Clinical trials: Priming
Influenza, Vaccine
Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine
The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.
- Trial name
- NCT03300050
- Testing
- cH8/1N1 LAIV, AS03-adjuvanted cH5/1N1 IIV, cH5/1N1 IIV
- Where
- 2 sites in United States
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- PATH
Breast Cancer, Breast Neoplasms
Pembrolizumab, IRX-2, and Chemotherapy in Triple Negative Breast Cancer
This is a Phase II, randomized, open-label trial to evaluate the clinical and immunologic activity of pembrolizumab plus chemotherapy when combined with various immunotherapy induction regimens as neoadjuvant therapy for triple…
- Trial name
- NCT04373031
- Testing
- Pembrolizumab, IRX 2
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Providence Health & Services
Hypoxic-Ischemic Encephalopathy, Brain Injury
Prospective Research in Infants With Mild Encephalopathy
A multicenter observational pilot study will be conducted to determine the natural history of infants with early diagnosis (≤ 6 hrs of age) of mild neonatal encephalopathy (NE) who are not qualified for therapeutic hypothermia.
- Conditions
- Hypoxic-Ischemic Encephalopathy, Brain Injury, Neonatal Seizure
- Trial name
- PRIME (NCT01747863)
- Testing
- Neurologic examination
- Where
- 7 sites in United States, Canada and 2 more
- Volunteers
- 63 people
- Sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
Spinal Cord Injuries, Paraplegia, Spinal
Transspinal Stimulation Plus Locomotor Training for SCI
Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury.
- Conditions
- Spinal Cord Injuries, Paraplegia, Spinal, Tetraplegia/Tetraparesis, Paraplegia, Spastic
- Trial name
- NCT04807764
- Testing
- Standing transspinal stimulation followed by robotic gait training, Lying transspinal stimulation followed by robotic gait training
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- City University of New York
HIV Infections
A Study to Assess the Safety and Immune Response to Env-C DNA and Protein Vaccines in Kenya
This is a study of HIV vaccines. A vaccine is a medical product given to prevent certain diseases. The vaccine may educate the body to form a defensive response to try to prevent the disease from the beginning, or preventing it…
- Trial name
- NCT04826094
- Testing
- Env-C Plasmid DNA, HIV Env gp145 C.6980 protein, Rehydragel®
- Where
- Kenya
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Infections, Meningococcal
Study to Asses DTPw-HBV/Hib at 15-18 Months (m) and Mencevax™ ACW at 24 to 30 m in Primed Subjects
The purpose of this study is to assess the safety and reactogenicity of a booster dose of diphtheria-tetanus-whole cell pertussis-hepatitis B virus/Haemophilus influenzae type b vaccine (DTPw-HBV/Hib) at 15-18 m and to assess the…
- Trial name
- NCT00317109
- Testing
- Tritanrix™- HepB, Hiberix™, Mencevax™ ACW
- Where
- 3 sites in South Africa
- Volunteers
- 168 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Angina, Coronary Occlusion
XIENCE PRIME Japan Post-Marketing Surveillance (PMS)
The objectives of the PMS are to observe the frequency, type, and degree of device deficiency to assure the safety of the new medical device (XIENCE PRIME) as well as to collect information on evaluation of the efficacy and…
- Conditions
- Angina, Coronary Occlusion, Coronary Artery Disease, Coronary Artery Stenosis
- Trial name
- NCT01721096
- Testing
- XIENCE PRIME - Long Length (LL), XIENCE PRIME - Core Size
- Where
- Japan
- Volunteers
- 536 people
- Sponsor
- Abbott Medical Devices
Pancreas, Mass Lesion
Assessing Effects of Heparin Priming and Pass Number on Tissue Quality of Fine Needle Biopsies
This is a randomized study that will enroll patients scheduled for an endoscopic ultrasound biopsy of a pancreas lesion to be in the heparin or saline group during the procedure.
- Trial name
- NCT04764396
- Testing
- Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe), Saline
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Michigan
Infections, Meningococcal
Co-administration of Meningococcal Vaccine GSK134612 and Pneumococcal Vaccine GSK1024850A vs Individual Administration
The purpose of this study is to demonstrate, in 12-23 months old subjects, the non-inferiority of meningococcal vaccine GSK134612 and pneumococcal vaccine GSK1024850A when co-administered, compared to each vaccine administered…
- Trial name
- NCT00758264
- Testing
- Meningococcal vaccine GSK134612, Pneumococcal vaccine GSK1024850A
- Where
- 5 sites in Mexico, Taiwan
- Volunteers
- 363 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Immunization of Children Previously Primed With GSK Pneumococcal Vaccine GSK1024850A and of Unprimed Children in Nigeria
The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination…
- Trial name
- NCT01153893
- Testing
- Pneumococcal vaccine GSK1024850A, InfanrixTM
- Where
- Nigeria
- Volunteers
- 105 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Infections, Streptococcal
Assess Reacto- and Immunogenicity of Pneumococcal Conjugate Vaccine When Given as Booster or a 2 Dose Catch up Schedule
This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose…
- Trial name
- NCT00513409
- Testing
- Synflorix, Infanrix Hexa, Havrix
- Where
- Chile
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Neurodermatitis
Study of Dupilumab for the Treatment of Patients With Prurigo Nodularis, Inadequately Controlled on Topical Prescription Therapies or When Those Therapies Are Not Advisable (LIBERTY-PN PRIME)
Primary Objective: To demonstrate the efficacy of dupilumab on itch response in participants with prurigo nodularis (PN), inadequately controlled on topical prescription therapies or when those therapies are not advisable.
- Trial name
- NCT04183335
- Testing
- Dupilumab SAR231893, Moisturizers, Low to medium potent topical corticosteroids
- Where
- 63 sites in United States, Argentina and 6 more
- Volunteers
- 151 people
- Sponsor
- Sanofi
Vascular Disease, Myocardial Ischemia
A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population
The purpose of this study is to evaluate the safety and effectiveness of the AVJ-09-385 Small Vessel Everolimus Eluting Coronary Stent System (EECSS) (2.25 mm diameter stent) in treatment of subjects with ischemic heart disease…
- Conditions
- Vascular Disease, Myocardial Ischemia, Coronary Artery Stenosis, Coronary Disease
- Trial name
- SV JAPAN (NCT01115933)
- Testing
- XIENCE PRIME SV EECSS
- Where
- 14 sites in Japan
- Volunteers
- 65 people
- Sponsor
- Abbott Medical Devices
Hemorrhagic Fever, Ebola
Safety, Tolerability and Immunogenicity Study of 2-dose Heterologous Regimens for Ebola Vaccines Ad26.ZEBOV/MVA-BN-Filo
The purpose of this study is to assess the safety, tolerability and immunogenicity of different vaccination schedules of Ad26.ZEBOV and MVA-BN-Filo administered intramuscularly (IM) as 2-dose heterologous regimens in healthy and…
- Trial name
- NCT02598388
- Testing
- Ad26.ZEBOV, MVA-BN-Filo
- Where
- 7 sites in United States, Kenya and 4 more
- Volunteers
- 578 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Postoperative Pulmonary Complications
An Anesthesia-Centered Bundle to Reduce Postoperative Pulmonary Complications: The PRIME-AIR Study
Postoperative pulmonary complications (PPCs) are a major cause of morbidity and mortality in surgical patients. National estimates suggest 1,062,000 PPCs per year, with 46,200 deaths, and 4.8 million additional days of…
- Trial name
- PRIME-AIR (NCT04108130)
- Testing
- Preoperative Education, Intraoperative PEEP (Positive End-Expiratory Pressure) Individualization, Individualization of Neuromuscular Blockade
- Where
- 16 sites in United States
- Volunteers
- 794 people
- Sponsor
- Columbia University
Human Immunodeficiency Virus
Safety and Efficacy Study of Vaccine Schedule With Ad26.Mos.HIV and MVA-Mosaic in Human Immunodeficiency Virus (HIV)-Infected Adults
The purpose of the study is to assess: 1 safety and tolerability of adenovirus serotype 26 (Ad26) prime and Modified Vaccinia Ankara (MVA) boost versus placebo in participants on suppressive antiretroviral therapy (ART) that was…
- Trial name
- NCT02919306
- Testing
- Ad26.Mos.HIV, MVA-Mosaic
- Where
- Thailand
- Volunteers
- 27 people
- Sponsor
- Janssen Vaccines & Prevention B.V.
Infections, Streptococcal
Pneumococcal Vaccine Booster Study in Healthy Children 12-18 Mths Old Previously Primed With the Same Vaccines
The purpose of this observer blind study is to assess the safety in terms of fever >39°C (rectal temperature) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK…
- Trial name
- NCT00547248
- Testing
- Synflorix, Tritanrix-HepB, Hiberix
- Where
- 7 sites in Philippines, Poland
- Volunteers
- 756 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
HIV Infection
Immunogenicity and Safety of 4 Prime-boost Combinations of HIV Vaccine Candidates in Healthy Volunteers
The development of a safe and effective HIV-1 vaccine strategy would probably be the best solution for the ultimate control of the worldwide AIDS pandemic.
- Trial name
- VRI01 (NCT02038842)
- Testing
- LIPO-5, MVA HIV-B (MVATG17401), GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
- Where
- France
- Volunteers
- 92 people, healthy volunteers welcome
- Sponsor
- ANRS, Emerging Infectious Diseases
HIV-1, HIV Infections
A Study of Safety, Tolerability, and Immunogenicity of the MRKAd5 Gag/Pol/Nef Vaccine in Healthy Adults (V520-016)
The goal of this study is to understand the safety, tolerability and immunogenicity of the Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef Vaccine (MRKAd 5 HIV-1 gag/pol/nef) vaccine in healthy human volunteers compared…
- Trial name
- NCT00849680
- Testing
- Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose), Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose)
- Volunteers
- 317 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Pain, Chronic, Depressive Symptoms
Pain Reduction Through Empowered Recovery (PRIME) Study
Chronic pain and depression or low mood are often experience by women who age with or into disabilities. Due to various factors women with disabilities often experience this cycle of pain and depression.
- Conditions
- Pain, Chronic, Depressive Symptoms, Depression, Disability Physical
- Trial name
- PRIME (NCT05619510)
- Testing
- PRIME Intervention
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Johns Hopkins University