A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine (NCT07703475) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
United States80 participantsStarted 2026-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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\*\*\*.
. 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\*.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurrence of abnormal clinical safety laboratory adverse events (AEs)
Timeframe: Through Day 15
2
Occurrence of Adverse Events of Special Interest (AESIs)
Timeframe: Through Day 181
3
Occurrence of Medically-Attended Adverse Events (MAAEs)
Timeframe: Through Day 181
4
Occurrence of solicited local adverse events (AEs)
Timeframe: Through Day 15
5
Occurrence of solicited systemic adverse events (AEs)
Timeframe: Through Day 15
6
Occurrence of unsolicited adverse events (AEs)
Timeframe: Through Day 29
7
Occurrence of New-Onset Chronic Medical Conditions (NOCMCs)
Timeframe: Through Day 181
8
Trial details
NCT IDNCT07703475
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.
. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per the investigator's discretion\*.
Exclusion criteria
. Must agree to have samples stored for secondary research.
. Positive SARS-CoV-2 PCR at screening.
. Abnormal vital signs (Grade 1 or higher)\*.
. 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.