH
• vakcinace MeSH
• zvířata MeSH
• Check Tag
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• pertusová vakcína * MeSH
• protilátky bakteriální MeSH

The immunogenicity and reactogenicity of primary vaccination at 3, 4 and 5 months and boosting at 12-18 months with a new DTPw-HBV vaccine was compared with either licensed DTPw and HBV vaccines given separately or a licensed DTPw-HBV combination (Tritanrix-HepB) in this randomized, partially double-blind primary vaccination and single-blind booster vaccination study in healthy infants (n = 239; Trial DTPw-HBV-001/004). One month after primary vaccination with the new DTPw-HBV vaccine, seroprotection against diphtheria, tetanus, hepatitis B and vaccine response to B. pertussis was seen in 100%, 98.7%, 94.9% and 98.7% of subjects, respectively, compared to 100%, > or =98.5%, 89.2% and 92.2% of subjects in the comparator groups, respectively. One month after the booster dose, a marked response to all vaccine antigens was observed, resulting in seroprotection against diphtheria, tetanus, hepatitis B in all DTPw-HBV recipients and response to B. pertussis in over 98.6%. After primary vaccination, there was evidence that fever > or =38.0 degrees C (rectal route) occurred more frequently after the new vaccine (following 41.6% of doses, compared with 32.2% and 29.3% in the comparator groups, p < 0.05) and that pain and drowsiness occurred more frequently than after licensed DTPw-HBV (45.3% versus 35.1% and 37.1% versus 24.9%, respectively). However after primary and booster doses Grade 3 symptoms occurred at similar frequencies in the three groups suggesting these possible differences are of minimal clinical significance. In conclusion, within the framework of this study the immunogenicity and safety profiles of GSK Biologicals' new DTPw-HBV vaccine when used for primary and booster vaccination were acceptable.

• MeSH
• dvojitá slepá metoda MeSH
• hepatitida B - protilátky analýza   MeSH
• kojenec MeSH
• kombinované vakcíny škodlivé účinky   imunologie   MeSH
• lidé MeSH
• protilátky bakteriální analýza   MeSH
• sekundární imunizace MeSH
• vakcína proti diftérii, tetanu a pertusi škodlivé účinky   imunologie   MeSH
• vakcína proti hepatitidě B škodlivé účinky   imunologie   MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• multicentrická studie MeSH
• práce podpořená grantem MeSH
• randomizované kontrolované studie MeSH
• srovnávací studie MeSH
• Názvy látek
• Engerix-B MeSH Prohlížeč
• hepatitida B - protilátky MeSH
• kombinované vakcíny MeSH
• protilátky bakteriální MeSH
• Tritanrix-HepB vaccine MeSH Prohlížeč
• vakcína proti diftérii, tetanu a pertusi MeSH
• vakcína proti hepatitidě B MeSH

Two doses of a recombinant Lyme disease vaccine (15 and 30 microg) were administered to children 2-5 years old (0-1-month schedule) and were well tolerated. Both doses were highly immunogenic with geometric mean titers 1 month after vaccination of 4366 and 9877 ELISA units (EU)/mL, respectively. Nearly all subjects had antibody levels of > or = 1400 EU/mL, suggesting protective tick titre for one tick season.

• MeSH
• antigeny povrchové imunologie   MeSH
• bakteriální vakcíny MeSH
• Borrelia burgdorferi komplex imunologie   MeSH
• lidé MeSH
• lipoproteiny * MeSH
• lymeská nemoc imunologie   mikrobiologie   prevence a kontrola   MeSH
• předškolní dítě MeSH
• proteiny vnější bakteriální membrány imunologie   MeSH
• protilátky bakteriální krev   MeSH
• syntetické vakcíny škodlivé účinky   imunologie   MeSH
• vakcína proti lymeské nemoci škodlivé účinky   genetika   imunologie   MeSH
• Check Tag
• lidé MeSH
• předškolní dítě MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky, fáze II MeSH
• klinické zkoušky MeSH
• Názvy látek
• antigeny povrchové MeSH
• bakteriální vakcíny MeSH
• lipoproteiny * MeSH
• OspA protein MeSH Prohlížeč
• proteiny vnější bakteriální membrány MeSH
• protilátky bakteriální MeSH
• syntetické vakcíny MeSH
• vakcína proti lymeské nemoci MeSH

The leishmaniases are globally important parasitic diseases for which no human vaccines are currently available. To facilitate vaccine development, we conducted an open-label observational study to establish a controlled human infection model (CHIM) of sand fly-transmitted cutaneous leishmaniasis (CL) caused by Leishmania major. Between 24 January and 12 August 2022, we exposed 14 participants to L. major-infected Phlebotomus duboscqi. The primary objective was to demonstrate effectiveness of lesion development (take rate) and safety (absence of CL lesion at 12 months). Secondary and exploratory objectives included rate of lesion development, parasite load and analysis of local immune responses by immunohistology and spatial transcriptomics. Lesion development was terminated by therapeutic biopsy (between days 14 and 42 after bite) in ten participants with clinically compatible lesions, one of which was not confirmed by parasite detection. We estimated an overall take rate for CL development of 64% (9/14). Two of ten participants had one and one of ten participants had two lesion recurrences 4-8 months after biopsy that were treated successfully with cryotherapy. No severe or serious adverse events were recorded, but as expected, scarring due to a combination of CL and the biopsy procedure was evident. All participants were lesion free at >12-month follow-up. We provide the first comprehensive map of immune cell distribution and cytokine/chemokine expression in human CL lesions, revealing discrete immune niches. This CHIM offers opportunities for vaccine candidate selection based on human efficacy data and for a greater understanding of immune-mediated pathology. ClinicalTrials.gov identifier: NCT04512742 .

• MeSH
• dospělí MeSH
• Leishmania major * imunologie   MeSH
• leishmanióza kožní * imunologie   parazitologie   patologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• parazitární zátěž MeSH
• Phlebotomus parazitologie   imunologie   MeSH
• zvířata MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladý dospělý MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• zvířata MeSH
• Publikační typ
• časopisecké články MeSH
• pozorovací studie MeSH

BACKGROUND: Vaccines against hepatitis A and typhoid fever are well established and have an excellent safety and immunogenicity profile. Yet these diseases, which share the same geographic distribution, remain an important cause of morbidity in travelers to endemic countries. Combined vaccination provides dual protection and improves compliance and coverage for travelers. METHODS: This multicenter study evaluated the consistency of three lots of combined hepatitis A and typhoid fever vaccine. A total of 462 healthy subjects, aged 15-50 years, were enrolled and randomly allocated to 3 groups. The single dose of vaccine contains 25 microg typhoid Vi polysaccharide and at least 1,440 ELISA units of inactivated hepatitis A in a 1 mL dose. RESULTS: Bioequivalence of all production lots was shown in terms of safety and immunogenicity. Pain at injection site was the most frequent reported local symptom, and headache was the most frequent reported general symptom. As early as 14 days after immunization >95% of the subjects were positive for anti-Vi antibodies and >86% were positive for anti-HAV antibodies. The GMTs and seropositivity rates were maintained during the 6 month follow-up. CONCLUSION: The first combined vaccine against typhoid fever and hepatitis A was safe and elicited a very good immune response, with the majority of subjects seropositive at 1 month for both antigens. This combined vaccine offered more convenience and rapid seroconversion to travelers.

• MeSH
• bakteriální polysacharidy aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• dospělí MeSH
• dvojitá slepá metoda MeSH
• hepatitida - protilátky krev   MeSH
• hepatitida A - protilátky MeSH
• Hepatovirus imunologie   MeSH
• inaktivované vakcíny aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• kombinované vakcíny aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• protilátky bakteriální krev   MeSH
• Salmonella typhi imunologie   MeSH
• vakcína proti hepatitidě A aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• vakcíny proti tyfu a paratyfu aplikace a dávkování   škodlivé účinky   imunologie   MeSH
• Check Tag
• dospělí MeSH
• lidé středního věku MeSH
• lidé MeSH
• mladiství MeSH
• mužské pohlaví MeSH
• ženské pohlaví MeSH
• Publikační typ
• časopisecké články MeSH
• klinické zkoušky MeSH
• multicentrická studie MeSH
• randomizované kontrolované studie MeSH
• Názvy látek
• bakteriální polysacharidy MeSH
• capsular polysaccharide, Salmonella MeSH Prohlížeč
• hepatitida - protilátky MeSH
• hepatitida A - protilátky MeSH
• inaktivované vakcíny MeSH
• kombinované vakcíny MeSH
• protilátky bakteriální MeSH
• vakcína proti hepatitidě A MeSH
• vakcíny proti tyfu a paratyfu MeSH
• Vi polysaccharide vaccine, typhoid MeSH Prohlížeč

• MeSH
• difterický toxoid aplikace a dávkování   MeSH
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• pertusová vakcína aplikace a dávkování   MeSH
• tělesná teplota MeSH
• tetanový toxoid aplikace a dávkování   MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• difterický toxoid MeSH
• pertusová vakcína MeSH
• tetanový toxoid MeSH

In the Republic of Belarus, immunization of children against measles and mumps had been carried out using monovalent preparations according to the national schedule of measles vaccination at 12 months of age and mumps vaccination at 24 months of age. A rise of rubella incidence in the last few years (i.e., for the official registration period 1980 to 1998, there was an increase from 72.2 to 607.5 cases per 100,000 population) made it necessary to implement immunization against this infection, as well. Therefore, in 1996, combined vaccination against measles, mumps, and rubella of 12-month-old children was carried out for the first time in a clinical trial that used the vaccine Trimovax [Aventis Pasteur (formerly, Pasteur Mérieux Connaught), Lyon, France]. The reactogenicity of the vaccine was investigated in 372 children. Post-vaccination reactions were noted in 5.6% of children; in 1.3% of children the reactions were classified as severe [i.e. associated with body (axillary) temperature > or = 38.6 degrees C]. For the evaluation of immunogenicity, sera from 324 children were obtained 2 to 2.5 months after inoculation, and serum antibody levels were measured by enzyme immunoassays. Among the vaccines, protective antibody titers (expressed in inverse of dilution units) were observed to measles (> or = 1:50) in 97.8%, to mumps (> or = 1:50) in 93.8%, and to rubella (> or = 1:100) in 96.0% of children. Antibodies to all three components of the vaccine were mainly present in intermediate (1:200-1:800) or high (> or = 1:1600) titers: to measles in 96.3%; to mumps in 75.8%; and to rubella in 73.5% of vaccines. The results of these trials are evidence of the good safety and immunogenicity of this MMR vaccine, which provides an alternative to the currently used measles and mumps monovaccines, with the additional benefit of providing immunity against rubella, as well.

• MeSH
• kojenec MeSH
• lidé MeSH
• příušnice imunologie   prevence a kontrola   MeSH
• protilátky virové biosyntéza   MeSH
• spalničky imunologie   prevence a kontrola   MeSH
• vakcína proti spalničkám, příušnicím a zarděnkám škodlivé účinky   imunologie   MeSH
• zarděnky imunologie   prevence a kontrola   MeSH
• Check Tag
• kojenec MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Geografické názvy
• Běloruská republika MeSH
• Názvy látek
• protilátky virové MeSH
• vakcína proti spalničkám, příušnicím a zarděnkám MeSH

• MeSH
• adsorpce MeSH
• bakteriální vakcíny * aplikace a dávkování   škodlivé účinky   MeSH
• difterický toxoid * MeSH
• difterie prevence a kontrola   MeSH
• dítě MeSH
• erytém etiologie   MeSH
• kojenec MeSH
• lidé MeSH
• pertuse prevence a kontrola   MeSH
• pertusová vakcína * MeSH
• tetanový toxoid * MeSH
• tetanus prevence a kontrola   MeSH
• tvorba protilátek MeSH
• vakcinace MeSH
• Check Tag
• dítě MeSH
• kojenec MeSH
• lidé MeSH
• Publikační typ
• časopisecké články MeSH
• Názvy látek
• bakteriální vakcíny * MeSH
• difterický toxoid * MeSH
• pertusová vakcína * MeSH
• tetanový toxoid * MeSH