A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults (NCT05389319) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults
Germany96 participantsStarted 2022-06-24
Plain-language summary
This is an open-label, first-in-human, dose-finding study to evaluate the safety and immunogenicity of a booster vaccination of Prime-2-CoV\_Beta in healthy participants.
Who can participate
Age range
18 Years – 55 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
. Healthy adult men or women aged 18 to 55 years
. Previous COVID-19 vaccination and previous SARS-CoV-2 infection as follows:
. Cohorts 1 to 7a: Full course of vaccination e.g., having received at least 3 doses of a licensed mRNA COVID-19 vaccine or having received at least 2 doses of a licensed mRNA COVID-19 vaccine and a prior SARS-CoV-2 infection, with the last dose of the vaccine being administered ≥ 10 weeks before Day 1 as documented in a respective vaccination certificate
. Cohort 7b: No more than 2 doses of any licensed COVID-19 vaccine. Those with fewer COVID-19 vaccinations, preferably none or just one, will be given preference. Non-mRNA COVID-19 vaccines are acceptable. The last vaccine dose must have been given ≥ 10 weeks before Day 1 as documented in a respective vaccination certificate
. Able to understand the participant information and providing written informed consent
. Body mass index of 18.5 to 30.0 kg/m² and weight \> 50 kg at Screening
. Women of childbearing potential must:
. have a negative pregnancy test at Screening (blood) and at Day 1 (urine)
Exclusion criteria
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.
1This is a Phase 1 trial focused mainly on safety and immune response — does that mean there's less long-term data available compared to the COVID-19 vaccines already approved, and how does that affect whether this might be right for me?
2The trial is tracking specific side effects like fever, fatigue, chills, and injection site reactions in the first 7 days after the booster — given my current health and any conditions I have, are there particular reactions on that list I should be especially prepared for?
3Since this booster is called Prime-2-CoV_Beta, which seems to target the Beta variant, how does that fit with the COVID-19 strains circulating now, and would a currently authorized updated booster potentially serve me better?
4The study is no longer actively recruiting — does that mean I can't participate, and if so, are there similar Phase 1 or Phase 2 booster trials currently open that my care team thinks would be worth looking into?
5How would joining a Phase 1 safety study like this compare to simply getting a standard recommended COVID-19 booster, in terms of what's known about protection and risk?
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
Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study
Timeframe: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
2
Proportion of participants with solicited local adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): pain at injection site, redness, induration, and swelling.
Timeframe: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
3
Proportion of participants with solicited systemic adverse events (first 7 days after Prime-2-CoV_Beta booster vaccination): fever, fatigue, headache, chills, vomiting, nausea, diarrhea, new or worsened muscle pain, new or worsened joint pain.
Timeframe: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
4
Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
Timeframe: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
. Receipt of any vaccine (licensed or investigational) from 4 weeks before Prime-2-CoV\_Beta booster vaccination or anticipated vaccination during the study until 6 weeks after the Prime-2-CoV\_Beta booster vaccination
. Previous vaccination against COVID-19 with vaccines (licensed or investigational) other than mRNA-based vaccines (licensed or investigational) only applicable for Cohorts 1 to 7a
. Current or previous treatment with another investigational drug and/or medical device (within 30 days of enrollment or 5 half-lives of that investigational drug)
. Administration of immunoglobulins or any blood products within 2 months of Prime-2-CoV\_Beta booster vaccination
. Chronic administration of medication associated with impaired immune responsiveness as judged by the investigator (including, but not limited to: immunosuppressive therapy, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy shots for hypo-sensitization, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs) within 2 months before the Prime-2-CoV\_Beta booster vaccination (Day 1). Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
. Active SARS-CoV-2 infection, confirmed by a commercially available SARS-CoV-2 rapid antigen test at Day 1, or currently on quarantine
. {deleted}
. Known history of severe adverse reactions to any vaccine and/or severe allergic reactions to any component of the study vaccine, to any drug, or to any other exposure