First-in-human Study to Evaluate the Safety and Immunogenicity of Three Dose Levels of the OVX033 Coronavirus Vaccine Candidate in Healthy Volunteers

NCT06128382 | Completed Phase 1 DMC

• 1 other identifier: OVX033-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Coronavirus

Outcome Measures

Primary Outcomes (6)

• 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

  during 7 days after vaccine administration

• Number and percentage of subjects reporting unsolicited adverse events

  during 29 days after vaccine administration

• Occurrence of adverse event of special interest

  during the whole study duration, 180 days

• Occurrence of serious adverse event

  during the whole study duration, 180 days

• Number and percentage of subjects with medically-attended adverse events (classified by type and reason)

  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

  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)

  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

  at Day 1 (pre-injection baseline) and Days 8 and 29

• Geometric mean titers (GMTs) of anti-N IgG (ELISA, serum)

  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

  on Days 8, 29, 90 and 180, with respect to preinjection baseline (Day 1)

• Anti-OVX313 IgG (ELISA, serum) titers

  at Days 29, 90 and 180 versus pre-injection baseline (Day 1)

Study Arms (6)

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.

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.

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.

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.

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.

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.

Biological: Saline solution

Interventions

OVX033 BIOLOGICAL

One single administration intramuscularly on Day 1

OVX033 - 100µg dose level; OVX033 - 250µg dose level; OVX033 - 500µg dose level

Saline solution BIOLOGICAL

One single administration intramuscularly on Day 1

Saline solution - 0.2mL; Saline solution - 0.5mL; Saline solution - 1.0mL

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Osivax: lead
• CIC 1417 Cochin Pasteur Hôpital Cochin Paris France: collaborator

Study Sites (1)

CIC Cochin Pasteur CIC 1417 Hôpital Cochin

Paris, France

Location

MeSH Terms

Conditions

Coronavirus Infections

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Odile Launay, MD

  CIC Cochin Pasteur CIC 1417 Hôpital Cochin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Dose escalation

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: November 13, 2023
• Study Start: January 8, 2024
• Primary Completion: July 8, 2024
• Study Completion: November 29, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)