None listed
Conditions
Brief summary
This Phase 1 trial is designed to assess the safety, reactogenicity, and immunogenicity of a single IM booster dose of PVX-001 across three ascending dose levels in previously vaccinated healthy adults, in a controlled clinical setting with staged sentinel dosing and an independent Safety Review Committee. This study will be conducted in healthy women aged 18 to 64 years and healthy men aged 30 to 64 years of age.
Interventions
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 adminis
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.
Sponsors
PopVax Australia Proprietary Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed