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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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]

2019nCoV- 311

Universal Trial Number (UTN)

Trial acronym

COVID-19

Linked study record

Health condition

Health condition(s) or problem(s) studied:

COVID-19

SARS CoV 2 Infection

Condition category

Condition code

Infection

Other infectious diseases

Respiratory

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs

Timepoint [1]

Day 14

Primary outcome [2]

Part 1: MN50 titer concentrations to the Omicron BA.1 subvariant vaccine expressed as seroresponse rates (SRRs)

Timepoint [2]

Day 14

Primary outcome [3]

Part 2: Neutralizing Antibody (NAb) GMTs to the Omicron BA.5 subvariant expressed as GMTs

Timepoint [3]

Day 28

Primary outcome [4]

Part 2: Neutralizing Antibody (NAb) titers to the Omicron BA.5 subvariant expressed as SRRs

Timepoint [4]

Day 28

Primary outcome [5]

Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) strain expressed as GMTs

Timepoint [5]

Day 28

Secondary outcome [1]

Part 1: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan),and Omicron BA.1 viruses expressed as GMT

Timepoint [1]

Day 0 to Day 240

Secondary outcome [2]

Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as GMFR

Timepoint [2]

Day 7 to Day 240

Secondary outcome [3]

Part 1: MN50 titer concentrations to the ancestral (Wuhan), and Omicron BA.1 viruses expressed as SRRs

Timepoint [3]

Day 7 to Day 240

Secondary outcome [4]

Part 1: Immunoglobulin G (IgG) antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as GMT

Timepoint [4]

Day 0 to Day 240

Secondary outcome [5]

Part 1:IgG antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR

Timepoint [5]

Day 0 to Day 240

Secondary outcome [6]

Part 1: IgG antibody levels to the ancestral (Wuhan), Omicron BA.1 and Omicron BA.5 viruses expressed as SRRs

Timepoint [6]

Day 0 to Day 240

Secondary outcome [7]

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]

Day 0 to Day 240

Secondary outcome [8]

Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR

Timepoint [8]

Day 0 to Day 240

Secondary outcome [9]

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]

Day 0 to Day 240

Secondary outcome [10]

Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMT

Timepoint [10]

Day 14

Secondary outcome [11]

Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMFR

Timepoint [11]

Day 14

Secondary outcome [12]

Part 1: SRRs in MN50 titer concentrations to the ancestral (Wuhan) virus expressed as SRRs

Timepoint [12]

Day 14

Secondary outcome [13]

Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMT

Timepoint [13]

Day 14

Secondary outcome [14]

Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMFR

Timepoint [14]

Day 14

Secondary outcome [15]

Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as SRR

Timepoint [15]

Day 14

Secondary outcome [16]

Part 1 and Part 2: Incidence of solicited local and systemic Adverse Events (AEs)

Timepoint [16]

Day 7

Secondary outcome [17]

Part 1 and Part 2 : Incidence of unsolicited AEs

Timepoint [17]

Day 28

Secondary outcome [18]

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]

Day 0 to Day 270

Secondary outcome [19]

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]

Day 0 to Day 240

Secondary outcome [20]

Part 1: IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR

Timepoint [20]

Day 0 to Day 240

Secondary outcome [21]

Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR

Timepoint [21]

Day 0 to Day 240

Secondary outcome [22]

Part 1: GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR

Timepoint [22]

Day 0 to Day 240

Secondary outcome [23]

Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMTs

Timepoint [23]

Day 0 to Day 270

Secondary outcome [24]

Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as GMFRs

Timepoint [24]

Day 0 to Day 270

Secondary outcome [25]

Part 2: Neutralizing Antibody (NAb) titers to the ancestral (Wuhan) and Omicron BA.5 strains expressed as SRRs

Timepoint [25]

Day 0 to Day 270

Secondary outcome [26]

Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMTs

Timepoint [26]

Day 0 to Day 270

Secondary outcome [27]

Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as GMFRs

Timepoint [27]

Day 0 to Day 270

Secondary outcome [28]

Part 2: IgG GMEUs antibody levels to the ancestral (Wuhan) and Omicron BA.5 S proteins expressed as SRRs

Timepoint [28]

Day 0 to Day 270

Secondary outcome [29]

Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan),and Omicron BA.5 S proteins expressed as GMTs

Timepoint [29]

Day 0 to Day 270

Secondary outcome [30]

Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as GMFRs

Timepoint [30]

Day 0 to Day 270

Secondary outcome [31]

Part 2:hACE2 receptor binding inhibition assay to the ancestral (Wuhan), and Omicron BA.5 S proteins expressed as SRRs

Timepoint [31]

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]

Paratus Clinical Research Canberra - Bruce

Recruitment hospital [2]

Paratus Clinical Research Western Sydney - Blacktown

Recruitment hospital [3]

Emeritus Research - Botany

Recruitment hospital [4]

Northern Beaches Clinical Research - Brookvale

Recruitment hospital [5]

Paratus Clinical Research Central Coast - Kanwal

Recruitment hospital [6]

Australian Clinical Research Network (ACRN) - Maroubra

Recruitment hospital [7]

AIM Centre (Hunter Diabetes Centre) - Merewether

Recruitment hospital [8]

Novatrials - Newcastle

Recruitment hospital [9]

Holdsworth House Medical Practice - Sydney

Recruitment hospital [10]

Paratus Clinical Research Brisbane - Albion

Recruitment hospital [11]

Core Research Group Pty Ltd - Milton

Recruitment hospital [12]

Griffith University Clinical Trial Unit - Southport

Recruitment hospital [13]

Data Health Australia PTY Ltd t/a Austrials - Taringa

Recruitment hospital [14]

AusTrials Wellers Hill - Wellers Hill

Recruitment hospital [15]

Clinical Medical and Analytical Excellence (CMAX) - Adelaide

Recruitment hospital [16]

Eastern Health-Box Hill Hospital - Box Hill

Recruitment hospital [17]

Emeritus Research - Camberwell

Recruitment hospital [18]

University Hospital Geelong-Barwon Health - Geelong

Recruitment hospital [19]

Monash Health -Monash Medical Centre - Melbourne

Recruitment postcode(s) [1]

2617 - Bruce

Recruitment postcode(s) [2]

2148 - Blacktown

Recruitment postcode(s) [3]

2019 - Botany

Recruitment postcode(s) [4]

2100 - Brookvale

Recruitment postcode(s) [5]

2291 - Kanwal

Recruitment postcode(s) [6]

2035 - Maroubra

Recruitment postcode(s) [7]

2291 - Merewether

Recruitment postcode(s) [8]

2289 - Newcastle

Recruitment postcode(s) [9]

2010 - Sydney

Recruitment postcode(s) [10]

4010 - Albion

Recruitment postcode(s) [11]

4064 - Milton

Recruitment postcode(s) [12]

4222 - Southport

Recruitment postcode(s) [13]

4068 - Taringa

Recruitment postcode(s) [14]

4121 - Wellers Hill

Recruitment postcode(s) [15]

5000 - Adelaide

Recruitment postcode(s) [16]

3128 - Box Hill

Recruitment postcode(s) [17]

3124 - Camberwell

Recruitment postcode(s) [18]

3220 - Geelong

Recruitment postcode(s) [19]

3168 - Melbourne

Funding & Sponsors

Primary sponsor type

Commercial sector/Industry

Name

Novavax

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

This is a Multi-Part, Phase 3, randomized, observer-blinded study to evaluate the safety and
immunogenicity of booster doses of Omicron subvariant severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccines
(SARS-CoV-2 rS) adjuvanted with Matrix-M™ adjuvant (NVX-CoV2515 [BA.1] and NVX-CoV2540
[BA.5]) and bivalent (NVX-CoV2373 [prototype] + Omicron subvariant) SARS-CoV-2 rS vaccines
(NVX-CoV2373 + NVX CoV2515 and NVX CoV2373 + NVX CoV2540) in previously vaccinated adults 18
years of age and older.

Trial website

https://clinicaltrials.gov/ct2/show/NCT05372588

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Clinical Development

Address

Novavax, Inc.

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05372588