Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000715572
Ethics application status
Approved
Date submitted
15/02/2024
Date registered
11/06/2024
Date last updated
11/06/2024
Date data sharing statement initially provided
11/06/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
A study to test the safety of HN-0001 SARS-CoV-2 'COVID-19' Vaccine in Healthy Adults
Scientific title
A Phase 1, Ascending Dose Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 mRNA/LNP Vaccine (HN-0001) in Healthy Adults
Secondary ID [1] 311395 0
CPHN-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 (COVID-19) 332681 0
Condition category
Condition code
Infection 329388 329388 0 0
Other infectious diseases
Respiratory 329517 329517 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
mRNA/LNP COVID-19 Booster Vaccine (HN-0001)
This 5 cohort study will evaluate escalating doses of HN-0001 administered by intramuscular injection, in previously vaccinated healthy adults:
- Cohort 1: Single dose of 3mcg HN-0001
- Cohort 2: Single dose of 10mcg HN-0001
- Cohort 3: Registered separately
- Cohort 4: Single-dose of 100mcg HN-0001
- Cohort 5: Single-dose of 150mcg HN-0001

A suitably qualified member of the research team will administer the injection and all participants will be followed up for 180 days after the vaccination. Safety will be assessed after the dosing of 2 participants in each cohort before dosing further participants. After all participants in a cohort complete at least 7 days of follow-up the safety review committee will determine if the next dose level cohort will be initiated.
Intervention code [1] 327844 0
Prevention
Intervention code [2] 327845 0
Treatment: Drugs
Comparator / control treatment
No control or comparator group for Cohort 1, 2, 4 and 5.
For comparator arm, refer to Cohort 3 - registered separately.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337214 0
To describe the safety profile of a single dose administration of HN-0001, across up to 5 cohorts in healthy adults. The frequency and grade of local and systemic adverse events will be assessed.
Timepoint [1] 337214 0
Daily for 7 days; post administration of the study vaccine, Day 1 to Day 8.
Primary outcome [2] 337305 0
To describe the safety profile of a single dose administration of HN-0001, across up to 5 cohorts in healthy adults. The frequency and grade of unsolicited local and systemic adverse events will be assessed.
Timepoint [2] 337305 0
Daily for 28 days, post-administration of study vaccine Day 1 to Day 29.
Primary outcome [3] 337306 0
To describe the safety profile of a single dose administration of HN-0001, across up to 5 cohorts in healthy adults. The frequency and grade of SAEs, MAAEs and AESIs will be assessed.
Timepoint [3] 337306 0
Daily throughout the study from Day 1 to Day 180 (end of study) after administration of the study vaccine.
Secondary outcome [1] 431317 0
To assess serum neutralising antibodies (nAbs) induced following administration of the study drug against S protein and/or the receptor binding domain (RBD) of S protein from SARS-CoV-2 strain B.A.4/B.A.5 and/or strain X.BB.1.5.
Timepoint [1] 431317 0
Pre-dose on Day 1, and post administration of study vaccine on Day 8, Day 15, Day 29, Day 90 and Day 180 (end of study).
Secondary outcome [2] 432552 0
To assess serum IgG antibodies induced following administration of the study drug against S protein and/or the receptor binding domain (RBD) of S protein from SARS-CoV-2 strain B.A.4/B.A.5 and/or strain X.BB.1.5.
Timepoint [2] 432552 0
Pre-dose on Day 1, and post administration of study vaccine on Day 8, Day 15, Day 29, Day 90 and Day 180 (end of study).
Secondary outcome [3] 432556 0
Primary Outcome:
To describe the safety profile of a single dose administration of HN-0001, across up to 5 cohorts in healthy adults. Clinical safety laboratory parameters will be assessed.
Timepoint [3] 432556 0
Pre-dose on Day 1, post-administration of the study vaccine on Day 1, then Day 2, Day 3, Day 8, Day 15, Day 29, Day 90 and Day 180 (end of study).
Secondary outcome [4] 432557 0
Primary Outcome:
To describe the tolerability profile of a single dose administration of HN-0001 across up to 5 cohorts in healthy adults. The frequency and grade of local and systemic adverse events will be assessed.
Timepoint [4] 432557 0
Daily for 7 days, post administration of study vaccine, Day 1 to Day 8.
Secondary outcome [5] 432558 0
Primary Outcome:
To describe the tolerability profile of a single dose administration of HN-0001 across up to 5 cohorts in healthy adults. The frequency and grade of unsolicited local and systemic adverse events will be assessed.
Timepoint [5] 432558 0
Daily for 28 days, post administration of study vaccine Day 1 to Day 29.

Eligibility
Key inclusion criteria
Participants are eligible for enrolment in the study only if all the following criteria are met at the time of screening:
1. Healthy male or female between the ages of 18 and 65 years (inclusive) at the time of screening. Healthy status will be determined by the Investigator based on the medical history, clinical laboratory results, vital sign and electrocardiogram measurements, and physical examination at screening.
2. Participants willing and able to give personal signed informed consent and comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures, including storage of blood samples for secondary use in research.
3. Has received at least one vaccination against COVID-19 (most recent dose was received >180 days prior).
4. Negative for SARS-CoV-2 infection as determined by PCR test at screening (visit 1) and rapid antigen test on Day 1 (first-dose/baseline).
5. Screening laboratory values must be within the laboratory reference ranges or meets the definition of a less than or equal to Grade 1 abnormality on the toxicity scale and deemed not clinically significant by the Investigator. The prothrombin time, fibrinogen, and activated partial thromboembolism (aPPT) must be in the reference range.
6. Females must not be pregnant or lactating, or trying to become pregnant as demonstrated by either one of the following A or B:
A. Not of child bearing potential: surgically sterile (at least six weeks post bilateral salpingectomy, bilateral oophorectomy, or hysterectomy); or post-menopausal (history of >12 consecutive months without menses prior to Day 1 in the absence of other pathologic or physiologic causes and confirmed by follicle stimulating hormone [FSH] level >40 mIU/mL.
OR
B. Women of childbearing potential who are not planning to be pregnant and/or lactating from screening until at least 30 days after vaccination and who meet all of criteria i-iii:
(i). Negative serum pregnancy test at the screening visit, and negative serum or urine pregnancy test at baseline (Day 1).
(ii). Is not lactating.
(iii). Using ne of the following highly effecting methods of contraception:
- Combine oestrogen and progesterone, or progesterone-only hormonal contraception associated with inhibition of ovulation (e.g.: implants, pills, patches) initiated >30 days prior to study Day 1/baseline.
- Intrauterine device (IUD) or intrauterine system (IUS) inserted >30 days prior to study Day 1/baseline.
- Vasectomised partner (the vasectomised partner should have had the procedure at least 6 months prior to Day 1/baseline and be the sole partner for that subject.
For male participants that have not had a vasectomy (at least 6 months prior to Day 1/baseline), they must agree to use either a barrier method of contraception from the time of vaccination until at least 90 days after vaccination. Note: female partners (that are of childbearing potential) of male participants (that have not had a vasectomy) should use one of the effective contraceptive methods (e.g.: hormonal contraception, IUD, IUS, or barrier type). Also, male participants must not donate sperm for the duration of 90 days after vaccination.
Note: Contraception requirements do not apply for participants in an exclusively same-sex relationship.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants meeting any of the following criteria at the time of screening will be excluded from enrolment:
1. Any concomitant disease, condition, or treatment that could interfere with the conduct of the study, or that would, in the opinion of the Investigator or Sponsor, pose an unacceptable risk to the participant in the study or interfere with the interpretation of study data.
2. Has had a confirmed SARS-CoV-2 infection within the 6 months before vaccine administration.
3. Has an acute illness, as determine by the site PI or delegate, with or without fever (temperature >38 degrees Centigrade [100 degrees Fahrenheit]) 48 hours prior to vaccination.
4. Has a history of hypersensitivity or severe allergic reaction to any previous licensed or unlicensed vaccines or component thereof.
5. Received immunoglobulins and/or any blood or blood products within the 6 months before vaccine administration.
6. Has any blood dyscrasia or any significant disorder or coagulation.
7. Has any abnormality or permanent body art (e.g.: tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
8. Received or plans to receive any licensed vaccine within 4 weeks or after vaccination.
9. Receipt of any other SARS-CoV-2 or other experimental COVID vaccine within 180 days before vaccination or any planned receipt during the study duration.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised 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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
16/04/2024
Date of last participant enrolment
Anticipated
6/09/2024
Actual
Date of last data collection
Anticipated
31/03/2025
Actual
Sample size
Target
48
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26131 0
University of the Sunshine Coast Clinical Trials Centre - South Bank - South Brisbane
Recruitment postcode(s) [1] 41990 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 315654 0
Commercial sector/Industry
Name [1] 315654 0
HelixNano Australia Pty Ltd
Country [1] 315654 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
HelixNano Australia Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 317848 0
None
Name [1] 317848 0
Address [1] 317848 0
Country [1] 317848 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314538 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 314538 0
https://bellberry.com.au/
Ethics committee country [1] 314538 0
Australia
Date submitted for ethics approval [1] 314538 0
05/02/2024
Approval date [1] 314538 0
15/03/2024
Ethics approval number [1] 314538 0

Summary
Brief summary
The purpose of this study is to assess safety, reactogenicity (reactions that occur to the body soon after vaccination), and immunogenicity (the ability of a vaccine to provoke an immune reaction in the body) of a COVID-19 vaccine, HN-0001. The HN-0001 vaccine will be administered via intramuscular injection. This study will be conducted in healthy men or women, 18-65 years of age.

Across up to five groups, participants will receive escalating doses of the HN-0001 vaccine (3mcg, 10mcg, 30mcg, 100mcg, and 150mcg). Information regarding participants receiving 30 mcg can be found registered separately. Across cohorts 1, 2, 4, and 5, 48 participants will be enrolled in the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131938 0
Dr Nischal Sahai
Address 131938 0
University of the Sunshine Coast Clinical Trials, Southbank Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101
Country 131938 0
Australia
Phone 131938 0
+61 7 54563978
Fax 131938 0
Email 131938 0
nsahai@usc.edu.au
Contact person for public queries
Name 131939 0
Mr Greg Plunkett
Address 131939 0
Accelagen Pty Ltd Suite 2.02, t85 Toorak Road Hawthorn East, VIC 3123
Country 131939 0
Australia
Phone 131939 0
+61 3 9114 2270
Fax 131939 0
Email 131939 0
greg.plunkett@accelagen.com.au
Contact person for scientific queries
Name 131940 0
Nischal Sahai
Address 131940 0
University of the Sunshine Coast Clinical Trials, Southbank Building A1, SW1 Complex, 32 Cordelia Street, South Brisbane QLD 4101
Country 131940 0
Australia
Phone 131940 0
+61 7 54563978
Fax 131940 0
Email 131940 0
nsahai@usc.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.