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

NCT03594890 | Completed Phase 1 DMC

• 1 other identifier: OVX836-001
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

influenza; vaccine; nucleoprotein

Outcome Measures

Primary Outcomes (4)

• Out-of-Range Safety Lab data

  Frequency (number and percentage) of subjects with deviations from normal values of hematological and biochemical blood tests

  28 days after last vaccine administration.

• Safety: Solicited local and systemic reactions

  Frequency (number and percentage) of subjects with reported solicited local and systemic reactions

  7 days after last vaccine administration.

• Safety: Unsolicited Adverse Events

  Frequency (number and percentage) of subjects with reported unsolicited Adverse Event (AE)

  28 days after last vaccine administration.

• Safety: Serious Adverse Events

  Frequency (number and percentage) of subjects with reported Serious Adverse Event (SAE)

  at end of study visit (i.e. Week 22)

Secondary Outcomes (6)

• Immune response: frequency of subjects with anti-NP IgG antibody titres

  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.

• Immune response: anti-NP IgG antibody titres (geometric mean)

  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.

• Immune response: frequency of subjects with anti-NP IgA antibody titres

  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.

• Immune response: anti-NP IgA antibody titres (geometric mean)

  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.

• Immune response: frequency of subjects with NP T cell resoonse

  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).

Study Arms (4)

OVX836 (Intramuscular)

EXPERIMENTAL

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)

Placebo (Intramuscular)

PLACEBO COMPARATOR

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)

OVX836 (Intranasal)

EXPERIMENTAL

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)

Placebo (Intranasal)

PLACEBO COMPARATOR

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)

Interventions

OVX836 (Intramuscular) BIOLOGICAL

2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

OVX836 (Intramuscular)

Placebo (Intramuscular) BIOLOGICAL

2 consecutive administrations of placebo at Day 1 and Day 29.

Placebo (Intramuscular)

OVX836 (Intranasal) BIOLOGICAL

2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.

OVX836 (Intranasal)

Placebo (Intranasal) BIOLOGICAL

2 consecutive administrations of placebo at Day 1 and Day 29.

Placebo (Intranasal)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• Previous Influenza vaccination within the 6 months before screening.
• 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.
• For female subjects: pregnant or breast-feeding or of childbearing potential without appropriate contraceptive methods or with positive pregnancy test at screening.
• Having received another vaccination within 3 months prior to screening.
• Plan to receive other vaccine during the study period.
• Administration of any investigational or non-registered drug or vaccine within 3 months prior to the first administration of study vaccine.
• History of receiving blood or blood component or IgG within 3 months prior to screening.
• Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
• 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.
• History of alcoholism and/or drug abuse or tabagism (above 10 cigarettes a day).
• 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.
• Positive test for HIV, HBV or HCV at screening.
• History of severe allergic reactions and/or anaphylaxis or serious adverse reactions to vaccines and antibiotics.
• Any contraindication to intranasal or 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.

Sponsors & Collaborators

• Osivax: lead
• Aepodia: collaborator

Study Sites (1)

Centre for the Evaluation of Vaccination, University of Antwerp

Antwerp, 2610, Belgium

Location

Related Links

• Sponsor
• Clinical Unit
• Phase 1 Randomized, Placebo-Controlled, Dose-Escalating Study to Evaluate OVX836, a Nucleoprotein-Based Influenza Vaccine: Intramuscular Results

MeSH Terms

Conditions

Influenza, Human

Interventions

Injections, Intramuscular

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Injections; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Pierre Van Damme, MD, PhD

  Centre for the Evaluation of Vaccination, University of Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This study will be an observer-blind study with the subject-blind and the investigator-blind.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Phase I, single center, randomized, observer-blind, placebo-controlled study.

Study Record Dates

• First Submitted: June 20, 2018
• First Posted: July 20, 2018
• Study Start: June 12, 2018
• Primary Completion: August 7, 2019
• Study Completion: August 7, 2019
• Last Updated: September 22, 2022

Record last verified: 2022-09

Locations

BE (1)