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.
1 Primary · 3 Secondary · Reporting Duration: 365 days
Awards & Highlights
7 Treatment Groups
Cohort 6: NDV-HXP-S high dose IM
1 of 7
Cohort 2: NDV-HXP-S low dose IN
1 of 7
Cohort 3: NDV-HXP-S low dose IM
1 of 7
Cohort 4: NDV-HXP-S low dose IN+IM in combination
1 of 7
Cohort 5: NDV-HXP-S high dose IN
1 of 7
Cohort 7: NDV-HXP-S high dose IN+IM in combination
1 of 7
Cohort 1: Placebo / Sodium Chloride
1 of 7
35 Total Participants · 7 Treatment Groups
Primary Treatment: Cohort 6: NDV-HXP-S high dose IM · Has Placebo Group · Phase 1
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18 - 59 · All Participants · 0 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
- Punnee Pitisuttithum, Viravarn Luvira, Saranath Lawpoolsri, Sant Muangnoicharoen, Supitcha Kamolratanakul, Chaisith Sivakorn, Piengthong Narakorn, Somchaiya Surichan, Sumalee Prangpratanporn, Suttida Puksuriwong, Steven Lamola, Laina D Mercer, Rama Raghunandan, Weina Sun, Yonghong Liu, Juan Manuel Carreño, Rami Scharf, Weerapong Phumratanaprapin, Fatima Amanat, Luc Gagnon, Ching-Lin Hsieh, Ruangchai Kaweepornpoj, Sarwat Khan, Manjari Lal, Stephen McCroskery, Jason McLellan, Ignacio Mena, Marcia Meseck, Benjaluck Phonrat, Yupa Sabmee, Ratsamikorn Singchareon, Stefan Slamanig, Nava Suthepakul, Johnstone Tcheou, Narumon Thantamnu, Sompone Theerasurakarn, Steven Tran, Thanakrit Vilasmongkolchai, Jessica A White, Adolfo Garcia-Sastre, Peter Palese, Florian Krammer, Kittisak Poopipatpol, Ponthip Wirachwong, Richard Hjorth, Bruce L Innis. Safety and Immunogenicity of an Inactivated Recombinant Newcastle Disease Virus Vaccine Expressing SARS-CoV-2 Spike: Interim Results of a Randomised, Placebo-Controlled, Phase 1/2 Trial. medRxiv 2021.09.17.21263758; doi: https://doi.org/10.1101/2021.09.17.21263758
- Sun, Weina, Stephen McCroskery, Wen-Chun Liu, Sarah R. Leist, Yonghong Liu, Randy A. Albrecht, Stefan Slamanig, et al.. 2020. “A Newcastle Disease Virus (NDV) Expressing a Membrane-anchored Spike as a Cost-effective Inactivated Sars-cov-2 Vaccine”. Vaccines. MDPI AG. doi:10.3390/vaccines8040771.
- Sun W, McCroskery S, Liu WC, Leist SR, Liu Y, Albrecht RA, Slamanig S, Oliva J, Amanat F, Schafer A, Dinnon KH 3rd, Innis BL, Garcia-Sastre A, Krammer F, Baric RS, Palese P. A Newcastle Disease Virus (NDV) Expressing a Membrane-Anchored Spike as a Cost-Effective Inactivated SARS-CoV-2 Vaccine. Vaccines (Basel). 2020 Dec 17;8(4):771. doi: 10.3390/vaccines8040771.
- Sean Liu 2022. "A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05181709.
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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" - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor