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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05029856




Registration number
NCT05029856
Ethics application status
Date submitted
25/08/2021
Date registered
1/09/2021
Date last updated
16/09/2021

Titles & IDs
Public title
Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
Scientific 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
Secondary ID [1] 0 0
2019nCoV-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - SII B.1.351
Other interventions - SII B.1.351
Other interventions - SII Bivalent
Other interventions - SII Bivalent
Other interventions - SII B.1.617.2

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.

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.

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.

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.

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.

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.

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.

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.


Other interventions: 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 interventions: 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 interventions: 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 interventions: 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 interventions: 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.

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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);
Timepoint [1] 0 0
Day 14 and Day 35
Primary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 14 and Day 35
Primary outcome [3] 0 0
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);
Timepoint [3] 0 0
Day 14 and Day 35
Primary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 14 and Day 35
Primary outcome [5] 0 0
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
Timepoint [5] 0 0
Day 0 to Day 7
Primary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 0 to Day 28
Primary outcome [7] 0 0
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.
Timepoint [7] 0 0
Day 0 to Day 217
Secondary outcome [1] 0 0
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
Timepoint [1] 0 0
Day 0 to Day 189
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Day 0 to Day 217
Secondary outcome [3] 0 0
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
Timepoint [3] 0 0
Day 0 to Day 189
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Day 0 to Day 217
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Day 0 to Day 217
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Day 0 to Day 189
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Day 0 to Day 217
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Day 0 to Day 189
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Day 0 to Day 189
Secondary outcome [10] 0 0
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.
Timepoint [10] 0 0
Day 0 to Day 217
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Day 0 to Day 217
Secondary outcome [12] 0 0
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
Timepoint [12] 0 0
Day 0 to Day 189
Secondary outcome [13] 0 0
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
Timepoint [13] 0 0
Day 0 to Day 189
Secondary outcome [14] 0 0
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.
Timepoint [14] 0 0
Day 0 to Day 217
Secondary outcome [15] 0 0
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
Timepoint [15] 0 0
Day 0 to Day 189
Secondary outcome [16] 0 0
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.
Timepoint [16] 0 0
Day 0 to Day 217
Secondary outcome [17] 0 0
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.
Timepoint [17] 0 0
Day 0 to Day 217
Secondary outcome [18] 0 0
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
Timepoint [18] 0 0
Day 0 to Day 189
Secondary outcome [19] 0 0
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.
Timepoint [19] 0 0
Day 0 to Day 217
Secondary outcome [20] 0 0
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
Timepoint [20] 0 0
Day 0 to Day 189

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
64 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1/Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research - Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Paratus Clinical Research - Central Coast - Kanwal
Recruitment hospital [3] 0 0
Australian Clinical Research Network (ACRN) - Maroubra
Recruitment hospital [4] 0 0
Holdsworth House Medical Practice - Sydney - Sydney
Recruitment hospital [5] 0 0
University Hospital Geelong-Barwon Health - Geelong
Recruitment hospital [6] 0 0
Emeritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2259 - Kanwal
Recruitment postcode(s) [3] 0 0
2035 - Maroubra
Recruitment postcode(s) [4] 0 0
2010 - Sydney
Recruitment postcode(s) [5] 0 0
3320 - Geelong
Recruitment postcode(s) [6] 0 0
3124 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novavax
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT05029856
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Lisa Golden
Address 0 0
Country 0 0
Phone 0 0
+610-999-1180
Fax 0 0
Email 0 0
lgolden@novavax.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05029856