Safety and Immune Response of One Dose of OVX836 at Two Dose Levels, in Comparison to Influvac TetraTM, After Intramuscular Administration in Healthy Subjects Aged 18-65 Years

NCT04192500 | Completed Phase 2 FDA Drug

• 1 other identifier: OVX836-002
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This Phase 2a clinical study is designed to evaluate the immunogenicity and the safety of one dose of OVX836 influenza vaccine administered IM, confirm the dose level and regimen, and expand immunogenicity and safety data to adults through age 65.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• NP-specific IFNγ T-cell increase measured by ELISPOT at Day 8 versus pre-injection baseline (Day 1) in the pooled age strata

  at Day 8 versus pre-injection baseline (Day 1)

Secondary Outcomes (8)

• Proportion of subjects reporting solicited local (Injection site redness, Injection site swelling, Injection site pain) and systemic symptoms (Fatigue, Headache, Arthralgia, Malaise, Myalgia, Fever) using an electronic Diary

  during 7 days after vaccine administration

• Proportion of subjects reporting unsolicited Adverse Events

  during 28 days after vaccine administration

• Proportion of subjects with Influenza-Like-Illness cases associated with laboratory-confirmed influenza

  during the whole study duration, 180 days

• Severity scores of Influenza-Like-Illness cases (as per Flu-PRO® questionnaire)

  during the whole study duration, 180 days

• Proportion of subjects reporting Serious Adverse Events

  during the whole study duration, 180 days

Study Arms (3)

OVX836 - 90µg dose

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 90µg dose on Day 1.

Biological: OVX836

OVX836 - 180µg dose

EXPERIMENTAL

Adjuvant-free recombinant influenza candidate vaccine based on the Nucleoprotein (NP) of the influenza virus. One single administration intramuscularly of a 180µg dose on Day 1.

Biological: OVX836

Quadrivalent seasonal influenza vaccine (Influvac TetraTM)

ACTIVE COMPARATOR

Licensed quadrivalent seasonal influenza subunit vaccine for season 2019-2020. One full dose to be administered at Day 1

Biological: Quadrivalent seasonal influenza vaccine (Influvac TetraTM)

Interventions

OVX836 BIOLOGICAL

One single administration intramuscularly at Day 1.

OVX836 - 180µg dose; OVX836 - 90µg dose

Quadrivalent seasonal influenza vaccine (Influvac TetraTM) BIOLOGICAL

One single administration intramuscularly at Day 1.

Quadrivalent seasonal influenza vaccine (Influvac TetraTM)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent.
• Healthy male or female subjects, as determined by medical history and medical examination.
• Between the ages of 18 and 65 years, inclusive.
• Reliable and willing to make themselves available for the duration of the study, and willing and able to follow study procedures.

You may not qualify if:

• Subject with a body mass index (BMI) ≥35 kg/m² on the day of vaccination.
• Previous influenza vaccination within 6 months before the day of vaccination, or planned to receive during the study duration.
• Any known or suspected immunodeficient conditions.
• Past or current history of significant autoimmune diseases, as judged by the Investigator.
• Current history of significant uncontrolled medical illness such as diabetes, hypertension, heart, renal or hepatic diseases, as judged by the Investigator.
• Female subjects: pregnant, breast-feeding or of childbearing potential without appropriate contraceptive methods in place for 2 months before enrolment, or with positive pregnancy test on the day of vaccination. Appropriate contraceptive methods are defined by the Clinical Trial Facilitation Group \[CTFG\] as follow: "Contraceptive methods that can achieve a failure rate of less than 1% per year when used consistently and correctly are considered as highly effective birth control methods. Such methods include: combined (estrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable intrauterine device, intrauterine hormone-releasing system), bilateral tubal occlusion, vasectomized partner and/or sexual abstinence (refraining from heterosexual intercourse)."
• 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.
• Administration of any investigational or non-registered drug or vaccine within 3 months prior to the administration of study vaccines, or planned administration of any such product during the whole study period.
• 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.
• 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 history of alcohol or drug abuse, or current smoking habit above 10 cigarettes per day.
• Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (\>800 μg/day beclomethasone or equivalent; occasional inhaled corticosteroids for asthma therapy are allowed), radiation treatment, cytotoxic drugs, or current or recent (within 30 days 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.
• Subjects with known or suspected anemia.

Sponsors & Collaborators

• Osivax: lead
• University Ghent: collaborator

Study Sites (1)

Centre for Vaccinology (CEVAC)

Ghent, 9000, Belgium

Location

Related Publications (1)

• Leroux-Roels I, Waerlop G, Tourneur J, De Boever F, Maes C, Bruhwyler J, Guyon-Gellin D, Moris P, Del Campo J, Willems P, Leroux-Roels G, Le Vert A, Nicolas F. Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine. Front Immunol. 2022 Apr 7;13:852904. doi: 10.3389/fimmu.2022.852904. eCollection 2022.

  PMID: 35464450 DERIVED

Related Links

• Randomized, Double-Blind, Reference-Controlled, Phase 2a Study Evaluating the Immunogenicity and Safety of OVX836, A Nucleoprotein-Based Influenza Vaccine

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Isabel Leroux-Roels, MD, PhD

  Centre for Vaccinology (CEVAC), Ghent University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized assignment to experimental vaccine (2 dosage levels or active control (commercial influenza vaccine) in a 1:1:1 ratio.

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 10, 2019
• Study Start: December 11, 2019
• Primary Completion: September 7, 2020
• Study Completion: September 7, 2020
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)