Chřipka je velmi závažné onemocnění, které je každoročně pričinou tisíců úmrtí na celém světě. Protože do současné doby neexistuje dostatečně efektivní kauzální léčba chřipky, v prevenci je prioritní především vakcinace. Chripka je velkým problémem především v kolektivních zařízeních. Proto je i v Armádě České republiky kladen důraz na vakcinaci vojenských kolektivů a kontrolu vlastností použitých očkovacích látek. Cílem klinické studie bylo především zhodnocení reaktogenity a imunogenity dvou inaktivovaných štěpených vakcín proti chřipce Fluarix TM a Vaxigrip® mezi zdravými dospělými dobrovolníky ve věku 18 - 60 let s důrazem na vojenské kolektivy. Studie byla plánována jako otevřená klinická studie se 2 skupinanú (každá v jednom centru) po 100 vakcinovaných. Nebyla však provedena randomizace a tak každá skupina dostala jen předem určenou vakcínu. Obě hodnocené inaktivované štěpené vakcíny Vaxigrip® a Fluarix™ jsou vysoce imunogenní jak proti deklarovaným, tak i dalším antigenním variantám chřipky. Studie prokázala priznivý trend pri pripravě chřipkových vakcín projevující se výrazným snížením celkových nežádoucích reakcí oproti předcházejícím letům. Vakcíny i přes drobné rozdíly v imunogenitě a reaktogenitě jsou v globálním pohledu srovnatelné a u zdravých osob ve věku 18-60 let vyvolávají dostatečnou ochranu proti vzniku a rozvoji chřipkového onemocnění. Výsledky naši otevřené klinické studie (bez provedené randomizace) opět potvrdily, že oba výrobci pripravují vakcíny vysokého evropského standardu.

Influenza is a very serious illness annually causing thousands of deaths all over the worid. Since hitherto there is no sufficiently effective causal therapy of influenza, vaccination has top priority in its prevention. Influenza is a grave problem in collective facilities. Therefore in the Army of the Czech Republic emphasis is given to vaccination of military personnel and control of the efficacy of vaccines used. The chief purpose of this clinical investigation was the evaluation of the reactogenicity and immunogenicity of two inactivated split influenza vaccines Fluarix TM and Vaxigrip® among healthy adult volunteers 18 to 60 years of age with emphasis on army groups. The investigation was designed as an open clinical study of two groups (each in one center) per 100 vaccines. There was no randomization, so each group was given only one predetermined vaccine. Both inactivated split vaccines, Fluarix™ and Vaxigrip®, proved highly immunogenic, not only against the declared influenzavirus, but also against its other antigenic variants. The investigation revealed a favorable trend in the preparation of influenza vaccines in that there is a significant decrease of general undesirable reactions among the vaccinated in comparison with preceding years. The vaccines, disregarding minor differences in immunogenicity and reactogenicity, are, in general, comparable and in healthy persons 18 to 60 years of age elicit sufficient protection against infection and development of influenza. Results of our open nonrandomized clinical investigation confirmed again that both producers prepare vaccines of high European standard.

• Keywords
• FLUARIX (SM.KL.BEECH.BIOL.,RIXENSART,BELGIE), VAXIGRIP (PASTEUR MERIÉUX, LYON, FRANCIE),
• MeSH
• Influenza, Human immunology   prevention & control   MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Influenza Vaccines pharmacology   immunology   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Male MeSH
• Publication type
• Evaluation Study MeSH
• Comparative Study MeSH

• Keywords
• VAXIGRIP, FLUARIX TM,
• MeSH
• Drug Evaluation MeSH
• Humans MeSH
• Military Personnel MeSH
• Vaccination MeSH
• Influenza Vaccines adverse effects   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Publication type
• Clinical Trial 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
• Double-Blind Method MeSH
• Financing, Organized MeSH
• Hepatitis B Antibodies analysis   MeSH
• Infant MeSH
• Vaccines, Combined immunology   adverse effects   MeSH
• Humans MeSH
• Antibodies, Bacterial MeSH
• Immunization, Secondary MeSH
• Diphtheria-Tetanus-Pertussis Vaccine adverse effects   immunology   MeSH
• Hepatitis B Vaccines immunology   adverse effects   MeSH
• Check Tag
• Infant MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH
• Comparative Study MeSH

• Keywords
• VAXIGRIP, FLUARIX,
• MeSH
• Influenza, Human prevention & control   MeSH
• Child MeSH
• Adult MeSH
• Humans MeSH
• Antibody Formation MeSH
• Influenza Vaccines MeSH
• Age Factors MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Humans MeSH
• Publication type
• Clinical Trial MeSH

• MeSH
• Polysaccharides, Bacterial administration & dosage   immunology   adverse effects   MeSH
• Hepatitis Antibodies blood   MeSH
• Hepatitis A administration & dosage   immunology   adverse effects   MeSH
• Vaccines, Inactivated administration & dosage   immunology   adverse effects   MeSH
• Vaccines, Combined administration & dosage   immunology   adverse effects   MeSH
• Humans MeSH
• Typhoid-Paratyphoid Vaccines administration & dosage   immunology   adverse effects   MeSH
• Check Tag
• Humans MeSH
• Male MeSH
• Female 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
• Adult MeSH
• Leishmania major * immunology   MeSH
• Leishmaniasis, Cutaneous * immunology   parasitology   pathology   MeSH
• Middle Aged MeSH
• Humans MeSH
• Young Adult MeSH
• Parasite Load MeSH
• Phlebotomus parasitology   immunology   MeSH
• Animals MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Female MeSH
• Animals MeSH
• Publication type
• Journal Article MeSH
• Observational Study MeSH

• MeSH
• Adsorption MeSH
• Bacterial Vaccines administration & dosage   adverse effects   MeSH
• Diphtheria Toxoid MeSH
• Diphtheria prevention & control   MeSH
• Child MeSH
• Erythema etiology   MeSH
• Infant MeSH
• Humans MeSH
• Whooping Cough prevention & control   MeSH
• Pertussis Vaccine MeSH
• Tetanus Toxoid MeSH
• Tetanus prevention & control   MeSH
• Antibody Formation MeSH
• Vaccination MeSH
• Check Tag
• Child MeSH
• Infant MeSH
• Humans MeSH

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.

• MeSH
• Bacterial Proteins immunology   MeSH
• Fever etiology   MeSH
• Immunogenicity, Vaccine * MeSH
• Infant MeSH
• Vaccines, Combined immunology   MeSH
• Humans MeSH
• Pneumococcal Infections prevention & control   MeSH
• Pneumococcal Vaccines administration & dosage   adverse effects   immunology   MeSH
• Antibodies, Bacterial blood   MeSH
• Immunization, Secondary MeSH
• Serogroup MeSH
• Streptococcus pneumoniae chemistry   immunology   MeSH
• Streptolysins immunology   MeSH
• Vaccination MeSH
• Vaccines, Conjugate immunology   MeSH
• Check Tag
• Infant MeSH
• Humans MeSH
• Male MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial, Phase II MeSH
• Multicenter Study MeSH
• Randomized Controlled Trial MeSH

• MeSH
• Child MeSH
• Infant MeSH
• Vaccines, Combined immunology   therapeutic use   MeSH
• Humans MeSH
• Measles Vaccine immunology   therapeutic use   MeSH
• Antibody Formation MeSH
• Mumps Vaccine immunology   therapeutic use   MeSH
• Rubella Vaccine immunology   therapeutic use   MeSH
• Check Tag
• Child MeSH
• Infant MeSH
• Humans MeSH
• Geographicals
• Republic of Belarus MeSH

• MeSH
• Diphtheria drug therapy   immunology   prevention & control   MeSH
• Child MeSH
• Drug Therapy methods   MeSH
• Hepatitis B drug therapy   immunology   prevention & control   MeSH
• Humans MeSH
• Drug-Related Side Effects and Adverse Reactions MeSH
• Whooping Cough drug therapy   prevention & control   MeSH
• Poliomyelitis drug therapy   immunology   prevention & control   MeSH
• Tetanus drug therapy   immunology   prevention & control   MeSH
• Vaccination MeSH
• Check Tag
• Child MeSH
• Humans MeSH