View clinical trials related to Immunization; Infection.
Filter by:In July 2023, the Food and Drug Administration approved nirsevimab (Beyfortus®), a long-acting monoclonal antibody, for passive immunization to prevent RSV-associated lower respiratory tract infection (Bronchiolitis) among infants and young children. In Europe, The European Medicines Agency approved the use of BEYFORTUS in October 2022. In France, The Haute Autorité de Santé (HAS) approved the use of BEYFORTUS in July 2023 starting in September 2023. Beyfortus is administered as a single intramuscular injection prior to or during RSV season. This single dose may provide protection during the whole RSV season. The safety and efficacy of Beyfortus® were supported by three clinical trials (1-3). The key measure of efficacy was the incidence of medically attended RSV lower respiratory tract infection (MA RSV LRTI ) evaluated during the 150 days after Beyfortus® administration. Beyfortus® reduced the risk of MA RSV LRTI by approximately 70% to 75% relative to placebo. The objective of this observational study is to assess in the real-world the effectiveness of nirsevimab on the Emergency Department use for bronchiolitis as well on the effectiveness of nirsevimab to reduce hospitalization and healthcare usage in France where a national campaign to administer nirsevimab to young infants stated on September 14th, 2023. Type of study Retrospective observational study of medical records which include systematic and prospective data on nirsevimab immunization status of patients visiting the Emergency Department. Methodology This retrospective observational study will include two data set analysis. On one part, data from all infants presenting to the emergency department and diagnosed as having bronchiolitis will be retrieved from medical and nursing records and those who had been given nirsevimab will be compared with those who did not receive this medication prior to the ED visit. On the other part, since the investigators have included nirsevimab administration in their systematic data collection on immunization of all infants visiting our ED, the investigators will use the nirsevimab immunization status of infants diagnosed as having bronchiolitis with those do not having bronchiolitis in order to assess the effectiveness (real-world effect) of nirsevimab on the ED use and hospitalization.
Influenza virus is a significant pathogen in pediatric solid organ transplant (SOT) recipients. However, these individuals respond poorly to standard-dose (SD) inactivated influenza vaccine (IIV). Recent studies have investigated two strategies to overcome poor immune responses in SOT recipients: (1) administration of high-dose (HD)-IIV compared to SD-IIV and (2) two doses of SD-IIV compared to one dose of SD-IIV in the same influenza season. One study compared HD-IIV vs. SD-IIV in adult SOT recipients and noted that HD-IIV was safe and more immunogenic; however, the median post-transplant period was 38 months. A phase I pediatric study comparing a single dose of HD-IIV vs. SD-IIV was safe with higher immunogenicity, but the study was limited by small sample size and median post-transplant vaccine administration was 26 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV one month apart compared to one-dose of SD-IIV revealed modestly increased immunogenicity when given at a median of 18 months post-transplant. Therefore, these studies lack both evaluation in the early post-transplant period and substantive pediatric populations. Additionally, the administration of two-doses of HD-IIV in the same influenza season has not been evaluated in pediatric SOT recipients. Thus, the optimal immunization strategy for pediatric SOT recipients less than 24 months post-transplant is unknown. In addition, immunologic predictors and correlates of influenza vaccine immunogenicity in pediatric SOT recipients have not been well-defined. The central hypothesis of our proposal is that pediatric SOT recipients 1-23 months post-transplant who receive two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have similar safety but higher Hemagglutination Inhibition (HAI) geometric mean titers (GMTs) to influenza antigens compared to pediatric SOT recipients receiving two doses of SD-QIV.
The goal of this clinical trial is to assess the immune response to the yellow fever vaccine 17D in adults with prior 17D vaccination. The main questions this study aims to answer are: - how does prior vaccination affect antibody responses to re-vaccination? - how does prior vaccination affect the immune cell response to re-vaccination? Participants will: - have been previously vaccinated with 17D. - be re-vaccinated with 17D. - provide medical and travel histories. - provide a blood sample prior to vaccination - provide a blood sample approximately every other day for 14 days after vaccination. - provide a blood sample approximately 28 days after vaccination. - complete a daily diary of symptoms following vaccination for 14 days. - report any additional symptoms after 14 days.
The goal of this observational study is to evaluate the protective effect of immune barrier on secondary infection after COVID-19 (coronavirus disease 2019) vaccination or COVID-19 virus Omicron B A. 5.2 strain infection by dynamically monitoring the COVID-19 antibody titer, cellular immune function and the occurrence of secondary infection of healthy participants, mainly medical staff in our hospital, to understand the cross protective effect of COVID-19 antibody on different variants of Omicron, and explore the best time to use COVID-19 vaccine to strengthen immunity after Omicron mutant infection.
Immunization is one of the most cost-effective and successful public health strategy in reducing the health, economic and societal burden of many infectious diseases. Pakistan and Afghanistan remain the only countries where polio is endemic, and Pakistan reports the most cases in the world. Although the rate is lower than in previous years, the situation remains alarming. This study objective is to decrease polio vaccine refusals and zero-dose vaccines by motivating behaviour change
The elderly population and individuals with chronic diseases are at high risk for influenza and influenza-related pneumonia, and it is emphasized that taking pneumonia and influenza vaccine together is effective in reducing mortality as well as hospitalization rates and costs due to pneumonia, influenza, and congestive heart disease. This study that will be carried out will enable to determine the population-based prevalence of the relevant vaccines in the elderly and to determine the determinants of vaccination with the case group to be determined based on this. The aim of the study is two phases. 1. Determination of the prevalence of seasonal influenza and pneumococcal vaccination in elderly people over the over the age of 65 living in Ankara. 2. Investigation of socioeconomic characteristics and vaccine indecision and some health-related determinants of vaccination through the case group created based on the preliminary study on the prevalence of seasonal influenza and pneumococcal vaccination in the elderly over the age of 65 living in Ankara. The study, which includes cross-sectional prevalence and retrospective case-control stages, is planned to be carried out with individuals over the age of 65 living in Ankara province between November 1 and December 31, 2022.
COVID-19 infection during pregnancy is associated with increased risk of pre-eclampsia, preterm birth and stillbirth. Pregnant people with COVID-19 have a higher rate of ICU admission and intubation than those who are not pregnant. COVID-19 vaccine is recommended before pregnancy and during pregnancy to decrease these risks. Despite the benefits of COVID-19 vaccination, only 71% of pregnant women were vaccinated for COVID-19 as of June 2022 (most prior to pregnancy), with a much lower rate of 58% among non-Hispanic Black women. An effective intervention is needed to improve COVID vaccination rates for pregnant people overall. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of increasing maternal COVID-19 vaccination rates.
Lung allograft recipients have a higher burden of influenza disease and greater associated morbidity and mortality compared with healthy controls. Induction and early maintenance immunosuppression is thought to impair immunogenicity to standard dose inactivated influenza vaccine. This early post-transplant period is when immunity is most desirable, since influenza disease during this time frame is associated with adverse consequences. Thus, strategies to reduce severe influenza disease in this highly susceptible population are critical. No trials in lung transplant recipients have evaluated two doses of HD-IIV within the same influenza season as a strategy to improve immunogenicity and durability of influenza prevention. Furthermore, no influenza vaccine trials have focused on enrollment of subjects at early post-transplant timepoints. Very few studies have been performed in solely lung allograft recipients. Immunosuppression intensity is highest in lung patients, thereby limiting comparisons to recipients of heart, liver, and kidney transplants. Therefore, studies to assess both HD-IIV and two-dose strategies in the same influenza season in post-lung transplant recipients are greatly needed. The central hypothesis of our proposal is that lung allograft recipients who are 1-35 months post-transplant and receiving two doses of HD-quadrivalent inactivated influenza vaccine (QIV) will have higher HAI geometric mean titers (GMT) to influenza antigens compared to those receiving two doses of SD-QIV. To test this hypothesis and address the above critical knowledge gaps, we propose to conduct a phase II, multi-center, randomized, double-blind, controlled immunogenicity and safety trial comparing the administration of two doses of HD-QIV to two doses of SD-QIV in lung allograft recipients 1-35 months post-transplant. The results of this clinical trial will address significant knowledge gaps regarding influenza vaccine strategies (e.g., one vs. two doses and HD-QIV vs. SD-QIV) and immune responses in lung transplant recipients and will guide vaccine recommendations during the post-transplant period.
A pneumonia of unknown cause detected in Wuhan, China, was first reported in December 2019. On 08 January 2020, the pathogen causing this outbreak was identified as a novel coronavirus 2019. The outbreak was declared a Public Health Emergency of International Concern on 30 January 2020. On 12 February 2020, the virus was officially named as severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the WHO officially named the disease caused by SARS-CoV-2 as coronavirus disease 2019 (COVID-19). On 11 March 2020, the WHO upgraded the status of the COVID-19 outbreak from epidemic to pandemic, which is now spreading globally at high speed. There are currently few licensed vaccines to prevent infection with SARS-CoV-2 or COVID-19 and the duration of response is unknown. Given the rapid transmission of COVID-19 and incidence of disease on a worldwide basis, the rapid development of effective vaccines with sufficient protection and duration of response is of utmost importance. IAU has developed a thermally stable plasmid DNA (pDNA)-based vaccine candidate using a platform approach that enables the rapid development of vaccines against emerging viral diseases, including SARS-CoV-2. The pDNA vaccine developed by IAU is a synthetic, codon-optimized, encode either the full-length Spike (S) gene or S1 domain of SARS-CoV-2 as genes of interest. Here, we aim to test a synthetic, codon optimized pDNA encoding S.opt.FL as vaccine candidate against COVID-19. A key advantage of pDNA vaccine is that multiple immunization can be used without the limitations of anti-vector responses. This study is intended to investigate the safety, immunogenicity, and tolerbilty of this prophylactic vaccine against COVID-19 administered as intramuscular immunization (i.m.).
The COSI BAIR trial will involve approximately 60 children, aged 5 to 8 years old, comprising a subset of participants from the Melbourne Infant Study BCG for Allergy and Infection Reduction (MIS BAIR) randomised controlled trial. The overall aim of this trial is to investigate the specific and heterologous effects of COVID-19 vaccination on immunity in children. COSI BAIR will aim to recruit its participants from the MIS BAIR Bacillus Calmette-Guérin (BCG)-naïve group. These children will be followed up until 28 days after their final Coronavirus Disease 2019 (COVID-19) vaccination. Venous blood samples will be collected at two study visits, at Murdoch Children's Research Institute (MCRI): 1. Day 0 - baseline (day of COVID-19 vaccination #1), and 2. Day 84 (28 days after COVID-19 vaccination #2).