Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults

NCT06441968 | Completed Phase 1 FDA Drug

• 1 other identifier: 23-1101
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

A clinical trial to evaluate the safety, reactogenicity, and immunogenicity of MPV/S-2P administered intranasally to adults who have previously received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine. The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults.

Conditions

COVID-19

Keywords

adults; MPV/S-2P; phase 1; SARS-CoV-2; trial; vaccine

Outcome Measures

Primary Outcomes (12)

• Frequency of abnormal clinical safety laboratory AEs

  Day 8

• Frequency of solicited local adverse events (AEs)

  Through Day 14 following vaccination

• Frequency of systemic adverse events (AEs)

  Through Day 14 following vaccination

• Frequency of unsolicited AEs

  Through Day 28 following vaccination

• Occurrence of adverse events of special interest (AESIs)

  Through Month 12 after vaccination

• Occurrence of medically-attended adverse events (MAAEs)

  Through Month 12 after vaccination

• Occurrence of new-onset chronic medical conditions (NOCMCs)

  Through Month 12 after vaccination

• Occurrence of serious adverse events (SAEs)

  Through Month 12 after vaccination

• Severity of abnormal clinical safety laboratory AEs

  Day 8

• Severity of solicited local adverse events (AEs)

  Through Day 14 following vaccination

• Severity of systemic adverse events (AEs)

  Through Day 14 following vaccination

• Severity of unsolicited AEs

  Through Day 28 following vaccination

Secondary Outcomes (12)

• Geometric Mean Fold Rise (GMFR) of anti-vector antibodies

  Through Day 366

• Geometric Mean Fold Rise (GMFR) of mucosal anti-S binding antibodies (IgA, IgG)

  Through Day 366

• Geometric Mean Fold Rise (GMFR) of serum anti-S binding antibody (IgA and IgG)

  Through Day 366

• Geometric Mean Fold Rise (GMFR) of serum neutralizing antibodies to Spike variants

  Through Day 366

• Geometric Mean Titer (GMT) of anti-vector antibodies

  Through Day 366

Study Arms (3)

Cohort 1

EXPERIMENTAL

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^4 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Biological: MPV/S-2P

Cohort 2

EXPERIMENTAL

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^5 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Biological: MPV/S-2P

Cohort 3

EXPERIMENTAL

Healthy adults between 18 - 64 years who have received a primary series and at least one booster with an authorized or licensed mRNA SARS-CoV-2 parenteral vaccine will receive 1 x 10\^6 PFU of MPV/S-2P administered intranasally (approximately 0.5 mL per nostril) using VaxINator (Teleflex) for 1 year. N=20

Biological: MPV/S-2P

Interventions

MPV/S-2P BIOLOGICAL

A live murine pneumonia virus (MPV) vector expressing an additional SARS-CoV-2 S-protein, stabilized in its prefusion form, is being tested for its efficacy in protecting against the SARS-CoV-2 virus. It is speculated to be a next-generation vaccine for COVID-19.

Cohort 1; Cohort 2; Cohort 3

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provides written informed consent prior to initiation of any study procedures.
• Able to understand and agrees to comply with planned study procedures and be available for all study visits.
• Non-pregnant adults, 18-64 years of age at time of vaccination.
• Participants of childbearing potential \* must agree to use or have practiced true abstinence \*\* or use at least one acceptable primary form of contraception \*\*\* \* These criteria are applicable to persons assigned female at birth who have sexual intercourse with a person assigned male at birth, and who are of childbearing potential. Not of childbearing potential include post-menopausal females (defined as having a history of amenorrhea for at least one year) or a documented status as being surgically sterile (hysterectomy, bilateral oophorectomy, tubal ligation/salpingectomy, or Essure (R) placement) \*\* True abstinence is 100 percent of time no sexual intercourse (penis enters the vagina). Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\] and withdrawal are not acceptable methods.
• \*\*\* Acceptable forms of primary contraception include monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more prior to the participant's vaccination, intrauterine devices, birth control pills, and injectable/implantable/insertable/transdermal hormonal birth control products. Must have used at least one acceptable primary form of contraception for at least 30 days prior to vaccination and agree to continue at least one acceptable primary form of contraception through 60 days after vaccination
• Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours prior to study vaccination.
• In general good health\*.
• Receipt of a complete primary COVID-19 mRNA vaccine series and at least one mRNA booster\* with last vaccination at least 16 weeks prior to study vaccination.
• Booster may be either homologous or heterologous to the primary vaccine series and must be an FDA authorized/licensed mRNA vaccine though doses may have been received as part of a clinical trial.
• Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion\*.
• Must agree to have samples stored for secondary research.
• Must agree to wearing a surgical mask (or KN-95 or N-95) within 6 feet of others for 14 days after study vaccination, and potentially longer if asked by study team based on data gathered.

You may not qualify if:

• Positive SARS-CoV-2 PCR at screening.
• Abnormal vital signs (Grade 1 or higher)\*
• \*Grade 1 or higher is equivalent to: Systolic blood pressure (SBP) \>/= 141 mmHg or \</= 89 mmHg Diastolic blood pressure (DBP) \>/= 91 mmHg Heart rate (HR) is \>/= 101 beats per minute or \</= 54 beats per minute Oral temperature \>/= 38.0°C (100.4°F)
• History of SARS-CoV-2 infection or receipt of any COVID-19 vaccine \< 16 weeks prior to study vaccination.
• Participant who is pregnant or breastfeeding.
• Blood or plasma donation within 4 weeks prior to study vaccination.
• Receipt of antibody or blood-derived products within 90 days prior to study vaccination.
• Any self-reported or documented significant medical or psychiatric diseases\* or any other condition that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation.
• \*Significant medical or psychiatric conditions include but are not limited to respiratory disease (e.g., chronic obstructive pulmonary disease \[COPD\]) requiring daily medications currently, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years. Significant kidney disease, liver disease, or cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis or pericarditis, or uncontrolled cardiac arrhythmia. Neurological or neurodevelopmental conditions (e.g., history of Bell's palsy, history of four or more migraine headaches in the past 12 months that interfered with normal daily activity or any migraine headache in the past 5 years that required emergency or inpatient medical care, epilepsy, seizures in the last 5 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease, amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease). Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding treated basal cell and squamous cell carcinoma of the skin, which are allowed. Any autoimmune disease, including hypothyroidism without a defined non-autoimmune cause.
• Any significant nasal or upper airway disease\*.
• \*(Including, but not limited to, being prone to epistaxis, a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head/neck radiation history, anosmia/dysosmia, conditions that require prescription or over the counter intranasal medication (intermittent use will be allowed if no use occurred for 30 days before study vaccination and participant agrees to not use intranasal medication (other than steroids) for 30 days after study vaccination and to not use intranasal steroids for 6 months after study vaccination), and certain ear, nose and throat (ENT) conditions, including significant upper airway/nasopharyngeal disease or abnormal anatomy such as CSF leak.
• Has an acute illness, as determined by the site PI or appropriate sub-investigator within 72 hours prior to study vaccination\*.
• \*An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
• Has a positive test result for hepatitis B surface antigen, hepatitis C virus RNA (by reflex testing), or human immunodeficiency virus (HIV) antigen/antibody test at screening.
• Has any confirmed or suspected immunosuppressive or immunodeficient state such as asplenia, recurrent severe infections and chronic\* immunosuppressant medication within the past 6 months\*\*.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (3)

The Hope Clinic of Emory University

Decatur, Georgia, 30030-1705, United States

Location

NYU Grossman Long Island School of Medicine - Vaccine Center

Mineola, New York, 11501, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3411, United States

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 4, 2024
• Study Start: July 1, 2024
• Primary Completion: November 12, 2025
• Study Completion: November 12, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-07

Locations

US (3)