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 range18 Years – 55 Years

SexALL

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

✕. 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

What they're measuring

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)

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)

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)

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)

Trial details

NCT IDNCT05389319

SponsorUniversity Hospital Tuebingen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

University Hospital Tübingen

+49 7071 2987179 ITMPM@med.uni-tuebingen.de

View on ClinicalTrials.gov More COVID-19 trials

Who can participate

Age range18 Years – 55 Years

SexALL

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

✕. 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

What they're measuring

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)

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)

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)