A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine

NCT07703475 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: 25-1107
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 4

Brief 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. 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.

Conditions

COVID -19

Keywords

Boost; Boster; Coronavirus; COVID; Intranasal; Next Generation; Phase 1; RVX-sCPD9; SARS-CoV-2; Vaccine

Outcome Measures

Primary Outcomes (8)

• Occurrence of abnormal clinical safety laboratory adverse events (AEs)

  Through Day 15

• Occurrence of Adverse Events of Special Interest (AESIs)

  Through Day 181

• Occurrence of Medically-Attended Adverse Events (MAAEs)

  Through Day 181

• Occurrence of solicited local adverse events (AEs)

  Through Day 15

• Occurrence of solicited systemic adverse events (AEs)

  Through Day 15

• Occurrence of unsolicited adverse events (AEs)

  Through Day 29

• Occurrence of New-Onset Chronic Medical Conditions (NOCMCs)

  Through Day 181

• Occurrence of Serious Adverse Events (SAEs)

  Through Day 181

Secondary Outcomes (5)

• Nasal mucosal Immunoglobulin A (IgA) anti-S binding antibodies

  Through Day 181

• Nasal mucosal Immunoglobulin G (IgG) anti-S binding antibodies

  Through Day 181

• Serum anti-S binding Immunoglobulin A (IgA) antibodies

  Through Day 181

• Serum anti-S binding Immunoglobulin G (IgG) antibodies

  Through Day 181

• Serum anti-S neutralizing antibodies

  Through Day 181

Study Arms (4)

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

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

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

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

Biological: RVX-sCPD9

Interventions

RVX-sCPD9 BIOLOGICAL

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.

Arm 1; Arm 2; Arm 3; Arm 4

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 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.
• \*\*\*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\*.
• 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\*.
• Must agree to have samples stored for secondary research.

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 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.
• 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\*.

Sponsors & Collaborators

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

Study Sites (4)

New York University School of Medicine - Langone Medical Center - Vaccine Center

New York, New York, 10016-6402, United States

Location

Duke Vaccine and Trials Unit

Durham, North Carolina, 27703, United States

Location

Cincinnati Children's Hospital Medical Center Vaccine Research Center

Cincinnati, Ohio, 45229-3039, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3411, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Hana M El Sahly

CONTACT

17137982058; Hana.ElSahly@bcm.edu

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: July 9, 2026
• First Posted: July 14, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): November 15, 2027
• Study Completion (Estimated): November 15, 2027
• Last Updated: July 31, 2026

Record last verified: 2026-07-09

Locations

US (4)