COVID-19Phase 1ITV2002NCT05604690

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

A Phase 1 study testing Avacc 10 in people with COVID-19, run by Intravacc B.V. at 1 site in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: COVID-19
What is being tested?: Avacc 10
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteAustralia
Study dates: 3 Nov 2022to 15 Jan 2024
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

To be eligible for this study, a participant has to meet all of the following inclusion criteria:
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.

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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.

Who cannot join

A participant who meets any of the following exclusion criteria must be excluded from the study:
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.

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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.
Screening 12-lead ECG following at least 5 minutes of supine rest demonstrating a Fridericia corrected QT (QTcF) interval ˃ 450 msec (for males) or > 470 msec (for females) or a QRS interval ≥ 120 msec. If QTcF exceeds 450 msec for men or 470 msec for females, or QRS exceeds ≥ 120 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF (or QRS) values should be used to determine the subjects' eligibility.
Subjects with clinically significant abnormalities (as determined by the Investigator) in clinical laboratory tests at Screening, as assessed by the study-specific clinical laboratory. A single repeat test may be conducted if deemed necessary. Exception may be granted at the discretion of the Investigator where no confounding factors are expected to impact the safety of the subjects or the integrity of the study
Pregnant, lactating, or planning to become pregnant (self or partner) at any time during the study, or 90 days after last intranasal administration.
Blood or plasma donation of approximately 500 mL or more within 90 days prior to the first intranasal administration.
Previous history of intolerance or hypersensitivity to any component of the IP formulation.
Subjects who have previously experienced a Grade 3 or higher AE to receipt of a SARS-CoV-2 vaccination.
Subjects who are investigational site staff members directly involved in the conduct of this study and their family members, site staff otherwise supervised by the Investigator, and participants who are employees of the Sponsor or are agents of the Sponsor.
Any other reason, criteria that may interfere with the interpretation of study results or, in the judgement of the Investigator, would make the subject inappropriate for entry into this study.

Trial locations and contacts

1 site in 1 country.

Australia1 site

University of the Sunshine Coast Clinical Trial Centre
Sippy Downs, Queensland, 4556

Other trials in Australia

About this study

Official title: A Randomized, Double-Blind, Placebo- and OMV-Controlled Phase I Study to Evaluate the Safety, Tolerance, and Immunogenicity of the Avacc 10 Vaccine Administered Intranasally to Healthy Adult Volunteers

Read the detailed description

Approximately 36 subjects are planned to be enrolled across 2 cohorts (n=18 per cohort). Cohort 1 will receive a low dose of Avacc 10 and Cohort 2 will receive a high dose of Avacc 10.

Conditions: COVID-19
Being tested: Avacc 10, Outer Membrane Vesicles (OMV) : OMV alone in vehicle, Placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Avacc 10Biological
Intranasal application of either low dose or high dose of Covid 19 vaccine.
Outer Membrane Vesicles (OMV) : OMV alone in vehicleCombination product
OMV will be administered via intranasal route.
PlaceboOther
Placebo will be administered via intranasal route.

Study groups in NCT05604690
Study group	Role	What they receive
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 Receives: 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 Receives: 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 Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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®
Measured: 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®
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Assessment will be performed of the association between changes in immunogenicity outcomes of SARS-CoV-2 NAbs in serum, anti-SARS-CoV-2 IgA and IgG in serum. The Immunogenicity Population will be the primary population for immunogenicity endpoints.
Measured: 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.
Assessment will be performed of the association between changes in immunogenicity outcomes of anti-SARS-CoV-2 IgA in nasal wash. The Immunogenicity Population will be the primary population for immunogenicity endpoints.
Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Nov 202215 Jan 2024

First posted3 Nov 2022
Study start3 Nov 2022
Primary completion9 Aug 2023
Study completion15 Jan 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COVID-19Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05604690
Sponsor's protocol ID: ITV2002
Acronym: ITV2002
Status last verified: Mar 2024
First submitted: 15 Sep 2022
Last updated: 22 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo- and OMV-Controlled Phase I Study to Evaluate the Safety, Tolerance, and Immunogenicity of the Avacc 10 Vaccine Administered Intranasally to Healthy Adult Volunteers
ClinicalTrials.gov ID: NCT05604690
Acronym / sponsor ID: ITV2002 / ITV2002
Conditions: COVID-19
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Intravacc B.V.Industry (pharma, biotech, devices)
Collaborators: Novotech (Australia) Pty Limited
Study start: 3 Nov 2022 (actual)
Primary completion: 9 Aug 2023 (actual)
Study completion: 15 Jan 2024 (actual)
First posted: 3 Nov 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Approximately 36 subjects are planned to be enrolled across 2 cohorts (n=18 per cohort). Cohort 1 will receive a low dose of Avacc 10 and Cohort 2 will receive a high dose of Avacc 10.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Treatment Arm: Cohort 1 and 2	Experimental	Biological: Avacc 10Subjects 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
OMV Arm: Cohort 1 and 2	Active comparator	Combination Product: Outer Membrane Vesicles (OMV) : OMV alone in vehicleSubjects 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
Placebo Are: Cohort 1 and 2	Placebo comparator	Other: PlaceboSubjects 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

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

To be eligible for this study, a participant has to meet all of the following inclusion criteria:

Key exclusion criteria (24 listed)

A participant who meets any of the following exclusion criteria must be excluded from the study:

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Avacc 10Intranasal application of either low dose or high dose of Covid 19 vaccine.	Biological	Treatment Arm: Cohort 1 and 2
Outer Membrane Vesicles (OMV) : OMV alone in vehicleOMV will be administered via intranasal route.	Combination product	OMV Arm: Cohort 1 and 2
PlaceboPlacebo will be administered via intranasal route.	Other	Placebo Are: Cohort 1 and 2

Primary outcome

To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of adverse events.
Time frame: Screening to end of the follow up period; up to 28 days post final administration period
Adverse Events will be coded using the most current version of the MedDRA®
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by evaluating serious adverse events.
Time frame: Screening to end of the follow up period; up to 28 days post final administration period
Serious Adverse Events will be coded using the most current version of the MedDRA®
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant laboratory findings
Time frame: Screening to end of the follow up period; up to 28 days post final administration period
Clinical laboratory samples will consist of hematology, biochemistry, and urinalysis
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant ECG findings
Time frame: Screening to end of the follow up period; up to 28 days post final administration period
ECG findings will be used for safety analysis.
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant vital signs
Time frame: Screening to end of the follow up period; up to 28 days post final administration period
BP [systolic and diastolic], PR, and temperature will be measured for analysis of vital signs

2 secondary outcomes

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.
Time frame: 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.
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Avacc 10 in people with COVID-19, run by Intravacc B.V. at 1 site in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of adverse events. (time frame: Screening to end of the follow up period; up to 28 days post final administration period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05604690.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.