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Safety and Immune Response of Increasing Doses of OVX836 After Intramuscular or Intranasal Administrations in Healthy Subjects

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ClinicalTrials.gov Identifier: NCT03594890
Recruitment Status : Recruiting
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Collaborator:
Aepodia
Information provided by (Responsible Party):
Osivax S.A.S

Brief Summary:

The present study is a first-in-man clinical trial evaluating OVX836, a recombinant broad spectrum vaccine for Influenza.

This clinical trial will evaluate the safety and the immune response of increasing doses of OVX836 after intramuscular or intranasal administrations in healthy volunteers.


Condition or disease Intervention/treatment Phase
Influenza Biological: OVX836 (Intramuscular) Biological: Placebo (Intramuscular) Biological: OVX836 (Intranasal) Biological: Placebo (Intranasal) Phase 1

Detailed Description:

This study is a single center, randomized, sequential dose escalation, placebo-controlled, observer-blind study conducted in healthy subjects aged 18-49 years.

The OVX836 recombinant vaccine is based on the well conserved nucleoprotein of the Influenza virus.

Three different dose levels of OVX836 (30µg, 90µg, 180µg) will be assessed sequentially and administered either by the intramuscular route (Study Part A) or by the intranasal route (Study Part B).

There will be 6 cohorts in total with one cohort testing one dose level and one route of administration. Each study cohort will be composed of 12 subjects, with 9 subjects receiving the OVX836 vaccine and 3 subjects receiving the placebo. Each subject will receive one administration of OVX836 or placebo on Day 1 and one administration on Day 29.

The study duration for each subject is approximately 5 months.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Phase I, single center, randomized, observer-blind, placebo-controlled study.
Masking: Double (Participant, Investigator)
Masking Description: This study will be an observer-blind study with the subject-blind and the investigator-blind.
Primary Purpose: Prevention
Official Title: A First-in-human Phase I, Single Center, Randomized, Observer-blind, Placebo-controlled Study to Evaluate the Safety and Immune Response of Increasing Doses of OVX836 Vaccine After Intramuscular (IM) or Intranasal (IN) Administrations in Healthy Subjects Aged 18-49 Years.
Actual Study Start Date : June 12, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: OVX836 (Intramuscular)

OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant.

3 Dose levels tested: 30µg, 90 µg and 180 µg.

Biological: OVX836 (Intramuscular)
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

Placebo Comparator: Placebo (Intramuscular)
The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine.
Biological: Placebo (Intramuscular)
2 consecutive administrations of placebo at Day 1 and Day 29.

Experimental: OVX836 (Intranasal)

OVX836 is a recombinant Influenza vaccine based on the NP of the Influenza virus. OVX836 vaccine is a ready to use sterile liquid clear and colourless solution, presented in 2 mL glass vials filled with 1.2 mL solution. It contains 300 µg/mL of OVX836 vaccine and is formulated without adjuvant.

3 Dose levels tested: 30µg, 90 µg and 180 µg.

Biological: OVX836 (Intranasal)
2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

Placebo Comparator: Placebo (Intranasal)
The Placebo, is Sodium Chloride 0.9 % ready to use sterile solution. The volume of placebo to be administered will be similar to the one of the experimental vaccine.
Biological: Placebo (Intranasal)
2 consecutive administrations of placebo at Day 1 and Day 29.




Primary Outcome Measures :
  1. Out-of-Range Safety Lab data [ Time Frame: 28 days after last vaccine administration. ]
    Frequency (number and percentage) of subjects with deviations from normal values of hematological and biochemical blood tests

  2. Safety: Solicited local and systemic reactions [ Time Frame: 7 days after last vaccine administration. ]
    Frequency (number and percentage) of subjects with reported solicited local and systemic reactions

  3. Safety: Unsolicited Adverse Events [ Time Frame: 28 days after last vaccine administration. ]
    Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE)

  4. Safety: Serious Adverse Events [ Time Frame: at end of study visit (i.e. Week 22) ]
    Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE)


Secondary Outcome Measures :
  1. Immune response: frequency of subjects with anti-NP IgG antibody titres [ Time Frame: 28 days post each vaccine administration and 5 months after the 1st vaccine administration (i.e. Day 29, Day 57, Day 150) versus Day 1 pre-dose. ]
    Frequency (number and percentage) of subjects with an increase of anti-NP Immunoglobulin G (IgG) (ELISA, serum) for each dose level of OVX836 administered by the intramuscular or intranasal route.

  2. Immune response: anti-NP IgG antibody titres (geometric mean) [ Time Frame: 28 days post each vaccine administration and 5 months after the 1st vaccine administration (i.e. Day 29, Day 57, Day 150) versus Day 1 pre-dose. ]
    Geometric Mean in anti-NP Immunoglobulin G (IgG) (ELISA, serum) for each dose level of OVX836 administered by the intramuscular or intranasal route.

  3. Immune response: frequency of subjects with anti-NP IgA antibody titres [ Time Frame: 28 days post each vaccine administration and 5 months post 1st vaccine administration (e.g. Day 29, Day 57, Day 150) versus Day 1 pre-dose. ]
    Frequency (number and percentage) of subjects with an increase of Anti-NP Immunoglobulin A (IgA) (ELISA, nasal swab) for each dose level of OVX836 administered by the intranasal route.

  4. Immune response: anti-NP IgA antibody titres (geometric mean) [ Time Frame: 28 days post each vaccine administration and 5 months post 1st vaccine administration (e.g. Day 29, Day 57, Day 150) versus Day 1 pre-dose. ]
    Geometric Mean in anti-NP Immunoglobulin A (IgA) (ELISA, serum) for each dose level of OVX836 administered by the intranasal route.

  5. Immune response: frequency of subjects with NP T cell resoonse [ Time Frame: Day 1 pre-dose, 7 days and 28 days post each vaccine administration, and 5 months post 1st vaccine administration (e.g. Day 1, Day 8, Day 29, Day 36, Day 57, Day 150). ]
    Frequency (number and percentage) of subjects with NP T cell response (ELISPOT, Peripheral Blood Mononuclear Cells (PBMC)) for each dose level of OVX836 by the intramuscular or intranasal route.

  6. Immune response: mean NP T cell response [ Time Frame: Day 1 pre-dose, 7 days and 28 days post each vaccine administration, and 5 months post 1st vaccine administration (e.g. Day 1, Day 8, Day 29, Day 36, Day 57, Day 150). ]
    NP T cell response (mean ELISPOT counts) for each dose level of OVX836 administered by the intramuscular or intranasal route.



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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Have given written informed consent approved by the relevant Ethical Committee governing the site.
  2. Overtly healthy male or female subjects, as determined by medical history and medical examination.
  3. Between the ages of 18 and 49 years, inclusive, on screening.
  4. Between the Body Mass Index of 18 and 24 kg/m2, inclusive, on screening.
  5. Clinical laboratory test results within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator.
  6. Blood Pressure and Heart Rate within normal reference range, or results with acceptable deviations that are judged to be Non Clinically Significant by the Investigator.
  7. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.

Exclusion Criteria:

  1. Previous Influenza vaccination within the 6 months before screening.
  2. History of significant medical illness such as auto immune diseases, immune deficiency, uncontrolled diabetes or hypertension, heart or renal or hepatic diseases, as judged by the investigator.
  3. For female subjects: pregnant or breast-feeding or of childbearing potential without appropriate contraceptive methods or with positive pregnancy test at screening.
  4. Having received another vaccination within 3 months prior to screening.
  5. Plan to receive other vaccine during the study period.
  6. Administration of any investigational or non-registered drug or vaccine within 3 months prior to the first administration of study vaccine.
  7. History of receiving blood or blood component or IgG within 3 months prior to screening.
  8. Presence of acute febrile illness (temperature > 38°C, temporary exclusion criteria).
  9. For intranasal route: common cold and rhinitis (temporary exclusion criteria).
  10. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
  11. Individuals with 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.
  12. History of alcoholism and/or drug abuse or tabagism (above 10 cigarettes a day).
  13. Treatment that can affect immune response such as systemic or high dose inhaled corticosteroids (>800µg/day beclometasone or equivalent), radiation treatment, cytotoxic drugs or chronic non-steroidal anti-inflammatory drugs (more than 4 weeks), interferon, immunomodulators, allergy shots, as judged by the Investigator.
  14. Positive test for HIV, HBV or HCV at screening.
  15. History of severe allergic reactions and/or anaphylaxis or serious adverse reactions to vaccines and antibiotics.
  16. Any contraindication to intranasal or intramuscular administration, as judged by the Investigator.
  17. 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.
  18. Sponsor employees or Investigator site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594890


Contacts
Contact: Leen Suykens +3232652945 ext +3232652945 leen.suykens@uantwerpen.be

Locations
Belgium
Centre for the Evaluation of Vaccination, University of Antwerp Recruiting
Antwerpen, Belgium, 2610
Contact: Leen Suykens    +32 3 265 2945    leen.suykens@uantwerpen.be   
Principal Investigator: Pierre Van Damme, MD, PhD         
Sponsors and Collaborators
Osivax S.A.S
Aepodia
Investigators
Principal Investigator: Pierre Van Damme, MD, PhD Centre for the Evaluation of Vaccination, University of Antwerp

Additional Information:
Responsible Party: Osivax S.A.S
ClinicalTrials.gov Identifier: NCT03594890     History of Changes
Other Study ID Numbers: OVX836-001
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Osivax S.A.S:
influenza
vaccine
nucleoprotein

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs