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1.
Int J Cancer ; 138(10): 2428-38, 2016 May 15.
Artículo en Inglés | MEDLINE | ID: mdl-26685704

RESUMEN

The control arm of the phase III VIVIANE (Human PapillomaVIrus: Vaccine Immunogenicity ANd Efficacy; NCT00294047) study in women >25 years was studied to assess risk of progression from cervical HPV infection to detectable cervical intraepithelial neoplasia (CIN). The risk of detecting CIN associated with the same HPV type as the reference infection was analysed using Kaplan-Meier and multivariable Cox models. Infections were categorised depending upon persistence as 6-month persistent infection (6MPI) or infection of any duration. The 4-year interim analysis included 2,838 women, of whom 1,073 (37.8%) experienced 2,615 infections of any duration and 708 (24.9%) experienced 1,130 6MPIs. Infection with oncogenic HPV types significantly increased the risk of detecting CIN grade 2 or greater (CIN2+) versus non-oncogenic types. For 6MPI, the highest risk was associated with HPV-33 (hazard ratio [HR]: 31.9 [8.3-122.2, p < 0.0001]). The next highest risk was with HPV-16 (21.1 [6.3-70.0], p < 0.0001). Similar findings were seen for infections of any duration. Significant risk was also observed for HPV-18, HPV-31, and HPV-45. Concomitant HPV infection or CIN grade 1 or greater associated with a different oncogenic HPV type increased risk. Most women (79.3%) with an HPV infection at baseline cleared detectable infections of any duration, and 69.9% cleared a 6MPI. The risk of progression of HPV infection to CIN2+ in women >25 years in this study was similar to that in women 15-25 years in PATRICIA.


Asunto(s)
Infecciones por Papillomavirus/complicaciones , Neoplasias del Cuello Uterino/etiología , Neoplasias del Cuello Uterino/patología , Adulto , Alphapapillomavirus/clasificación , Ensayos Clínicos Fase III como Asunto , Progresión de la Enfermedad , Detección Precoz del Cáncer , Femenino , Estudios de Seguimiento , Humanos , Persona de Mediana Edad , Infecciones por Papillomavirus/prevención & control , Infecciones por Papillomavirus/virología , Vacunas contra Papillomavirus/inmunología , Vigilancia en Salud Pública , Riesgo , Neoplasias del Cuello Uterino/epidemiología , Displasia del Cuello del Útero/epidemiología , Displasia del Cuello del Útero/etiología , Displasia del Cuello del Útero/patología
2.
Hum Vaccin Immunother ; 18(1): 1959148, 2022 01 31.
Artículo en Inglés | MEDLINE | ID: mdl-34435933

RESUMEN

In Russia, a universal varicella vaccination (UVV) program has not been implemented, and varicella vaccination coverage is low. We assessed the efficacy, antibody persistence, and safety of one- and two-dose varicella vaccination schedules in Russian children with a ten-year follow-up period, as part of an international phase IIIB, observer-blind, randomized, controlled trial (NCT00226499). Children aged 12-22 months were randomized (3:3:1) to receive two doses of tetravalent measles-mumps-rubella-varicella vaccine (V2 group), one dose trivalent measles-mumps-rubella (MMR) vaccine and one dose of varicella vaccine (V1 group), or two doses of MMR vaccine (V0 [control] group), 42 days apart. Main study outcomes were: vaccine efficacy (VE) against confirmed varicella cases, anti-varicella zoster virus (VZV) seropositivity rates and geometric mean concentrations, and reporting of (serious) adverse events ([S]AEs). The total vaccinated cohort in Russia comprised 1000 children; 900 were followed up until study end (year [Y] 10). VE estimates against confirmed varicella (Y10) were 92.4% in the V2 group and 74.7% in the V1 group. Anti-VZV seropositivity rates remained ≥99.4% in the V2 group and ≥89.7% in the V1 group from day 42 post-vaccination 2 until Y10. Occurrence of (un)solicited AEs and SAEs was similar across groups and confirmed the safety profile of the vaccines. No vaccination-related SAEs or deaths were reported. These results are consistent with the global trial results, i.e., the highest VE estimates observed following the two-dose schedule compared to the one-dose schedule. These data may inform decision-making related to potential implementation of a UVV program.


What is the context?Varicella is a common childhood disease caused by the highly contagious varicella zoster virus.Varicella vaccines have been used for more than three decades.A large clinical trial conducted in ten countries assessed the efficacy and safety of one dose of monovalent varicella vaccine or two doses of combined varicella vaccine (MMRV). The enrolled children were also followed up for a ten-year period to evaluate the persistence of the immune response and the long-term efficacy of the vaccine.What is new?Here, we present the long-term efficacy, immunogenicity, and safety results in the cohort of children enrolled in Russia, as part of the global ten-year follow-up study. We found that:The monovalent and combined vaccines reduced the number of varicella cases.The MMRV two-dose regimen displayed higher efficacy in preventing varicella of all severities compared to the one-dose regimen.The immune response conferred by the vaccine persisted up to ten years post-vaccination.No vaccination-related deaths occurred, and no safety concerns were raised.What is the impact?Vaccination against varicella resulted in long-term protective efficacy and antibody persistence over ten years post-vaccination in Russian children.Although one-dose varicella vaccination was effective at protecting against varicella, a two-dose schedule provided a more complete protection. This could inform health policy decisions regarding the implementation of varicella vaccination in routine immunization program in Russia.


Asunto(s)
Vacuna contra el Herpes Zóster , Vacunación , Niño , Estudios de Seguimiento , Vacuna contra el Herpes Zóster/administración & dosificación , Vacuna contra el Herpes Zóster/efectos adversos , Humanos , Esquemas de Inmunización , Lactante , Vacunación/efectos adversos , Vacunación/métodos , Vacunas Atenuadas/efectos adversos
3.
Indian Pediatr ; 55(12): 1050-1055, 2018 Dec 15.
Artículo en Inglés | MEDLINE | ID: mdl-30745476

RESUMEN

OBJECTIVE: Evaluation of tolerability, safety and immunogenicity of a two-dose series of a quadrivalent meningococcal polysaccharide diptheria toxoid conjugate (ACYW-D) vaccine in Indian and Russian infants/toddlers. DESIGN: Open-label, single-arm, phase III multi-national trial. STUDY PARTICIPANTS: 300 children aged 9-17 months, previously unvaccinated against meningococcal disease from four sites each in India (n=200) and the Russian Federation (n=100). INTERVENTION: Two 0.5 mL doses of ACYW-D by intramuscular injection, 3-6 months apart. MAIN OUTCOME MEASURES: Meningococcal antibody titers to serogroups A, C, W-135 and Y, determined using a serum bactericidal assay in the presence of human complement before vaccination and 28 days after the second vaccination. Titers ≥1:8 against either/all of the A, C, W-135 or Y were considered sero-protective. RESULTS: After dose 2, 95.7-99.5% and 92.9-99.0% of infants/toddlers achieved seroprotection across the four serogroups in India and the Russian Federation, respectively. No immediate adverse events were reported after any dose of ACYW-D. Solicited reactions were reported in 49.2% of participants, and were mainly of Grade 1 severity, and resolved within three days. Unsolicited adverse events were reported in 19.1% of infants: one event (Grade 3 diarrhea, resolving within one day) was considered related to study vaccine. No non-serious adverse events led to premature withdrawal from the study. Four serious adverse events were reported; none were considered related to study vaccine. No deaths occurred during the study. CONCLUSIONS: A two-dose series of ACYW-D vaccine in Indian and Russian children (9-17 month) was well-tolerated with no safety concerns, and induced robust bactericidal antibody responses against the meningococcal serogroups contained in the vaccine.


Asunto(s)
Toxoide Diftérico/inmunología , Vacunas Meningococicas/inmunología , Toxoide Diftérico/administración & dosificación , Toxoide Diftérico/efectos adversos , Femenino , Humanos , India , Lactante , Masculino , Vacunas Meningococicas/administración & dosificación , Vacunas Meningococicas/efectos adversos , Seguridad del Paciente , Federación de Rusia , Vacunas Conjugadas/administración & dosificación , Vacunas Conjugadas/efectos adversos , Vacunas Conjugadas/inmunología
4.
Vaccine ; 26(19): 2378-88, 2008 05 02.
Artículo en Inglés | MEDLINE | ID: mdl-18407382

RESUMEN

A multicentre, randomized, phase III clinical trial in 5071 healthy adults was conducted to evaluate the safety and reactogenicity of a 15 microg HA dose of a candidate oil-in-water emulsion-based adjuvant system (AS)-adjuvanted split-virion H5N1 (AS-H5N1) vaccine compared to a licensed seasonal influenza vaccine, Fluarix.(1) Stringent criteria were used to evaluate adverse events and reactogenicity profile. Overall, 96.7% of the 5071 vaccinated subjects completed the study. Significantly more participants in the AS-H5N1 vaccine group reported general or local adverse events. Pain was the most common symptom in both treatment groups. Less than 1% of subjects withdrew from the study due to adverse events and no withdrawals were due to serious adverse events related to vaccination. The safety and reactogenicity profile of the AS-H5N1 candidate vaccine can be considered clinically acceptable in the context of its use against pandemic influenza.


Asunto(s)
Adyuvantes Inmunológicos/efectos adversos , Subtipo H5N1 del Virus de la Influenza A/inmunología , Vacunas contra la Influenza/efectos adversos , Adyuvantes Inmunológicos/administración & dosificación , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Brotes de Enfermedades/prevención & control , Emulsiones/administración & dosificación , Emulsiones/efectos adversos , Femenino , Humanos , Vacunas contra la Influenza/administración & dosificación , Gripe Humana/prevención & control , Gripe Humana/virología , Masculino , Persona de Mediana Edad
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