AzTrials
AzTrials

COVID-19Phase 3COVID-19NCT05372588

Phase 3 Boosting Study for the SARS-CoV-2 rS Variant Vaccines

A Phase 3 study testing NVX-CoV2515, NVX-Cov2373 and NVX-CoV2373 + NVX-CoV2515 in people with COVID-19 and SARS CoV 2 Infection, run by Novavax at 19 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19, SARS CoV 2 Infection
What is being tested?
NVX-CoV2515, NVX-Cov2373 and NVX-CoV2373 + NVX-CoV2515
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,340 participants
Where
19 sitesAustralia
Study dates
25 May 2022to 7 Apr 2024
Phase
Phase 3
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

  • To be included in this study, each individual must satisfy all the following criteria:
  • Adults ≥ 18 and ≤ 64 years of age 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 ≥ 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.
  • 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.
  • Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
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  • 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.
  • To be included in this study, each individual must satisfy all of the following criteria:
  • Adults and adolescents ≥ 18 years of age 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 ≥ 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.
  • 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.
  • Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.
  • 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.

Who cannot join

  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID- 19 vaccines.
  • Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination.
  • 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.
  • Any known allergies to products contained in the investigational product.
  • Any history of anaphylaxis to any prior vaccine.
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  • Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  • Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to study vaccination.
  • 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.
  • 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).
  • Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of the study.
  • 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.
  • 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, clinical research organization (CRO), and study site personnel involved in the conduct or planning of the study).
  • Part 2
  • If an individual meets any of the following criteria, he or she is ineligible for this study:
  • Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
  • Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.
  • 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.
  • Any known allergies to products contained in the investigational product.
  • 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 immunosuppressant, 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, except for rabies immunoglobulin which may be given if medically indicated.
  • 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, clinical research organization [CRO], and study site personnel involved in the conduct or planning of the study).
  • Participants with a history of myocarditis or pericarditis

Trial locations and contacts

19 sites in 1 country.

19 sites in 1 country

Australia19 sites

  • Clinical Medical and Analytical Excellence (CMAX)

    Adelaide, South Australia, 5000

  • Paratus Clinical Research Brisbane

    Albion, Queensland, 4010

  • Paratus Clinical Research Western Sydney

    Blacktown, New South Wales, 2148

  • Emeritus Research

    Botany, New South Wales, 2019

  • Eastern Health-Box Hill Hospital

    Box Hill, Victoria, 3128

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100

  • Paratus Clinical Research Canberra

    Bruce, Australian Capital Territory, 2617

  • Emeritus Research

    Camberwell, Victoria, 3124

  • University Hospital Geelong-Barwon Health

    Geelong, Victoria, 3220

  • Paratus Clinical Research Central Coast

    Kanwal, New South Wales, 2291

  • Australian Clinical Research Network (ACRN)

    Maroubra, New South Wales, 2035

  • Monash Health -Monash Medical Centre

    Melbourne, Victoria, 3168

  • AIM Centre (Hunter Diabetes Centre)

    Merewether, New South Wales, 2291

  • Core Research Group Pty Ltd

    Milton, Queensland, 4064

  • Novatrials

    Newcastle, New South Wales, 2289

  • Griffith University Clinical Trial Unit

    Southport, Queensland, 4222

  • Holdsworth House Medical Practice

    Sydney, New South Whales, 2010

  • Data Health Australia PTY Ltd t/a Austrials

    Taringa, Queensland, 4068

  • AusTrials Wellers Hill

    Wellers Hill, Queensland, 4121

Other trials in Australia

About this study

Official 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

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.

Being tested
NVX-CoV2515, NVX-Cov2373, NVX-CoV2373 + NVX-CoV2515, NVX-CoV2540, NVX-CoV2373 + NVX-CoV2540
Keywords
Coronavirus
Medical subject headings
COVID-19, Coronavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NVX-CoV2515Drug

    Also called Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant

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

  • NVX-Cov2373Drug

    Also called SARS-CoV-2 rS/Matrix-M Adjuvant

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

  • NVX-CoV2373 + NVX-CoV2515Drug

    Also called Prototype/BA.1 Bivalent Vaccine

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

  • NVX-CoV2540Drug

    Also called Omicron BA.5 SARS-CoV-2 rS /Matrix-M Adjuvant

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

  • NVX-CoV2373 + NVX-CoV2540Drug

    Also called Prototype/BA.5 Bivalent Vaccine

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

Study groups in NCT05372588
Study groupRoleWhat they receive
Group A (NVX-CoV2515 )Experimental1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.
Receives: Drug: NVX-CoV2515
Group B (NVX-CoV2373 )Experimental1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.
Receives: Drug: NVX-Cov2373
Group C (NVX-CoV2515 )Experimental1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0.
Receives: Drug: NVX-CoV2515
Group D (NVX-CoV2373)Experimental1 intramuscular (IM) injection of NVX-CoV2373 of 0.5 mL injection volume on Day 0.
Receives: Drug: NVX-Cov2373
Group E (BA.1 Bivalent Vaccine)Experimental1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2515) of 0.5 mL injection volume on Day 0.
Receives: Drug: NVX-CoV2373 + NVX-CoV2515
Group F (NVX-CoV2540)Experimental2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
Receives: Drug: NVX-CoV2540
Group G (NVX-CoV2373)Experimental2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
Receives: Drug: NVX-Cov2373
Group H (NVX-CoV2373 + NVX-CoV2540)Experimental2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 90.
Receives: Drug: NVX-CoV2373 + NVX-CoV2540

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Microneutralization [MN] geometric mean titers (GMTs) with an inhibitory concentration of 50% (MN50) to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    Seroresponse rates (SRRs) (proportion of participants who achieve ≥ 4-fold increase from baseline [Day 0]) in MN50 titer concentrations to the Omicron BA.1 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    Neutralizing antibody (NAb) GMTs to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination.

    Measured: Day 28

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

    SRRs in NAb titer concentrations to the Omicron BA.5 subvariant, assessed at Day 28 following initial study vaccination

    Measured: Day 28

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

    NAb GMTs to the ancestral (Wuhan) strain, assessed at Day 28 following initial study vaccination.

    Measured: Day 28

Secondary outcomes (31)

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

    MN50 GMTs to the ancestral (Wuhan), and Omicron BA.1 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), and Omicron BA.1 viruses at relevant time points (Days 7, 14, 28, and 240) from baseline (Day 0) and analyzed by previous vaccine combination received.

    Measured: Day 7 to Day 240

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

    SRRs in MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 7 to Day 240

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

    Immunoglobulin G (IgG) antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combinations received.

    Measured: Day 0 to Day 240

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

    IgG antibody levels to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    IgG antibody levels to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

  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

    hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.

    Measured: Day 0 to Day 240

  9. Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR

    hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.

    Measured: Day 0 to Day 240

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

    MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.

    Measured: Day 14

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

    MN50 GMTs to the Omicron BA.1 subvariant virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    MN50 GMFRs to the Omicron BA.1 subvariant virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.

    Measured: Day 14

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

    SRR in MN50 titer concentrations to the Omicron BA.1 variant virus, assessed at Day 14 following initial study vaccination.

    Measured: Day 14

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

    Incidence, duration, and severity of solicited local and systemic AEs for 7 days following vaccination.

    Measured: Day 7

  17. Part 1 and Part 2 : Incidence of unsolicited AEs

    Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after vaccination.

    Measured: Day 28

  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)

    Incidence and relationship of MAAEs, AESIs (predefined list), and SAEs throughout the study

    Measured: Day 0 to Day 270

  19. Part 1: IgG Geometric Mean Concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR

    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, and 240) and analyzed by previous vaccine combination received.

    Measured: Day 0 to Day 240

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

    NAb GMTs to the ancestral (Wuhan) and Omicron BA.5 strains at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    NAb GMFR to the ancestral (Wuhan), and Omicron BA.5 strains at relevant time points (Days 14, 28, 104, 118, and 270) from baseline (Day 0 or Day 90) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    SRRs in NAb titers to the ancestral (Wuhan) and Omicron BA.5 strains at relevant time points (Days 14, 28, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    IgG GMEUs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

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

    hACE2 receptor binding inhibition assay GMTs to the ancestral (Wuhan) and Omicron BA.5 S proteins at relevant time points (Days 0, 14, 28, 90, 104, 118, and 270) and analyzed by age group (overall, 18 to 54, and ≥ 55 years of age).

    Measured: Day 0 to Day 270

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 May 2022
  2. Study start25 May 2022
  3. Primary completion17 Jul 2022
  4. Study completion7 Apr 2024

Resources

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05372588
Sponsor's protocol ID
2019nCoV- 311
Acronym
COVID-19
Status last verified
Apr 2024
First submitted
9 May 2022
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bennett C, Rivers EJ, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, Pardey TM, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Buchanan A, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM. Immunogenicity and Safety of Heterologous Omicron BA.1 and Bivalent SARS-CoV-2 Recombinant Spike Protein Booster Vaccines: A Phase 3 Randomized Clinical Trial. J Infect Dis. 2024 Jul 25;230(1):e4-e16. doi: 10.1093/infdis/jiad508.

    PubMed 39052718

  • Bennett C, Woo W, Bloch M, Cheung K, Griffin P, Mohan R, Deshmukh S, Arya M, Cumming O, Neville AM, McCallum Pardey TG, Plested JS, Cloney-Clark S, Zhu M, Kalkeri R, Patel N, Marcheschi A, Swan J, Smith G, Cho I, Glenn GM, Walker R, Mallory RM; Novavax 2019nCoV-311 Study Group. Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial. Lancet Infect Dis. 2024 Jun;24(6):581-593. doi: 10.1016/S1473-3099(24)00077-X. Epub 2024 Mar 6.

    PubMed 38460525

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NVX-CoV2515, NVX-Cov2373 and NVX-CoV2373 + NVX-CoV2515 in people with COVID-19 and SARS CoV 2 Infection, run by Novavax at 19 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 30 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs (time frame: Day 14). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05372588, which also lists 2 linked publications.

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 23 Apr 2024.

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