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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05604690




Registration number
NCT05604690
Ethics application status
Date submitted
15/09/2022
Date registered
3/11/2022
Date last updated
22/03/2024

Titles & IDs
Public title
Safety and Efficacy of Intranasal Administration of Avacc 10 Vaccine Against COVID-19 in Healthy Volunteers
Scientific 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
Secondary ID [1] 0 0
ITV2002
Universal Trial Number (UTN)
Trial acronym
ITV2002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Avacc 10
Combination Product - Outer Membrane Vesicles (OMV) : OMV alone in vehicle
Other interventions - Placebo

Experimental: Treatment Arm: Cohort 1 and 2 - 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

Active Comparator: OMV Arm: Cohort 1 and 2 - 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

Placebo Comparator: Placebo Are: Cohort 1 and 2 - 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 interventions: Avacc 10
Intranasal application of either low dose or high dose of Covid 19 vaccine.

Combination Product: Outer Membrane Vesicles (OMV) : OMV alone in vehicle
OMV will be administered via intranasal route.

Other interventions: Placebo
Placebo will be administered via intranasal route.
Intervention code [1] 0 0
Other interventions
Intervention code [2] 0 0
Combination Product
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of adverse events.
Timepoint [1] 0 0
Screening to end of the follow up period; up to 28 days post final administration period
Primary outcome [2] 0 0
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by evaluating serious adverse events.
Timepoint [2] 0 0
Screening to end of the follow up period; up to 28 days post final administration period
Primary outcome [3] 0 0
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant laboratory findings
Timepoint [3] 0 0
Screening to end of the follow up period; up to 28 days post final administration period
Primary outcome [4] 0 0
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant ECG findings
Timepoint [4] 0 0
Screening to end of the follow up period; up to 28 days post final administration period
Primary outcome [5] 0 0
To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of clinically significant vital signs
Timepoint [5] 0 0
Screening to end of the follow up period; up to 28 days post final administration period
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
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
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
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

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

1. 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).

2. 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.

3. Negative test for SARS-CoV-2 at first visit (Day 1) prior to dosing.

4. Females must be non-pregnant and non-lactating and must use an acceptable, highly
effective contraception in the case of heterosexual intercourse.

5. Males must use highly effective contraception in the case of heterosexual
intercourse.

6. 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.

7. Written or electronic informed consent from the patient prior to any study
procedures in a manner approved by a HREC.

8. Willing and able to comply with the scheduled visits, confinement period,
treatment plan, laboratory tests, and other trial procedures and requirements.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- A participant who meets any of the following exclusion criteria must be excluded from
the study:

1. 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).

2. History of clinically significant autoimmune disorder (such as Guillain-Barré
syndrome).

3. History of febrile illness within 14 days prior to the first dose.

4. Confirmed SARS-CoV-2 infection within the last 4 months prior to study
enrollment.

5. Known exposure to another person with SARS-CoV-2 infection within the last 14
days prior to study enrolment.

6. 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.

7. Vaccination against N. meningitidis (type B).

8. History of frequent epistaxis (defined as a weekly occurrence, or more
frequently).

9. Evidence of a deviated septum, or other nasal abnormality, which may impede the
ability for intranasal administration of any study medication.

10. 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).

11. 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.

12. Documented history of alcohol, cocaine, or IV drug abused within 6 months of
study enrollment.

13. Treatment with an IP within 90 days, preceding study enrollment.

14. 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.

15. 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.

16. 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.

17. 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

18. Pregnant, lactating, or planning to become pregnant (self or partner) at any time
during the study, or 90 days after last intranasal administration.

19. Blood or plasma donation of approximately 500 mL or more within 90 days prior to
the first intranasal administration.

20. Previous history of intolerance or hypersensitivity to any component of the IP
formulation.

21. Subjects who have previously experienced a Grade 3 or higher AE to receipt of a
SARS-CoV-2 vaccination.

22. 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.

23. 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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/01/2024
Sample size
Target
Accrual to date
Final
40
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
University of the Sunshine Coast Clinical Trial Centre - Sippy Downs
Recruitment postcode(s) [1] 0 0
4556 - Sippy Downs

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Intravacc B.V.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Novotech (Australia) Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05604690
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05604690