Safety and Efficacy of Intranasal Administration of Avacc 10 Vaccine Against COVID-19 in Healthy Volunteers

NCT05604690 | Completed Phase 1 DMC

• 1 other identifier: ITV2002
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase I, first-in-human (FIH), double-blind, placebo- and OMV-controlled study of Avacc 10 in healthy adult male and female subjects to investigate the safety, tolerability, and immunogenicity of intranasally administered Avacc 10.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (5)

• To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of adverse events.

  Adverse Events will be coded using the most current version of the MedDRA®

  Screening to end of the follow up period; up to 28 days post final administration period

• To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by evaluating serious adverse events.

  Serious Adverse Events will be coded using the most current version of the MedDRA®

  Screening to end of the follow up period; up to 28 days post final administration period

• To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant laboratory findings

  Clinical laboratory samples will consist of hematology, biochemistry, and urinalysis

  Screening to end of the follow up period; up to 28 days post final administration period

• To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant ECG findings

  ECG findings will be used for safety analysis.

  Screening to end of the follow up period; up to 28 days post final administration period

• To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant vital signs

  BP \[systolic and diastolic\], PR, and temperature will be measured for analysis of vital signs

  Screening to end of the follow up period; up to 28 days post final administration period

Secondary Outcomes (2)

• To evaluate the immunogenic response of intranasal administration of Avacc 10 in healthy subjects. Immunogenicity evaluations will be done via serum analysis for biomarkers representative of an immunogenic response to a SARSCoV-2 vaccine.

  At Screening (at least 3 days prior to first administration), at the follow-up visits 2 weeks following each dose (Day 15 [± 1 day] and Day 36 [± 1 day]), and at the follow-up visit 28 days (window 28-35 days) following the second treatment dose

• To evaluate the immunogenic response of intranasal administration of Avacc 10 in healthy subjects. Immunogenicity evaluations will be done via nasal wash analyses for biomarkers representative of an immunogenic response to a SARS-CoV-2 vaccine.

  At Screening (at least 3 days prior to first administration), at the follow-up visits 2 weeks following each dose (Day 15 [± 1 day] and Day 36 [± 1 day]), and at the follow-up visit 28 days (window 28-35 days) following the second treatment dose

Study Arms (3)

Treatment Arm: Cohort 1 and 2

EXPERIMENTAL

Subjects will receive 2 doses of Avacc 10 via intranasal application. * Cohort 1 will receive a low dose of Avacc 10 * Cohort 2 will receive a high dose of Avacc 10. Dosage Form: Liquid Unit Dose: Investigational product (IP) in Phosphate Buffered Saline Route of Administration: Intranasal Physical Description: Slightly opalescent in glass vial

Biological: Avacc 10

OMV Arm: Cohort 1 and 2

ACTIVE COMPARATOR

Subjects will receive 2 doses of Outer Membrane Vesicles (OMV) comparator via intranasal application. Dosage Form: Liquid Unit Dose: OMV comparator in TRIS/sucrose buffer Route of Administration: Intranasal Physical Description: Slightly opalescent in glass vial

Combination Product: Outer Membrane Vesicles (OMV) : OMV alone in vehicle

Placebo Are: Cohort 1 and 2

PLACEBO COMPARATOR

Subjects will receive 2 doses of placebo via intranasal application. Dosage Form: Liquid Unit Dose: Placebo in TRIS/sucrose buffer Route of Administration: Intranasal Physical Description: Clear, colorless in glass vial

Other: Placebo

Interventions

Avacc 10 BIOLOGICAL

Intranasal application of either low dose or high dose of Covid 19 vaccine.

Treatment Arm: Cohort 1 and 2

Outer Membrane Vesicles (OMV) : OMV alone in vehicle COMBINATION_PRODUCT

OMV will be administered via intranasal route.

OMV Arm: Cohort 1 and 2

Placebo OTHER

Placebo will be administered via intranasal route.

Placebo Are: Cohort 1 and 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female subjects between the ages of 18 and 55 years, inclusive. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, a full physical/neurological examination including vital signs (including systolic and diastolic BP, temperature, and PR), a 12-lead ECG, and clinical laboratory tests).
• Participant must have received a vaccination against SARS-CoV-2 or have been exposed to SARS-CoV-2 at least ≥ 4 months prior to the first study dose or shown to be sero-positive to IgG by any of the serological tests marketed as EUA and authorized by the FDA.
• Negative test for SARS-CoV-2 at first visit (Day 1) prior to dosing.
• Females must be non-pregnant and non-lactating and must use an acceptable, highly effective contraception in the case of heterosexual intercourse.
• Males must use highly effective contraception in the case of heterosexual intercourse.
• BMI between 18.0 to 32.0 kg/m2 , inclusive; and a total body weight ≥ 50.0 kg for males and ≥ 45.0 kg for females.
• Written or electronic informed consent from the patient prior to any study procedures in a manner approved by a HREC.
• Willing and able to comply with the scheduled visits, confinement period, treatment plan, laboratory tests, and other trial procedures and requirements.

You may not qualify if:

• Evidence or history of medical conditions which are unstable, or under investigations currently, defined as major changes to management/medication or surgery/hospitalization in the last 12 months, including hematological (including clotting disorders), renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, and untreated seasonal allergies at time of dosing).
• History of clinically significant autoimmune disorder (such as Guillain-Barré syndrome).
• History of febrile illness within 14 days prior to the first dose.
• Confirmed SARS-CoV-2 infection within the last 4 months prior to study enrollment.
• Known exposure to another person with SARS-CoV-2 infection within the last 14 days prior to study enrolment.
• Vaccination with a live vaccine within the 4 weeks prior to study enrollment or any non-live vaccination within the 2 weeks prior to study enrollment, or that is planned during study participation.
• Vaccination against N. meningitidis (type B).
• History of frequent epistaxis (defined as a weekly occurrence, or more frequently).
• Evidence of a deviated septum, or other nasal abnormality, which may impede the ability for intranasal administration of any study medication.
• History of, or current positive results for, any of the following serological tests: HIV, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HbcAb), or hepatitis C antibody (HCVAb).
• Malignancy or a history of malignancy in the previous 5 years, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin or adequately treated cervical carcinoma-in-situ.
• Documented history of alcohol, cocaine, or IV drug abused within 6 months of study enrollment.
• Treatment with an IP within 90 days, preceding study enrollment.
• Use of prescription and non-prescription intranasal drug within 7 days prior to first dose of intranasal administration and throughout the study, until 1 month after the last intranasal administration.
• Screening supine BP ≥ 155 mmHg (systolic) or ≥ 95 mmHg (diastolic), following at least 5 minutes of supine rest. If BP is ≥ 155 mmHg (systolic) or ≥ 95 mmHg (diastolic), the BP should be repeated 2 more times with the subject at supine rest and the average of the 3 BP values should be used to determine the subjects' eligibility.

Sponsors & Collaborators

• Intravacc B.V.: lead
• Novotech (Australia) Pty Limited: collaborator

Study Sites (1)

University of the Sunshine Coast Clinical Trial Centre

Sippy Downs, Queensland, 4556, Australia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind. The Sponsor, Investigator, Medical Monitor, study personnel, and participants are not to make any effort to determine which study drug therapy is being received. Unblinded pharmacy (or other qualified site) personnel will be used in this study to prepare the study drug. Assigned unblinded clinical staff will be responsible for overseeing treatment administration.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: November 3, 2022
• Study Start: November 3, 2022
• Primary Completion: August 9, 2023
• Study Completion: January 15, 2024
• Last Updated: March 22, 2024

Record last verified: 2024-03

Locations

AU (1)