SARS-CoV-2Phase 1NCT05181709

A Live Recombinant Newcastle Disease Virus-vectored COVID-19 Vaccine Phase 1 Study.

A Phase 1 study testing Sodium Chloride, NDV-HXP-S IN low dose and NDV-HXP-S IM low dose in people with SARS-CoV-2, run by Sean Liu at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will be a phase-1, open-label, placebo-controlled, evaluation of two-dosages of a live, recombinant Newcastle disease virus expressing the spike protein of SARS-CoV-2 (NDV-HXP-S), an investigational product for IN, IM, or a combined IN+IM vaccination in healthy adults previously immunized against COVID-19. Read more about this study

Who is it for?: Ages 18 to 59 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2
What is being tested?: Sodium Chloride, NDV-HXP-S IN low dose and NDV-HXP-S IM low dose
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 9 Feb 2022to 19 Apr 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 59 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Willing and able to provide written informed consent prior to performing study procedures.
Males and non-pregnant females who are between 18 to 59 years of age.
Asymptomatic, RT-PCR negative (at screening) AND without a known prior history of COVID-19 infection (requiring a negative SARS-CoV-2 nucleocapsid antibody test result at screening).
Provides documentation showing completion of an FDA authorized or approved COVID-19 vaccination regimen, where the last administration was ≥ 6 months (180 days) from the study enrollment date.
IF FEMALE PARTICIPANT: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:
Is not a woman of child-bearing potential (WOCBP); OR

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Is a WOCBP and using an acceptable contraceptive method during the intervention period (for a minimum of 90 days after NDV-HXP-S vaccination). The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. Only highly effective methods of contraception that have a low user dependency or a combination of highly effective methods that are user dependent may be used.
IF MALE PARTICIPANT: Agrees to the following requirements during the intervention period and for at least 90 days after NDV-HXP-S vaccination, which corresponds to the time needed to eliminate reproductive safety risk of the study intervention(s):
Refrain from donating sperm AND be abstinent from heterosexual intercourse with a female of childbearing potential as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR
Must agree to use a male condom when engaging in any activity that allows for passage of ejaculate to another person. In addition to male condom use, a highly effective method of contraception may be considered in WOCBP partners of male participants.
Participant understands and agrees to comply with planned study procedures.
Participant agrees to not participate in another clinical trial for treatment of COVID-19 or SARS-CoV-2 through Day 365.
Participant agrees to not receive any other vaccination (including COVID-19 vaccines) through day 56 of the study.
Provides consent for release of information for hospitalization records and other medically attended visits during the study.

Who cannot join

Clinical and/or laboratory evidence indicative of COVID-19 infection.
Demonstrates a STRONG COVID-19 positive antibody serology (>12500 AU/ml per chemiluminescent microparticle immunoassay (including AdviseDx SARS-CoV-2 IgG II)) or a NEGATIVE COVID-19 serology on screening against SARS-CoV-2 spike protein.
History of hypersensitivity to egg products.
History of severe reactions to vaccinations.
Potential for prior NDV exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with NDV).
History of an immunocompromising medical condition (such as primary immunodeficiencies, AIDS, or neutropenia).

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Current or recent use of immunosuppressive medications (i.e., any systemic corticosteroids, chemotherapeutics, immunoglobulin therapies, etc.) based on the assessment of their half-life by the investigator.
Any history of HIV, hepatitis C, hepatitis B (by laboratory testing and/or history), Guillain-Barré syndrome, and/or recent receipt of immunoglobulins and/or blood products.
Pregnancy or actively breastfeeding.
Other medical condition or abnormal laboratory values which may place participant at increased risk for harm due to participation in the study as determined by the investigator.
In the opinion of the investigator that it would be unwise to allow the participant to be randomized into the study, including those persons who the investigator would consider as high risk of SARS-CoV-2 exposure, including healthcare workers with direct patient care and laboratory workers who handle SARS-CoV-2.
Participants at higher risk of severe COVID-19, as defined by CDC guidance (https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/index.html), where severity of risk and eligibility will be determined by the investigator. This guidance includes details regarding older adults, people with specific medical conditions, and pregnant and recently pregnant people.
Participants with fever or signs of acute infection, including symptoms that could indicate SARS-CoV-2 infection.
Participants with a history of chronic rhinitis, nasal septal defect, cleft palate, nasal polyps, or other nasal abnormality that might affect vaccine administration.
Participants who prepare food in the food industry and childcare workers who have direct contact with children 5 years of age or younger.
Participants who have close or household high-risk contacts including but not limited to:
Persons more than or equal to 65 years of age
Children less than or equal to 5 years of age.
Residents of nursing homes.
Persons of any age with significant chronic medical conditions as well as immunosuppression or cancer.
Women who are pregnant, trying to become pregnant, or breastfeeding.
Participants who are students, post-doctoral candidates, or trainees of the study site, or are members of the research staff.
Participants with a history of myocarditis or pericarditis and individuals with an abnormal troponin or abnormal ECG as determined by the investigator. Participants with a screening 12-lead ECG that shows an average QTc interval >500 msec, complete left bundle branch block, ST-T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias should be excluded from study participation.

Trial locations and contacts

1 site in 1 country.

United States1 site

Icahn School of Medicine at Mount Sinai
New York, New York, 10029

Other trials in United States

About this study

Official title: A Phase-1, Open-Label, Placebo-Controlled Evaluation of a Live, Recombinant Newcastle Disease Virus Expressing the Spike Protein of SARS-CoV-2 (NDV-HXP-S), an Investigational Product for Intranasal (IN) and/or Intramuscular (IM) Vaccination in Healthy Adults Previously Immunized Against COVID-19.

Read the detailed description

Primary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 14 days after administration.

Secondary Study Objective: To evaluate the safety and tolerability profile of two dose levels of the NDV-HXP-S vaccine as an IN, IM, or a combined administration IN+IM to healthy, previously immunized adults up to 365 days after administration.

Conditions: SARS-CoV-2
Being tested: Sodium Chloride, NDV-HXP-S IN low dose, NDV-HXP-S IM low dose, NDV-HXP-S IN high dose, NDV-HXP-S IM high dose
Keywords: SARS-CoV-2, COVID-19, Vaccine, Booster
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sodium ChlorideDrug
Also called Placebo
Administered intranasal (IN) and intramuscular (IM) in combination
NDV-HXP-S IN low doseBiological
Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride.
Strength: 3.3x108^8 EID50.
NDV-HXP-S IM low doseBiological
Allantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride.
Strength: 3.3x10^8 EID50.
NDV-HXP-S IN high doseBiological
Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.
NDV-HXP-S IM high doseBiological
Allantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.

Study groups in NCT05181709
Study group	Role	What they receive
Cohort 1: Placebo / Sodium Chloride	Placebo comparator	Participants in Cohort 1 will receive placebo given IN+IM in combination. Placebo administration will be given in an ambulatory setting. IN administration will be immediately followed by IM administration. Participants will be monitored by the research staff for 1-hour after administration. Participants will be permitted to receive any additional federally authorized or approved vaccines 56 days after receiving placebo. Receives: Drug: Sodium Chloride
Cohort 2: NDV-HXP-S low dose IN	Active comparator	Participants in Cohort 2 (low, IN) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IN low dose
Cohort 3: NDV-HXP-S low dose IM	Active comparator	Participants in Cohort 3 (low, IM) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IM low dose
Cohort 4: NDV-HXP-S low dose IN+IM in combination	Active comparator	Participants in Cohort 4 (low, IN+IM) will receive low doses of NDV-HXP-S at 3.3x108 EID50. Participants will be given NDV-HXP-S in an ambulatory setting where IN and IM doses will be given in succession. Participants will be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IN low dose; Biological: NDV-HXP-S IM low dose
Cohort 5: NDV-HXP-S high dose IN	Active comparator	Participants in Cohort 5 (high, IN) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 5 if Cohort 2 (low dose IN) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IN high dose
Cohort 6: NDV-HXP-S high dose IM	Active comparator	Participants in Cohort 6 (high, IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 6 if Cohort 3 (low dose IM) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IM high dose
Cohort 7: NDV-HXP-S high dose IN+IM in combination	Active comparator	Participants in Cohort 7 (high, IN+IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will only enroll into Cohort 7 if Cohort 4 did not have an SAE that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collection and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection. Receives: Biological: NDV-HXP-S IN high dose; Biological: NDV-HXP-S IM high dose

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of local and systemic reactions
The safety and tolerability profile assessed by the number of local and systemic reactions.
Measured: 14 days

Secondary outcomes (3)

Number of adverse events (AEs)
The safety and tolerability profile assessed by the number of serious adverse events.
Measured: 365 days
Number of serious adverse events (SAEs)
The safety and tolerability profile assessed by the number of serious adverse events.
Measured: 365 days
Number of medically-attended adverse events (MAAEs)
The safety and tolerability profile assessed by the number of medically-attended adverse events (MAAEs).
Measured: 365 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Feb 202219 Apr 2024

First posted6 Jan 2022
Study start9 Feb 2022
Primary completion3 May 2023
Study completion19 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Model description: Random and Sequential Assignment
Masking: None (open label)
Enrolment: 35 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05181709
Sponsor's protocol ID: STUDY-21-01589
Status last verified: Apr 2025
First submitted: 4 Jan 2022
Last updated: 17 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after de-identification.

Publications

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.
PubMed 33348607
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
Liu STH, Gonzalez-Dominguez I, Martinez-Perez A, Bozkus CC, Bladh O, Broomes-Pennicott T, Jen A, Egan E, Leiva-Ortiz E, Abid A, Aguilera K, Aberg M, Bhavsar D, Yellin T, Abbad A, Singh G, Carreno JM, Adams J, Quigley C, Saxena M, Meseck M, Ceglia I, Thalin C, Weiskopf D, Garcia-Sastre A, Palese P, Sun W, Krammer F, Aberg JA. Phase 1 trial of intranasal NDV-HXP-S in previously vaccinated adults. Vaccine. 2026 Jun 30;89:128870. doi: 10.1016/j.vaccine.2026.128870. Online ahead of print.
PubMed 42378814
Slamanig S, Lemus N, Lai TY, Singh G, Mishra M, Abdeljawad A, Boza M, Dolange V, Singh G, Lee B, Gonzalez-Dominguez I, Schotsaert M, Krammer F, Palese P, Sun W. A single immunization with intranasal Newcastle disease virus (NDV)-based XBB.1.5 variant vaccine reduces disease and transmission in animals against matched-variant challenge. Vaccine. 2025 Jan 25;45:126586. doi: 10.1016/j.vaccine.2024.126586. Epub 2024 Dec 12.
PubMed 39667115

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase-1, Open-Label, Placebo-Controlled Evaluation of a Live, Recombinant Newcastle Disease Virus Expressing the Spike Protein of SARS-CoV-2 (NDV-HXP-S), an Investigational Product for Intranasal (IN) and/or Intramuscular (IM) Vaccination in Healthy Adults Previously Immunized Against COVID-19.
ClinicalTrials.gov ID: NCT05181709
Acronym / sponsor ID: STUDY-21-01589
Conditions: SARS-CoV-2
Keywords: SARS-CoV-2, COVID-19, Vaccine, Booster
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 35 participants (actual)
Lead sponsor: Sean LiuUniversity, hospital or other
Study start: 9 Feb 2022 (actual)
Primary completion: 3 May 2023 (actual)
Study completion: 19 Apr 2024 (actual)
First posted: 6 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: Random and Sequential Assignment

Arm	Type	Receives
Cohort 1: Placebo / Sodium Chloride	Placebo comparator	Drug: Sodium ChlorideParticipants in Cohort 1 will receive placebo given IN+IM in combination. Placebo administration will be given in an ambulatory setting. IN administration will be immediately followed by IM administration. Participants will be monitored by the research staff for 1-hour after administration. Participants will be permitted to receive any additional federally authorized or approved vaccines 56 days after receiving placebo.
Cohort 2: NDV-HXP-S low dose IN	Active comparator	Biological: NDV-HXP-S IN low doseParticipants in Cohort 2 (low, IN) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
Cohort 3: NDV-HXP-S low dose IM	Active comparator	Biological: NDV-HXP-S IM low doseParticipants in Cohort 3 (low, IM) will receive a single administration of a low dose of NDV-HXP-S at 3.3x108 Egg-Infectious Dose50 (EID50). Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
Cohort 4: NDV-HXP-S low dose IN+IM in combination	Active comparator	Biological: NDV-HXP-S IN low dose, Biological: NDV-HXP-S IM low doseParticipants in Cohort 4 (low, IN+IM) will receive low doses of NDV-HXP-S at 3.3x108 EID50. Participants will be given NDV-HXP-S in an ambulatory setting where IN and IM doses will be given in succession. Participants will be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
Cohort 5: NDV-HXP-S high dose IN	Active comparator	Biological: NDV-HXP-S IN high doseParticipants in Cohort 5 (high, IN) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 5 if Cohort 2 (low dose IN) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
Cohort 6: NDV-HXP-S high dose IM	Active comparator	Biological: NDV-HXP-S IM high doseParticipants in Cohort 6 (high, IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will ONLY enroll into Cohort 6 if Cohort 3 (low dose IM) did not have any SAEs that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collections and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.
Cohort 7: NDV-HXP-S high dose IN+IM in combination	Active comparator	Biological: NDV-HXP-S IN high dose, Biological: NDV-HXP-S IM high doseParticipants in Cohort 7 (high, IN+IM) will receive high doses of NDV-HXP-S at 1x109 EID50. Participants will only enroll into Cohort 7 if Cohort 4 did not have an SAE that required additional participants. Participants will be given NDV-HXP-S in an ambulatory setting and be monitored by the research staff for 4 hours post-administration. Participants will then return home under home isolation. Home isolation will require daily at-home sample collection and online symptom reporting. Discontinuation of home isolation will require laboratory confirmation of negative NDV-HXP-S virus detection.

Who may qualify

Ages: 18 to 59 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (14 listed)

Willing and able to provide written informed consent prior to performing study procedures.
Males and non-pregnant females who are between 18 to 59 years of age.
Asymptomatic, RT-PCR negative (at screening) AND without a known prior history of COVID-19 infection (requiring a negative SARS-CoV-2 nucleocapsid antibody test result at screening).
Provides documentation showing completion of an FDA authorized or approved COVID-19 vaccination regimen, where the last administration was ≥ 6 months (180 days) from the study enrollment date.
IF FEMALE PARTICIPANT: A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

Key exclusion criteria (23 listed)

Clinical and/or laboratory evidence indicative of COVID-19 infection.
Demonstrates a STRONG COVID-19 positive antibody serology (>12500 AU/ml per chemiluminescent microparticle immunoassay (including AdviseDx SARS-CoV-2 IgG II)) or a NEGATIVE COVID-19 serology on screening against SARS-CoV-2 spike protein.
History of hypersensitivity to egg products.
History of severe reactions to vaccinations.
Potential for prior NDV exposures (i.e., experience as a bird-handler, poultry farmer, or scientist conducting research with NDV).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sodium ChlorideAlso: PlaceboAdministered intranasal (IN) and intramuscular (IM) in combination	Drug	Cohort 1: Placebo / Sodium Chloride
NDV-HXP-S IN low doseAllantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride. Strength: 3.3x108^8 EID50.	Biological	Cohort 2: NDV-HXP-S low dose IN, Cohort 4: NDV-HXP-S low dose IN+IM in combination
NDV-HXP-S IM low doseAllantoic fluid diluted in Phosphate buffered saline (PBS), to be further diluted to dose strength in sodium chloride. Strength: 3.3x10^8 EID50.	Biological	Cohort 3: NDV-HXP-S low dose IM, Cohort 4: NDV-HXP-S low dose IN+IM in combination
NDV-HXP-S IN high doseAllantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.	Biological	Cohort 5: NDV-HXP-S high dose IN, Cohort 7: NDV-HXP-S high dose IN+IM in combination
NDV-HXP-S IM high doseAllantoic fluid diluted in Phosphate buffered saline (PBS). Strength: 1x10^9 EID50.	Biological	Cohort 6: NDV-HXP-S high dose IM, Cohort 7: NDV-HXP-S high dose IN+IM in combination

Primary outcome

Number of local and systemic reactions
Time frame: 14 days
The safety and tolerability profile assessed by the number of local and systemic reactions.

3 secondary outcomes

Number of adverse events (AEs)
Time frame: 365 days
Number of serious adverse events (SAEs)
Time frame: 365 days
Number of medically-attended adverse events (MAAEs)
Time frame: 365 days

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
Background: PubMed 33348607Sun 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.
BackgroundPunnee 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
Derived from this study: PubMed 42378814Liu STH, Gonzalez-Dominguez I, Martinez-Perez A, Bozkus CC, Bladh O, Broomes-Pennicott T, Jen A, Egan E, Leiva-Ortiz E, Abid A, Aguilera K, Aberg M, Bhavsar D, Yellin T, Abbad A, Singh G, Carreno JM, Adams J, Quigley C, Saxena M, Meseck M, Ceglia I, Thalin C, Weiskopf D, Garcia-Sastre A, Palese P, Sun W, Krammer F, Aberg JA. Phase 1 trial of intranasal NDV-HXP-S in previously vaccinated adults. Vaccine. 2026 Jun 30;89:128870. doi: 10.1016/j.vaccine.2026.128870. Online ahead of print.
Derived from this study: PubMed 39667115Slamanig S, Lemus N, Lai TY, Singh G, Mishra M, Abdeljawad A, Boza M, Dolange V, Singh G, Lee B, Gonzalez-Dominguez I, Schotsaert M, Krammer F, Palese P, Sun W. A single immunization with intranasal Newcastle disease virus (NDV)-based XBB.1.5 variant vaccine reduces disease and transmission in animals against matched-variant challenge. Vaccine. 2025 Jan 25;45:126586. doi: 10.1016/j.vaccine.2024.126586. Epub 2024 Dec 12.
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after de-identification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sean Liu, MD, PhD principal investigator

Icahn School of Medicine at Mount Sinai

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Sodium Chloride, NDV-HXP-S IN low dose and NDV-HXP-S IM low dose in people with SARS-CoV-2, run by Sean Liu at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of local and systemic reactions (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181709, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.