15 Clinical Trials for Various Conditions
This project aims to monitor the side effects of COVID-19 vaccines worldwide actively. The primary objectives of the project include a) to estimate the prevalence of each local and systemic side effect of each COVID-19 vaccine among healthcare workers (HCW), old adults over +65 (OA), and schoolteachers (ST); b) to evaluate the potential demographic and medical risk factors for side effects frequency and intensity; c) to evaluate the long-term consequences of COVID-19 vaccines. The secondary objectives include a) to evaluate the relative safety of COVID-19 vaccines compared to each other; b) to evaluate the impact of palliative drugs used by the recently vaccinated individuals on their short-term side effects resolution.
The goal of this clinical trial is to evaluate whether metabolic modulation with a combined nutraceutical product can improve symptoms and metabolic health in adults diagnosed with post-acute Covid-19 vaccination syndrome (PACVS), a condition characterized by persistent fatigue and exercise intolerance attributed to Covid-19 vaccination and confirmed by laboratory testing. The main questions it aims to answer are: Does the combined nutraceutical intervention improve quality of life (measured by the PAC-19QoL questionnaire) in PACVS patients? Does the intervention improve metabolic, inflammatory, and functional biomarkers (e.g., HbA1c, blood lactate, CRP, spike protein levels, heart rate variability, 6-minute walk distance)? Researchers will compare the intervention group (receiving the ViTAL SCAN nutraceutical) to a placebo group (receiving rice protein powder with vitamin C) to determine if the intervention leads to greater improvements in symptoms and biomarker profiles. Participants will: Take the assigned supplement daily for 3 months (ViTAL SCAN or placebo) Attend clinic visits for blood and urine sampling, physical performance tests (6-minute walk test), and heart rate monitoring Complete quality of life and health behavior questionnaires Undergo measurements of metabolic and inflammatory markers (HbA1c, lactate, CRP, spike protein) Record supplement intake This study is currently pending IRB approval and aims to enroll 100 adults with PACVS for a randomized, placebo-controlled trial.
The purpose of this study is to vaccinate plasma donors with ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacturing of Vaccinia Immune Globulin Intravenous (VIGIV).
If your serious vaccine-induced adverse event has been entered in the CDC Vaccine Adverse Event Reporting System (VAERS) we are interested in enrolling you for this study in order to log your symptoms. The primary goal of this study is to create a national database and gather vaccine-associated serious adverse events/injury data from newly vaccinated individuals in the US in order to identify the possible underlying causal relationships and plausible underlying biological mechanisms. The project aims to identify the genetic determinants of vaccine-induced adverse response by studying host genetics. We plan to use whole genome sequencing to identify single nucleotide polymorphisms associated with cardiovascular, neurological, gastrointestinal, musculoskeletal and immunological symptoms induced by vaccine administration. The secondary goal is to establish criteria that enable classification of vaccine-induced adverse events/injuries compare data from our database with the official Vaccine Injury Table National Vaccine Injury Compensation Program on or after March 21, 2017. The tertiary goal is to establish a database to gather detailed long-term adverse reaction data from subjects enrolled in FDA Emergency Use Authorized vaccine clinical trials.
To determine if patients with a history of Diabetes Mellitus Type I or II developed a change in blood glucose levels as reported on Continuous glucose monitoring devices (CGMS) within the first week following administration of each dose of the COVID-19 vaccine.
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic presents a great challenge to global health. The first case was identified in December 2019 in Wuhan, China and since has infected nearly 100 million people and claimed almost 2 million lives worldwide. In response, the medical community and scientists have worked hard to develop effective therapies and guidelines to treat a wide range of symptoms including the use of the antiviral drug remdesivir, convalescent plasma, antibiotics, steroids, and anticoagulant therapy. To prevent the spread of the disease, multiple vaccines based on mRNA and DNA technologies that include inactivated viral components have been developed and millions of doses are currently being administered worldwide. Early analysis of data from the phase III Pfizer/BioNTech and Moderna vaccine trials suggested the vaccine was more than 90% effective in preventing the illness with a good safety profile (Polack et al., 2020). However, there are still many unknowns regarding the long-term safety of these newer vaccine technologies and the level and duration of immunogenicity. SARS-CoV-2 infection results in seroconversion and production of anti-SARS-CoV-2 antibodies. The antibodies may suppress viral replication through neutralization but might also participate in COVID-19 pathogenesis through a process termed antibody-dependent enhancement (Lu et al., 2020). Rapid progress has been made in the research of antibody response and therapy in COVID-19 patients, including characterization of the clinical features of antibody responses in different populations infected by SARS-CoV-2, treatment of COVID-19 patients with convalescent plasma and intravenous immunoglobin products, isolation and characterization of a large panel of monoclonal neutralizing antibodies and early clinical testing, as well as clinical results from several COVID-19 vaccine candidates. In this study, we plan to assess the effic of both vaccines on the healthcare workers. As healthcare workers begin to receive their first vaccination dosage, we will start looking for traces of antibodies within the blood and saliva. The data provided will help us determine the efficacy of the vaccine over a period of 1 year, identify any difference in efficacy amongst different populations (gender, age, and ethnicities) differences among vaccine types, demographics and follow-up on any potential side effects. We will collaborate with Nirmidas Biotech Inc. based in Palto Alto, California, a Stanford University spinoff on this project. Nirmidas Biotech. Inc is a young diagnostic company that have received several FDA EUA tests for COVID-19. We will perform IgG/IgM antibody detection by the NIRMIDAS MidaSpot™ COVID-19 Antibody Combo Detection Kit approved by FDA EUA for POC testing in our hospital site for qualitative antibody testing. We will then send dry blood spot and saliva to Nirmidas for the pGOLD™ COVID-19 High Accuracy IgG/IgM Assay to quantify antibody levels and avidity, both of which are important to immunity. The pGOLD assay is a novel nanotechnology assay platform capable of quantifying antibody levels and binding affinity to viruses. We collaborated recently with Nirmidas on this platform and published a joint paper in Nature Biomedical Engineering on COVID-19 Ab pGOLD assay (Liu et al., 2020). It is also capable of detecting antibodies in saliva samples and could offer a non-invasive approach to assessing antibody response for vaccination.
VOICES is a longitudinal, prospective, observational study that will enroll up to 10,000 subjects of diverse racial backgrounds being administered an emergency use authorized COVID-19 vaccine, for collection and analysis of stool and blood samples. It has recently been shown that the gut microbiome, the collection of microbes that line our GI tract, play a significant role in vaccine immune response and severe complications from COVID-19. The identification of biomarkers may aid in predicting response to vaccination and are critical towards improving vaccine-induced immunity. These real-world patient derived biomarkers could be used as interventional targets for the design of innovative adjuvant co-therapies that can boost an effective immune response to the vaccine, enhancing efficacy for a broader population, including those at most risk. Subjects who meet the entry criteria will provide two samples each of blood, one prior to and one following vaccine administration. Follow-up questionnaires will be sent at 3, 6, 9, and 12 months to determine if participants have contracted COVID-19 or have experienced any adverse effects of the vaccine. Nasal swab samples will also be collected from participants that have contracted COVID-19. The samples will be analyzed to determine the impact of gut microbiome composition and function on the immune system and vaccine efficacy.
This is a prospective randomized, open label clinical trial in approximately 300 children aged 5-11 years with a physician diagnosis of persistent asthma. Participants will be randomized 1:1 to receive either a single intranasal dose of licensed quadrivalent LAIV (LAIV4) or an intramuscular injection of quadrivalent IIV4 (IIV4).
This study will evaluate the safety of administering an additional dose of an mRNA COVID-19 vaccine or mRNA bivalent COVID-19 booster vaccine to individuals who have had adverse reactions to a previous dose or administering an initial dose of an mRNA COVID-19 vaccine to individuals with a personal history of allergic reaction. In addition, this study will evaluate the safety of administering an initial or additional dose or bivalent booster of an mRNA COVID-19 vaccine to individuals experiencing an adverse reaction to a natural COVID-19 infection ("long COVID"). Eligible participants enrolled in this trial will receive an initial or additional dose of either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna COVID-19 bivalent vaccine. Participants will also be required to have 1-2 in person visits along with phone call follow up visits. We hypothesize that individuals who have had adverse reactions to a previous dose of an mRNA COVID-19 vaccine will tolerate an additional dose of the primary mRNA vaccine or bivalent booster, as indicated, and those with a personal history of allergic reaction will tolerate an initial dose of an mRNA COVID-19 vaccine. We also hypothesize that those individuals experiencing an adverse reaction will tolerate an initial or additional dose of a primary mRNA COVID-19 bivalent vaccine, as indicated. The study hypothesizes that individuals that have had adverse reactions to a dose of an mRNA COVID-19 vaccine will tolerate an additional dose and those with a personal history of allergic reaction will tolerate vaccination with an mRNA COVID-19 vaccine.
Primary Objective: • To evaluate the safety and tolerability of cAd3-EBO-S and cAd3 Marburg vaccines when administered Intramuscular (IM) at a dose of 1 x 10\^11 particle units (PU) to healthy adults. Secondary Objectives: * To evaluate the antibody response to Monovalent Chimpanzee Adenoviral Vectored Filovirus Ebola-S (cAd3-EBO-S) and Monovalent Chimpanzee Adenoviral Vectored Filovirus (Marburg) (cAd3 Marburg) vaccines as assessed by antigen glycoprotein (GP) specific (enzyme-linked immunosorbent assay) ELISA * To collect sufficient post-vaccination plasma to support further development of filovirus assays
During the study, members of different online and offline communities will be followed post COVID-19 vaccination. Injection-site (local) and systemic reaction data will be assessed on vaccination day and afterwards using either web surveys or personal communication, depending on study participant preference. Hypothesis to be tested: The safety profile and the magnitude and durability of immune responses to the COVID-19 vaccines as well as adverse reactions depend on health conditions, metabolism and microbiomes.
This is a prospective, observational study. During the study, children and adolescents (ages ≥ 5 to \< 16) will be followed post administration of mRNA COVID-19 vaccines. Injection site (local), systemic reaction, and unsolicited adverse event data will be assessed on vaccination day and during the 7 days following each vaccination using either identical web-based or paper diaries, depending on study participant preference. At Duke University, Cincinnati's Children Hospital, and Kaiser Permanente Northern California, serum samples will be collected for optional assessment of antibody titers to COVID-19. Each participant who opts in will have baseline (within 3 days of vaccination) serologies obtained and immunogenicity assessment at 28 (+7) days after each dose. All participants will be followed for 180 days after dose 2 for serious adverse events and adverse events of special interest.
This study is a prospective, randomized clinical trial. During this study, participants will be randomly assigned to receive quadrivalent inactivated influenza vaccine (IIV4) and mRNA COVID-19 vaccine either simultaneously or sequentially, 7-14 days apart. Persons in the simultaneous group will receive mRNA COVID-19 and IIV4 at Visit 1 (Day 1) and a saline placebo injection at Visit 2. Persons in the sequential group will receive mRNA COVID-19 vaccine and a saline placebo at Visit 1 (Day 1) and IIV4 injection at Visit 2. For participants receiving their primary dose series, a second dose of mRNA COVID-19 vaccine will be administered either 3 to 8 weeks or 4 to 8 weeks following the first dose, depending upon the mRNA COVID-19 vaccine provided. For those receiving a booster dose of mRNA COVID-19 only a single mRNA COVID-19 will be received in this study. Solicited symptoms of reactogenicity and adverse events will be assessed on vaccination day and daily during the 7 days following each Vaccination Visit using either electronic or paper symptoms diaries, depending on study participant preference. Quality of life data will be collected using electronic or paper diaries on day of Vaccination Visit 1 and daily during the 7 days following the visit. Serious adverse events and adverse events of special interest will be collected throughout the duration of the study. Participants are followed through Day 121. Serum samples from participants will be collected for determination of SARS-CoV-2 seropositivity at baseline. Serum samples will be taken throughout the study to determine IIV4 and COVID-19 vaccine immunogenicity and for potential future studies.
The overall aim of the study is to compare the safety of simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Quadrivalent Influenza Vaccine, Adjuvanted (FLUAD®) versus simultaneous Zoster Vaccine Recombinant, Adjuvanted (RZV) (SHINGRIX®) and Fluzone® High-Dose Quadrivalent vaccine in persons age ≥65 years. A prospective, randomized, blinded clinical trial that will be conducted during the 2021/2022 and 2022/2023 influenza seasons. Over the course of these two influenza seasons, approximately 220 older adults will be enrolled at Duke University Medical Center, and 180 older adults at Johns Hopkins University Medical Center. Eligible subjects will be randomized to receive either simultaneous RZV/FLUAD® or RZV/Fluzone® High-Dose vaccines. All subjects will be assessed for 7 days post-injection and safety and tolerability compared between the two groups. Serious adverse events and adverse events of clinical interest will be assessed 42 days post-vaccination and compared between the two groups. Health-related quality of life will be assessed pre-vaccination Day 1 through Day 8. Serious Adverse Events and Adverse Events of Clinical Interest were also assessed throughout the study period.
The overall aim of the study is to compare safety and immunogenicity of inactivated influenza vaccine (IIV), adjuvanted (FLUAD®) versus High-Dose inactivated influenza (Fluzone® High-Dose) vaccine in persons ≥65 years (20% aged ≥80 years). A prospective, randomized, blinded clinical trial that will be conducted during the 2017/2018 and 2018/2019 influenza seasons. During each season, approximately 220 older adults will be enrolled at Duke University Medical Center and 140 older adults at Boston University Medical Center. Eligible subjects will be randomized to receive either adjuvanted influenza vaccine or High-Dose influenza vaccine. All subjects will receive vaccine and provide a blood draw at Visit 1, and then return for a second blood draw without vaccination about 4 weeks later to assess for influenza antibody titers. A subset of 100 subjects at Duke will provide a third blood draw 6 months post-vaccination to assess for waning of influenza antibody titers. Subjects will record the occurrence of local and systemic reactions (including fever, pain, tenderness, swelling, redness, general systemic systems), unsolicited adverse events, medical care utilization, and changes in medications over 8 days following vaccination. In addition, serious adverse events and events of clinical interest will be assessed through 42 days post-vaccination. Health-related quality of life will be assessed pre-vaccination (Day 1) and on Days 3 and 9 post-vaccination.