SARS-CoV-2 InfectionPhase 1NCT05367843
A Study Assessing the Safety, Tolerability, Immunogenicity of COVID-19 Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV_2 Spike and Nucleocapsid Proteins
A Phase 1 study testing PRIME-2-CoV_Beta in people with SARS-CoV-2 Infection, run by Speransa Therapeutics at 7 sites in 2 countries.
Trial summary
PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- SARS-CoV-2 Infection
- What is being tested?
- PRIME-2-CoV_Beta
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 20 Jun 2022to 8 Nov 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female participants between the ages of 18 and 55 years, (A-cohorts), and 65 and 85 years (B-cohorts), inclusive at study entry.
- Body mass index (BMI) over 19 kg/m^2 and under 32 kg/m^2 and weight at least 50 kg at study entry.
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the Investigator to be eligible for inclusion in the study.
- Note: Healthy participants may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment.
- Able to give personal signed informed consent and willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
- Participants must agree not to be vaccinated with any SARS-CoV-2 vaccine, starting after Visit 0 and continuously until 6 months after receiving the first study immunization.
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- Participants who have previously received at least two vaccinations with a licensed SARS-CoV-2 mRNA vaccine (Spikevax/Moderna and/or Comirnaty/Pfizer administered as two-dose primary series with or without booster vaccination[s]) with the last vaccination having occurred at least 3 months prior.
- Participants who are SARS-CoV-2 vaccine-naïve (applies to vaccine-naïve group of Cohort A only):
- Currently not working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel) (vaccine-naïve group of Cohort A only).
- No previous vaccination with any SARS-CoV-2 vaccine (vaccine-naïve group of Cohort A only).
- If the participant is a woman of child bearing potential (WOCBP) must:
- have a negative beta-human chorionic gonadotropin (hCG)-urine test at Visit 0 and Visit 1.
- agree to practice a highly effective form of contraception for at least 14 days prior to study vaccination and continuously until a minimum of 28 days after receiving the last immunization.
- agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study, starting after Visit 0 and continuously until 28 days after receiving the last immunization.
- Note: Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.
- Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner during the study, starting from Visit 1 (pre-dose) and continuously until a minimum of 28 days after receiving the last immunization.
- Men must be willing to refrain from sperm donation, starting from Visit 1 (pre-dose) and continuously until a minimum of 28 days after receiving the last immunization.
Who cannot join
- SARS-CoV-2 nucleic acid amplification test (NAAT)-positive pharyngeal swab within 24 hours before receipt of study vaccine.
- Previously NAAT-confirmed COVID-19 within the last 2 months prior to vaccination.
- Participants who are taking medications which may prevent or treat COVID-19.
- Participants who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 in a period of 6 months.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine(s).
- Current clinical or microbiological diagnosis of COVID-19, including active respiratory or non-respiratory symptoms associated with COVID-19 disease (i.e. symptomatic COVID-19 disease).
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- Any respiratory illness deemed clinically relevant by the investigator within the past month OR hospitalization >24 hours for any reason within the past month.
- History of or current cardiac disease, including but not limited to individuals with uncontrolled hypertension (defined as grade 1 hypertension or higher as per ISH guidelines with or without antihypertensive medication), congenital structural heart diseases, myocarditis and/or pericarditis, coronary heart disease (with/without angina pectoris) or myocardial infarction.
- Individuals with myocarditis after mRNA vaccination, or individuals with AEs after mRNA-vaccination that are in nature and severity beyond the common AEs that can be expected.
- Individuals at high risk for severe COVID-19, including those with any of the following risk factors: cancer; chronic kidney disease; chronic obstructive pulmonary disease (COPD); immunocompromised state (weakened immune system) from solid organ transplant; rheumatologic or autoinflammatory conditions requiring immunosuppressive medication, malignancies; obesity (BMI of 32 or higher); serious heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies; sickle cell disease; insulin-dependent type 2 diabetes mellitus.
- Anticipating the need for immunosuppressive treatment within the next 6 months.
- Any screening hematology and/or blood chemistry laboratory value outside normal range (defined as ≥Grade 1 abnormality) and deemed clinically relevant by the investigator.
- Note: Except bilirubin, participants with any stable Grade 1 abnormalities may be considered eligible at the discretion of the Investigator.
- Chronic immunosuppressive therapy (defined as ≥14 days), including cytotoxic agents, systemic corticosteroids exceeding 10mg/d prednisone equivalent, disease-modifying antirheumatic drugs [DMARDs]) or any other immunomodulating agents within the last 3 months or planned receipt throughout the study.
- Note: If systemic corticosteroids have been administered short-term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
- Receipt of blood/plasma products or immunoglobulin from 60 days before study vaccine administration or planned receipt throughout the study.
- Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
- Individuals with a history of or active autoimmune disease requiring therapeutic intervention.
- Note: subjects with vitiligo or thyroid disease on stable dose thyroid hormone replacement may be enrolled at the discretion of the investigator.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- History of human immunodeficiency virus (HIV), known seropositivity or active infection with HIV.
- History of known seropositivity for or evidence of active viral infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Exception: Participants who are seropositive because of HBV vaccine are eligible. Participants who had HCV but have received an antiviral treatment and show no detectable HCV viral deoxyribonucleic acid (DNA) for 6 months are eligible.
- Known history of active or latent tuberculosis (bacillus tuberculosis).
- Any concomitant serious health condition or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, which, in the opinion of the Investigator, would place the participant at undue risk from the study.
- Has received a live vaccine within 28 days of planned start of study vaccinations (i.e. 28 days before the first and after the last vaccination).
- If a participant has contraindication to IM injections according to investigator's assessment or received therapeutic-intensity anticoagulation for a thromboembolic event within a period of 60 days before vaccination.
- Note: stable long-term prophylactic-dose anticoagulation is allowed.
- Participants with prolonged exposure to sheep or goats (e.g., shepherds, sheep farmer).
- Pregnant and/or nursing women.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
Cedar Crosse Research Center
Chicago, Illinois, 60607
Cedar Health Research - DFW-East
Dallas, Texas, 75251
Caroline Institute for Clinical Research
Fayetteville, North Carolina, 28303
Accel Research Sites (ARS) - DeLand Clinical Research Unit
Florida City, Florida, 32720
AMR - Center for Pharmaceutical Research - Kansas City
Kansas City, Missouri, 64114
Germany2 sites
Clinical Research Center Hannover
Hanover, 30625
Ludwig-Maximilians-University Munich (LMU)
Munich, 80802
About this study
Official title: A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)
PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.
Read the detailed description
The Phase 1 dose-finding study (ORFEUS) will assess the safety, tolerability and immunogenicity of a two-dose regimen (28-days apart) of PRIME-2-CoV_Beta administered by intramuscular (IM) route in adult participants.
In the first part, the safety and immunogenicity of increasing doses of PRIME-2-CoV_Beta will be assessed in adult healthy participants aged 18 to 55 years who have been vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine (i.e. primary sequence with or without booster vaccination, subsequently referred to as "pre-vaccinated"). In addition, one dose level which has been identified as optimal will be assessed in a small cohort (12 participants) of participants 18 to 55 years of age who are SARS-CoV-2 vaccine-naïve.
In addition, three dose levels identified in pre-vaccinated participants will be further evaluated for safety and immunogenicity in pre-vaccinated elderly participants aged 65-85 years (B-cohorts).
- Conditions
- SARS-CoV-2 Infection
- Being tested
- PRIME-2-CoV_Beta
- Keywords
- SARS-CoV-2, Coronavirus, COVID-19, PRIME-2-CoV_Beta
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRIME-2-CoV_BetaDrug
Intramuscular (IM) injection
| Study group | Role | What they receive |
|---|---|---|
| A-Cohorts: Pre-vaccinated | Experimental | Participants aged 18-55 years who have been pre-vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to five groups that receive increasing doses of PRIME-2-CoV_Beta (two doses, 28 days apart). Receives: Drug: PRIME-2-CoV_Beta |
| A-Cohorts: SARS-CoV-2 Vaccine-naïve | Experimental | Participants aged 18-55 years who are SARS-CoV-2 vaccine-naïve will receive one preferred dose level of PRIME-2-CoV_Beta that has been identified as optimal in pre-vaccinated A-Cohorts (two doses, 28 days apart). Receives: Drug: PRIME-2-CoV_Beta |
| B-Cohorts: Pre-vaccinated elderly | Experimental | Elderly participants aged 65-85 years who have been previously vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to three groups to receive previously identified doses of PRIME-2-CoV_Beta (two doses, 28 days apart). Receives: Drug: PRIME-2-CoV_Beta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Measured: Up to 7 days after first immunization (Day 1 up to 8)
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Measured: Up to 7 days after second immunization (Day 29 up to 36)
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Measured: Up to 7 days after first immunization (Day 1 up to 8)
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Measured: Up to 7 days after second immunization (Day 29 up to 36)
Number of participants who experience at least one unsolicited Treatment-emergent Adverse Event (TEAE)
Measured: Day 1 up to Day 57
Secondary outcomes (10)
Geometric mean of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains at each time point
Measured: Up to 6 months
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Measured: Up to 6 months
Number of participants who achieve ≥ 4-fold rise from baseline in SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Measured: Up to 6 months
Geometric Mean Concentration (GMC) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Measured: Up to 6 months
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Measured: Up to 6 months
Number of participants who achieve ≥ 4-fold rise in SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Measured: Up to 6 months
Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta
RP2D based on an integrated analysis of overall safety and immunogenicity endpoints (change in SARS-CoV-2-specific serum neutralizing titers and SARS-CoV-2-spike protein-specific and -nucleocapsid protein-specific binding antibody levels.
Measured: Up to 12 months
Safety and tolerability assessed as incidence of changes from baseline in clinical laboratory values, vital Signs, and Electrocardiograms (ECGs)
Endpoint is assessed as a composite of clinical lab values, vital signs, and ECGs.
Measured: Up to 6 months
Number of participants with solicited local reactions at the injection site
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Measured: Up to Day 15
Number of participants with solicited systemic reactions
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Measured: Up to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start20 Jun 2022
- Primary completion18 Jul 2023
- Study completion8 Nov 2023
Why it stopped: Business Decision
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 SARS-CoV-2 InfectionStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Speransa Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05367843
- Sponsor's protocol ID
- D1701-VrV-101
- Other IDs
- 2021-005219-30
- Status last verified
- Feb 2024
- First submitted
- 2 May 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Klinkardt U, Schunk M, Ervin J, Schindler C, Sugimoto D, Rankin B, Amann R, Monti M, Kutschenko A, Schumacher C, Huber K, Zeder A, Heikkila N, Didierlaurent AM, Schwarz SE, Derouazi M. A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity. Hum Vaccin Immunother. 2024 Dec 31;20(1):2410574. doi: 10.1080/21645515.2024.2410574. Epub 2024 Oct 14.
PubMed 39397784
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Dose Ranging Study Assessing the Safety, Tolerability, Immunogenicity of Vaccine Candidate PRIME-2-CoV_Beta, Orf Virus Expressing SARS-CoV-2 Spike and Nucleocapsid Proteins (ORFEUS Study)
- ClinicalTrials.gov ID
- NCT05367843
- Acronym / sponsor ID
- D1701-VrV-101
- Conditions
- SARS-CoV-2 Infection
- Keywords
- SARS-CoV-2, Coronavirus, COVID-19, PRIME-2-CoV_Beta
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Speransa TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 20 Jun 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 10 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.
PRIME-2-CoV_Beta is the first clinical candidate based on the attenuated 2nd generation Orf virus (ORFV) vaccine platform which encodes for the structural spike (S)- and nucleocapsid (N) protein of SARS-CoV-2. The aim of the multivalent vaccine is to broaden the specific immune response against SARS-CoV-2 and to increase the probability of cross-protection against emerging variants.
Detailed description
The Phase 1 dose-finding study (ORFEUS) will assess the safety, tolerability and immunogenicity of a two-dose regimen (28-days apart) of PRIME-2-CoV_Beta administered by intramuscular (IM) route in adult participants.
In the first part, the safety and immunogenicity of increasing doses of PRIME-2-CoV_Beta will be assessed in adult healthy participants aged 18 to 55 years who have been vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine (i.e. primary sequence with or without booster vaccination, subsequently referred to as "pre-vaccinated"). In addition, one dose level which has been identified as optimal will be assessed in a small cohort (12 participants) of participants 18 to 55 years of age who are SARS-CoV-2 vaccine-naïve.
In addition, three dose levels identified in pre-vaccinated participants will be further evaluated for safety and immunogenicity in pre-vaccinated elderly participants aged 65-85 years (B-cohorts).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A-Cohorts: Pre-vaccinated | Experimental | Drug: PRIME-2-CoV_BetaParticipants aged 18-55 years who have been pre-vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to five groups that receive increasing doses of PRIME-2-CoV_Beta (two doses, 28 days apart). |
| A-Cohorts: SARS-CoV-2 Vaccine-naïve | Experimental | Drug: PRIME-2-CoV_BetaParticipants aged 18-55 years who are SARS-CoV-2 vaccine-naïve will receive one preferred dose level of PRIME-2-CoV_Beta that has been identified as optimal in pre-vaccinated A-Cohorts (two doses, 28 days apart). |
| B-Cohorts: Pre-vaccinated elderly | Experimental | Drug: PRIME-2-CoV_BetaElderly participants aged 65-85 years who have been previously vaccinated against COVID-19 with at least two doses of a SARS-CoV-2 mRNA vaccine will be assigned to three groups to receive previously identified doses of PRIME-2-CoV_Beta (two doses, 28 days apart). |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Male or female participants between the ages of 18 and 55 years, (A-cohorts), and 65 and 85 years (B-cohorts), inclusive at study entry.
- Body mass index (BMI) over 19 kg/m^2 and under 32 kg/m^2 and weight at least 50 kg at study entry.
- Healthy participants who are determined by medical history, physical examination, and clinical judgment of the Investigator to be eligible for inclusion in the study.
- Note: Healthy participants may have stable pre-existing disease defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment.
- Able to give personal signed informed consent and willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, and other study procedures.
Key exclusion criteria (30 listed)
- SARS-CoV-2 nucleic acid amplification test (NAAT)-positive pharyngeal swab within 24 hours before receipt of study vaccine.
- Previously NAAT-confirmed COVID-19 within the last 2 months prior to vaccination.
- Participants who are taking medications which may prevent or treat COVID-19.
- Participants who received convalescent serum or prior therapeutic antibodies against SARS-CoV-2 in a period of 6 months.
- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine(s).
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_BetaIntramuscular (IM) injection | Drug | A-Cohorts: Pre-vaccinated, A-Cohorts: SARS-CoV-2 Vaccine-naïve, B-Cohorts: Pre-vaccinated elderly |
Primary outcome
Number of participants with solicited local reactions at the injection site
Time frame: Up to 7 days after first immunization (Day 1 up to 8)
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Number of participants with solicited local reactions at the injection site
Time frame: Up to 7 days after second immunization (Day 29 up to 36)
Solicited local reactions are described as pain, erythema/redness and induration/swelling.
Number of participants with solicited systemic reactions
Time frame: Up to 7 days after first immunization (Day 1 up to 8)
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Number of participants with solicited systemic reactions
Time frame: Up to 7 days after second immunization (Day 29 up to 36)
Solicited systemic reactions are described as nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever.
Number of participants who experience at least one unsolicited Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 up to Day 57
10 secondary outcomes
Geometric mean of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains at each time point
Time frame: Up to 6 months
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Time frame: Up to 6 months
Number of participants who achieve ≥ 4-fold rise from baseline in SARS-CoV-2-specific serum neutralizing titers against ancestral and variant SARS-CoV-2 strains from baseline to each subsequent timepoint
Time frame: Up to 6 months
Geometric Mean Concentration (GMC) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Geometric Mean-fold Rise (GMFR) of SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Number of participants who achieve ≥ 4-fold rise in SARS-CoV-2-spike and nucleocapsid-protein specific binding antibody levels from baseline to each subsequent time point
Time frame: Up to 6 months
Recommended Phase 2 Dose (RP2D) of PRIME-2-CoV_Beta
Time frame: Up to 12 months
Safety and tolerability assessed as incidence of changes from baseline in clinical laboratory values, vital Signs, and Electrocardiograms (ECGs)
Time frame: Up to 6 months
Number of participants with solicited local reactions at the injection site
Time frame: Up to Day 15
Number of participants with solicited systemic reactions
Time frame: Up to Day 15
Results and safety
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Derived from this study: PubMed 39397784Klinkardt U, Schunk M, Ervin J, Schindler C, Sugimoto D, Rankin B, Amann R, Monti M, Kutschenko A, Schumacher C, Huber K, Zeder A, Heikkila N, Didierlaurent AM, Schwarz SE, Derouazi M. A novel orf virus vector-based COVID-19 booster vaccine shows cross-neutralizing activity in the absence of anti-vector neutralizing immunity. Hum Vaccin Immunother. 2024 Dec 31;20(1):2410574. doi: 10.1080/21645515.2024.2410574. Epub 2024 Oct 14.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: 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 SARS-CoV-2 Infection, run by Speransa Therapeutics at 7 sites in 2 countries.
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 17 inclusion and 30 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: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, 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?
The study was stopped early (reason given: Business Decision). Results are not available in the source record.
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?
Number of participants with solicited local reactions at the injection site (time frame: Up to 7 days after first immunization (Day 1 up to 8)). The study lists 5 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 NCT05367843, 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 9 Feb 2024; AzTrials last refreshed its copy on 7 Nov 2026.