Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05372588




Registration number
NCT05372588
Ethics application status
Date submitted
9/05/2022
Date registered
12/05/2022
Date last updated
23/04/2024

Titles & IDs
Public title
Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines
Scientific title
A Multi-Part, Phase 3, Randomized, Observer Blinded Study to Evaluate the Safety and Immunogenicity of Omicron Subvariant and Bivalent SARS-CoV-2 rS Vaccines in Adults Previously Vaccinated With Other COVID-19 Vaccines
Secondary ID [1] 0 0
2019nCoV- 311
Universal Trial Number (UTN)
Trial acronym
COVID-19
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
SARS CoV 2 Infection 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
Treatment: Drugs - NVX-CoV2515
Treatment: Drugs - NVX-Cov2373
Treatment: Drugs - NVX-CoV2373 + NVX-CoV2515
Treatment: Drugs - NVX-CoV2540
Treatment: Drugs - NVX-CoV2373 + NVX-CoV2540

Experimental: Group A (NVX-CoV2515 ) - 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.

Experimental: Group B (NVX-CoV2373 ) - 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.

Experimental: Group C (NVX-CoV2515 ) - 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.

Experimental: Group D (NVX-CoV2373) - 1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.

Experimental: Group E (BA.1 Bivalent Vaccine) - 1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0.

Experimental: Group F (NVX-CoV2540) - 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.

Experimental: Group G (NVX-CoV2373) - 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.

Experimental: Group H (NVX-CoV2373 + NVX-CoV2540) - 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.


Treatment: Drugs: NVX-CoV2515
Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL).

Treatment: Drugs: NVX-Cov2373
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).

Treatment: Drugs: NVX-CoV2373 + NVX-CoV2515
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.

Treatment: Drugs: NVX-CoV2540
Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL).

Treatment: Drugs: NVX-CoV2373 + NVX-CoV2540
Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2515) with 50 µg Matrix-M adjuvant.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs
Timepoint [1] 0 0
Day 14
Primary outcome [2] 0 0
Part 1: MN50 titer concentrations to the Omicron BA.1 subvariant vaccine expressed as seroresponse rates (SRRs)
Timepoint [2] 0 0
Day 14
Primary outcome [3] 0 0
Part 2: Neutralizing Antibody (NAb) GMTs to the Omicron BA.5 subvariant expressed as GMTs
Timepoint [3] 0 0
Day 28
Primary outcome [4] 0 0
Part 2: Neutralizing Antibody (NAb) titers to the Omicron BA.5 subvariant expressed as SRRs
Timepoint [4] 0 0
Day 28
Primary outcome [5] 0 0
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) strain expressed as GMTs
Timepoint [5] 0 0
Day 28
Secondary outcome [1] 0 0
Part 1: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan),and Omicron BA.1 viruses expressed as GMT
Timepoint [1] 0 0
Day 0 to Day 240
Secondary outcome [2] 0 0
Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as GMFR
Timepoint [2] 0 0
Day 7 to Day 240
Secondary outcome [3] 0 0
Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as SRRs
Timepoint [3] 0 0
Day 7 to Day 240
Secondary outcome [4] 0 0
Part 1: Immunoglobulin G (IgG) antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as GMT
Timepoint [4] 0 0
Day 0 to Day 240
Secondary outcome [5] 0 0
Part 1:IgG antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR
Timepoint [5] 0 0
Day 0 to Day 240
Secondary outcome [6] 0 0
Part 1: IgG antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as SRRs
Timepoint [6] 0 0
Day 0 to Day 240
Secondary outcome [7] 0 0
Part 1: Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs
Timepoint [7] 0 0
Day 0 to Day 240
Secondary outcome [8] 0 0
Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR
Timepoint [8] 0 0
Day 0 to Day 240
Secondary outcome [9] 0 0
Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
Timepoint [9] 0 0
Day 0 to Day 240
Secondary outcome [10] 0 0
Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMT
Timepoint [10] 0 0
Day 14
Secondary outcome [11] 0 0
Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMFR
Timepoint [11] 0 0
Day 14
Secondary outcome [12] 0 0
Part 1: SRRs in MN50 titer concentrations to the ancestral (Wuhan) virus expressed as SRRs
Timepoint [12] 0 0
Day 14
Secondary outcome [13] 0 0
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMT
Timepoint [13] 0 0
Day 14
Secondary outcome [14] 0 0
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMFR
Timepoint [14] 0 0
Day 14
Secondary outcome [15] 0 0
Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as SRR
Timepoint [15] 0 0
Day 14
Secondary outcome [16] 0 0
Part 1 and Part 2: Incidence of solicited local and systemic Adverse Events (AEs)
Timepoint [16] 0 0
Day 7
Secondary outcome [17] 0 0
Part 1 and Part 2 : Incidence of unsolicited AEs
Timepoint [17] 0 0
Day 28
Secondary outcome [18] 0 0
Part 1 and Part 2 :Incidence and relationship of Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs)
Timepoint [18] 0 0
Day 0 to Day 270
Secondary outcome [19] 0 0
Part 1: IgG Geometric Mean Concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR
Timepoint [19] 0 0
Day 0 to Day 240
Secondary outcome [20] 0 0
Part 1: IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
Timepoint [20] 0 0
Day 0 to Day 240
Secondary outcome [21] 0 0
Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR
Timepoint [21] 0 0
Day 0 to Day 240
Secondary outcome [22] 0 0
Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR
Timepoint [22] 0 0
Day 0 to Day 240
Secondary outcome [23] 0 0
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMTs
Timepoint [23] 0 0
Day 0 to Day 270
Secondary outcome [24] 0 0
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMFRs
Timepoint [24] 0 0
Day 0 to Day 270
Secondary outcome [25] 0 0
Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as SRRs
Timepoint [25] 0 0
Day 0 to Day 270
Secondary outcome [26] 0 0
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMTs
Timepoint [26] 0 0
Day 0 to Day 270
Secondary outcome [27] 0 0
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMFRs
Timepoint [27] 0 0
Day 0 to Day 270
Secondary outcome [28] 0 0
Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as SRRs
Timepoint [28] 0 0
Day 0 to Day 270
Secondary outcome [29] 0 0
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan),and Omicron BA.5 S proteins expressed as GMTs
Timepoint [29] 0 0
Day 0 to Day 270
Secondary outcome [30] 0 0
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as GMFRs
Timepoint [30] 0 0
Day 0 to Day 270
Secondary outcome [31] 0 0
Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as SRRs
Timepoint [31] 0 0
Day 0 to Day 270

Eligibility
Key inclusion criteria
Part 1



To be included in this study, each individual must satisfy all the following criteria:

1. Adults = 18 and = 64 years of age 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 = 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 = 28 days prior to and through the end of the study.
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 vaccination.
5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
6. Have previously received 2 doses of the Moderna and/or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given = 180 days prior to study vaccination or 3 doses of the Moderna and/or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given = 90 days previously prior to the study vaccination.
Minimum age
18 Years
Maximum age
64 Years
Sex
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. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID- 19 vaccines.
2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
3. Received any vaccine = 90 days prior to study vaccination, except for influenza vaccination which may be received > 14 days prior to study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to the first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. Active cancer (malignancy) on therapy within 3 years prior to 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).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of the study.
11. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
12. 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).
13. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization (CRO), and study site personnel involved in the conduct or planning of the study).

Part 2

Inclusion Criteria:

To be included in this study, each individual must satisfy all of the following criteria:

1. Adults and adolescents = 18 years of age 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 = 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 = 28 days prior to enrollment and through the end of the study.
4. Is medically stable, as determined by the investigator (based on 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.
6. Have previously received = 3 doses of the Moderna and/or Pfizer-BioNTech monovalent and/or bivalent COVID-19 vaccines with the last dose having been given = 90 days previously prior to first study booster.



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

1. Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
2. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
3. Received any vaccine = 90 days prior to study vaccination, except for influenza vaccination which may be received > 14 days prior to first study vaccination, or rabies vaccine which may be given if medically indicated.
4. Any known allergies to products contained in the investigational product.
5. Any history of anaphylaxis to any prior vaccine.
6. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
7. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
8. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination, except for rabies immunoglobulin which may be given if medically indicated.
9. 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).
10. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
11. 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.
12. 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).
13. Study team member or immediate family member of any study team member (inclusive of Sponsor, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
14. Participants with a history of myocarditis or pericarditis

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 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/05/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/04/2024
Sample size
Target
Accrual to date
Final
1340
Recruitment in Australia
Recruitment state(s)
ACT,NSW,New South WhalesQLD,SA,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Canberra - Bruce
Recruitment hospital [2] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [3] 0 0
Emeritus Research - Botany
Recruitment hospital [4] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [5] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [6] 0 0
Australian Clinical Research Network (ACRN) - Maroubra
Recruitment hospital [7] 0 0
AIM Centre (Hunter Diabetes Centre) - Merewether
Recruitment hospital [8] 0 0
Novatrials - Newcastle
Recruitment hospital [9] 0 0
Holdsworth House Medical Practice - Sydney
Recruitment hospital [10] 0 0
Paratus Clinical Research Brisbane - Albion
Recruitment hospital [11] 0 0
Core Research Group Pty Ltd - Milton
Recruitment hospital [12] 0 0
Griffith University Clinical Trial Unit - Southport
Recruitment hospital [13] 0 0
Data Health Australia PTY Ltd t/a Austrials - Taringa
Recruitment hospital [14] 0 0
AusTrials Wellers Hill - Wellers Hill
Recruitment hospital [15] 0 0
Clinical Medical and Analytical Excellence (CMAX) - Adelaide
Recruitment hospital [16] 0 0
Eastern Health-Box Hill Hospital - Box Hill
Recruitment hospital [17] 0 0
Emeritus Research - Camberwell
Recruitment hospital [18] 0 0
University Hospital Geelong-Barwon Health - Geelong
Recruitment hospital [19] 0 0
Monash Health -Monash Medical Centre - Melbourne
Recruitment postcode(s) [1] 0 0
2617 - Bruce
Recruitment postcode(s) [2] 0 0
2148 - Blacktown
Recruitment postcode(s) [3] 0 0
2019 - Botany
Recruitment postcode(s) [4] 0 0
2100 - Brookvale
Recruitment postcode(s) [5] 0 0
2291 - Kanwal
Recruitment postcode(s) [6] 0 0
2035 - Maroubra
Recruitment postcode(s) [7] 0 0
2291 - Merewether
Recruitment postcode(s) [8] 0 0
2289 - Newcastle
Recruitment postcode(s) [9] 0 0
2010 - Sydney
Recruitment postcode(s) [10] 0 0
4010 - Albion
Recruitment postcode(s) [11] 0 0
4064 - Milton
Recruitment postcode(s) [12] 0 0
4222 - Southport
Recruitment postcode(s) [13] 0 0
4068 - Taringa
Recruitment postcode(s) [14] 0 0
4121 - Wellers Hill
Recruitment postcode(s) [15] 0 0
5000 - Adelaide
Recruitment postcode(s) [16] 0 0
3128 - Box Hill
Recruitment postcode(s) [17] 0 0
3124 - Camberwell
Recruitment postcode(s) [18] 0 0
3220 - Geelong
Recruitment postcode(s) [19] 0 0
3168 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Development
Address 0 0
Novavax, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05372588