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 range18 Years – 64 Years
SexALL
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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.
✓. 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
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
Occurrence of serious adverse events (SAEs)
Timeframe: Through Month 12 after vaccination
Trial details
NCT IDNCT06441968
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. 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.
9
Severity of abnormal clinical safety laboratory AEs