Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000891325
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
27/06/2026
Date registered
Help: Date registered
20/07/2026
Date last updated
Help: Date last updated
1/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/07/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A first-in-human Phase 1 Study to evaluate the Safety, Tolerability, and Immunogenicity of PVX-001, an mRNA vaccine against SARS-CoV-2, as a Booster in Healthy Adults
Scientific title
A Phase 1 Open-Label, Single-Center, Dose-Finding Trial to Assess the Safety, Tolerability, and Immunogenicity of PVX-001, a SARS-CoV-2 Spike Receptor Binding Domain (RBD)-Ferritin messenger ribonucleic acid (mRNA) Lipid Nanoparticle (LNP) Vaccine as a Single Intramuscular Booster Dose in Previously Vaccinated Adults
Additional trial identifiers [1] 317646 0
PVX-001_P1
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
SARS-CoV-2 342423 0
Condition category
Condition code
Infection 338558 338558 0 0
Other infectious diseases
Respiratory 338745 338745 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
PVX-001 is a KP.2 SARS-CoV-2 spike receptor-binding domain (RBD)-ferritin mRNA-lipid nanoparticle (LNP) vaccine, supplied as a sterile, preservative-free liquid for intramuscular (IM) injection at dose strengths:
1. 10 micrograms (mcg)/0.5 mL
2. 30 mcg/0.5 mL
3. 50 mcg/0.5 mL.
PVX-001 is a KP.2 SARS-CoV-2 spike receptor-binding domain (RBD)-ferritin mRNA-lipid nanoparticle (LNP) vaccine, supplied as a sterile, preservative-free liquid for intramuscular injection. Registered nurses will administer the vaccine under PI supervision. This 3-cohort study will evaluate escalating single doses of PVX-001 administered by intramuscular injection into the deltoid muscle, in previously vaccinated healthy adults:

Cohort 1: Single dose of 10 mcg PVX-001 (10 mcg/0.5 mL)
Cohort 2: Single dose of 30 mcg PVX-001 (30 mcg/0.5 mL)
Cohort 3: Single dose of 50 mcg PVX-001 (50 mcg/0.5 mL)

A total of 36 healthy participants (n=12 per cohort) will be enrolled. A suitably qualified member of the research team will administer the injection, and all participants will be followed up for 181 days after vaccination. Within each cohort, an initial sentinel group of 2 participants will be dosed and assessed for safety, including a 4-hour post-vaccination observation period, before the remaining participants in that cohort are dosed. After all participants in a cohort complete at least 7 days of follow-up, the Safety Review Committee (SRC) will determine whether the next dose-level cohort will be initiated. Dose escalation across cohorts is gated by SRC evaluation.

After the PVX-001 dosage on Day 1, telephonic follow-ups and clinic visits shall be performed as per study protocol which will be followed up by the site monitors and clinical research associates as per the monitoring plan.
Intervention code [1] 334477 0
Prevention
Description of the comparator or control
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345843 0
To assess the safety and reactogenicity of PVX-001 at 3 dose levels of 10, 30 and 50 µg by monitoring the frequency and severity (grade) of solicited local adverse events (reactogenicity) following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [1] 345843 0
Daily from Day 1 (day of vaccination) through Day 8, i.e. the day of administration and the 7 subsequent days.
Primary outcome [2] 345844 0
To assess the safety of PVX-001 at 3 dose levels of 10, 30, and 50 µg by monitoring the frequency and severity (grade) of unsolicited adverse events following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [2] 345844 0
Daily from Day 1 through Day 29 (28 days post-vaccination).
Primary outcome [3] 345845 0
Frequency of serious adverse events (SAEs) following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [3] 345845 0
Daily throughout the study from Day 1 to Day 181 (end of study) after administration of the study vaccine.
Secondary outcome [1] 463483 0
To assess serum neutralising antibodies (nAbs) induced following administration of PVX-001 against SARS-CoV-2 variants KP.2, JN.1, KP.3.1.1, and LP.8.1.
Timepoint [1] 463483 0
Pre-dose on Day 1, and post vaccine administration on study days 29, and 181.
Secondary outcome [2] 463484 0
To assess serum binding IgG antibodies induced following administration of PVX-001 against the receptor binding domain (RBD)/Spike of SARS-CoV-2 variants KP.2, JN.1, KP.3.1.1, and LP.8.1.
Timepoint [2] 463484 0
Pre-dose on Day 1, and post vaccine administration on study days 29, and 181.
Secondary outcome [3] 464875 0
This is an additional primary outcome. To assess the safety and reactogenicity of PVX-001 at 3 dose levels of 10, 30 and 50 µg by monitoring the frequency and severity (grade) of solicited systemic adverse events (reactogenicity) following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [3] 464875 0
Daily from Day 1 (day of vaccination) through Day 8, i.e. the day of administration and the 7 subsequent days.
Secondary outcome [4] 464876 0
This is an additional primary outcome. Frequency of medically attended adverse events (MAAEs) following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [4] 464876 0
Regularly throughout the study from Day 1 to Day 181 (end of study) after administration of the study vaccine.
Secondary outcome [5] 464877 0
This is an additional primary outcome. Frequency of adverse events of special interest (AESIs) following a single intramuscular dose of PVX-001 in healthy adults.
Timepoint [5] 464877 0
Regularly throughout the study from Day 1 to Day 181 (end of study) after administration of the study vaccine.

Eligibility
Key inclusion criteria
Participants are eligible to participate in this trial only if they meet ALL of the following inclusion criteria at the time of screening (V01) and reconfirmed prior to vaccination (V02):
1. Provide written informed consent prior to initiation of any study procedures.
2. Understand and comply with planned study procedures, including completion of the participant diary and availability for all study visits.
3. Agree to the collection of venous blood samples per protocol.
4. Have adequate venous access for phlebotomy.
5. Be a male, 30 to 64 years of age, or a female 18 to 64 years of age, at the time of enrolment.
6. Have received at least a 2-dose primary series of any approved SARS-CoV-2 vaccine.
7. Are in good health as determined by medical history and physical examination [Footnote 1].
8. Have a tympanic temperature less than 37.5 °C.
9. Have a pulse of 40 to 100 beats per minute, inclusive.
10. Have a systolic blood pressure of 90 to 140 mmHg, inclusive.
11. Have a diastolic blood pressure of 55 to 90 mmHg, inclusive.
12. Have a calculated body mass index (BMI) between 18 and 35.0 kg/m², inclusive at screening.
13. Have screening laboratory parameters within acceptable parameters defined in the laboratory manual or assessed as not clinically significant as per investigator discretion.
14. Have no clinically significant findings on a 12-lead electrocardiogram (ECG) [Footnote 2].
15. Females of childbearing potential [Footnote 3] must have a negative serum ß-hCG pregnancy test at screening and a negative urine pregnancy test within 24 hours prior to study vaccination, and must agree to comply with the double-protection contraception requirements (or abstinence) at least 30 days prior to vaccination through at least 60 days after study vaccination as specified by the site staff.
16. Females of childbearing potential who become pregnant during the trial-reporting period agree to allow follow-up through pregnancy outcome.
17. Agree to have blood collected, stored, and potentially used for autoantibody studies if a suspected AESI occurs in this participant.

[Footnote 1] Good health is defined by the site PI or appropriate sub-investigator to evaluate acute or chronic medical diagnoses or conditions that would affect the assessment of the safety of participants or the immunogenicity of study vaccinations. Chronic medical diagnoses or conditions, defined as those present for at least 60 days, should be stable (not worsening) for the last 60 days (no hospitalisations, ER/urgent care, or invasive medical procedures for the condition; no medication changes indicative of worsening disease/use of supplemental oxygen). Prescription changes that are due to insurance, provider change, or financial reasons are not considered deviations. Participants may take chronic or as-needed (PRN) medications if, in the opinion of the PI/sub-investigator, they pose no additional risk and do not indicate worsening disease. Herbals, vitamins, and supplements are permitted.
[Footnote 2] Clinical significance of ECG findings will be determined by the PI or sub-investigator. Examples leading to exclusion include significant left ventricular hypertrophy, right or left bundle branch block, advanced AV heart block, non-sinus rhythm (excluding isolated premature atrial contractions), pathologic Q waves, significant ST-T wave changes, and prolonged QTc interval.
[Footnote 3] A female of childbearing potential (FOCBP) is any female who does not meet the criteria for female of non-childbearing potential (FONCBP). FONCBP is defined as: (a) surgically sterile via bilateral oophorectomy, bilateral salpingectomy, or hysterectomy (documented in source records); or (b) postmenopausal, defined as greater than or equal to 12 months of spontaneous amenorrhea without an alternative medical cause AND serum follicle-stimulating hormone (FSH) greater than or equal to 40 mIU/mL measured at screening. Essure® placement is not accepted as a basis for FONCBP status, as the device was withdrawn from the market in 2018–2019.
Minimum age
18 Years
Maximum age
64 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
Participants who meet ANY of the following criteria are not eligible to participate in this trial:
1. Acute illness, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to study vaccination [Footnote 1].
2. Any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation [Footnote 2].
With significant skin conditions or tattoos/scaring on upper arms that would affect assessment of ISRs.
3. Immunosuppression as a result of an underlying illness or treatment, recent history, or current use of immunosuppressive or immunomodulating disease therapy [Footnote 3].
4. Use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
5. Known active or recently active (within 12 months) neoplastic disease or any history of haematologic malignancy. Non-melanoma skin cancers, treated, are permitted.
6. Known human immunodeficiency virus (HIV), chronic hepatitis B, or hepatitis C infection.
7. Known hypersensitivity or allergy to any component of the study vaccine.
8. Documented episode of SARS-CoV-2 infection or COVID-19 illness within 90 days prior to enrolment.
9. History of myocarditis, pericarditis, or myopericarditis.
10. History of alcohol or drug abuse within 2 years prior to study enrolment that would interfere with participant compliance or safety evaluations [Footnote 4]. A positive alcohol breath test or urine drug of abuse test at Screening. A positive result for cotinine is not exclusionary.
11. Any current or past diagnosis of schizophrenia, bipolar disorder, or other psychiatric diagnosis that would interfere with participant compliance or safety evaluations [Footnote 5].
12. Receipt of, or planned receipt of, any vaccine within 30 days before or after study vaccination.
13. Receipt of, or planned receipt of, a vaccine against SARS-CoV-2 within 90 days prior to study vaccination.
14. Receipt of immunoglobulin or other blood products within 90 days prior to study vaccination.
15. Receipt of an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days or 5 half-lives prior to study vaccination, or expected receipt of another experimental agent during the trial-reporting period (approximately 6 months after vaccination).
16. Participation or planned participation in another clinical trial with an interventional agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) that would be received during the trial-reporting period (approximately 6 months after vaccination).
17. Female participants who are breastfeeding or plan to breastfeed from the time of enrolment through 90 days after study vaccination.
18. Planned blood donation within 4 months following vaccination.
19. Planned elective surgery during study participation.
20. Member or immediate family member of the site research staff listed on the delegation log.
[Footnote 1] An acute illness which is nearly resolved with only minor residual symptoms is allowable if, in the opinion of the PI/sub-investigator, the residual symptoms will not interfere with safety/reactogenicity assessment.
[Footnote 2] Including any acute, subacute, intermittent, or chronic medical condition that would place the participant at unacceptable risk, render compliance with the protocol infeasible, or interfere with evaluation of responses or trial completion.
[Footnote 3] Including oral or parenteral (including intra-articular) corticosteroids of any dose within 30 days prior to vaccination. Intranasal or inhaled corticosteroids are not exclusionary; low- and moderate-potency topical corticosteroids are permitted.
[Footnote 4] Per the judgment of the site PI or appropriate sub-investigator.
[Footnote 5] Per the judgment of the site PI or appropriate sub-investigator.

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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/07/2026
Actual
5/08/2026
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
8
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 29658 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 46005 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 322185 0
Commercial sector/Industry
Name [1] 322185 0
PopVax Australia Proprietary Limited
Country [1] 322185 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
PopVax Australia Proprietary Limited
Address
Country
Australia
Secondary sponsor category [1] 325094 0
None
Name [1] 325094 0
Address [1] 325094 0
Country [1] 325094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320714 0
Bellberry Human Research Ethics Committee C
Ethics committee address [1] 320714 0
Ethics committee country [1] 320714 0
Australia
Date submitted for ethics approval [1] 320714 0
10/06/2026
Approval date [1] 320714 0
17/07/2026
Ethics approval number [1] 320714 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 151382 0
Dr Christina Chang
Address 151382 0
Nucleus Network Pty Ltd Commercial Road, Level 5 Burnet Tower, 89 Commercial Rd, Melbourne, VIC 3004
Country 151382 0
Australia
Phone 151382 0
+61429001089
Fax 151382 0
Email 151382 0
[email protected]
Contact person for public queries
Name 151383 0
Nucleus Network Melbourne
Address 151383 0
Level 5, Burnet Tower, 89 Commercial Rd, Melbourne, Victoria, 3004
Country 151383 0
Australia
Phone 151383 0
+61 1800 243 733
Fax 151383 0
Email 151383 0
[email protected]
Contact person for scientific queries
Name 151384 0
Darshit Mehta
Address 151384 0
PopVax Australia Proprietary Limited, L 2 169 Pirie Street, Adelaide, South Australia, 5000, Australia
Country 151384 0
Australia
Phone 151384 0
+61 283 495 200
Fax 151384 0
Email 151384 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.