Novavax Phase 3 COVID-19 Omicron Trial Results(nvax 二阶)

v
va168
楼主 (文学城)

Novavax Phase 3 COVID-19 Omicron Trial Supports the Continued and Future Use of Novavax Prototype Vaccine as a Booster

 

Nov 8, 2022 The Novavax BA.1 vaccine candidate met its primary strain-change endpoint allowing for development of variant vaccines, if necessary Novavax' prototype vaccine induced broad immune response against original Wuhan, BA.1, and BA.5 strains The trial showed no benefit for a bivalent vaccine utilizing Novavax' recombinant protein/adjuvant technology

GAITHERSBURG, Md., Nov. 8, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced topline results from its Phase 3 Boosting Trial for the SARS-CoV-2 rS Variant Vaccines (COVID-19) showing that the Company's BA.1 vaccine candidate (NVX-CoV2515) met the primary strain-change endpoint. The data demonstrate that the BA.1 vaccine candidate neutralizing responses in those not previously exposed to COVID-19 were greater than those of the prototype vaccine (NVX-CoV2373), enabling a shift to a new variant vaccine, if necessary (see chart 1).

Additionally, data show no benefit for the Novavax bivalent vaccine candidate compared to the BA.1 vaccine candidate or prototype vaccine in the overall trial population. Immunoglobulin G (IgG) antibody responses against BA.1 and prototype strains showed similar responses across the three vaccine groups (prototype [n=273], BA.1 vaccine candidate [n=279], and bivalent – prototype + BA.1 vaccine candidate [n=277]).* Importantly, for the BA.5 strain (which is structurally similar to BA.1), pseudoneutralization responses demonstrated that there was no benefit for the BA.1 or bivalent vaccine candidates compared to the prototype vaccine.**

Overall, the data demonstrated that the prototype vaccine induced a broad immune response against original prototype, BA.1, and BA.5 strains. The prototype vaccine induced robust IgG responses to both BA.1 and the matched prototype strain.* Pseudoneutralization responses against BA.5 for the prototype vaccine were comparable to those induced by the more closely matched BA.1 vaccine and bivalent vaccine candidates.*

"Today's results show that use of our prototype vaccine as a booster induces cross-reactive responses to a broad range of variants with the potential to protect against future strains. This is a hallmark of our vaccine technology and shows the suitability of our current prototype vaccine as a booster even as the COVID-19 landscape continues to evolve," said Gregory M. Glenn, M.D., President of Research and Development, Novavax. "Our vaccine, which provides broad immune response even in the face of evolving variants, presents a potential strategy to protect against COVID-19 now and into the future."

When given as a second booster dose (fourth dose), all three vaccine formulations were similarly well-tolerated, consistent with the well-established safety profile of the prototype vaccine. The most common local solicited symptom was pain/tenderness (BA.1 69%, prototype 71%, bivalent 65%). The most common systemic solicited symptoms were fatigue and malaise (BA.1 45%, prototype 41%, bivalent 45%), headache (BA.1 38%, prototype 35%, bivalent 36%), muscle pain (BA.1 25%, prototype 24%, bivalent 24%), and joint pain (BA.1 10%, prototype 11%, bivalent 6%), with the majority of reactions being mild or moderate.

Chart 1: Geometric Mean Ratio of BA.1 wild-type Neutralizing Responses (Day 14) Study Arm in Participants Not Previously Infected

 

Group Comparisons

Neutralizing antibodies for BA.1

BA.1 vaccine to
prototype vaccine

Bivalent vaccine to
prototype vaccine

Bivalent vaccine to
BA.1 vaccine

Geometric Mean Ratio (GMR)

1.6

1.2

0.7

GMR 95% Confidence Interval

1.31, 2.03

0.94, 1.44

0.57, 0.89

*IgG responses are not statistically significant.
**Fit-for-purpose analysis being confirmed with validated assay.

About the Phase 3 Omicron Trial
Novavax' Phase 3 Omicron trial is a two-part, observer blinded, randomized trial to evaluate Omicron subvariant vaccine candidates. NVX-CoV2515 (BA.1) and bivalent (NVX-CoV2373 + Omicron subvariant NVX-CoV2515) vaccine candidates were compared to NVX-CoV2373 in adults aged 18 to 64 previously vaccinated with three doses of mRNA vaccines. All formulations include the Matrix-M™ adjuvant to enhance and broaden the immune response. The trial is evaluating the reactogenicity and immune responses to all three formulations. The trial's primary endpoints include measures of immune response, and its secondary endpoints include additional measurements of immune responses and safety measures. The trial plans to enroll 2,090 adults aged 18 to 64 across 19 sites in Australia.

5
5181
为啥nvax2阶疫苗要做3期.mRNA疫苗不需要????汇报一下,打过第2针了.

疼觉-带状疱疹疫苗最疼(还需去打第二针)大于流感疫苗大于肺20价疫苗大于nvax疫苗.

 

 

v
va168
恭喜打完第二针,NVAX2阶临床结果也不错。
周老大
因为不是美国的“赵家人”
M
Michelangelo
难道不应该做三期?
v
va168
想打nvax booster 的,可以考虑直接打2阶。
周老大
mRNA只做了耗子
r
rancho2008
已经有二阶的打了吗
v
va168
还没有,但临床试验做完了,很不错,估计就等FDA批了...
f
fuz
很难找到你这样的”裸”人了,不得不用小白鼠

在医学生物学实验中,把没有接受过待试样品的生物体称为“裸”。

周老大
红脖应该很多没打,只是他们不会去做小白鼠
三丝
FDA 批的时候还没有3期结果,现在结果出来了,

MODERNA'S BA.4/BA.5 TARGETING BIVALENT BOOSTER, MRNA-1273.222, MEETS PRIMARY ENDPOINT OF SUPERIORITY AGAINST OMICRON VARIANTS COMPARED TO BOOSTER DOSE OF MRNA-1273 IN PHASE 2/3 CLINICAL TRIAL
三丝
从immunogenicty 来说,Novavax 和PFizer的 2价是BA.1, 对BA.5 没有什么用,不如磨得
f
fuz
跟打不打没多大关系,那些人基本上被染上几次了。你的裸,是纯裸,没抗体
周老大
哈哈,奇货可居
v
va168
不是,Novavax 2价对BA.1/BA.5都有效,你需要重读这篇文章重要结论。

Novavax' prototype vaccine induced broad immune response against original Wuhan, BA.1, and BA.5 strains
周老大
未做先打,现在四期结果都出来,还做什么三期?
v
va168
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   Go to  

 

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   Go to  

 

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   Go to  

 

Primary Outcome Measures  : 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. 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. 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. 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  : 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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 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 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. 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. 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. 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 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. 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   Go to    

 

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:

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 enrollment and through the end of the study.

Condoms (male or female) with spermicide (if acceptable in-country) Diaphragm with spermicide Cervical cap with spermicide Intrauterine device Oral or patch contraceptives Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle.

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 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:

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 the 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

Part 2:

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 enrollment and through the end of the study.

Condoms (male or female) with spermicide (if acceptable in country) Diaphragm with spermicide Cervical cap with spermicide Intrauterine device Oral or patch contraceptives Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle 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 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:

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