Covid19Phase 1/2NCT05029856
Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
A Phase 1/2 study testing SII B.1.351, SII Bivalent and SII B.1.617.2 in people with Covid19, run by Novavax at 4 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- SII B.1.351, SII Bivalent and SII B.1.617.2
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 4 sitesAustralia
- Study dates
- 4 Feb 2022to Aug 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults 18 to 64 years of age, inclusive, at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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.
- Condoms (male or female) with spermicide (if acceptable in country)
- Diaphragm with spermicide
- Cervical cap with spermicide
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- Intrauterine device
- Oral or patch contraceptives
- Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy
- Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle
- 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.
- 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):
- 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.
Who cannot join
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomization/enrollment.
- 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.
- Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to the first study vaccination.
- Any known allergies to products contained in the investigational product.
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- Any history of anaphylaxis to any prior vaccine.
- Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
- Chronic administration (defined as > 14 continuous days) of immunosuppressants, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
- Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
- 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).
- Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
- 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.
- 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).
- 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).
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
University Hospital Geelong-Barwon Health
Geelong, Victoria, 3320
Australian Clinical Research Network (ACRN)
Maroubra, New South Wales, 2035
Emeritus Research
Melbourne, Victoria, 3124
Holdsworth House Medical Practice - Sydney
Sydney, New South Wales, 2010
About this study
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
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).
- Conditions
- Covid19
- Being tested
- SII B.1.351, SII Bivalent, SII B.1.617.2
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SII B.1.351Biological
Also called (Monovalent B.1.351 [Beta] variant strain vaccine)
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.
SII B.1.351Biological
Also called (Monovalent B.1.351 [Beta] variant strain vaccine)
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.
SII BivalentBiological
Also called (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)
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.
SII BivalentBiological
Also called (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)
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.
SII B.1.617.2Biological
Also called (Monovalent B.1.617.2 [Delta] variant strain vaccine)
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | 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. Receives: Biological: SII B.1.351 |
| Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | 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. Receives: Biological: SII B.1.351 |
| Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | 1 dose of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0. Receives: Biological: SII B.1.351 |
| Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | 1 dose of 5 μg SII B.1.351 Vaccine + 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0. Receives: Biological: SII B.1.351 |
| Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant | Experimental | 2 doses of 6 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21. Receives: Biological: SII Bivalent |
| Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant | Experimental | 2 doses of 10 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21. Receives: Biological: SII Bivalent |
| Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant | Experimental | 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. Receives: Biological: SII B.1.617.2 |
| Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant | Experimental | 1 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose on Days 0. Receives: Biological: SII B.1.617.2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT
(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);
Measured: Day 14 and Day 35
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs
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.
Measured: Day 14 and Day 35
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT
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);
Measured: Day 14 and Day 35
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs
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.
Measured: Day 14 and Day 35
Incidence, duration, and severity of solicited local and systemic adverse events (AEs)
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following each vaccination
Measured: Day 0 to Day 7
Incidence, duration, severity, and relationship of unsolicited AEs through 28 days
Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination
Measured: Day 0 to Day 28
Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs)
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.
Measured: Day 0 to Day 217
Secondary outcomes (20)
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated patients
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
Measured: Day 0 to Day 189
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline
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.
Measured: Day 0 to Day 217
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in previously vaccinated patients
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
Measured: Day 0 to Day 189
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs in participants seronegative at baseline.
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.
Measured: Day 0 to Day 217
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in participants seronegative at baseline
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.
Measured: Day 0 to Day 217
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta) expressed as GMFR in previously vaccinated participants
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
Measured: Day 0 to Day 189
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in participants seronegative at baseline
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.
Measured: Day 0 to Day 217
MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/ SRRs in previously vaccinated participants
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
Measured: Day 0 to Day 189
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in previously vaccinated participants
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
Measured: Day 0 to Day 189
IgG geometric mean concentrations (GMCs) to the SARS-CoV-2 B.1.351 (Beta) expressed as GMFR in participants seronegative at baseline
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.
Measured: Day 0 to Day 217
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
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.
Measured: Day 0 to Day 217
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
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
Measured: Day 0 to Day 189
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
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
Measured: Day 0 to Day 189
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
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.
Measured: Day 0 to Day 217
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
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
Measured: Day 0 to Day 189
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
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.
Measured: Day 0 to Day 217
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
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.
Measured: Day 0 to Day 217
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
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
Measured: Day 0 to Day 189
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
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.
Measured: Day 0 to Day 217
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
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
Measured: Day 0 to Day 189
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start4 Feb 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionAug 2022 (estimated)
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development, Study director, Novavax
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029856
- Sponsor's protocol ID
- 2019nCoV-102
- Status last verified
- May 2022
- First submitted
- 25 Aug 2021
- Last updated
- 31 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05029856
- Acronym / sponsor ID
- 2019nCoV-102
- Conditions
- Covid19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- 4 Feb 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Aug 2022 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.3512 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. |
| Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.3512 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. |
| Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.3511 dose of 3 μg SII B.1.351 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0. |
| Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.3511 dose of 5 μg SII B.1.351 Vaccine + 50 μg Matrix-M1 adjuvant (co-formulated) .1 dose on Day 0. |
| Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII Bivalent2 doses of 6 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21. |
| Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII Bivalent2 doses of 10 μg SII Bivalent Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose each on Days 0 and Day 21. |
| Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.617.22 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. |
| Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant | Experimental | Biological: SII B.1.617.21 doses of 5 μg SII B.1.617.2 Vaccine+ 50 μg Matrix-M1 adjuvant (co-formulated) . 1 dose on Days 0. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Adults 18 to 64 years of age, inclusive, at screening.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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.
- 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.
- Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
Key exclusion criteria (15 listed)
- If an individual meets any of the following criteria, he or she is ineligible for this study:
- History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection at any time prior to randomization/enrollment.
- 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.
- Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
- Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to the first study vaccination.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SII B.1.351Also: (Monovalent B.1.351 [Beta] variant strain vaccine)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. | Biological | Group A- SII B.1.351 Vaccine / Matrix-M1 Adjuvant, Group C- SII B.1.351 Vaccine / Matrix-M1 Adjuvant |
| SII B.1.351Also: (Monovalent B.1.351 [Beta] variant strain vaccine)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. | Biological | Group B- SII B.1.351 Vaccine / Matrix-M1 Adjuvant, Group D - SII B.1.351 Vaccine / Matrix-M1 Adjuvant |
| SII BivalentAlso: (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)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. | Biological | Group E -SII Bivalent Vaccine / Matrix-M1 Adjuvant |
| SII BivalentAlso: (Bivalent ancestral and B.1.351 [Beta] variant strain vaccine)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. | Biological | Group F- SII Bivalent Vaccine / Matrix-M1 Adjuvant |
| SII B.1.617.2Also: (Monovalent B.1.617.2 [Delta] variant strain vaccine)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. | Biological | Group G- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant, Group H- SII B.1.617.2 Vaccine / Matrix-M1 Adjuvant |
Primary outcome
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);
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.
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);
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.
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
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
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.
20 secondary outcomes
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) 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) 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) 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) 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) 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)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)expressed as SCRs/ SRRs 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) 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) expressed as GMFR in participants seronegative at baseline
Time frame: Day 0 to Day 217
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 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
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
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
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
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
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
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
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
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Development study director
Novavax
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SII B.1.351, SII Bivalent and SII B.1.617.2 in people with Covid19, run by Novavax at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT (time frame: Day 14 and Day 35). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.