CoronavirusPhase 1NCT06128382
First-in-human Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Coronavirus Vaccine Candidate in Healthy Volunteers
A Phase 1 study testing OVX033 and Saline solution in people with Coronavirus, run by Osivax at 1 site in France.
Trial summary
This first-in-human clinical trial is designed to evaluate the safety and immunogenicity of one administration of OVX033 coronavirus vaccine at different dose levels (100µg, 250µg and 500µg) Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- OVX033 and Saline solution
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to 29 Nov 2024
- 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 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination.
- Aged 18 to 49 years.
- Subjects who have been vaccinated (2 to 4 doses) with a licensed SARS-CoV-2 (COVID-19) vaccine. The last dose should be >6 months before administration of the investigational vaccine.
- Reliable and willing to make themselves available for the duration of the study, willing and able to follow study procedures.
- Willing to refrain from strenuous physical exercise during the week preceding any blood sampling, including between screening and vaccination visit (Visit 2).
Who cannot join
- Subjects with a body mass index (BMI) <18 kg/m² or >30 kg/m² at screening.
- Subjects weighing less than 50 kg.
- Subjects with abnormal safety laboratory (hematology, biochemistry, coagulation and urinalysis) parameter at screening.
- Subjects having previously received a non-licensed SARSCoV-2 vaccine or only one single dose of a licensed SARSCoV-2 vaccine.
- Subjects having presented medically significant adverse event after having received a SARS-CoV-2 licensed vaccine.
- Subjects currently treated with medications intended to prevent SARS-CoV-2 infection or disease (COVID-19) complications.
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- SARS-CoV-2 infection within the past 3 months prior to enrolment, RT-PCR-confirmed SARS-CoV-2 infection at screening or ongoing symptom of COVID-19.
- Subjects having received another vaccination within 3 months prior to the day of study vaccination for live attenuated vaccines, or within 1 month prior to the day of study vaccination for inactivated vaccines.
- Planning to receive other vaccines during the first 28 days following the study vaccine administration.
- Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for at least 2 months before enrolment, or with positive pregnancy test at screening or on the day of vaccination. Appropriate contraceptive methods are to be maintained until the end of the trial.
- Subjects receiving treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 3 months before study entry) chronic or prolonged (>10 days) use of systemic non-steroidal anti-inflammatory drugs, interferon, immunomodulators, allergy shots, as judged by the Investigator.
- Any known or suspected immunodeficient conditions.
- Past or current history of significant autoimmune diseases, as judged by the Investigator.
- Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) at screening.
- Current history of medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
- Hereditary or acquired hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or history of serious bleeding, or history of massive bleeding after intramuscular injection, intravenous puncture or ecchymosis.
- History of receiving blood, blood components or immunoglobulins within 3 months prior to the day of vaccination, or planned to receive such product during the whole study period.
- Presence of an acute febrile illness on the day of planned vaccination or within 72 hours prior of it (oral temperature>38.0°C; temporary exclusion criterion).
- Past or current history of any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
- Behavioral or cognitive impairment, or psychiatric disease that, in the opinion of the Investigator, may interfere with the subject's ability to participate in the study.
- Past (stopped less than 6 months before enrolment) or current smoking habit above 10 cigarettes per day.
- Past (stopped less than 6 months before enrolment) or current history of alcohol consumption (more than 2 glasses per day, more than 10 glasses per week, or absence of any days within a week without consumption. A standard glass contains 10 g of alcohol corresponding to 10 cl of wine, 25 cl of beer at 5% or 3 cl of alcohol at 40% [Société Française d'Alcoologie, 2023]).
- Past (stopped less than 6 months before enrolment) or current history of use of recreational drugs.
- Prophylactic or therapeutic use of any anti(retro)virals by systemic route during the study. Topical application is allowed.
- History of severe allergic reactions and/or anaphylaxis, or serious adverse reactions to vaccines or allergy to kanamycin.
- Any contraindication to intramuscular administration, as judged by the Investigator.
- Individuals with history of any illness that, in the opinion of the Investigator, might interfere with the results of the study, or pose additional risk to the subjects due to participation in the study, either directly or through any treatments administered for that illness.
- Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse (or assimilated), parent, child or sibling, whether biological or legally adopted.
- Subjects receiving ≥10 mg/day of prednisone or equivalent for more than 3 months before study entry.
- Health professionals and/or students for whom vaccination against SARS-CoV-2 is strongly recommended.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A First-in-human Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-49 Years
This first-in-human clinical trial is designed to evaluate the safety and immunogenicity of one administration of OVX033 coronavirus vaccine at different dose levels (100µg, 250µg and 500µg)
Read the detailed description
This trial is a first-in-human phase 1, single center, randomized, double-blind, placebo-controlled study in 48 adult subjects to evaluate the safety and immunogenicity of OVX033 sarbecovirus vaccine at different dose levels (100µg, 250µg and 500µg).
One single dose of OVX033 vaccine or of Placebo will be administered intramuscularly in healthy subjects aged 18-49 years.
- Conditions
- Coronavirus
- Being tested
- OVX033, Saline solution
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OVX033Biological
One single administration intramuscularly on Day 1
Saline solutionBiological
One single administration intramuscularly on Day 1
| Study group | Role | What they receive |
|---|---|---|
| OVX033 - 100µg dose level | Experimental | Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 100µg (0.2mL) dose on Day 1. Receives: Biological: OVX033 |
| OVX033 - 250µg dose level | Experimental | Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 250µg (0.5mL) dose on Day 1. Receives: Biological: OVX033 |
| OVX033 - 500µg dose level | Experimental | Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 500µg (1.0mL) dose on Day 1. Receives: Biological: OVX033 |
| Saline solution - 0.2mL | Placebo comparator | Saline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.2mL dose on Day 1. Receives: Biological: Saline solution |
| Saline solution - 0.5mL | Placebo comparator | Saline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.5mL dose on Day 1. Receives: Biological: Saline solution |
| Saline solution - 1.0mL | Placebo comparator | Saline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 1.0mL dose on Day 1. Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and percentage of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) signs and symptoms
Measured: during 7 days after vaccine administration
Number and percentage of subjects reporting unsolicited adverse events
Measured: during 29 days after vaccine administration
Occurrence of adverse event of special interest
Measured: during the whole study duration, 180 days
Occurrence of serious adverse event
Measured: during the whole study duration, 180 days
Number and percentage of subjects with medically-attended adverse events (classified by type and reason)
Measured: during the whole study duration, 180 days
Number and percentage of subjects with deviations from normal values (judged clinically relevant or not by the Investigator) of safety laboratory tests
Measured: during 29 days after vaccine administration
Secondary outcomes (7)
Cell-mediated immune response in terms of change of N-specific T-cell number in PBMCs, measured by IFNγ ELISPOT (after in vitro stimulation)
Measured: at Days 8, 29, 90 and 180 versus pre-injection baseline (Day 1)
N-specific CD4+ and CD8+T-cell percentages measured by flow cytometry (on PBMCs), identified as expressing markers (after in vitro stimulation), such as IL-2, TNFα and/or IFNγ
Measured: at Day 1 (pre-injection baseline) and Days 8 and 29
Geometric mean titers (GMTs) of anti-N IgG (ELISA, serum)
Measured: at Day 1 (pre-injection baseline), and Days 8, 29, 90 and 180
Number and percentage of subjects with an increase (four-fold) in anti-N IgG titer
Measured: on Days 8, 29, 90 and 180, with respect to preinjection baseline (Day 1)
Anti-OVX313 IgG (ELISA, serum) titers
Measured: at Days 29, 90 and 180 versus pre-injection baseline (Day 1)
anti-hC4BP oligomerization domain IgG (ELISA, serum) titers [If positive result for anti-OVX313]
Measured: at Days 29, 90 and 180 versus pre-injection baseline (Day 1)
Number and percentage of subjects with a RT-PCR-confirmed SARS-CoV-2 and/or influenza A or B infection
Measured: during the whole study duration, 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start8 Jan 2024
- Primary completion8 Jul 2024
- Study completion29 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- Dose escalation
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Osivax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CIC 1417 Cochin Pasteur Hôpital Cochin Paris France
- Responsible party
- Sponsor
- Investigators
- Odile Launay, MD, Principal investigator, CIC Cochin Pasteur CIC 1417 Hôpital Cochin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06128382
- Sponsor's protocol ID
- OVX033-001
- Status last verified
- Sep 2026
- First submitted
- 7 Nov 2023
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-human Phase 1, Single Center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Vaccine, After Intramuscular Administration in Healthy Subjects Aged 18-49 Years
- ClinicalTrials.gov ID
- NCT06128382
- Acronym / sponsor ID
- OVX033-001
- Conditions
- Coronavirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- OsivaxIndustry (pharma, biotech, devices)
- Collaborators
- CIC 1417 Cochin Pasteur Hôpital Cochin Paris France
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 29 Nov 2024 (actual)
- First posted
- 13 Nov 2023 (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 first-in-human clinical trial is designed to evaluate the safety and immunogenicity of one administration of OVX033 coronavirus vaccine at different dose levels (100µg, 250µg and 500µg)
Detailed description
This trial is a first-in-human phase 1, single center, randomized, double-blind, placebo-controlled study in 48 adult subjects to evaluate the safety and immunogenicity of OVX033 sarbecovirus vaccine at different dose levels (100µg, 250µg and 500µg).
One single dose of OVX033 vaccine or of Placebo will be administered intramuscularly in healthy subjects aged 18-49 years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
- Model description
- Dose escalation
| Arm | Type | Receives |
|---|---|---|
| OVX033 - 100µg dose level | Experimental | Biological: OVX033Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 100µg (0.2mL) dose on Day 1. |
| OVX033 - 250µg dose level | Experimental | Biological: OVX033Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 250µg (0.5mL) dose on Day 1. |
| OVX033 - 500µg dose level | Experimental | Biological: OVX033Recombinant sarbecovirus vaccine based on the nucleocapsid of SARS-CoV-2. One single administration intramuscularly of a 500µg (1.0mL) dose on Day 1. |
| Saline solution - 0.2mL | Placebo comparator | Biological: Saline solutionSaline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.2mL dose on Day 1. |
| Saline solution - 0.5mL | Placebo comparator | Biological: Saline solutionSaline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 0.5mL dose on Day 1. |
| Saline solution - 1.0mL | Placebo comparator | Biological: Saline solutionSaline solution (NaCl 0.9%), B. Braun Ecoflac® Plus 50mL. One single administration intramuscularly of a 1.0mL dose on Day 1. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Written informed consent.
- Healthy male or female subjects, as determined by medical history and medical examination.
- Aged 18 to 49 years.
- Subjects who have been vaccinated (2 to 4 doses) with a licensed SARS-CoV-2 (COVID-19) vaccine. The last dose should be >6 months before administration of the investigational vaccine.
- Reliable and willing to make themselves available for the duration of the study, willing and able to follow study procedures.
Key exclusion criteria (30 listed)
- Subjects with a body mass index (BMI) <18 kg/m² or >30 kg/m² at screening.
- Subjects weighing less than 50 kg.
- Subjects with abnormal safety laboratory (hematology, biochemistry, coagulation and urinalysis) parameter at screening.
- Subjects having previously received a non-licensed SARSCoV-2 vaccine or only one single dose of a licensed SARSCoV-2 vaccine.
- Subjects having presented medically significant adverse event after having received a SARS-CoV-2 licensed vaccine.
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 |
|---|---|---|
| OVX033One single administration intramuscularly on Day 1 | Biological | OVX033 - 100µg dose level, OVX033 - 250µg dose level, OVX033 - 500µg dose level |
| Saline solutionOne single administration intramuscularly on Day 1 | Biological | Saline solution - 0.2mL, Saline solution - 0.5mL, Saline solution - 1.0mL |
Primary outcome
Number and percentage of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) signs and symptoms
Time frame: during 7 days after vaccine administration
Number and percentage of subjects reporting unsolicited adverse events
Time frame: during 29 days after vaccine administration
Occurrence of adverse event of special interest
Time frame: during the whole study duration, 180 days
Occurrence of serious adverse event
Time frame: during the whole study duration, 180 days
Number and percentage of subjects with medically-attended adverse events (classified by type and reason)
Time frame: during the whole study duration, 180 days
Number and percentage of subjects with deviations from normal values (judged clinically relevant or not by the Investigator) of safety laboratory tests
Time frame: during 29 days after vaccine administration
7 secondary outcomes
Cell-mediated immune response in terms of change of N-specific T-cell number in PBMCs, measured by IFNγ ELISPOT (after in vitro stimulation)
Time frame: at Days 8, 29, 90 and 180 versus pre-injection baseline (Day 1)
N-specific CD4+ and CD8+T-cell percentages measured by flow cytometry (on PBMCs), identified as expressing markers (after in vitro stimulation), such as IL-2, TNFα and/or IFNγ
Time frame: at Day 1 (pre-injection baseline) and Days 8 and 29
Geometric mean titers (GMTs) of anti-N IgG (ELISA, serum)
Time frame: at Day 1 (pre-injection baseline), and Days 8, 29, 90 and 180
Number and percentage of subjects with an increase (four-fold) in anti-N IgG titer
Time frame: on Days 8, 29, 90 and 180, with respect to preinjection baseline (Day 1)
Anti-OVX313 IgG (ELISA, serum) titers
Time frame: at Days 29, 90 and 180 versus pre-injection baseline (Day 1)
anti-hC4BP oligomerization domain IgG (ELISA, serum) titers [If positive result for anti-OVX313]
Time frame: at Days 29, 90 and 180 versus pre-injection baseline (Day 1)
Number and percentage of subjects with a RT-PCR-confirmed SARS-CoV-2 and/or influenza A or B infection
Time frame: during the whole study duration, 180 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- 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.
Odile Launay, MD principal investigator
CIC Cochin Pasteur CIC 1417 Hôpital Cochin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OVX033 and Saline solution in people with Coronavirus, run by Osivax at 1 site in France.
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 6 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: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and percentage of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) signs and symptoms (time frame: during 7 days after vaccine administration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2026.