COVID-19Phase 1NCT05389319

A Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine Booster in Healthy Adults

A Phase 1 study testing Prime-2-CoV_Beta in people with COVID-19, run by University Hospital Tuebingen at 2 sites in Germany.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Prime-2-CoV_Beta
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 96 participants
Where: 2 sitesGermany
Study dates: 24 Jun 2022to 31 Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

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Women of childbearing potential must:
have a negative pregnancy test at Screening (blood) and at Day 1 (urine)
agree to use, and be able to comply with, highly effective measures of contraception without interruption, from 14 days before Prime-2-CoV_Beta booster vaccination until the end of the study.
A highly effective method of contraception or birth control (failure rate less than 1% per year when used consistently and correctly) for this study: combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal, injectable), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, sexual abstinence or vasectomized sexual partner. Abstinence is only acceptable as true abstinence when this is in line with the preferred and usual lifestyle of the participant (abstinent on a long-term and persistent basis). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods and withdrawal] are not acceptable methods of contraception.) Postmenopausal (no menses for at least 1 year without alternative medical cause) or surgically sterile women (tubal ligation, hysterectomy or bilateral oophorectomy) may be enrolled.
Male participants must agree not to intend to father a child or to donate sperm starting at Screening, throughout the clinical study. Male participants must also
abstain from sexual intercourse with a female partner (acceptable only if it is the participant's usual form of birth control/lifestyle choice: abstinent on a long-term and persistent basis). The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the participant or
use adequate barrier contraception (male condom) during treatment with the investigational product until the end of the study, and
ensure that, if they have a female partner of childbearing potential, the partner uses a highly effective contraceptive method as outlined in inclusion criterion number 5
use condoms during the entire study if they have a pregnant partner, to avoid exposure of the fetus to the investigational product
Willing and able to comply with all study procedures based on the investigator's judgment

Who cannot join

Previous and concomitant therapy:
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.

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Previous and concomitant medical condition:
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
Known history of angioedema
Pregnant or lactating women
Any confirmed or suspected immunosuppressive or immunodeficient condition
Known history of Guillain-Barré Syndrome
Known infection with human immunodeficiency virus, hepatitis C virus or hepatitis B virus
Active cancer (malignancy) within 5 years before Day 1 (except for adequately treated non-melanomatous skin carcinoma, at the discretion of the investigator)
Moderate or severe illness and/or fever > 38.0 °C within 1 week before Prime-2-CoV_Beta booster vaccination
Any clinically significant health problem (medical history and physical examination) or clinically significantly abnormal finding in biochemistry and/or hematology blood tests, urinalysis, or electrocardiogram at Screening according to the investigator's opinion
Current or history of cardiovascular disease or structural cardiac disease (including chronic or congenital heart conditions, such as chronic hypertension, coronary heart disease, myocardial infarction and arrhythmias, hypertrophic cardiomyopathy, as well as a history of myocarditis after mRNA vaccinations)
History of mRNA vaccination-associated adverse events that were in nature and severity beyond the common AEs expected
Current or history of gastrointestinal disease, liver disease, renal disease or endocrine disorders, (including diabetes) and neurological illness (excluding migraine), when judged as clinically significant according to the investigator's opinion
Current or history of chronic respiratory diseases, including mild asthma treated by on-demand medication (resolved childhood asthma is allowed)
Current or history of alcohol and/or drug abuse within the last 6 months before Day 1
Previous and concomitant clinical study experience
Current participation in another study or previous enrollment in this clinical study
Other exclusion criteria
Investigator or employee of the study group or sponsor with direct involvement in the proposed study or relatives of the research staff with direct involvement in the proposed study
Prolonged exposure to sheep or goats (e.g., shepherds, sheep farmer)

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Bernhard-Nocht-Institut für Tropenmedizin
Hamburg, Free and Hanseatic City of Hamburg, 20359
University Hospital Tübingen, Institute of Tropical Medicine
Tübingen, Baden-Wurttemberg, 72074

Other trials in Germany

About this study

Official title: A Phase I/IIa, Dose-finding Study to Assess the Safety and Immunogenicity of an Orf Virus-based COVID-19 Vaccine Booster (Prime-2-CoV_Beta) in Healthy Adults

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.

Read the detailed description

Eligible participants will undergo baseline assessments and will receive 1 injection of Prime-2-CoV_Beta at Day 1. Participants will be followed up through 6 months post-booster vaccination. Follow-up visits will be performed at Days 4, 8, 15, 29, and Months 3 and 6, to assess the safety, tolerability, and immunogenicity of Prime-2-CoV_Beta. Additional safety and tolerability data will be assessed 1 day and 2 days after booster vaccination (Days 2 and 3) by telephone. Initially, a total of 60 participants were planned to be vaccinated in 5 cohorts of 12 participants each. Dose ranging of Prime-2-CoV_Beta was planned to be done by dose escalation with doses ranging from 3x104 plaque forming units (PFUs) up to 3x10^7 PFUs.

With protocol Version 7.0, Cohort 6 with 12 participants was added with 6x10^7 PFU. With protocol Version 8.0, 1 additional cohort, Cohort 7 (1.2x10^8 PFU, stratified by previous COVID-19 vaccinations and previous SARS-CoV-2 infections) with 24 participants will be added (total number thus 96 participants).

Procedures for Cohorts 6 and 7 will be the same as for Cohorts 1 - 5, except that for some participants in Cohort 7 ORFV shedding in urine, saliva, blood, and stool will be evaluated.

Conditions: COVID-19
Being tested: Prime-2-CoV_Beta
Keywords: COVID-19, vaccine, Orf virus, SARS-CoV-2
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Prime-2-CoV_BetaBiological
1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1

Study groups in NCT05389319
Study group	Role	What they receive
Cohort 1	Experimental	Prime-2-CoV_Beta, dose: 30 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 2	Experimental	Prime-2-CoV_Beta, dose: 300 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 3	Experimental	Prime-2-CoV_Beta, dose: 3 000 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 4	Experimental	Prime-2-CoV_Beta, dose: 150 000 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 5	Experimental	Prime-2-CoV_Beta, dose: 30 000 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 6	Experimental	Prime-2-CoV_Beta, dose: 60 000 000 PFUs Receives: Biological: Prime-2-CoV_Beta
Cohort 7	Experimental	Prime-2-CoV_Beta, dose: 1 200 000 000 PFUs Receives: Biological: Prime-2-CoV_Beta

What is being measured

The primary outcome is the main question the study is designed to answer.

Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study
All safety data will be summarized descriptively overall and by cohort. TEAEs will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Measured: 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.
Solicited local adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Measured: 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.
Solicited systemic adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Measured: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
All unsolicited adverse events which occur after the first administration of investigational product are defined as treatment-emergent adverse events. Treatment-emergent adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
Measured: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)

Secondary outcomes (6)

Level of neutralizing antibody titers versus SARS CoV-2 (Wuhan wild type) at each post-booster vaccination assessment
Immunogenicity endpoints will be descriptively analyzed by cohort and visit. Separate analyses will be done for the different parameters, e.g., different antibodies evaluated with different serological immunogenicity assays.
Measured: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean fold rise (GMFR) of neutralizing antibodies (versus Wuhan wild type) from Baseline to each post-booster vaccination assessment
The fold change from Baseline will be computed for each participant. The fold rise is calculated as the ratio of the post- vs pre-vaccination titer value. The fold change from Baseline will be summarized using descriptive statistics by cohort and visit. Additionally, the GMFR with 95% CI will be presented.
Measured: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
IgG antibody titer versus SARS-CoV-2 receptor-binding protein
Immunogenicity endpoints will be descriptively analyzed by cohort and visit. Separate analyses will be done for the different parameters, e.g., different antibodies evaluated with different serological immunogenicity assays.
Measured: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean titers (GMT) of receptor-binding protein-specific IgG antibodies
Immunogenicity endpoints will be descriptively analyzed by cohort and visit. Separate analyses will be done for the different parameters, e.g., different antibodies evaluated with different serological immunogenicity assays.
Measured: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean fold rise of receptor-binding protein-specific IgG antibodies from Baseline
The fold change from Baseline will be computed for each participant. The fold rise is calculated as the ratio of the post- vs pre-vaccination titer value. The fold change from Baseline will be summarized using descriptive statistics by cohort and visit. Additionally, the geometric mean fold rise with 95% confidence interval will be presented.
Measured: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Proportion of participants with adverse events of special interest throughout the study
Adverse events of special interest will be summarized by descriptive statistics using contingency tables (counts of events,number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
The frequency (% of participants) of adverse events of special interest throughout the study will be tabulated.
Measured: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Jun 202231 Dec 2026

First posted25 May 2022
Study start24 Jun 2022
Primary completion31 Dec 2026 (estimated)
Study completion31 Dec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies of the same condition, open and under way.
More trials run by University Hospital TuebingenThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Model description: All cohorts will include a safety lead with 1 sentinel participant. If no safety issues occurred within the on-site monitoring period as assessed by the investigator and solicited during telephone visits, the next 2 participants in that dose cohort will be vaccinated. After an 48-hour observation period and assuming no safety issues were identified in these 2 participants, an additional 4 participants will be vaccinated. After a 48-hour observation period, and assuming that no safety problems were noted in these 4 participants, the remaining participants in the dosing group will be vaccinated. Each participant will be observed for at least 4 hours at the study center after Prime-2-CoV\_Beta booster vaccination. After the last participant of each of the Cohorts 1 to 4 and 6 has completed 7 days of follow up after the Prime-2-CoV\_Beta booster vaccination, all safety data will be reviewed by the safety review committee.
Masking: None (open label)
Enrolment: 96 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05389319
Sponsor's protocol ID: PRiME2_21_1
Other IDs: 2024-511266-36-00, WHO UTN Number
Status last verified: Jun 2026
First submitted: 24 May 2022
Last updated: 15 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Esen M, Fischer-Herr J, Gabor JJ, Gaile JM, Fleischmann WA, Smeenk GW, de Moraes RA, Belard S, Calle CL, Woldearegai TG, Egger-Adam D, Haug V, Metz C, Reguzova A, Loffler MW, Balode B, Matthies LC, Ramharter M, Amann R, Kremsner PG. First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster. Vaccines (Basel). 2024 Nov 18;12(11):1288. doi: 10.3390/vaccines12111288.
PubMed 39591190

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/IIa, Dose-finding Study to Assess the Safety and Immunogenicity of an Orf Virus-based COVID-19 Vaccine Booster (Prime-2-CoV_Beta) in Healthy Adults
ClinicalTrials.gov ID: NCT05389319
Acronym / sponsor ID: PRiME2_21_1
Conditions: COVID-19
Keywords: COVID-19, vaccine, Orf virus, SARS-CoV-2
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 96 participants (estimated)
Lead sponsor: University Hospital TuebingenUniversity, hospital or other
Collaborators: FGK Clinical Research GmbH, VisMederi srl, Staburo GmbH, Viedoc Technologies AB
Study start: 24 Jun 2022 (actual)
Primary completion: 31 Dec 2026 (estimated)
Study completion: 31 Dec 2026 (estimated)
First posted: 25 May 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Procedures for Cohorts 6 and 7 will be the same as for Cohorts 1 - 5, except that for some participants in Cohort 7 ORFV shedding in urine, saliva, blood, and stool will be evaluated.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 7
Model description: All cohorts will include a safety lead with 1 sentinel participant. If no safety issues occurred within the on-site monitoring period as assessed by the investigator and solicited during telephone visits, the next 2 participants in that dose cohort will be vaccinated. After an 48-hour observation period and assuming no safety issues were identified in these 2 participants, an additional 4 participants will be vaccinated. After a 48-hour observation period, and assuming that no safety problems were noted in these 4 participants, the remaining participants in the dosing group will be vaccinated. Each participant will be observed for at least 4 hours at the study center after Prime-2-CoV_Beta booster vaccination. After the last participant of each of the Cohorts 1 to 4 and 6 has completed 7 days of follow up after the Prime-2-CoV_Beta booster vaccination, all safety data will be reviewed by the safety review committee.

Arm	Type	Receives
Cohort 1	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 30 000 PFUs
Cohort 2	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 300 000 PFUs
Cohort 3	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 3 000 000 PFUs
Cohort 4	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 150 000 000 PFUs
Cohort 5	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 30 000 000 PFUs
Cohort 6	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 60 000 000 PFUs
Cohort 7	Experimental	Biological: Prime-2-CoV_BetaPrime-2-CoV_Beta, dose: 1 200 000 000 PFUs

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (16 listed)

Healthy adult men or women aged 18 to 55 years
Previous COVID-19 vaccination and previous SARS-CoV-2 infection as follows:
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:

Key exclusion criteria (28 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Prime-2-CoV_Beta1 intramuscular injection (1.0 mL each) into the deltoid muscle on Day 1	Biological	Cohort 1, Cohort 2, Cohort 3, Cohort 4, Cohort 5, Cohort 6, Cohort 7

Primary outcome

Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study
Time frame: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All safety data will be summarized descriptively overall and by cohort. TEAEs will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.
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.
Time frame: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited local adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
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.
Time frame: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)
Solicited systemic adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events).
Proportion of participants with unsolicited treatment-emergent adverse events throughout the study
Time frame: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)
All unsolicited adverse events which occur after the first administration of investigational product are defined as treatment-emergent adverse events. Treatment-emergent adverse events will be summarized by descriptive statistics using contingency tables (counts of events, number and proportion of participants with events) and presented by system organ class and preferred term, as well as by severity.

6 secondary outcomes

Level of neutralizing antibody titers versus SARS CoV-2 (Wuhan wild type) at each post-booster vaccination assessment
Time frame: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean fold rise (GMFR) of neutralizing antibodies (versus Wuhan wild type) from Baseline to each post-booster vaccination assessment
Time frame: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
IgG antibody titer versus SARS-CoV-2 receptor-binding protein
Time frame: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean titers (GMT) of receptor-binding protein-specific IgG antibodies
Time frame: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Geometric mean fold rise of receptor-binding protein-specific IgG antibodies from Baseline
Time frame: Day 1 (vaccination day), day 8 (±1 day), day 15 (±2 days), day 29 (±1 day), month 3 (±14 days), month 6 (end of study visit, ±14 days)
Proportion of participants with adverse events of special interest throughout the study
Time frame: Day 1 (vaccination day) to day 8 (Visit 3; ±1 day)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Derived from this study: PubMed 39591190Esen M, Fischer-Herr J, Gabor JJ, Gaile JM, Fleischmann WA, Smeenk GW, de Moraes RA, Belard S, Calle CL, Woldearegai TG, Egger-Adam D, Haug V, Metz C, Reguzova A, Loffler MW, Balode B, Matthies LC, Ramharter M, Amann R, Kremsner PG. First-in-Human Phase I Trial to Assess the Safety and Immunogenicity of an Orf Virus-Based COVID-19 Vaccine Booster. Vaccines (Basel). 2024 Nov 18;12(11):1288. doi: 10.3390/vaccines12111288.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Meral Esen, Dr. principal investigator

University Hospital Tübingen, Institute of Tropical Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prime-2-CoV_Beta in people with COVID-19, run by University Hospital Tuebingen at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) throughout the study (time frame: Day 1 (vaccination day) to month 6 (end of study visit, ±14 days)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05389319, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2026.