CoV2515 for BA.1 and CoV2540 for BA.5 ...

 

Brief Summary:

This is a 2 part, Phase 3, randomized, observer-blinded, study to evaluate the safety and immunogenicity of 2 booster doses of the Omicron subvariant and a bivalent SARS-CoV-2 rS (Severe acute respiratory syndrome coronavirus 2 recombinant spike protein) (NVXCoV2373 + NVX-CoV2515) in previously vaccinated adults.

 

Condition or disease	Intervention/treatment	Phase
COVID-19SARS CoV 2 Infection	Drug: NVX-CoV2515Drug: NVX-Cov2373Drug: NVX-CoV2373 + NVX-CoV2515Drug: NVX-Cov2540Drug: NVX-CoV2373 + NVX-CoV2540	Phase 3

 

Detailed Description:

This 2-Part study is designed to assess the immune responses induced by the Novavax Omicron BA.1 and BA.5 subvariant vaccines (NVX CoV2515 and NVX-CoV2540, respectively) alone or in combination with the prototype Novavax vaccine (NVX-CoV2373) as bivalent products and to compare responses to that of the prototype Novavax vaccine (NVX-CoV2373) in adult participants ≥ 18 and ≤ 64 years of age who previously received 2, 3, or ≥ 3 doses of approved mRNA (messenger ribonucleic acid) prototype vaccines.

Study Design

 

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Study Type  :	Interventional  (Clinical Trial)
Estimated Enrollment  :	2090 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Prevention
Official Title:	A 2 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
Actual Study Start Date  :	May 25, 2022
Actual Primary Completion Date  :	July 17, 2022
Estimated Study Completion Date  :	July 2023

 

Resource links provided by the National Library of Medicine

 

 

MedlinePlus related topics: COVID-19 (Coronavirus Disease 2019) Vaccines

U.S. FDA Resources

Arms and Interventions

 

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Arm	Intervention/treatment
Experimental: Group A (NVX-CoV2515 / NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0 and 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on day 150.	Drug: NVX-CoV2515 Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL). Other Name: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant
Experimental: Group B (NVX-CoV2373 ) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 150 for randomized participants continuing in group B.	Drug: NVX-Cov2373 Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group B1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for participants randomized to group B1.	Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant
Experimental: Group C (NVX-CoV2515 / NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2515 of 0.5 mL injection volume on Day 0 and 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on day 150.	Drug: NVX-CoV2515 Intramuscular (deltoid) injection of co-formulated Omicron BA.1 SARS-CoV-2 rS vaccine with Matrix-M adjuvant (0.5 mL). Other Name: Omicron BA.1 SARS-CoV-2 rS /Matrix-M Adjuvant Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant
Experimental: Group D (NVX-CoV2373) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and on Day 150 for randomized participants continuing in group D.	Drug: NVX-Cov2373 Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group D1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for participants randomized to group D1.	Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant
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 and 1 intramuscular (IM) injection of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2540) of 0.5 mL injection volume on day 150.	Drug: 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. Other Name: Prototype/BA.1 Bivalent Vaccine Drug: NVX-CoV2373 + NVX-CoV2540 Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2540) with 50 µg Matrix-M adjuvant. Other Name: Prototype/BA.5 Bivalent Vaccine
Experimental: Group F (NVX-CoV2540) 2 intramuscular (IM) injections of NVX-CoV2540 of 0.5 mL injection volume on Day 0 and Day 150.	Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant
Experimental: Group G (BA.5 Bivalent Vaccine ) 2 intramuscular (IM) injections of Bivalent Vaccine (NVX-CoV2373 + NVX-CoV2540) of 0.5 mL injection volume on Day 0 and Day 150.	Drug: NVX-CoV2373 + NVX-CoV2540 Intramuscular (deltoid) injection of 5 µg total (2.5 µg NVX-CoV2373 + 2.5 µg NVX-CoV2540) with 50 µg Matrix-M adjuvant. Other Name: Prototype/BA.5 Bivalent Vaccine
Experimental: Group H (NVX-CoV2373) 2 intramuscular (IM) injections of NVX-CoV2373 of 0.5 mL injection volume on Day 0 and Day 150 for randomized participants continuing in group H.	Drug: NVX-Cov2373 Intramuscular (deltoid) injection of co-formulated prototype SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: SARS-CoV-2 rS/Matrix-M Adjuvant
Experimental: Group H1 (NVX-CoV2540) 1 intramuscular (IM) injection of NVX-CoV2540 of 0.5 mL injection volume on Day 150 for participants randomized to group H1.	Drug: NVX-Cov2540 Intramuscular (deltoid) injection of co-formulated Omicron BA.5 SARS-CoV-2 rS vaccine with Matrix-M adjuvant(0.5 mL). Other Name: Omicron BA.5 SARS-CoV-2 rS/Matrix-M adjuvant

 

Outcome Measures

 

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Primary Outcome Measures  :

1. Part 1: MN50 geometric mean titers (GMTs) to the Omicron BA.1 subvariant expressed as GMTs [ Time Frame: Day 14 ]
   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.
2. Part 1: MN50 titer concentrations to the Omicron BA.1 subvariant vaccine expressed as seroresponse rates (SRRs) [ Time Frame: Day 14 ]
   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.
3. Part 2: MN50 geometric mean titers (GMTs) to the Omicron BA.5 subvariant expressed as GMTs [ Time Frame: Day 14 ]
   MN50 GMTs to the Omicron BA.5 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
4. Part 2: MN50 geometric mean titers (GMTs) to the Omicron BA.5 subvariant expressed as SRRs [ Time Frame: Day 14 ]
   SRRs in MN50 titer concentrations to the Omicron BA.5 subvariant, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.

 

Secondary Outcome Measures  :

1. Part 1: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMT [ Time Frame: Day 0 to Day 150 ]
   MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, and 150) and analyzed by previous vaccine combination received.
2. Part 1: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [ Time Frame: Day 7 to Day 150 ]
   MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, and 150) from baseline (Day 0) and analyzed by previous vaccine combination received.
3. Part 1: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRRs [ Time Frame: Day 7 to Day 150 ]
   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 150) and analyzed by previous vaccine combination received.
4. Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as GMT [ Time Frame: Day 150 to Day 270 ]
   MN50 GMTs to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
5. Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as GMFR [ Time Frame: Day 150 to Day 270 ]
   MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) from baseline (Day 150) and analyzed by previous vaccine combination received.
6. Part 1: MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses expressed as SRRs [ Time Frame: Day 150 to Day 270 ]
   SRRs in MN50 titer concentrations to the ancestral (Wuhan) and Omicron BA.5 viruses at relevant time points (Days 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
7. Part 1: Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
   IgG geometric mean concentrations (GMCs, EU/mL) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
8. Part 1: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRRs [ Time Frame: Day 0 to Day 270 ]
   IgG geometric mean concentrations (GMCs, EU/mL) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR.
9. 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 [ Time Frame: Day 0 to Day 270 ]
   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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
10. Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
11. Part 1: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
12. Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMT [ Time Frame: Day 14 ]
    MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
13. Part 1: MN50 GMTs to the to the ancestral (Wuhan) virus expressed as GMFR [ Time Frame: Day 14 ]
    MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
14. Part 1: SRRs in MN50 titer concentrations to the ancestral (Wuhan) virus expressed as SRRs [ Time Frame: Day 14 ]
    SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.
15. Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMT [ Time Frame: Day 14 ]
    MN50 GMTs to the Omicron BA.1 subvariant virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
16. Part 1: IgG GMCs to the to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
17. Part 1: IgG GMCs to the to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
18. Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as GMFR [ Time Frame: Day 14 ]
    MN50 GMFRs to the Omicron BA.1 subvariant virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
19. Part 1: MN50 GMTs to the Omicron BA.1 subvariant virus expressed as SRR [ Time Frame: Day 14 ]
    SRR in MN50 titer concentrations to the Omicron BA.1 variant virus, assessed at Day 14 following initial study vaccination.
20. Part 2: MN50 geometric mean titers (GMTs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMT [ Time Frame: Day 0 to Day 270 ]
    MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
21. Part 2: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [ Time Frame: Day 7 to Day 270 ]
    MN50 geometric mean fold rise (GMFR) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 7, 14, 28, 150, 164, 249, and 270) from baseline (Day 0 or 150) and analyzed by previous vaccine combination received.
22. Part 2: MN50 titer concentrations to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRRs [ Time Frame: Day 7 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
23. Part 2: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    IgG geometric mean concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
24. Part 2: IgG Geometric Mean Concentration (GMC) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRRs [ Time Frame: Day 0 to Day 270 ]
    IgG geometric mean concentrations (GMCs) to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
25. Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMTs [ Time Frame: Day 0 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received.
26. Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.
27. Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    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, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
28. Part 2: MN50 GMTs to the ancestral (Wuhan) virus expressed as GMFR [ Time Frame: Day 14 ]
    MN50 GMFRs to the ancestral (Wuhan) virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
29. Part 2: MN50 GMTs to the ancestral (Wuhan) virus expressed as GMT [ Time Frame: Day 14 ]
    MN50 GMTs to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
30. Part 2: MN50 titer concentrations to the ancestral (Wuhan) virus expressed as GMFR [ Time Frame: Day 14 ]
    SRR in MN50 titer concentrations to the ancestral (Wuhan) virus, assessed at Day 14 following initial study vaccination.
31. Part 2: MN50 GMTs to the Omicron BA.5 virus expressed as GMTs [ Time Frame: Day 14 ]
    MN50 GMTs to the Omicron BA.5 virus, assessed at Day 14 following initial study vaccination and analyzed by previous vaccine combination received.
32. Part 2: MN50 titer concentrations to the Omicron BA.5 virus expressed as GMFR [ Time Frame: Day 14 ]
    MN50 GMFRs to the Omicron BA.5 virus at Day 14, from baseline (Day 0) and analyzed by previous vaccine combination received.
33. Part 2: MN50 titer concentrations to the Omicron BA.5 virus expressed as SRR [ Time Frame: Day 14 ]
    SRR in MN50 titer concentrations to the Omicron BA.5 virus, assessed at Day 14 following initial study vaccination.
34. Part 2: MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR
35. Part 2: MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    MN50 GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 viruses at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR
36. Part 2: IgG GMC to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as GMFR [ Time Frame: Day 0 to Day 270 ]
    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 160, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include GMFR.
37. Part 1 and Part 2: Incidence of solicited local and systemic Adverse Events (AEs) [ Time Frame: Day 7 ]
    Incidence, duration, and severity of solicited local and systemic AEs for 7 days following each vaccination.
38. Part 1 and Part 2 : Incidence of unsolicited AEs [ Time Frame: Day 28 ]
    Incidence, duration, severity, and relationship of unsolicited AEs through 28 days after the last vaccination.
39. 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) [ Time Frame: Day 0 to Day 270 ]
    Incidence and relationship of MAAEs, AESIs (predefined list), and SAEs throughout the study
40. Part 2: IgG GMC to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    IgG GMCs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRR.
41. Part 2: hACE2 receptor binding inhibition assay to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins expressed as SRR [ Time Frame: Day 0 to Day 270 ]
    GMTs to the ancestral (Wuhan), Omicron BA.1, and Omicron BA.5 S proteins at relevant time points (Days 0, 7, 14, 28, 150, 164, 249, and 270) and analyzed by previous vaccine combination received. Derived/calculated endpoints based on these data will include SRRs.

Eligibility Criteria

 

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Information from the National Library of Medicine

 

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

 

Ages Eligible for Study:	18 Years to 64 Years   (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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 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 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 COVID-19 prototype vaccines with the last dose having been given ≥ 90 days previously prior to the first study booster.

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 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 the 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

Part 2:

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 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 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 COVID-19 prototype vaccines with the last dose having been given ≥ 90 days previously prior to first study booster.

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 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
15. Confirmed case (by Polymerase Chain Reaction [PCR] or rapid test) of symptomatic COVID-19 in the past 60 days.

Contacts and Locations

 

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Information from the National Library of Medicine

 

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05372588

 

Locations

 Show 19 study locations

Sponsors and Collaborators

Novavax

Investigators

Study Director:	Clinical Development	Novavax, Inc.

More Information

 

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Responsible Party:	Novavax
ClinicalTrials.gov Identifier:	NCT05372588     History of Changes
Other Study ID Numbers:	2019nCoV- 311
First Posted:	May 12, 2022    Key Record Dates
Last Update Posted:	September 2, 2022
Last Verified:	August 2022

 

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Novavax:

Coronavirus

Additional relevant MeSH terms:

COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections	Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vaccines Immunologic Factors Physiological Effects of Drugs