A FIRST IN HUMAN TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF SARS-CoV-2 UQSC2 VACCINE IN HEALTHY ADULTS.

NCT05775887 | Completed Phase 1

• 1 other identifier: UQ-2-UQSC2
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This will be a single centre, Phase 1, First-In-Human , Randomized, Active-controlled (2- arm) Double-blind, single dose, parallel design study. The study will be conducted in a young healthy adult population aged ≥ 18 - ≤ 50 years. This study will consist of a single cohort of 70 subjects (35 receiving a single dose of UQSC2 vaccine and 35 subjects receiving a single dose of a TGA (Therapeutic Goods Administration) registered SARS-CoV-2 vaccine NVX-CoV2373).

Conditions

COVID-19

Keywords

SARS-CoV-2 infection; vaccine

Outcome Measures

Primary Outcomes (6)

• Frequency, duration, and intensity of solicited local adverse events (AEs)

  Frequency, duration, and intensity of solicited local adverse events (AEs), including pain, redness, and induration for 7 days following vaccination.

  [Time Frame: Day 1-7]

• Frequency, duration, and intensity of solicited systemic adverse events (AEs)

  Frequency, duration, and intensity of solicited systemic adverse events (AEs), including fever, nausea, chills,diarrhoea, headache, fatigue, and myalgia for 7 days following vaccination.

  [Time Frame: Day 1-7]

• Frequency, duration, and intensity of solicited systemic adverse events (AEs)

  Frequency, duration, and intensity of solicited systemic adverse events (AEs)

  [Time Frame: Day 1-29]

• Frequency of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest and any AEs leading to study withdrawal at any time

  Frequency of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs, namely myocarditis, pericarditis, anaphylaxis, thrombocytopaenia, Acute disseminated encephalomyelitis (ADEM) and Guillain-Barre Syndrome (GBS) and any AEs leading to study withdrawal at any time during the study through to Day 183.

  [Time Frame: Dat 1-183]

• Geometric Mean Titres (GMT) of the serum NAb (Neutralising Antibody) titres to matched SARS-CoV-2 (prototypic strain) by microneutralisation (MN) assay.

  Geometric Mean Titres (GMT) of the serum NAb titres to matched SARS-CoV-2 (prototypic strain) by microneutralisation (MN) assay at Day 29 (28 days after vaccination) relative to day 1 (pre-dosing), compared to NVXCoV2373.

  [Time Frame: At Day 29]

• Seroresponse rate (SRR), where seroresponse is defined as ≥ 4-fold rise from pre-vaccination, Day 1) by MN assay to matched SARS-CoV-2 (prototypic strain).

  Seroresponse rate (SRR), where seroresponse is defined as ≥ 4-fold rise from pre-vaccination, Day 1) by MN assay to matched SARS-CoV-2 (prototypic strain) at Day 29 compared to NVX-CoV2373.

  [Time Frame: At Day 29]

Secondary Outcomes (5)

• GMT of the serum antibody response by SARS-CoV-2 Spike antigen specific ELISA

  [Time Frame: At Day 29]

• Seroresponse rate (SRR, where seroresponse is defined as ≥ 4-fold rise from pre-vaccination, Day 1) by ELISA

  [Time Frame: At Days 15, 29, 91 and 183]

• SRR by MN assay at Days 15, 29, 91 and183, compared to NVX-CoV2373

  [Time Frame: At Days 15, 29, 91 and 183]

• GMT to the SARS-CoV-2 Spike by antigen specific ELISA

  [Time Frame: At Days 1,15, 29, 91 and 183]

• GMT of the serum NAb titres to matched SARS-CoV-2 (prototypic strain) by MN assay

  [Time Frame: At Days 1,15, 29, 91 and 183]

Study Arms (2)

UQSC2 vaccine

EXPERIMENTAL

15mcg of UQSC2 (SARS-CoV-2 Sclamp2 antigen) adjuvanted with MF59

Biological: UQSC2 Vaccine

NVX-CoV2373 vaccine

ACTIVE COMPARATOR

5 mcg SARS-CoV-2 spike protein adjuvanted with Matrix-M

Biological: NVX-CoV2373 vaccine

Interventions

UQSC2 Vaccine BIOLOGICAL

Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373. The Study will be unblinded after Day 29, to enable subjects who received the investigational vaccine (UQSC2 vaccine) to seek vaccination with a TGA (Therapeutic Goods Administration) approved COVID-19 booster vaccine if indicated by public health authorities.

UQSC2 vaccine

NVX-CoV2373 vaccine BIOLOGICAL

Subjects will be assigned to treatment group (UQSC2 or NVX-CoV2373) via randomisation. Each treatment group will receive a single dose of either UQSC2 or NVX-CoV2373

NVX-CoV2373 vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or non-pregnant female, ≥18 and ≤50 years of age, with BMI ≥18 and ≤ 34.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Healthy as defined by:
• The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease.
• Non-smokers or social smokers (defined as the equivalent or fewer than 10 cigarettes per week). Ex-heavy smokers (heavy smoking is defined as the equivalent of 25 or more cigarettes per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 12 months. Ex-moderate level smokers (i.e. \>10 per week but \<25 per day) may be admitted if they have quit or reduced their cigarette intake to the defined level of social smoking, for a period of at least 6 months.
• All women of child bearing potential (WOCBP) and men must refrain from sperm/egg donation and must be able and willing to use at least 1 highly effective method of contraception commencing at least 28 days prior to vaccine administration and for 3 months after vaccine administration. Subjects in same sex relationships must be able and willing to refrain from sperm/egg donation for 3 months after vaccine administration. A female subject is considered to be a WOCBP following menarche and until she is in a post-menopausal state for 12 consecutive months (without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy). A follicle-stimulating hormone (FSH) test may be used to confirm a post-menopausal state. Examples of acceptable methods of contraceptive methods (for female subjects and female partners of male subjects) to be used throughout the study include
• Use of hormonal contraceptives, started at at least 28 days prior to study treatment administration and must agree to use the same hormonal contraceptive throughout the study;
• Use of an intra-uterine contraceptive device, placed at at least 28 days prior to study treatment administration;
• Use of a diaphragm, started at least 28 days prior to study treatment administration;
• Use of condoms for male subjects whose partners are pregnant to ensure that the foetus is not exposed to the study vaccine;
• Sterile male partner (vasectomized since at least 6 months prior to study treatment administration)
• True abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) from the time of enrollment and at for at least 28 days prior to study treatment administration and for at least the duration of the study. Periodic abstinence and withdrawal are not acceptable methods.
• Must meet the following COVID-19 vaccination status:
• Have completed a primary SARS-CoV-2 vaccination series with either the Pfizer or Moderna COVID-19 vaccine, and
• Have received at least one booster dose of the Pfizer or Moderna SARS-CoV-2 vaccine at least 3 months prior to study entry.
• WOCBP must return a negative urine pregnancy test prior to receiving the study treatment.

You may not qualify if:

• Subjects to whom any of the following applies will be excluded from the study:
• Any clinically significant abnormality or vital sign abnormality at physical examination (including baseline resting average high blood pressure \[average systolic blood pressure ≥140 mmHg or resting average diastolic blood pressure ≥90 mmHg or high random blood sugar \[nonfasting\]), clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening.
• Any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation. Subjects who have a chronic condition that is stable and controlled and otherwise healthy should not be excluded. Within at least the past 3 months must NOT have received another COVID-19 vaccine.
• Persons who received another COVID-19 vaccine within the past 3 months prior to dosing.
• Persons who received a primary vaccination series and or a booster vaccination dose of a non-mRNA COVID-19 vaccine (ie Matrix M adjuvanted COVID-19 vaccine, Novavax).
• Persons who have a history of COVID-19 or virologically confirmed SARS-CoV-2 infection in the past 3 months.
• Persons with a history of COVID-19 with ongoing sequelae.
• Persons with a history of myocarditis and/or pericarditis.
• Positive pregnancy, urine drug screen, or alcohol breath test at screening.
• Known history of allergic reactions or hypersensitivity to any vaccine, or to any excipient in the formulation (including the adjuvants: MF59C.1 and Matrix-M).
• Presence of a known, or suspected, impairment of the immune system including, but not limited to, HIV, autoimmune disorders, immunosuppressant therapy, and diabetes mellitus.
• History of a known, or suspected, respiratory system disorder including, but not limited to, cystic fibrosis, reactive airway disease, emphysema, chronic bronchitis, chronic obstructive pulmonary disease (COPD), or asthma, excluding childhood asthma.
• History of significant alcohol abuse within 12 months prior to screening.
• Positive test for drugs of abuse (such as marijuana/ tetrahydrocannabinol \[THC\] products, amphetamine, methamphetamine, methadone, barbiturates, benzodiazepines, cocaine, opiates, methylenedioxymethamphetamine \[MDMA\], or phencyclidine \[PCP\]) at screening, prior to dosing, or a history of drug abuse within 12months prior to screening.
• Participation in a clinical research study involving the administration of an investigational, or marketed, drug or device within 30 days prior to receiving the treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to dosing, or concomitant participation in an investigational study involving drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study.

Sponsors & Collaborators

• The University of Queensland: lead
• Coalition for Epidemic Preparedness Innovations: collaborator

Study Sites (1)

QPharm Pty.Ltd. (Nucleus Network Brisbane)

Herston, Queensland, 4006, Australia

Location

Related Publications (1)

• Chappell KJ, Mordant FL, Amarilla AA, Modhiran N, Liang B, Li Z, Lackenby JA, Jaberolansar N, O'Donnell J, Kienzle V, Kommajosyula V, Tardiota N, Bennet JK, Henderson CL, Dalrymple RL, Goh J, Hoger K, Gillard M, Jones ML, Hughes K, Hughes B, Barnes J, Reading PC, Ranasinghe C, Subbarao K, Munro TP, Young PR, Watterson D. Safety and immunogenicity of a SARS-CoV-2 spike, subunit vaccine stabilised in the prefusion conformation by second generation Molecular Clamp evaluated in adults aged 18-55 years: a randomised, double-blind, active comparator, Phase I trial. J Infect Dis. 2025 Nov 25:jiaf568. doi: 10.1093/infdis/jiaf568. Online ahead of print.

  PMID: 41285172 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

NVX-CoV2373 adjuvated lipid nanoparticle

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kristi Mclendon

  Nucleus Network Pty Ltd Brisbane

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: March 20, 2023
• Study Start: May 8, 2023
• Primary Completion: December 2, 2023
• Study Completion: December 16, 2023
• Last Updated: March 6, 2024

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)