805 Clinical Trials for Various Conditions
This is an observational study aiming at describing COVID-19 vaccination outcomes among HIV-positive and HIV-negative individuals, using electronic health records to observe their usual clinical care. This study will describe levels of COVID-19 vaccine response (i.e., Ig spike antibody measurements). Rates of antibody level decay after vaccination will be assessed. The efficacy of using antibody levels to help guide the timing of booster doses among HIV-negative and HIV-positive patients will be evaluated.
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.
The purpose of this study is to characterize the safety and immunogenicity of AZD9838 and AZD6563 when administered as a single dose vaccination against SARS-CoV-2 in adults.
The goal of this study is to assess the immunogenicity of inactivated influenza vaccination (IIV) in healthy elderly volunteers aged 50 years and older receiving one of two different health management trainings.
The overall goal of this study is to study influenza vaccine responses in HIV infected individuals. Immunocompromised individuals require special protection from influenza, but may not respond appropriately to the standard killed vaccine. Patients who receive the H1N1 flu vaccine as part of their standard of care will be asked to donate blood samples for immunologic studies. These studies will determine whether participants were able to produce the appropriate antibodies to the vaccine and possibly identify predictors of vaccine responsiveness. Our hypothesis is that vaccine responsiveness to the new H1N1 influenza vaccine will be compromised in HIV infected patients.
The purpose of this study is to characterize the immunogenicity and safety of 3 doses of GSK's avian flu vaccine GSK 1557484A given at different time intervals to adults aged 18 years or greater who are at increased occupational risk of H5N1 exposure.
Primary objective of this study is to describe the safety and tolerability of multiple doses of MEDI-534 in children 6 to less than (\<) 24 months of age and in infants 2 months of age.
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb). This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. GlaxoSmithKline Biological's has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also evaluating novel HPV vaccines formulations. This study will evaluate the long-term immunogenicity and safety of a novel GSK Biological's vaccine in approximately 376 subjects who received the novel vaccine or the control vaccine administered in the primary study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Human Papilloma viruses (HPV) are viruses that cause infections of the skin and genitals in men and women. Several types of HPV infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). This infection, if it persists, can lead over a long period of time to cancer of the cervix in women. In collaboration with MedImmune Inc., GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic types HPV-16 and HPV-18 formulated with the adjuvant AS04. GSK Biologicals is also evaluating novel HPV vaccine formulations.This study will evaluate the immunogenicity and safety of a novel GSK Biologicals HPV vaccine in women 18-25 years of age at study start. Approximately 376 study subjects will receive the novel HPV vaccine or the control vaccine administered intramuscularly according to a 0-1-6 month schedule.
This is a complimentary study to an elderly influenza study. Subjects 18-40 will receive a single dose flu vaccine and be evaluated for humoral and cell mediated immunity to influenza antigens.
The body's immune system (fights infection) is known to decline during the aging process, resulting in an increased risk of catching infections. Vaccinations also are not as effective in protecting older people against infection as they are in younger people. The purpose of this study is to better understand how and why vaccines are not as effective in older people. The researchers believe that the immune response in older people who get a higher dose vaccine will be similar to the immune response in young adults who get the standard (lower) dose vaccine. This study is a substudy to a main study, evaluating flu vaccines in people 65 years and older. Volunteers who are in the main study will be asked if they will participate in the substudy. The substudy requires them to give 2 additional blood samples for an in-depth look at their immune response to the flu vaccine given in the main study. Substudy volunteers will have up to 3 clinic visits and participate up to 28 weeks.
This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
The purpose of this study is to investigate the effectiveness, safety, and tolerability of an influenza vaccine. Influenza is a highly infectious disease that occurs throughout the world in the winter months. Infection with an influenza virus is a major public health threat as it has the ability to spread rapidly and affect large numbers of people. Up to 1359 healthy adults ages 18 to less than 65 years old will participate in this study for up to 24 days. Volunteers will receive an injection of either influenza vaccine with thimerosal, vaccine without thimerosal, or placebo with thimerosal. Volunteers will be asked to document information about any health changes for 21 days following vaccination. Volunteers will return to the clinic on days 5 and 21 after vaccination to share this information with study staff. On day 21, volunteers will have a physical examination. Blood samples will be taken prior to vaccination and at Day 21 post-vaccination.
This clinical trial is studying the newly licensed RSV vaccines in adults over age 60 years living in long-term care facilities (nursing homes) by comparing the immune response to their vaccine to adults over age 60 years living in the community.
The main purpose of the study is to evaluate the safety, reactogenicity, and the immunogenicity of mRNA-1010 vaccine candidate variations.
To measure levels of HPV antibodies in post-solid-organ transplant recipients who have gotten the HPV9 vaccine.
This is a phase II study that will examine the immunogenicity of the Shingrix vaccine in patients following an allogeneic stem cell transplant.
This clinical study will evaluate the safety, tolerability and reactogenicity of mRNA-1893 Zika vaccines in flavivirus seronegative and flavivirus seropositive participants
This is a phase II, randomized, double-blind, active-controlled study to evaluate the safety, immunogenicity, and effect on infant immune responses of a single dose of Tetanus diphtheria acellular pertussis vaccine (Tdap) in pregnant women in Mali. 200 healthy pregnant women, ages 18 through 39 years, inclusive, who meet all eligibility criteria will be randomly allocated in a 2:1 ratio to receive either Tdap (BOOSTRIX) or Tetanus diphtheria toxoid (Td) at 14 0/7 weeks through 26 6/7 weeks estimated Gestational Age (GA). For the fetuses of pregnant subjects, GA will be established by ultrasound, whenever possible, in combination with date of last menstrual period (LMP), when available, and fundal height. Study duration is 21 months: approximately 2 months in the start-up period, 6 months enrolling subjects, and 13 months (3-7 months while pregnant and 6 months postpartum) from last subject vaccinated until she and her infant complete follow-up. The primary objectives of this study are: 1) to assess the safety and tolerability of a single 0.5 mL intramuscular injection of BOOSTRIX in pregnant women; 2) to assess the safety of a single maternal BOOSTRIX vaccination on the fetus and infant; 3) to assess the level of Pertussis Toxin (PT) antibody at birth among infants whose mothers received a single dose of BOOSTRIX or Td while pregnant.
The purpose of this study is to evaluate the efficacy, safety and immunogenicity of the GSK3536852A vaccine, which was designed to protect against shigellosis caused by Shigella sonnei (S. sonnei) and is using the new Generalized Modules for Membrane Antigens (GMMA) platform technology developed by GlaxoSmithKline (GSK) Vaccines Institute for Global Health (GVGH). The study vaccine could be the stepping stone for the development of a multivalent broadly protective Shigella vaccine for vaccination of impoverished communities where shigellosis is endemic. However, a standalone monovalent vaccine against S. sonnei could be used to protect travelers against diarrheal shigellosis, as the vast majority of travelers' shigellosis is caused by S. sonnei, and even to protect infants in endemic regions where shigellosis is primarily caused by S. sonnei. The GSK3536852A vaccine has been tested in two Phase I dose escalation studies in Europe to assess its safety and immunogenicity via three routes of administration: intramuscular (IM), intranasal (IN) and intradermal (ID). The results from the first study (dose escalation with IM vaccination) have shown that the vaccine has an acceptable safety profile and is well-tolerated up to a dose of 100 micrograms (µg). The results from the second study (dose escalation with ID, IN and IM vaccination) showed that GSK3536852A vaccine is well-tolerated also when administered by the ID and IN routes of vaccination. However, immunogenicity data have shown that GSK3536852A vaccine administered by the ID and IN routes is not as immunogenic as GSK3536852A vaccine administered by the IM route. Therefore, it has been decided to proceed with the clinical development program of this vaccine only using the IM vaccination route. In terms of dosage, the regimen tested in Phase I studies (three doses given one month apart) did not show any significant benefit from the third dose in terms of immunogenicity, therefore a two dose schedule was selected for next studies. A Phase IIa study, conducted in endemic regions of Africa (i.e., Kenya), has been completed and confirmed the acceptable safety profile and immunogenicity of GSK3536852A vaccine. Performing this vaccine-human challenge study may give the opportunity to establish evidence of clinical protection induced by the candidate S. sonnei vaccine (GSK3536852A vaccine) at an early development stage.
This clinical study will assess the safety, reactogenicity and immunogenicity of mRNA-1647 and mRNA-1443 cytomegalovirus vaccines in healthy adults
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of two HIV-1 pDNA vaccines: p24CE1/2 pDNA and p55\^gag pDNA administered with IL-12 pDNA adjuvant, given by intramuscular (IM) injection with electroporation (EP), in healthy, HIV-uninfected adults.
The study is designed to evaluated if adjuvanted vaccine elicits higher T cell and B cell responses than non-adjuvanted standard dose influenza vaccine in nursing home residents.
A Phase 1, Open-Label Study to Evaluate the Safety, Tolerability, and Immunogenicity of GTL001 Vaccine Adjuvanted With Imiquimod Cream in HPV 16- and/or HPV 18-Infected Women Aged 25 to 65 Years, With Normal Cytology, ASCUS, or LSIL.
This is a phase I randomized, double blind clinical trial designed to evaluate the safety, tolerability and immunogenicity of the ID93 recombinant protein antigen alone or formulated with GLA-SE or AP10-602 adjuvant in 70 healthy adults 18-49 years of age. Subjects will receive a total of 3 doses administered intramuscularly on Days 1, 29 and 57. Subjects will be monitored for approximately 422 days (365 days following the third study injection), including safety laboratory analyses done just prior to and 7 days following each study injection. Blood samples will be obtained for immunological assays (Luminex, intracellular cytokine staining at Days 1 and 71, and antibody analysis at Days 1 and 85). The primary objective is to evaluate the safety and tolerability of 10 µg ID93 + 5 or 10 µg AP10-602 compared to 10 µg ID93 + 5 µg GLA-SE and 10 µg ID93 alone following three consecutive intramuscular injections administered on Days 1, 29 and 57.
The purpose of this study is to compare the effectiveness of a two dose versus a three dose schedule and intramuscular versus intradermal injection for pre-exposure prophylaxis.
This study, as a post-marketing commitment to the Food and Drug Administration, is designed to detect the effect of raxibacumab on anthrax vaccine adsorbed (AVA) immunogenicity in a healthy volunteer population. This is a randomized, open-label, parallel group, two arm study to compare the immunogenicity of AVA at 4 weeks after the first AVA dose, when AVA is administered alone or concomitantly with raxibacumab. The study is planned to enroll approximately 30 to 534 subjects in up to 3 cohorts. The total duration of the study will be approximately 26 weeks. The dates reflect cohort 1.
Background: - Vaccines create resistance to disease. This study tests experimental human immunodeficiency virus (HIV) vaccines that use an adenovirus as a transporter. Transporters may help vaccines stimulate an immune response against HIV. This means the body works to fight infection. Researchers want to see if different ways of giving the vaccines cause different immune responses. They also want to see if the vaccines adenovirus is contagious. Adenoviruses cause cold symptoms or mild eye infections. Participants cannot get HIV from these vaccines. But they can get the adenovirus, so their entire household and intimate contacts must participate. Objective: - To test the safety of experimental HIV vaccines. Eligibility: - Healthy adults 18-49 years old. Design: * Participants will be screened with medical history, physical exam, and blood and urine tests. * Participants will receive the vaccine 3 times over 6 months. Each time, they will have a physical exam and blood and urine tests. Samples will be taken from their nose, rectum, and cervix. * Some participants will receive the vaccine by swallowing 11 capsules with water. Clinic staff will observe them for 1 hour. * Some participants will receive the vaccine swabbed in their throat. They will get dose 1 at the hospital and stay there for 1 week. They will have medical tests and nose swabs. Doses 2 and 3 will not require a hospital stay. * Participants will have 7 follow-up visits over 6 months, with a physical exam and blood tests. Samples will be taken from their nose, throat, and rectum. * Household and intimate contacts will have 4 clinic visits over 8 months, with a physical exam and blood tests.
The overall goal of this study is to compare the safety and immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals. Our hypothesis is that Fluzone® HD will be safe and more immunogenic than the currently used vaccine