None listed
Conditions
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. A COMIRNATY (Pfizer) COVID-19 vaccine will be used as a comparator and will be administered via intramuscular injection. This study will be conducted in healthy men or women, 18-65 years of age. Across up to six groups, participants will receive escalating doses of the HN-0001 vaccine (3mcg, 10mcg, 30mcg, 50mcg, and 100mcg) or with a 30mcg dose of COMIRNATY (Pfizer) COVID-19 vaccine across cohorts 1, 2, 3, 4, and 5, Cohort 6 will receive a 30mcg dose of COMIRNATY (Pfizer) vaccine. 68 participants will be enrolled in the trial.
Interventions
mRNA/LNP COVID-19 Booster Vaccine (HN-0001) and COMIRNATY (Pfizer) COVID-19 vaccine comparator group.
This 6 cohort study will evaluate escalating doses of HN-0001 administered by intramuscular injection, using a comparator vaccine 30mcg COMIRNATY (Pfizer) COVID-19 vaccine for one cohort, in previously vaccinated healthy adults:
- Cohort 1: Single dose of 3mcg HN-0001
- Cohort 2: Single dose of 10mcg HN-0001
- Cohort 3: Single dose of 30mcg HN-0001
- Cohort 4: Single-dose of 50mcg HN-0001
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mRNA/LNP COVID-19 Booster Vaccine (HN-0001) and COMIRNATY (Pfizer) COVID-19 vaccine comparator group. This 6 cohort study will evaluate escalating doses of HN-0001 administered by intramuscular injection, using a comparator vaccine 30mcg COMIRNATY (Pfizer) COVID-19 vaccine for one cohort, in previously vaccinated healthy adults: - Cohort 1: Single dose of 3mcg HN-0001 - Cohort 2: Single dose of 10mcg HN-0001 - Cohort 3: Single dose of 30mcg HN-0001 - Cohort 4: Single-dose of 50mcg HN-0001 - Cohort 5: Single-dose of 100mcg HN-0001 - Cohort 6: Single-dose of 30mcg COMIRNATY (Pfizer) COVID-19 vaccine 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 (except for Cohort 6). 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.
Sponsors
HelixNano Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed