COVID-19
Conditions
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.
Detailed description
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. 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.
Interventions
BIOLOGICALAvacc 10
Intranasal application of either low dose or high dose of Covid 19 vaccine.
COMBINATION_PRODUCTOuter Membrane Vesicles (OMV) : OMV alone in vehicle
OMV will be administered via intranasal route.
OTHERPlacebo
Placebo will be administered via intranasal route.
Sponsors
Novotech (Australia) Pty Limited
Intravacc B.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Exclusion criteria
* A participant who meets any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by evaluating serious adverse events. | 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 ECG findings | 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 | 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 |
| To evaluate the safety and tolerability of intranasal administration of Avacc 10 in healthy subjects by incidence of adverse events. | 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 incidence of clinically significant laboratory findings | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
Countries
Australia
Outcome results
None listed