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Immunization; Infection clinical trials

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NCT ID: NCT05111899 Active, not recruiting - Clinical trials for Breastfeeding, Exclusive

Leading Advancements in the Uptake of Newborn Community Health

LAUNCH
Start date: July 11, 2022
Phase: N/A
Study type: Interventional

The primary objective of the study is to determine the impact of a behavior change intervention that partners Orthodox priests with members of the Health Development Army (HDA) and train them to conduct newborn health outreach to increase rates of early initiation of and exclusive breastfeeding through 6 months and vaccination coverage at six months. Secondary objectives include: - Determine the impact of the intervention on infant growth at six months, observed and self-reported changes in nutrition and feeding practices of mother and infants, and early identification of newborn illness. - Design a culturally relevant, scalable intervention for community-based newborn and infant health in Gondar in partnership with local partners, the Federal Ministry of Health, and the Gondar Regional Health Bureau.

NCT ID: NCT05104385 Completed - COVID-19 Pandemic Clinical Trials

Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences

HU-CoVaCS
Start date: June 21, 2021
Phase:
Study type: Observational

The first COVID-19 case in Turkey was reported on March 11, 2000. National COVID-19 mass vaccination was initiated on Jan 13, 202, with two doses of CoronaVac (R) inactivated vaccine (of Sinovac), 28 days apart. The health personnel were prioritized in the mass vaccination, given their high rates of exposure and fatality. National COVID-19 statistics have been limited to those announced in the media; data breakdown by gender, age, vaccine type and status etc. is not provided, nor is the association between non-pharmaceutical preventive measures (NPPM) and infection rates. Well-planned, longitudinal, detailed studies with laboratory support are clearly warranted. Hacettepe University is a leading institution in Turkey, with its large health sciences campus. Students of medical school (grades 4, 5, and 6) and dental school (grades 4 and 5) have been actively providing patient care in HU Hospitals, and more than 10% of medical interns had been reportedly diagnosed as COVID-19 cases prior to vaccination activities, despite (reportedly) strict non-pharmaceutical public preventive measures (NPPM) use inside/outside the occupational settings. A two-year prospective cohort study was planned for periodic evaluation of students' general health status and COVID-19 risk/exposure/infection, for timely referrals and quarantine/isolation, as needed. Anti- SARS-CoV-2-RBS antibodies will be measured periodically after vaccination, together with evaluation of potential adverse effects, presence and durability of vaccine-induced immunity. Comparison of antibody levels were planned for incident COVID-19 cases and two test-negative controls of the same gender, attending the same grade and faculty. A subcohort will be followed for aymptomatic infection risk. Institutional ethical approvals were obtained, as required. A step-wise informed consent was obtained from all participants, all tests will be done with de-personalized records, and all statistical analyses and reporting will be completed anonymously. Follow-up of participants will be ensured using participant-specific study identification numbers provided at enrollment. Study team is composed of academic personnel of 10 selected departments, nursing support is provided by the Students' Health Center in the Campus, and dental faculty are assigned for obtaining informed during the 4 subsequent study visits. The budget of the study is provided by the Hacettepe University Scientific Research Projects Office (BAP).

NCT ID: NCT04870021 Completed - Hepatitis B Clinical Trials

Hepatitis B Birth Dose for Newborns

HepB-BirD
Start date: March 15, 2015
Phase: Phase 4
Study type: Interventional

With 2.5% prevalence in general population, Pakistan is an intermediate endemicity country for hepatitis B. However, wide disparity exists across the country as disease prevalence in general population soars as high as 14% in hyper endemic areas. This hyper endemicity increases the risk of acquiring infection via vertical and horizontal routes of disease transmission. National immunization schedule in Pakistan administers the first vaccine against hepatitis B at 6th week after infant birth. Owing to this 6 week interlude the existing immunization schedule may not provide adequate protection to a newborn against the disease. A monovalent hepatitis B vaccination shot, administered within 12 hours of birth, is the preferred strategy for disease control in hyper endemic areas. The National Immunization Technical Advisory Groups around the world are expected to use rigorous scientific evidence and make changes in the immunization schedule and vaccine dosage, responding to the evolving epidemiology of childhood diseases. Such research on local evidence for hepatitis B vaccine in Pakistan is not available and our research fills this gap by This research studied the hepatitis B vaccine response, in two cohorts of healthy infants. An open labeled, randomized controlled, non-inferiority, vaccine trial methodology was used. Margin of non non-inferiority (Δ) was set at 5%. The trial administered hepatitis B birth dose as an intervention and vaccination done under the national immunization schedule was taken as standard of care.

NCT ID: NCT04824638 Completed - Healthy Clinical Trials

BNT162b2 Vaccination With 2 Doses in COVID-19 Negative Volunteers and With a Single Dose in COVID-19 Positive Volunteers

CoviCompareP
Start date: March 8, 2021
Phase: Phase 2
Study type: Interventional

As previously shown, individuals who experienced COVID-19 have developed some protective immunity to reinfection. The magnitude and duration of protection from reinfection conferred by the infection may be weaker after an asymptomatic infection as it is after a symptomatic COVID-19 episode. Moreover, it is known that immunity decreases among older adults compared to younger individuals often referred to as ''immune senescence,'' and leading to a decreased efficacy of vaccination. This study raises the question of whether a single administration of BNT162b2 in participants with prior SARS-CoV-2 infection leads to sufficient and durable immune response. We propose to evaluate the level of the single BNT162b2 vaccine dose response according to the severity of the previous SARS-CoV-2 infection in young and elderly participants with the same immunogenicity analyses to assess this response in participants receiving the two-dose vaccination regimen.

NCT ID: NCT04816760 Recruiting - Clinical trials for Endothelial Dysfunction

Immune Cells Phenotypes During COVID-19

IMMUNO-COVID
Start date: March 25, 2020
Phase:
Study type: Observational

The ongoing pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) has infected more than one hundred twenty million peoples worldwide one year after its onset with a case-fatality rate of almost 2%. The disease due to the coronavirus 2019 (i.e., COVID-19) is associated with a wide range of clinical symptoms. As the primary site of viral invasion is the upper respiratory airways, lung infection is the most common complication. Most infected patients are asymptomatic or experience mild or moderate form of the disease (80 %). A lower proportion (15%) develop severe pneumonia with variable level of hypoxia that may required hospitalization for oxygen therapy. In the most severe cases (5%), patients evolve towards critical illness with organ failure such as the acute respiratory distress syndrome (ARDS). At this stage, invasive mechanical ventilation is required in almost 70 % and the hospital mortality rises to 37 %. Immune cells are key players during SARS CoV-2 infection and several alterations have been reported including lymphocytes (T, B and NK) and monocytes depletion, and cells exhaustion. Such alterations were much more pronounced in patients with the most severe form of the disease. Beside, a dysregulated proinflammatory response has also been pointed out as a potential mechanism of lung damage. Finally, COVID-19 is associated with an unexpectedly high incidence of thrombosis which probably results from the viral invasion of endothelial cells. The investigators aim to explore prospectively the alterations of innate and adaptive immune cells during both the acute and the recovery phase of SARS CoV-2 pneumonia. Flow and Spectral cytometry will be used to perform deep subset profiling focusing on T, B, NK, NKT, gamma-gelta T, monocytes and dendritic cells. Each specific cell type will be further characterized using markers of activation/inhibition, maturation/differenciation and senescence as well as chemokines receptors. T-cell memory specificity will be explore using specific SARS CoV-2 pentamer. Platelet activation and circulating microparticles will be explore using flow cytometry. Serum SARS CoV-2 antibodies (IgA, IgM, IgG), serum cytokines, and serum biomarkers of alveolar epithelial and endothelial cells will be analyze using ELISA and correlate with the severity of the disease.

NCT ID: NCT04613206 Recruiting - Influenza Clinical Trials

High vs. Standard Dose Influenza Vaccine in Adult SOT Recipients

Start date: January 11, 2021
Phase: Phase 2
Study type: Interventional

The influenza virus is a significant cause of morbidity in adult solid organ transplant (SOT) recipients. However, these individuals show a suboptimal response to vaccines including the 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. The first study compared HD-IIV vs. SD-IIV in adult SOT and noted HD-IIV was safe and reported higher immunogenicity; however, the median post-transplant period was 38 months. In another phase II trial of adult SOT recipients, two doses of SD-IIV a month apart compared to one-dose SD-IIV revealed increased immunogenicity, with a median post-transplantation period of 18 months. Therefore, these studies lack evaluation in the early post-transplantation period in this vulnerable population when influenza disease is most severe. The administration of two-doses of HD-IIV in the same influenza season has also not been studied in SOT recipients. Moreover, the vast majority of SOT influenza vaccinations studies have not substantively evaluated prolonged immunogenicity. Thus, the optimal immunization strategy for SOT recipients less than 12 months post-transplant is poorly-defined. In addition, the immunologic predictors and correlates of influenza vaccine immunogenicity in SOT recipients have not been defined. The investigators hypothesize that adult solid organ transplant recipients that are 1-11 months out from transplant and are receiving high-dose inactivated influenza vaccine will have higher hemagglutination inhibition (HAI) geometric mean titers to influenza A antigens compared to adult SOT recipients receiving standard-dose inactivated influenza vaccine. To test this hypothesis and address the above critical knowledge gaps, The investigators propose to conduct a phase II multicenter randomized controlled trial comparing either two doses HD-IIV, two doses of SD-IIV, or one-dose of HD-IIV in adult kidney, heart, and liver SOT recipients 1-11 months post-transplantation. The results of this study will address significant gaps in knowledge regarding influenza vaccine strategies and immune responses in adult SOT recipients and will guide vaccine recommendations in this vulnerable population.

NCT ID: NCT04444518 Active, not recruiting - Pregnancy Related Clinical Trials

Increasing Influenza and Tdap Vaccination of Pregnant Women

Start date: November 11, 2020
Phase: N/A
Study type: Interventional

Pregnant women who get influenza are more likely than non-pregnant women to have serious complications, including hospitalizations, death, preterm labor and premature birth. Pertussis can cause hospitalization or death for newborns. However, influenza and Tdap vaccination rates for pregnant women are low nationally. In this study, the investigators will perform a randomized controlled trial aimed at practice change in obstetricians' offices, with an overall goal of reducing morbidity and mortality from influenza and pertussis infections.

NCT ID: NCT04347694 Recruiting - SARS-CoV 2 Clinical Trials

Study to Determine the Immunization Status Among Nephrological Health Care Personnel Against SARS-CoV-2 in a Single Center Over the Course of 12 Months During the Worldwide COVID-19 Pandemic.

CONEC
Start date: April 11, 2020
Phase:
Study type: Observational

Infections with Corona-Viruses have shown to be a menace for patients with comorbidities such as hypertension, diabetes, cardiovascular disease or immunosuppression. Those are features almost every nephrological patient brings along, especially those on maintenance dialysis and those with renal transplant. Since the emergence of the novel coronavirus SARS-CoV-2 in November 2019 in Mainland China the fear for pandemic infections has increased. But not only is the course of infection itself important, the prevention of transmission to and by attending medical personnel should be put into perspective. Thus there is a lack of sufficient data of occult immunization or persistent state on immunization. In our study up to 400 health care personnel will be screened serologically for IgM, IgA and IgG against the SARS-CoV-2 virus. Blood and urine samples throughout 12 months will be sampled and analyzed. The aim of the study is to identify the rate of occult immunization and at the same time to gather data about the persistence of immune response to an infection with SARS-CoV-02. The results will help provide sufficient safety measures for health care providers and renal patients undergoing unavoidable clinical treatment.

NCT ID: NCT04042246 Completed - Clinical trials for Educational Problems

Effect of Knowledge on Vaccine Take-up in Adamawa State, Northeastern Nigeria

Start date: September 15, 2019
Phase: N/A
Study type: Interventional

Child immunization is not a one-time behavior; rather, it is a repeated behavior within a specific timeframe. Not only the low immunization, but also the dropout of immunization and the delayed immunization from the recommended immunization schedule are prevalent and high in Africa. The most common reason for the incomplete vaccination is that caregivers thought the children had already been fully immunized (44.8%), according to Nigeria Multiple Indicator Cluster Survey (MICS) conducted in 2016/2017. Caregivers' misconception of the complete immunization can be attributed to the complicated immunization schedule. In Nigeria, infants are supposed to receive 9 different types of vaccines at 5 different times within the first year since the births. To make things more complicated, the vaccine schedule changes over time; for example in Nigeria, the new vaccine, inactivated polio vaccine (IPV) was introduced in 2015 to be received at 14 weeks after births, and rotavirus vaccine and meningococcal A vaccine are scheduled for the introduction in 2019. In this complicated and rapidly-changing environment regarding vaccination schedule, the goal of the study is to improve the understanding of vaccination completion and children's vaccination status among caregivers, which can then lead to the improved rate of full vaccination among children. Objectives The main objectives of this study are to understand the impact of providing the general and tailored information on the vaccination schedule and vaccination status of women's children on the vaccine take-up. In this study, the investigators focus on women who has a child who is 12 months old or younger. Hypothesis The main hypothesis of this proposed study are as follows: 1. Information on vaccination among caregivers: the general and tailored information on vaccination schedule and child's vaccination status, improves the knowledge on benefit and understanding of vaccination completion, vaccination schedule and the vaccination status of the children among caregivers 2. Full immunization rate: through the improved knowledge level on the concept of vaccination completion and their children's vaccination status, the proposed study increases the full immunization rate among children

NCT ID: NCT03908164 Active, not recruiting - Pregnancy Related Clinical Trials

Optimising the Timing of Whooping Cough Immunisation in MUMs

OpTIMUM
Start date: May 7, 2019
Phase: Phase 4
Study type: Interventional

A multicentre study to evaluate the impact of timing of whooping cough (pertussis) vaccination in pregnancy, with participants randomised to receive whooping cough vaccination at one of three time points in pregnancy.