COVID -19Phase 1NCT07703475
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
A Phase 1 study testing RVX-sCPD9 in people with COVID -19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. 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?
- RVX-sCPD9
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- 26 Sep 2026to 15 Nov 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 before initiation of any study procedures.
- Able to understand and agree to comply with planned study procedures and be available for all study visits.
- Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
- 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 apply to females who are in a heterosexual relationship 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, or tubal ligation/salpingectomy).
- True abstinence is 100% of the time, no sexual intercourse (penis enters the vagina). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods.
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- Acceptable forms of primary contraception include a monogamous relationship with a vasectomized partner who has been vasectomized for 180 days or more before the participant's study product administration, 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 before study product administration and agree to continue at least one acceptable primary form of contraception through 60 days after study product administration.
- Participants of childbearing potential must have a negative urine pregnancy test at screening and within 24 hours before study product administration.
- 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 the safety of participants. Chronic medical diagnoses/ conditions should be stable for the last 30 days (i.e., no hospitalizations, ER, or urgent care for the condition). This includes no change in chronic prescription medication, dose, or frequency due to deterioration of the chronic medical diagnosis/condition 30 days before the study product administration. Any prescription change due to a 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 authorized or approved COVID-19 vaccine series and at least one booster* with the last vaccination at least 16 weeks before study product administration.
- Booster may be either homologous or heterologous to the primary vaccine series. It must be an FDA-authorized/licensed vaccine, though doses may have been received during a clinical trial (see MOP for further details).
- Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per the investigator's discretion*.
- Laboratory evaluations include White Blood Cells [WBCs] with differential, hemoglobin [Hgb], platelets [PLTs], Alanine Transaminase [ALT], Aspartate Transaminase [AST], Creatinine [Cr], Alkaline Phosphatase [ALP], and Total Bilirubin [T. Bili]). Clinical laboratory evaluations that are below the site reference range, but not graded by the toxicology table, are not exclusionary unless deemed clinically significant by an investigator.
- Must agree to have samples stored for secondary research.
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 degrees Celsius (100.4 degrees Fahrenheit).
- Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.
- Participant who is pregnant or breastfeeding.
- Blood or plasma donation within 4 weeks before study product administration.
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- Receipt of antibody or blood-derived products within 90 days before study product administration.
- 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 drug or alcohol abuse within 6 months of enrollment, significant kidney disease, liver disease, ongoing malignancy, or recent diagnosis of malignancy in the last five years, excluding treated basal and squamous cell carcinoma of the skin and cervical carcinoma in situ, which are allowed.
- Neurological conditions*.
- Including 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.
- History of significant respiratory disease currently requiring daily medications, history of asthma in the past 5 years, or any treatment of respiratory disease exacerbations in the last 5 years.
- History of cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease), including any history of myocarditis, pericarditis, or uncontrolled cardiac arrhythmia.
- Any autoimmune disease, including hypothyroidism, without a defined non-autoimmune cause.
- Has an acute illness determined by the site PI or appropriate sub-investigator within 72 hours before study product administration*.
- An acute illness that 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 means more than 14 continuous days.
- Ophthalmic and topical steroids are allowed. See exclusion 19 for intranasal steroids.
- Has received any investigational study product within 60 days, or 5 half-lives, whichever is longer, before study product administration or is planning to receive one during the study.
- Has a history of hypersensitivity or severe allergic reaction* to any previous licensed or unlicensed vaccines or the candidate study product components**.
- (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction).
- See IB for study product formulation.
- Received or plans to receive licensed inactivated/subunit vaccine within 14 days of study product administration or live vaccine within 28 days of study product administration.
- Plan to receive a COVID-19 booster vaccine within the 180 days following study product administration.
- Regular use of intranasal medications, including steroids, and sinus rinsing treatments*.
- Participants must have had no intranasal medication use for 30 days before study product administration and do not plan to use intranasal medications for 30 days after study product administration for medications other than steroids and for 6 months after study product administration for intranasal steroids (including over the counter (OTC) fluticasone). Participants should not use nasal irrigation or sinus rinsing treatments (e.g., Neti pots or saline washes) for 28 days after the study product administration and 7 days before study visits for the duration of the trial.
- Use of illicit intranasal drugs in the 5 years before study product administration or plans to use during the study.
- Current smoker (including cigarettes, marijuana, and vaping) or smoking within the prior 3 months.
- Planned international travel between study product administration and Day 29 visit.
- Any significant nasal or upper airway disease*.
- Including, but not limited to, being prone to epistaxis, has a history of inflammatory rhinitis (including allergic rhinitis) that requires daily medications, cochlear implants, head/neck radiation history, anosmia/dysosmia, and certain ear, nose and throat (ENT) conditions, including major anatomic nasopharyngeal abnormality or sinus polyp disease due to chronic sinusitis.
- Living with a person who has a condition that predisposes to high risk of severe COVID-19 or >/=2 conditions that predisposes to increased risk of COVID-19 per IDSA guidelines.
- Healthcare workers with patient-facing responsibilities.
- Resides in or works in a nursing home or other skilled nursing facility.
- Allergy or contraindications to nirmatrelvir, ritonavir, or remdesivir.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, Ohio, 45229-3039
Site Recruitment Contact, 513-636-7699, VaccineResearch@cchmc.org
Duke Vaccine and Trials Unit
Durham, North Carolina, 27703
Site Recruitment Contact, 919-668-6030, byron.hauser@duke.edu
Baylor College of Medicine
Houston, Texas, 77030-3411
Site Recruitment Contact, 713-798-4912, VRC-NextGen@bcm.edu
New York University School of Medicine - Langone Medical Center - Vaccine Center
New York, New York, 10016-6402
Site Recruitment Contact, 877-919-2822, NYUVaccineCenter@nyulangone.org
About this study
Official title: A Phase 1, Open-Label, Safety, Reactogenicity, and Immunogenicity Trial of RVX-sCPD9, a Live-Attenuated SARS-CoV-2, as a Booster Vaccine, Via the Intranasal Route in Previously Vaccinated Adults
This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating four dose levels of RVX-sCPD9 administered IN (10^2, 10^3, 10^4, 5 x 10^4 FFU). A sample size of 80 participants (20 participants in each cohort).
The primary objective is to evaluate the safety and reactogenicity of a single IN administration of 4 ascending dosages of RVX-sCPD9 in previously vaccinated healthy adults.
Read the detailed description
This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9 administered as an intranasal (IN) booster in previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation trial assessing four dose levels of RVX-sCPD9 (10^2, 10^3, 10^4, and 5 × 10^4 FFU) delivered intranasally. A total of 80 participants will be enrolled, with 20 participants in each cohort.
Eligibility will be determined at screening and confirmed again on Day 1 prior to study product administration. Participants will be healthy adults aged 18 to 64 years, regardless of prior SARS-CoV-2 infection status, who have completed a primary COVID-19 vaccination series and received at least one booster dose, with the most recent vaccination administered at least 16 weeks prior to study vaccination.
Each participant will receive a single dose of RVX-sCPD9 administered intranasally using a nasal atomization device, delivering 0.25 mL per nostril. Three sentinel participants under 50 years of age will be enrolled initially, followed by enrollment of the remaining participants.
The total study duration is approximately 1.5 years, with each participant involved for up to 7 months. The primary objective is to evaluate the safety and reactogenicity of a single intranasal administration of 4 ascending dose levels of RVX-sCPD9 in previously vaccinated healthy adults. Secondary objectives include include evaluating systemic anti-Spike humoral immune responses and evaluating nasal mucosal Immunoglobulin A (IgA) and Immunoglobulin G (IgG) responses after intranasal administration of RVX-sCPD9.
- Conditions
- COVID -19
- Being tested
- RVX-sCPD9
- Keywords
- Boost, Boster, Coronavirus, COVID, Intranasal, Next Generation, Phase 1, RVX-sCPD9, SARS-CoV-2, Vaccine
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVX-sCPD9Biological
RVX-sCPD9 is a live-attenuated SARS-CoV-2 vaccine candidate engineered from the ancestral B.1 strain for intranasal administration to prevent coronavirus disease 2019 (COVID-19) and reduce viral transmission. The vaccine was generated through two complementary attenuation strategies: a codon-pair-deoptimization of the viral genome that reduced viral fitness while preserving protein amino acid sequence, and a deletion of the spike furin cleavage site (FCS), a modification known to prevent horizontal transmission and further attenuate pathogenicity.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Healthy adults will receive a single dose of 1x10^2 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 Receives: Biological: RVX-sCPD9 |
| Arm 2 | Experimental | Healthy adults will receive a single dose of 1x10^3 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 Receives: Biological: RVX-sCPD9 |
| Arm 3 | Experimental | Healthy adults will receive a single dose of 1x10^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 Receives: Biological: RVX-sCPD9 |
| Arm 4 | Experimental | Healthy adults will receive a single dose of 5x10^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 Receives: Biological: RVX-sCPD9 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of abnormal clinical safety laboratory adverse events (AEs)
Measured: Through Day 15
Occurrence of Adverse Events of Special Interest (AESIs)
Measured: Through Day 181
Occurrence of Medically-Attended Adverse Events (MAAEs)
Measured: Through Day 181
Occurrence of solicited local adverse events (AEs)
Measured: Through Day 15
Occurrence of solicited systemic adverse events (AEs)
Measured: Through Day 15
Occurrence of unsolicited adverse events (AEs)
Measured: Through Day 29
Occurrence of New-Onset Chronic Medical Conditions (NOCMCs)
Measured: Through Day 181
Occurrence of Serious Adverse Events (SAEs)
Measured: Through Day 181
Secondary outcomes (5)
Nasal mucosal Immunoglobulin A (IgA) anti-S binding antibodies
Measured: Through Day 181
Nasal mucosal Immunoglobulin G (IgG) anti-S binding antibodies
Measured: Through Day 181
Serum anti-S binding Immunoglobulin A (IgA) antibodies
Measured: Through Day 181
Serum anti-S binding Immunoglobulin G (IgG) antibodies
Measured: Through Day 181
Serum anti-S neutralizing antibodies
Measured: Through Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2026
- Study start26 Sep 2026 (estimated)
- Primary completion15 Nov 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
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
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07703475
- Sponsor's protocol ID
- 25-1107
- Status last verified
- 9 Jul 2026
- First submitted
- 9 Jul 2026
- Last updated
- 16 Oct 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 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Safety, Reactogenicity, and Immunogenicity Trial of RVX-sCPD9, a Live-Attenuated SARS-CoV-2, as a Booster Vaccine, Via the Intranasal Route in Previously Vaccinated Adults
- ClinicalTrials.gov ID
- NCT07703475
- Acronym / sponsor ID
- 25-1107
- Conditions
- COVID -19
- Keywords
- Boost, Boster, Coronavirus, COVID, Intranasal, Next Generation, Phase 1, RVX-sCPD9
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 26 Sep 2026 (estimated)
- Primary completion
- 15 Nov 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 14 Jul 2026 (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.
This phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9, given Intranasally (IN), as a booster dose to previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation clinical trial evaluating four dose levels of RVX-sCPD9 administered IN (10^2, 10^3, 10^4, 5 x 10^4 FFU). A sample size of 80 participants (20 participants in each cohort).
The primary objective is to evaluate the safety and reactogenicity of a single IN administration of 4 ascending dosages of RVX-sCPD9 in previously vaccinated healthy adults.
Detailed description
This Phase 1 clinical trial will evaluate the safety, reactogenicity, and immunogenicity of RVX-sCPD9 administered as an intranasal (IN) booster in previously vaccinated healthy adults. The study is designed as a non-randomized, open-label, dose-escalation trial assessing four dose levels of RVX-sCPD9 (10^2, 10^3, 10^4, and 5 × 10^4 FFU) delivered intranasally. A total of 80 participants will be enrolled, with 20 participants in each cohort.
Eligibility will be determined at screening and confirmed again on Day 1 prior to study product administration. Participants will be healthy adults aged 18 to 64 years, regardless of prior SARS-CoV-2 infection status, who have completed a primary COVID-19 vaccination series and received at least one booster dose, with the most recent vaccination administered at least 16 weeks prior to study vaccination.
Each participant will receive a single dose of RVX-sCPD9 administered intranasally using a nasal atomization device, delivering 0.25 mL per nostril. Three sentinel participants under 50 years of age will be enrolled initially, followed by enrollment of the remaining participants.
The total study duration is approximately 1.5 years, with each participant involved for up to 7 months. The primary objective is to evaluate the safety and reactogenicity of a single intranasal administration of 4 ascending dose levels of RVX-sCPD9 in previously vaccinated healthy adults. Secondary objectives include include evaluating systemic anti-Spike humoral immune responses and evaluating nasal mucosal Immunoglobulin A (IgA) and Immunoglobulin G (IgG) responses after intranasal administration of RVX-sCPD9.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: RVX-sCPD9Healthy adults will receive a single dose of 1x10^2 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 |
| Arm 2 | Experimental | Biological: RVX-sCPD9Healthy adults will receive a single dose of 1x10^3 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 |
| Arm 3 | Experimental | Biological: RVX-sCPD9Healthy adults will receive a single dose of 1x10^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 |
| Arm 4 | Experimental | Biological: RVX-sCPD9Healthy adults will receive a single dose of 5x10^4 FFU RVX-sCPD9 vaccine. It will be administered intranasally through a nasal atomization device with a spray divider to provide 0.25mL in each nostril. 3 sentinel participants, under 50 years of age, will be enrolled first and then the reminder. N= 20 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- Provides written informed consent before initiation of any study procedures.
- Able to understand and agree to comply with planned study procedures and be available for all study visits.
- Non-pregnant adults, 18 through 64 years of age at the time of study product administration.
- 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 apply to females who are in a heterosexual relationship 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, or tubal ligation/salpingectomy).
Key exclusion criteria (37 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 degrees Celsius (100.4 degrees Fahrenheit).
- Self-reported or medically documented SARS-CoV-2 infection (regardless of whether symptomatic or asymptomatic) within 16 weeks prior to study product administration.
- 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 |
|---|---|---|
| RVX-sCPD9RVX-sCPD9 is a live-attenuated SARS-CoV-2 vaccine candidate engineered from the ancestral B.1 strain for intranasal administration to prevent coronavirus disease 2019 (COVID-19) and reduce viral transmission. The vaccine was generated through two complementary attenuation strategies: a codon-pair-deoptimization of the viral genome that reduced viral fitness while preserving protein amino acid sequence, and a deletion of the spike furin cleavage site (FCS), a modification known to prevent horizontal transmission and further attenuate pathogenicity. | Biological | Arm 1, Arm 2, Arm 3, Arm 4 |
Primary outcome
Occurrence of abnormal clinical safety laboratory adverse events (AEs)
Time frame: Through Day 15
Occurrence of Adverse Events of Special Interest (AESIs)
Time frame: Through Day 181
Occurrence of Medically-Attended Adverse Events (MAAEs)
Time frame: Through Day 181
Occurrence of solicited local adverse events (AEs)
Time frame: Through Day 15
Occurrence of solicited systemic adverse events (AEs)
Time frame: Through Day 15
Occurrence of unsolicited adverse events (AEs)
Time frame: Through Day 29
Occurrence of New-Onset Chronic Medical Conditions (NOCMCs)
Time frame: Through Day 181
Occurrence of Serious Adverse Events (SAEs)
Time frame: Through Day 181
5 secondary outcomes
Nasal mucosal Immunoglobulin A (IgA) anti-S binding antibodies
Time frame: Through Day 181
Nasal mucosal Immunoglobulin G (IgG) anti-S binding antibodies
Time frame: Through Day 181
Serum anti-S binding Immunoglobulin A (IgA) antibodies
Time frame: Through Day 181
Serum anti-S binding Immunoglobulin G (IgG) antibodies
Time frame: Through Day 181
Serum anti-S neutralizing antibodies
Time frame: Through Day 181
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 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.
New York University School of Medicine - Langone Medical Center - Vaccine Center
New York, United States
Cincinnati Children's Hospital Medical Center Vaccine Research Center
Cincinnati, United States
4 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 RVX-sCPD9 in people with COVID -19, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 15 inclusion and 37 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of abnormal clinical safety laboratory adverse events (AEs) (time frame: Through Day 15). The study lists 8 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 16 Oct 2026.