COVID-19Phase 1NCT06441968
Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults
A Phase 1 study testing MPV/S-2P in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- MPV/S-2P
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Jul 2024to 12 Nov 2025
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- In general good health*.
- As determined by medical history and physical examination, including vital signs, to evaluate acute or ongoing chronic medical diagnoses/conditions that have been present for at least 90 days, which would affect the assessment of safety of participants. Chronic medical diagnoses/ conditions should be stable for the last 30 days (i.e., no hospitalizations, ER, or urgent care for condition). This includes no change in chronic prescription medication, dose, or frequency as a result of deterioration of the chronic medical diagnosis/condition in the 30 days before study vaccination. Any prescription change that is due to change of health care provider, insurance company, etc., or done for financial reasons, and in the same class of medication, will not be considered a deviation of this inclusion criterion. Participants may be on chronic or as needed (prn) medications if, in the opinion of the participating site PI or appropriate sub-investigator, they pose no additional risk to participant safety or assessment of reactogenicity and immunogenicity.
- 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*.
- White Blood Cells [WBCs] with differential, hemoglobin [Hgb], platelets [PLTs], Alanine Transaminase [ALT], Aspartate Transaminase [AST], Creatinine [Cr], Alkaline Phosphatase [ALP], Total Bilirubin [T. Bili]). ALT, AST, ALP, T. Bili and creatinine values that are below the reference range will not be exclusionary as these values below reference range are clinically insignificant.
- 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.
Who cannot join
- 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.
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- 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**.
- Chronic meaning more than 14 continuous days.
- Ophthalmic and topical steroids are allowed, see exclusion 19 for intranasal steroids.
- Has received any investigational product within 60 days, or 5 half-lives, whichever is longer, before vaccination; or is planning to receive one during the study.
- Has a history of hypersensitivity or severe allergic reaction* to any previous licensed or unlicensed vaccine or to the candidate vaccine components.
- (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction)
- See section 6.5.1 for vaccination formulation
- Resides in or works in a nursing home or other skilled nursing facility.
- Resides with or cares for immunocompromised persons, pregnant individuals, or children under 2 years of age (inclusive of health care workers and others with patient contact in health care settings).
- People who handle rodents (laboratory workers, vivarium workers, pet store workers, etc.) or keep rodents as pets.
- Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study vaccine administration or live vaccine within 28 days of study vaccine administration.
- Plan to receive a COVID-19 booster vaccine within the 180 days following study vaccination.
- Regular use of intranasal medications including steroids*.
- Participant must have had no intranasal medication use for 30 days prior to study vaccination and plans not to use intranasal medications for 30 days after study vaccination for medications other than steroids, and for 6 months after study vaccination for intranasal steroids (including over-the-counter Flonase).
- Use of intranasal illicit drugs in the 5 years prior to study vaccination or plans to use during the study.
- Planned international travel between vaccination and Day 29 visit.
- Current smoker (including cigarettes, marijuana, and vaping) or smoking within 3 months.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The Hope Clinic of Emory University
Decatur, Georgia, 30030-1705
Baylor College of Medicine
Houston, Texas, 77030-3411
NYU Grossman Long Island School of Medicine - Vaccine Center
Mineola, New York, 11501
About this study
Official title: A Phase 1 Open-Label Safety and Immunogenicity Trial of MPV/S-2P, a Next Generation SARS-CoV-2 Booster Vaccine, in Previously Vaccinated Adults
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.
Read the detailed description
A phase I 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 study is designed as a non-randomized, open-label, dose-escalation clinical trial in non-pregnant adult participants, 18-64 years of age (with a goal of 30 percent or more >/=50 years of age), with or without prior SARS-CoV-2 infection, who are in good health and meet all other eligibility criteria. For the evaluation of three doses of MPV/S-2P vaccine, a sample size of 60 participants is anticipated.
To evaluate for early safety signals vaccination will proceed in a staged fashion. For Cohort 1, three sentinel participants under 50 years of age will be enrolled over at least 2 days. A safety review of clinical data and virologic shedding data through at least Day 8 will be conducted by the Safety Review Committee (SRC) prior to enrollment of the remainder of the cohort. Once Cohort 1 is fully enrolled, progression to Cohort 2 will be based on evaluation of halting rules, and cumulative clinical safety and virologic shedding data from Cohort 1 through at least Day 8 by the SRC.
Cohort 2 and 3 enrollment and safety oversight will proceed in the same fashion as Cohort 1. At the discretion of the SRC, additional participants in the cohort may be designated sentinels for any cohort. If halting rules are met the study will be paused for the SRC safety data review.
The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults. The secondary objectives are 1) To evaluate the systemic anti-Spike humoral immune responses after vaccination 2) To evaluate nasal mucosal IgA and IgG responses after vaccination 3) To assess the duration and magnitude of viral vector (vaccine) shedding 4) To assess the immune response towards the vector.
- Conditions
- COVID-19
- Being tested
- MPV/S-2P
- Keywords
- adults, MPV/S-2P, phase 1, SARS-CoV-2, trial, vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MPV/S-2PBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Biological: MPV/S-2P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of abnormal clinical safety laboratory AEs
Measured: Day 8
Frequency of solicited local adverse events (AEs)
Measured: Through Day 14 following vaccination
Frequency of systemic adverse events (AEs)
Measured: Through Day 14 following vaccination
Frequency of unsolicited AEs
Measured: Through Day 28 following vaccination
Occurrence of adverse events of special interest (AESIs)
Measured: Through Month 12 after vaccination
Occurrence of medically-attended adverse events (MAAEs)
Measured: Through Month 12 after vaccination
Occurrence of new-onset chronic medical conditions (NOCMCs)
Measured: Through Month 12 after vaccination
Occurrence of serious adverse events (SAEs)
Measured: Through Month 12 after vaccination
Severity of abnormal clinical safety laboratory AEs
Measured: Day 8
Severity of solicited local adverse events (AEs)
Measured: Through Day 14 following vaccination
Severity of systemic adverse events (AEs)
Measured: Through Day 14 following vaccination
Severity of unsolicited AEs
Measured: Through Day 28 following vaccination
Secondary outcomes (12)
Geometric Mean Fold Rise (GMFR) of anti-vector antibodies
Measured: Through Day 366
Geometric Mean Fold Rise (GMFR) of mucosal anti-S binding antibodies (IgA, IgG)
Measured: Through Day 366
Geometric Mean Fold Rise (GMFR) of serum anti-S binding antibody (IgA and IgG)
Measured: Through Day 366
Geometric Mean Fold Rise (GMFR) of serum neutralizing antibodies to Spike variants
Measured: Through Day 366
Geometric Mean Titer (GMT) of anti-vector antibodies
Measured: Through Day 366
Geometric Mean Titer (GMT) of mucosal anti-S binding antibodies (IgA, IgG)
Measured: Through Day 366
Geometric Mean Titer (GMT) of serum anti-S binding antibody (Immunoglobulin A (IgA) and Immunoglobulin G (IgG ))
Measured: Through Day 366
Geometric Mean Titer (GMT) of serum neutralizing antibodies to Spike variants
Measured: Through Day 366
Median nasal swab quantitative polymerase chain reaction (qPCR) copy number for murine pneumonia virus (MPV)
Measured: Through Day 29
Percentage of participants positive for anti-vector antibodies
Measured: Through Day 366
Percentage of participants who seroconverted
Defined as a fourfold rise in serum neutralizing antibody titers
Measured: Day 29
Percentage of participants with polymerase chain reaction (PCR)-positive nasal swab for murine pneumonia virus (MPV)
Measured: Through Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start1 Jul 2024
- Primary completion12 Nov 2025
- Study completion12 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441968
- Sponsor's protocol ID
- 23-1101
- Status last verified
- 29 May 2024
- First submitted
- 31 May 2024
- Last updated
- 20 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open-Label Safety and Immunogenicity Trial of MPV/S-2P, a Next Generation SARS-CoV-2 Booster Vaccine, in Previously Vaccinated Adults
- ClinicalTrials.gov ID
- NCT06441968
- Acronym / sponsor ID
- 23-1101
- Conditions
- COVID-19
- Keywords
- adults, MPV/S-2P, phase 1, SARS-CoV-2, trial, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 12 Nov 2025 (actual)
- Study completion
- 12 Nov 2025 (actual)
- First posted
- 4 Jun 2024 (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.
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.
Detailed description
A phase I 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 study is designed as a non-randomized, open-label, dose-escalation clinical trial in non-pregnant adult participants, 18-64 years of age (with a goal of 30 percent or more >/=50 years of age), with or without prior SARS-CoV-2 infection, who are in good health and meet all other eligibility criteria. For the evaluation of three doses of MPV/S-2P vaccine, a sample size of 60 participants is anticipated.
To evaluate for early safety signals vaccination will proceed in a staged fashion. For Cohort 1, three sentinel participants under 50 years of age will be enrolled over at least 2 days. A safety review of clinical data and virologic shedding data through at least Day 8 will be conducted by the Safety Review Committee (SRC) prior to enrollment of the remainder of the cohort. Once Cohort 1 is fully enrolled, progression to Cohort 2 will be based on evaluation of halting rules, and cumulative clinical safety and virologic shedding data from Cohort 1 through at least Day 8 by the SRC.
Cohort 2 and 3 enrollment and safety oversight will proceed in the same fashion as Cohort 1. At the discretion of the SRC, additional participants in the cohort may be designated sentinels for any cohort. If halting rules are met the study will be paused for the SRC safety data review.
The primary objective is to evaluate the safety and reactogenicity of a single dose of MPV/S-2P in previously vaccinated healthy adults. The secondary objectives are 1) To evaluate the systemic anti-Spike humoral immune responses after vaccination 2) To evaluate nasal mucosal IgA and IgG responses after vaccination 3) To assess the duration and magnitude of viral vector (vaccine) shedding 4) To assess the immune response towards the vector.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: MPV/S-2PHealthy 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 |
| Cohort 2 | Experimental | Biological: MPV/S-2PHealthy 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 |
| Cohort 3 | Experimental | Biological: MPV/S-2PHealthy 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (31 listed)
- 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.
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 |
|---|---|---|
| MPV/S-2PA 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. | Biological | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Frequency of abnormal clinical safety laboratory AEs
Time frame: Day 8
Frequency of solicited local adverse events (AEs)
Time frame: Through Day 14 following vaccination
Frequency of systemic adverse events (AEs)
Time frame: Through Day 14 following vaccination
Frequency of unsolicited AEs
Time frame: Through Day 28 following vaccination
Occurrence of adverse events of special interest (AESIs)
Time frame: Through Month 12 after vaccination
Occurrence of medically-attended adverse events (MAAEs)
Time frame: Through Month 12 after vaccination
Occurrence of new-onset chronic medical conditions (NOCMCs)
Time frame: Through Month 12 after vaccination
Occurrence of serious adverse events (SAEs)
Time frame: Through Month 12 after vaccination
Severity of abnormal clinical safety laboratory AEs
Time frame: Day 8
Severity of solicited local adverse events (AEs)
Time frame: Through Day 14 following vaccination
Severity of systemic adverse events (AEs)
Time frame: Through Day 14 following vaccination
Severity of unsolicited AEs
Time frame: Through Day 28 following vaccination
12 secondary outcomes
Geometric Mean Fold Rise (GMFR) of anti-vector antibodies
Time frame: Through Day 366
Geometric Mean Fold Rise (GMFR) of mucosal anti-S binding antibodies (IgA, IgG)
Time frame: Through Day 366
Geometric Mean Fold Rise (GMFR) of serum anti-S binding antibody (IgA and IgG)
Time frame: Through Day 366
Geometric Mean Fold Rise (GMFR) of serum neutralizing antibodies to Spike variants
Time frame: Through Day 366
Geometric Mean Titer (GMT) of anti-vector antibodies
Time frame: Through Day 366
Geometric Mean Titer (GMT) of mucosal anti-S binding antibodies (IgA, IgG)
Time frame: Through Day 366
Geometric Mean Titer (GMT) of serum anti-S binding antibody (Immunoglobulin A (IgA) and Immunoglobulin G (IgG ))
Time frame: Through Day 366
Geometric Mean Titer (GMT) of serum neutralizing antibodies to Spike variants
Time frame: Through Day 366
Median nasal swab quantitative polymerase chain reaction (qPCR) copy number for murine pneumonia virus (MPV)
Time frame: Through Day 29
Percentage of participants positive for anti-vector antibodies
Time frame: Through Day 366
Percentage of participants who seroconverted
Time frame: Day 29
Percentage of participants with polymerase chain reaction (PCR)-positive nasal swab for murine pneumonia virus (MPV)
Time frame: Through Day 29
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 20 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MPV/S-2P in people with COVID-19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 31 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 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. 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?
Frequency of abnormal clinical safety laboratory AEs (time frame: Day 8). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2026.