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Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05029856
Recruitment Status : Not yet recruiting
First Posted : September 1, 2021
Last Update Posted : November 15, 2021
Sponsor:
Information provided by (Responsible Party):
Novavax

Brief Summary:
This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).

Condition or disease Intervention/treatment Phase
Covid19 Biological: SII B.1.351 Biological: SII Bivalent Biological: SII B.1.617.2 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults
Estimated Study Start Date : February 4, 2022
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Arm Intervention/treatment
Experimental: Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant
2 doses of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.
Biological: SII B.1.351

Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.351 [Beta] variant strain vaccine)

Experimental: Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant
2 doses of 5 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.
Biological: SII B.1.351

Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.351 [Beta] variant strain vaccine)

Experimental: Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant
1 dose of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.
Biological: SII B.1.351

Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.351 [Beta] variant strain vaccine)

Experimental: Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant
1 dose of 5 μg SII B.1.351 Vaccine + 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0.
Biological: SII B.1.351

Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.351 [Beta] variant strain vaccine)

Experimental: Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant
2 doses of 6 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.
Biological: SII Bivalent
Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.
Other Name: (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)

Experimental: Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant
2 doses of 10 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.
Biological: SII Bivalent
Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.
Other Name: (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)

Experimental: Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant
2 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21.
Biological: SII B.1.617.2

Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.617.2 [Delta] variant strain vaccine)

Experimental: Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant
1 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose on Days 0.
Biological: SII B.1.617.2

Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,

1 or 2 doses:1 on Day 0 and ± 1 on Day 21.

Other Name: (Monovalent B.1.617.2 [Delta] variant strain vaccine)




Primary Outcome Measures :
  1. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT [ Time Frame: Day 14 and Day 35 ]
    (MN50) geometric mean titers (GMTs) to the SARS-CoV-2 B.1.351 (Beta) variant at Day 14 (one-dose regimen; Groups C and D) and Day 35 (two-dose regimen; Groups A and B);

  2. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs [ Time Frame: Day 14 and Day 35 ]
    Seroconversion rates (SCRs) or seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 B.1.351 (Beta) variant following their last vaccination.

  3. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT [ Time Frame: Day 14 and Day 35 ]
    Neutralizing antibody MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant at Day 14 (one-dose regimen; Group H) and Day 35 (two-dose regimen; Group G);

  4. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs [ Time Frame: Day 14 and Day 35 ]
    SCRs/SRRs (proportion of participants who achieve ≥ 4-fold increase from baseline) in MN50 titer concentrations to the SARS-CoV-2 Delta variant following their last vaccination.

  5. Incidence, duration, and severity of solicited local and systemic adverse events (AEs) [ Time Frame: Day 0 to Day 7 ]
    Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following each vaccination

  6. Incidence, duration, severity, and relationship of unsolicited AEs through 28 days [ Time Frame: Day 0 to Day 28 ]
    Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination

  7. Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) [ Time Frame: Day 0 to Day 217 ]
    Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs) throughout the study.


Secondary Outcome Measures :
  1. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated patients [ Time Frame: Day 0 to Day 189 ]
    MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals

  2. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  3. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated patients [ Time Frame: Day 0 to Day 189 ]
    MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals

  4. MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline. [ Time Frame: Day 0 to Day 217 ]
    MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  5. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  6. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals

  7. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  8. MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variants and to the ancestral SARS-CoV-2 strain at Days 0, 14, and 189 in previously vaccinated individuals

  9. IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals

  10. IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  11. IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  12. IgG geometric mean concentrations (GMCs) to the B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals

  13. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals

  14. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  15. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 in previously vaccinated individuals

  16. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    GMTs to the SARS-CoV-2 B.1.351 (Beta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein at Days 0, 14, and 189 at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  17. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  18. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals

  19. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in participants seronegative at baseline [ Time Frame: Day 0 to Day 217 ]
    GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 21, 35, and 217 in participants seronegative at baseline.

  20. Human Angiotensin-Converting Enzyme 2 (hACE2) receptor binding inhibition assay GMT to the SARS-CoV-2 B.1.617.2 (Delta) expressed as SCRs/SRRs in previously vaccinated participants [ Time Frame: Day 0 to Day 189 ]
    GMTs to the SARS-CoV-2 B.1.617.2 (Delta) variant S proteins and to the ancestral SARS-CoV-2 strain S protein and at Days 0, 14, and 189 in previously vaccinated individuals



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Adults 18 to 64 years of age, inclusive, at screening.
  2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
  3. Female participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.

    1. Condoms (male or female) with spermicide (if acceptable in country)
    2. Diaphragm with spermicide
    3. Cervical cap with spermicide
    4. Intrauterine device
    5. Oral or patch contraceptives
    6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
    7. Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
  4. Is medically stable, as determined by the investigator (based on a review of health status, vital signs [to include body temperature], medical history, and targeted physical examination [to include body weight]). Vital signs must be within medically acceptable ranges prior to the first vaccination.
  5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

    For previously vaccinated Participants (Groups C, D and H):

  6. Documented receipt of 2 doses of the investigational Novavax vaccine with Matrix-M1 adjuvant (NVX-CoV2373) administered approximately 21 days apart or 2 doses of a TGA-authorized/approved COVID-19 vaccine administered at least 60 days prior to first study vaccination.

Exclusion Criteria:

If an individual meets any of the following criteria, he or she is ineligible for this study:

  1. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomization/enrollment.
  2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of SARS-CoV-2 infection, except for previously vaccinated participants.
  3. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
  4. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to the first study vaccination.
  5. Any known allergies to products contained in the investigational product.
  6. Any history of anaphylaxis to any prior vaccine.
  7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  8. Chronic administration (defined as > 14 continuous days) of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
  11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
  12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
  13. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the study vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
  14. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the study).

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): NCT05029856


Contacts
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Contact: Lisa Golden 240-368-5445 lgolden@novavax.com

Locations
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Australia, New South Wales
Paratus Clinical Research - Western Sydney
Blacktown, New South Wales, Australia, 2148
Contact: Rahul Mohan, Dr    +61 2 8608 8666    rahul.mohan@paratusclinical.com   
Paratus Clinical Research - Central Coast
Kanwal, New South Wales, Australia, 2259
Contact: Kim Joshua    +61 2 4393 3852    joshua.kim@paratusclinical.com   
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, Australia, 2035
Contact: Ktut Wiradjaja Arya, Dr    +61 2 8347 0645    markarya@acrn.com.au   
Holdsworth House Medical Practice - Sydney
Sydney, New South Wales, Australia, 2010
Contact: Mark Bloch    +61 2 9331 7228    mark.bloch@holdsworthhouse.com.au   
Australia, Victoria
University Hospital Geelong-Barwon Health
Geelong, Victoria, Australia, 3320
Contact: Athan Eugene, Prof    +61 2 8347 0645    eugene@barwonhealth.org.au   
Emeritus Research
Melbourne, Victoria, Australia, 3124
Contact: Louise Murdoch, Dr.    + 613 95096166    louisemurdoch@emeritusresearch.com   
Sponsors and Collaborators
Novavax
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Responsible Party: Novavax
ClinicalTrials.gov Identifier: NCT05029856    
Other Study ID Numbers: 2019nCoV-102
First Posted: September 1, 2021    Key Record Dates
Last Update Posted: November 15, 2021
Last Verified: November 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs