Safety, Tolerability and Immunogenicity Study of AV7909 Anthrax Vaccine in Healthy Adults
Completed
The purpose of this Phase 1 clinical trial is to evaluate the safety, tolerability, and immunogenicity of AV7909 anthrax vaccine in healthy adults. In this study, healthy male and female subjects between 18 and 50 years of age will receive vaccinations via the intramuscular (IM) route at Days 0 and 14. Safety and tolerability will be evaluated via laboratory tests, physical examinations, vital signs, adverse events (AEs), concomitant medications, and local and systemic signs and symptoms of reac... Read More
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
03/14/2024
Locations: Miami Research Associates, Miami, Florida +2 locations
Conditions: Bacillus Anthracis (Anthrax) Infection
Hepatitis B Virus Antibody Booster Program for the Production of Hepatitis B Immune Globulin (HBIG)
Terminated
Hepatitis B Virus Antibody Booster Program
Gender:
ALL
Ages:
Between 20 years and 55 years
Trial Updated:
03/14/2024
Locations: Cangene Plasma Resources, Mid-Florida, Altamonte Springs, Florida +1 locations
Conditions: Healthy Volunteers
Dose Study of ACAM2000 Smallpox Vaccine in Previously Vaccinated Adults
Completed
The objective of this study is to determine the minimum dose of ACAM2000 needed to produce a cutaneous reaction in at least 90% of a population of healthy adults at least 28 years of age and previously vaccinated against smallpox.
Gender:
ALL
Ages:
28 years and above
Trial Updated:
03/14/2024
Locations: PRA International, Lenexa, Kansas +2 locations
Conditions: Smallpox
A Phase 2 Safety and Immunogenicity Study for an Anthrax Vaccine Using 3 Schedules and Two Dose Levels
Completed
The purpose of this study is to assess the safety and immunogenicity of an anthrax vaccine. The vaccine schedule and dose will also be assessed.
Gender:
ALL
Ages:
Between 18 years and 50 years
Trial Updated:
03/14/2024
Locations: Miami Research Associates, Miami, Florida +3 locations
Conditions: Anthrax
Phase 3 Study of Novavax Vaccine(s) as Booster Dose After mRNA Vaccines
Completed
This is an open-label Phase 3 study evaluating the immunogenicity and safety of Novavax vaccine(s) with Matrix-M™ adjuvant (ancestral strain NVX-CoV2373 and an alternative strain and/or multivalent Novavax vaccine) as booster doses following a series of primary and booster doses of authorized/approved mRNA vaccines followed by a single booster dose of NVX-CoV2373 in the Novavax 2019nCoV-307 study (NCT05463068).
Gender:
ALL
Ages:
Between 18 years and 49 years
Trial Updated:
03/01/2024
Locations: Benchmark Research, Austin, Texas +4 locations
Conditions: COVID-19
A Study to Evaluate the Effects of Ocrelizumab on Immune Responses In Participants With Relapsing Forms of Multiple Sclerosis
Completed
This multicenter, randomized, open-label study will evaluate the immune response to vaccines (tetanus toxoid \[TT\]-containing adsorbed vaccine, 23-valent pneumococcal polysaccharide vaccine \[23-PPV\] either unboosted or boosted with 13-valent pneumococcal conjugate vaccine \[13-PCV\], influenza vaccine, keyhole limpet hemocyanin \[KLH\]) after administration of a dose of ocrelizumab (OCR) in participants with relapsing multiple sclerosis (RMS).
Gender:
ALL
Ages:
Between 18 years and 55 years
Trial Updated:
02/29/2024
Locations: North Central Neurology Associates, Cullman, Alabama +21 locations
Conditions: Multiple Sclerosis, Relapsing-Remitting
A Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Experimental Rabies Vaccine in Healthy Adults
Completed
The purpose of this first time-in-human (FTiH) study is to evaluate the safety, reactogenicity and immunogenicity of different dose levels of an experimental rabies glycoprotein G (RG) vaccine (RG-SAM \[CNE\] vaccine), made using a new technology, when administered intramuscularly (IM) on a 0, 2, 6 \*-month schedule to healthy adults. \* There will be no vaccinations with the third dose of any of the study treatments.
Gender:
ALL
Ages:
Between 18 years and 40 years
Trial Updated:
02/29/2024
Locations: GSK Investigational Site, South Miami, Florida +3 locations
Conditions: Virus Diseases
Serologic Response to SHINGRIX Vaccine in Patients With CLL and WM Treated With BTK Inhibitors
Completed
The primary objective of the study is to assess the capability of a patient with Chronic Lymphocytic Leukemia (CLL) or Waldenström Macroglobulinemia (WM) to generate an immune response to the Shingrix vaccine under first-line BTK inhibitors.
Gender:
ALL
Ages:
50 years and above
Trial Updated:
02/16/2024
Locations: University of Rochester, Rochester, New York
Conditions: Chronic Lymphocytic Leukemia (CLL), Waldenstrom Macroglobulinemia (WM)
Solid Organ Transplant SHINGRIX
Terminated
This study will assess the immune responses to the recombinant, AS01-adjuvanted varicella zoster virus subunit (HZ/su) vaccine or SHINGRIX in immunosuppressed patients, particularly those who have received a renal transplant, and aim to better understand if the vaccine and perhaps other adjuvanted vaccines are safe in these patients. 30 participants will be divided into 2 groups, one group will receive the 1st out of 2 doses of the vaccine 3-6 months after transplant per standard of care and th... Read More
Gender:
ALL
Ages:
50 years and above
Trial Updated:
02/15/2024
Locations: Hope Clinic, Atlanta, Georgia +3 locations
Conditions: Kidney Transplant; Complications
The Immunogenicity and Safety of Zostavax® and Shingrix® in Rheumatoid Arthritis Patients Using Abatacept
Active Not Recruiting
This investigator-initiated study will serve as a sub-study for the American College of Rheumatology-sponsored VERVE protocol currently funded by the NIH. This double-blinded multicenter randomized pragmatic trial is designed to determine whether Zostavax or Shingrix are safe and effective in patients with rheumatoid arthritis (RA) currently using anti-tumor necrosis factor (TNF) therapies. Inclusion/exclusion criteria for this sub-study mirror that of the parent VERVE trial with the exception o... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/12/2024
Locations: St. Luke's Health System, Boise, Idaho +4 locations
Conditions: Herpes Zoster, Inflammatory Disease, Rheumatoid Arthritis
The COVID-19 VaccinE Response and Co-Administration in Rheumatology Patients (COVER-CoAd)
Active Not Recruiting
Based on the experience with influenza, pneumococcal, and shingles vaccinations in rheumatic disease populations, it is clear that some disease modifying anti-rheumatic drugs and the immunomodulatory therapies used to treat immune-mediated inflammatory diseases have the capacity to blunt immune responses to COVID-19 vaccines. Several studies have suggested that patients with autoimmune conditions may be at increased risk of poor COVID-19 outcomes. There is an urgent need to better clarify the i... Read More
Gender:
ALL
Ages:
18 years and above
Trial Updated:
02/12/2024
Locations: Center for Rheumatic Diseases, Northport, Alabama +12 locations
Conditions: Rheumatic Diseases
Apnea in Hospitalized Preterm Infants Following the Administration of Routine Childhood Vaccines
Completed
A prospective, randomized open-label clinical trial will be conducted from July 2018 to October 2020. Approximately 300 preterm infants will be enrolled across three sites: Duke University Medical Center, the University of North Carolina, and Cincinnati Children's Hospital Medical Center. Eligible infants will be randomized 1:1 to receive either 2-month US licensed childhood vaccines (PCV13, DTaP, HBV, IPV an Hib) or no vaccines. After their participation in the study, healthcare providers of th... Read More
Gender:
ALL
Ages:
6 weeks and above
Trial Updated:
02/12/2024
Locations: Centers for Disease Control and Prevention, Atlanta, Georgia +3 locations
Conditions: Apnea, Apnea Neonatal, Prematurity