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NDV-HXP-S Vaccine for COVID-19
Study Summary
This trial will test a new vaccine for COVID-19 that is given either in the nose or in the arm. The vaccine is made from a live virus that has been modified to express the spike protein of SARS-CoV-2. The trial will compare two different doses of the vaccine and will also test a placebo vaccine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Media Library
- You have a high level of COVID-19 antibodies or tested negative for COVID-19 antibodies.I am currently taking or have recently taken drugs that weaken my immune system.You have been exposed to Newcastle Disease Virus (NDV) through handling birds, working on a poultry farm, or doing research with the virus.You have a higher chance of getting very sick from COVID-19 according to CDC guidelines.I have a history of nasal issues that could affect vaccine administration.I am not pregnant or breastfeeding and follow the required contraceptive guidelines.I am between 18 and 59 years old and not pregnant.You have been in close contact with someone who is at high risk of illness.I work in food preparation or childcare with kids under 5.You have had a bad reaction to eggs in the past.I have a history of HIV, hepatitis, Guillain-Barré syndrome, or recently received blood products.I have a history of heart inflammation or abnormal heart tests.I have not had COVID-19, tested negative, and have no symptoms.I have completed my COVID-19 vaccination over 6 months ago.I agree to follow specific rules during and for 90 days after getting the NDV-HXP-S vaccine.You have had serious reactions to vaccines in the past.I currently have a fever or signs of an infection.I have signs or tests suggesting I have COVID-19.
- Group 1: Cohort 6: NDV-HXP-S high dose IM
- Group 2: Cohort 4: NDV-HXP-S low dose IN+IM in combination
- Group 3: Cohort 7: NDV-HXP-S high dose IN+IM in combination
- Group 4: Cohort 5: NDV-HXP-S high dose IN
- Group 5: Cohort 1: Placebo / Sodium Chloride
- Group 6: Cohort 2: NDV-HXP-S low dose IN
- Group 7: Cohort 3: NDV-HXP-S low dose IM
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many volunteers are partaking in this clinical trial?
"Confirmed. The information hosted on clinicaltrials.gov reveals that recruitment for this medical trial is still underway, having been initiated February 1st 2022 and most recently updated June 30th 2022. 35 participants are needed at a single site to complete the study."
Is the research team recruiting patients for participation in this trial?
"According to clinicaltrials.gov, this investigation is still recruiting participants for their trial which was posted on February 1st 2022 and last amended on June 30th of the same year."
How perilous is the administration of high doses of NDV-HXP-S via intramuscular injection for individuals?
"Power's safety assessment of Cohort 6: NDV-HXP-S high dose IM is a 1, due to limited clinical evidence regarding its efficacy and security."
Who has the capability to participate in this experiment?
"This experimental trial is searching for 35 individuals diagnosed with Newcastle Disease between the ages of 19 and 59. Before enrolment, applicants must meet a variety of criteria such as providing written consent, being neither pregnant nor trying to conceive, testing negative on an RT-PCR test and SARS-CoV-2 nucleocapsid antibody test at screening, agreeing not to participate in another clinical study related to COVID until day 365 post intervention and granting permission for medical records release. In addition, male participants are asked to use condoms during sexual activity where ejaculate can be passed onto others while WOCBP partners may take advantage of additional highly"
Are individuals of a younger age bracket eligible to partake in this research?
"The ages of the patients selected for this medical trial must be between 19 and 59 years old."
What is the traditional function of Cohort 6: NDV-HXP-S high dose IM?
"Cohort 6: NDV-HXP-S high dose IM is a popular remedy for diarrhea, as well as inflammation of the nasal mucosa and corneal edema. It can be used in general surgery applications too."
Does the research literature contain any other studies related to Cohort 6: NDV-HXP-S high dose IM?
"Currently, there are 100 live experiments researching Cohort 6: NDV-HXP-S high dose IM with 25 trials in the Phase 3 stage. The concentration of these studies is predominantly found in Philadelphia, Pennsylvania; however 385 medical centres across the globe have conducted research on Cohort 6: NDV-HXP-S high dose IM."
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