Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults (NCT06441968) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Trial of MPV/S-2P SARS-CoV-2 Vaccine in Adults
United States60 participantsStarted 2024-07-01
Plain-language 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.
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 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.
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
Frequency of abnormal clinical safety laboratory AEs
Timeframe: Day 8
2
Frequency of solicited local adverse events (AEs)
Timeframe: Through Day 14 following vaccination
3
Frequency of systemic adverse events (AEs)
Timeframe: Through Day 14 following vaccination
4
Frequency of unsolicited AEs
Timeframe: Through Day 28 following vaccination
5
Occurrence of adverse events of special interest (AESIs)
Timeframe: Through Month 12 after vaccination
6
Occurrence of medically-attended adverse events (MAAEs)
Timeframe: Through Month 12 after vaccination
7
Occurrence of new-onset chronic medical conditions (NOCMCs)
Timeframe: Through Month 12 after vaccination
8
Trial details
NCT IDNCT06441968
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. 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.
. Clinical screening laboratory evaluations are within normal reference ranges or grade 1 with no clinical significance (NCS) per investigator discretion\*.
Exclusion criteria
. Must agree to have samples stored for secondary research.
0. 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.
. Positive SARS-CoV-2 PCR at screening.
. Abnormal vital signs (Grade 1 or higher)\*
. 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.
Occurrence of serious adverse events (SAEs)
Timeframe: Through Month 12 after vaccination
9
Severity of abnormal clinical safety laboratory AEs