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Trial record 1 of 1 for:    NCT04495933
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A Study on the Safety, Tolerability and Immune Response of SARS-CoV-2 Sclamp (COVID-19) Vaccine in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04495933
Recruitment Status : Recruiting
First Posted : August 3, 2020
Last Update Posted : September 4, 2020
Sponsor:
Collaborators:
Syneos Health
Coalition of Epidemic Preparedness Innovations (CEPI)
Information provided by (Responsible Party):
The University of Queensland

Brief Summary:
This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

Condition or disease Intervention/treatment Phase
SARS-CoV2 Covid19 Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Cohort 1: SARS-CoV-2 Sclamp vaccine 5 mcg, or placebo Cohort 2: SARS-CoV-2 Sclamp vaccine 15 mcg, or placebo Cohort 3: SARS-CoV-2 Sclamp vaccine 45 mcg, or placebo
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dosage-Escalation, Single Centre Study to Evaluate the Safety and Immunogenicity of an Adjuvanted SARS-CoV-2 Sclamp Protein Subunit Vaccine in Healthy Adults Aged 18 to 55 Years Old and Healthy Older Adults, Aged 56 Years and Over
Actual Study Start Date : July 13, 2020
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg
SARS-CoV-2 Sclamp antigen 5 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart.(Cohorts 1 & 4)
Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg

Other: Placebo
sterile saline

Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg
SARS-CoV-2 Sclamp antigen 15 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart. (Cohorts 2 & 5)
Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg

Other: Placebo
sterile saline

Experimental: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg
SARS-CoV-2 Sclamp antigen 45 mcg mixed with MF59 adjuvant in 0.5 mL suspension, administered in a two dose regimen, at least 28 days apart. (Cohorts 3 & 6)
Biological: MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg
MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg

Other: Placebo
sterile saline




Primary Outcome Measures :
  1. Frequency of Solicited local reactogenicity adverse events (AEs) [ Time Frame: 7 days following each vaccination (at Days 1 and 29) ]
    - the frequency of solicited local reactogenicity adverse events (AEs)

  2. Frequency of Solicited systemic reactogenicity adverse events (AEs) [ Time Frame: 7 days following each vaccination (at Days 1 and 29) ]
    - the frequency of solicited systemic reactogenicity AEs

  3. Grading of Solicited local reactogenicity adverse events (AEs) [ Time Frame: 7 days following each vaccination (at Days 1 and 29) ]
    - the grading of solicited local reactogenicity adverse events (AEs)

  4. Grading of Solicited systemic reactogenicity adverse events (AEs) [ Time Frame: 7 days following each vaccination (at Days 1 and 29) ]
    - the grading of solicited systemic reactogenicity AEs

  5. Unsolicited adverse events (AEs) [ Time Frame: 28 days following each vaccination (at Days 1 and 29) ]
    - the frequency, duration, intensity and relationship to vaccination of unsolicited local adverse events (AEs)

  6. Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study [ Time Frame: through study completion (394 days) ]
    - the frequency, duration, intensity and relationship to vaccination of Serious adverse events (SAEs), Medically attended adverse events (MAAEs) and any Adverse events (AEs) leading to study withdrawal at any time during the study (including decision by the Principal Investigator [PI] not to proceed with the second dose) at any time during the study

  7. Geometric Mean Titer (GMT) of the serum antibody response [ Time Frame: 28 days following each vaccination (Days 29 and 57) ]
    - Geometric mean titre (GMT) of the serum antibody response compared to placebo

  8. Geometric Mean Titer (GMT) of the serum neutralizing antibody (NAb) response to SARS-CoV-2 virus [ Time Frame: 28 days following each vaccination (Days 29 and 57) ]
    GMT of the serum NAb titres to SARS-CoV-2 virus compared to placebo


Secondary Outcome Measures :
  1. Total serum antibody immune responses [ Time Frame: through study completion (394 days) ]
    GMT of the serum antibody response compared to placebo

  2. proportion of participants with ≥ 4 fold increase in titer above baseline [ Time Frame: through study completion (394 days) ]
    proportion of participants with greater than or equal to 4 fold increase in titre above baseline compared to placebo.

  3. GMT of the serum neutralizing antibody (NAb) titres [ Time Frame: through study completion (394 days) ]
    GMT of the serum neutralizing antibody (NAb) immune responses compared to placebo



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male or non-pregnant female, ≥18 and ≤55 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 (Part 1); Healthy male or non-pregnant female, ≥56 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 (Part 2)
  • Healthy as defined by:

    1. The absence of clinically significant illness and surgery within 28 days prior to dosing. Subjects displaying signs or symptoms of an acute and/or febrile illness within 24 hours pre-dose (with at least 3 symptom-free pre-dose days required) will be carefully evaluated for upcoming illness/disease. Inclusion pre-dosing is at the discretion of the Investigator, and the subject may have their scheduled dosing postponed until the condition resolves.
    2. The absence of clinically significant history of neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease (Part 1); b. The absence of clinically significant history of a pre-existing medical condition that is not stable (neurological, endocrine, cardiovascular, respiratory, haematological, immunological, psychiatric, gastrointestinal, renal, hepatic, and metabolic disease). A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrolment (Part 2)
  • Non-smokers or social smokers (defined as the equivalent of fewer than 10 cigarettes per week). Ex-heavy smokers (heavy smoking 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.
  • Women of childbearing potential (WOCBP) or men whose sexual partners are WOCBP must be able and willing to use at least 2 highly effective methods of contraception commencing at enrolment, during the study and for 3 months after last treatment administration. A female subject is considered to be a WOCBP following menarche and until she is in a postmenopausal 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 post-menopausal state. Examples of acceptable methods of contraceptive methods (for female subjects) to be used throughout the study include:

    1. Simultaneous use of hormonal contraceptives, started at least 28 days prior to first study treatment administration and must agree to use the same hormonal contraceptive throughout the study, and condom for the male partner;
    2. Simultaneous use of intra-uterine contraceptive device, placed at least 28 days prior to first study treatment administration, and condom for the male partner;
    3. Simultaneous use of diaphragm or cervical cap and male condom for the male partner, started at least 28 days prior to first study treatment administration;
    4. Sterile male partner (vasectomized since at least 6 months prior to first study treatment administration);
    5. True abstinence, defined as no sexual intercourse with a male partner, (for heterosexual couples) for at least 28 days prior to first study treatment administration and for at least the duration of the study. Periodic abstinence and withdrawal are not acceptable methods.
  • WOCBP must have a negative urine pregnancy test prior to receiving each dose.
  • Male subjects (including men who have had a vasectomy) with a pregnant partner, a female partner not of childbearing potential, or a same sex partner, must agree to use a condom from the first study treatment administration until at least 90 days after the last study treatment administration.
  • Male subjects must be willing not to donate sperm until 90 days following the last study treatment administration.
  • Must be able to attend all visits for the duration of the study and to comply with all study procedures according to the study schedule.
  • Capable of, and have given, written informed consent.

Exclusion Criteria:

  • Any clinically significant abnormality or vital sign abnormality at physical examination (including baseline high blood pressure [140/90] after 3 repeated measurements or high random blood sugar [non-fasting]), clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening (Part 1); Any clinically significant abnormality or vital sign abnormality at physical examination, or uncontrolled hypertension in adults aged ≥ 56 years and older ,or high random blood sugar [non-fasting]), clinically significant abnormal laboratory test results or positive test for HIV, hepatitis B, or hepatitis C found during medical screening (Part 2).
  • Any acute or chronic ongoing illness which, in the judgement of the investigator, may preclude the subject's participation.
  • Any subject that has an active COVID-19 infection (positive COVID-19 test: nasal/oropharyngeal swab and/or positive serum antibody response) at screening, or Day 1, or has been in close contact with someone who has an active COVID-19 infection, or has recovered from a previous COVID-19, SARS-CoV-1, or MERS infection.
  • Positive pregnancy, urine drug screen, or alcohol breath test at screening.
  • Known history of allergic reactions or hypersensitivity to vaccines, or to any excipient in the formulation (including the adjuvant, MF59C.1).
  • 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 (Part 1); History of a known, or suspected, or currently unstable medical condition that may expose the participant to an increased risk for severe SARS-CoV-2 disease, such as a 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, uncontrolled hypertension, ischemic or structural heart disease, chronic kidney disease, chronic liver disease, endocrine disorder and neurological illness (Part 2).
  • 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 12 months 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 first treatment administration, or administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug, vaccine, or device administration, or intent to participate in another clinical study at any time during the conduct of the study.
  • Use of medications for the timeframes specified below, with the exception of hormonal contraceptives and medications exempted by the Investigator on a case-by-case basis because they are judged to interfere with subject safety e.g., topical drug products without significant systemic absorption are permissible:

    1. Prescription medication within 14 days prior to the first dosing (Part 1); Prescription medication within 14 days prior to the first dosing that in the opinion of the Investigator could impact the subjects safe participation in the study (Part 2)
    2. Any medication, or treatments, that may affect the immune system such as allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other drugs known to be frequently associated with significant major organ toxicity within 90 days prior to enrolment;
    3. Any registered vaccine administered within 30 days prior to enrolment in the study, or who plan to receive any non-study vaccines within 28 days of the second dose of the study vaccine
    4. Any other investigational coronavirus vaccine i.e. SARS-CoV-1, SARS-CoV-2, MERS etc. at any time prior to, or during, the study.
    5. Over-the-counter products within 7 days prior to the first dosing, with the exception of the occasional use of paracetamol (up to 2 g daily) and standard dose vitamins (Part 1); Over-the-counter products within 7 days prior to the first dosing, that in the opinion of the investigator could impact the subjects safe participation in the study. Paracetamol (up to 2 g daily) and standard dose vitamins will be permitted (Part 2).
  • Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than 499 mL within 56 days prior to the first dosing.
  • Receipt of blood products within 2 months prior to the first study treatment administration (Day 1), or planned receipt of blood products during the study period.
  • Breast-feeding subject, or subject who plans to breastfeed from the time of first dose through 60 days after last study treatment administration.
  • Presence of tattoos, scarring, skin discoloration, or any other skin disturbances at the injection site which, in the opinion of the Investigator, may inhibit the ability to effectively perform an injection site assessment.
  • Employee or immediate relative of an employee of the clinical site, any of its affiliates or partners, or Syneos Health.
  • Any reason which, in the opinion of the Investigator, would interfere with the primary study objectives or prevent the subject from participating in the study.
  • Permanent resident in an aged care facility (nursing or aged care home) (Part 2 only)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04495933


Contacts
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Contact: Paul Griffin, Dr +61402077302 p.griffin@nucleusnetwork.com.au
Contact: Christina Henderson rapid.response.trials@uq.edu.au

Locations
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Australia, Queensland
Nucleus Network Brisbane (Q-Pharm Pty Ltd) Recruiting
Herston, Queensland, Australia, 4007
Contact: Paul Griffin, Dr    +61402077302    p.griffin@nucleusnetwork.com.au   
Principal Investigator: Paul Griffin, Dr         
Sponsors and Collaborators
The University of Queensland
Syneos Health
Coalition of Epidemic Preparedness Innovations (CEPI)
Investigators
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Principal Investigator: Paul Griffin, Dr Nucleus Network Brisbane
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Responsible Party: The University of Queensland
ClinicalTrials.gov Identifier: NCT04495933    
Other Study ID Numbers: UQ-1-SARS-CoV-2-Sclamp
ACTRN12620000674932p ( Registry Identifier: ANZCTR )
First Posted: August 3, 2020    Key Record Dates
Last Update Posted: September 4, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: individual participant data underlying published results only on a case-by-case basis at the discretion of Primary Sponsor
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Immediately following publication, no end date
Access Criteria: Available only to achieve the aims in the approved proposal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by The University of Queensland:
SARS-CoV-2 infection
Additional relevant MeSH terms:
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Vaccines
MF59 oil emulsion
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic