COVID-19, SARS-CoV-2 Infection
Conditions
Keywords
Coronavirus, COVID-19
Brief summary
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373).The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive.
Detailed description
This is a randomized, Phase 3 study comparing the immunogenicity and safety of 3 different lots of Novavax vaccine with Matrix-M™ adjuvant (NVX-CoV2373). The study will enroll approximately 900 previously vaccinated adults 18 to 49 years of age, inclusive. Participants will be screened at baseline with the goal of enrolling approximately 900 previously vaccinated participants. Participants will be randomized 1:1:1 to receive 1 dose of the vaccine from 1 of 3 different lots, given on Day 1, at a dose level of 5 µg of antigen with 50 µg of Matrix-M adjuvant. All participants will remain on study for immunogenicity and safety data collection through 28 days following the vaccination.
Interventions
DRUGNVX-Cov2373
Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1
Sponsors
Novavax
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
To be included in this study, each individual must satisfy all of the following criteria: 1. Adults 18 to 49 years of age, inclusive, at screening 2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures. 3. 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 \[defined as amenorrhea at least 12 consecutive months\]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of study (EOS) visit OR agree to consistently use a medically acceptable method of contraception from at least 28 days prior to enrollment and through the EOS visit. 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 study vaccination 5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study. Note: For participants who become hospitalized with coronavirus disease 2019 (COVID-19), participation in investigational treatment studies is permitted. 6. Documented receipt of either 2 or 3 doses of the investigational Novavax vaccine with Matrix-M adjuvant (NVX- CoV2373); OR documented receipt of a full course of an FDA-authorized/approved COVID-19 vaccine; OR documented receipt of a full course of heterologous COVID-19 vaccines mentioned above. The most recent dose must have been administered at least 6 months prior to study vaccination.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study. 1. History of laboratory-confirmed (by polymerase chain reaction \[PCR\] or rapid antigen test)COVID-19 infection ≤ 4 months prior to randomization. 2. Current participation in research involving receipt of an investigational product (drug/biologic/device). 3. Any known allergies or history of anaphylaxis to the active substance or any of the other ingredients contained in the investigational product. 4. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) or therapy that causes clinically significant immunosuppression. 5. Received any vaccine ≤ 90 days prior to study vaccination, except for influenza vaccine which may be received 4 days prior to study vaccine, or rabies vaccine which may be received at any time if medically indicated. 6. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination, except for rabies immunoglobulin which may be given if medically indicated. 7. Active cancer (malignancy) on chemotherapy that is judged to cause significant immunocompromise within 1 year prior to first study vaccination (with the exception of malignancy cured via excision, at the discretion of the investigator). 8. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the EOS visit. 9. Suspected or known history of alcohol abuse or drug addiction within 3 months prior to the study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance. 10. 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 trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting). 11. 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). 12. Participants with a history of myocarditis or pericarditis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum Immunoglobulin G (IgG) Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Geometric Mean ELISA Unit [GMEUs] | Baseline (Day 1) and Day 29 | Serum Immunoglobulin G (IgG) geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum IgG Antibody Levels to the SARS-CoV-2 Spike Protein Expressed as Seroconversion Rate (SCR) | Day 29 | Proportion of participants in each treatment arm who achieve seroconversion (≥ 4-fold increase from baseline) in IgG concentrations to the SARS-CoV-2 spike protein at Day 29. |
| Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as Geometric Mean Titer [GMT] | Baseline (Day 1) to Day 29 | Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 1 and Day 29 |
| Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) Expressed as SCR | Day 29 | Neutralizing Antibody Titers for SARS-CoV-2 Wild-Type Virus (Wuhan) of 3 Lots of NVX-CoV2373 at Day 29 |
| hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as GMT | Baseline (Day 1) to Day 29 | hACE2 Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 1 to Day 29 |
| Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) Expressed as SCR | Day 29 | Human Angiotensin-Converting Enzyme 2 (hACE2) Receptor Binding Inhibition Antibody Titers Specific for the SARS-CoV-2 Spike Protein (Wuhan) the 3 Lots of NVX-CoV2373 at Day 29 |
| Number of Participants With Medically Attended Adverse Event(s) (MAAEs), Adverse Event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs) | Day 1 to Day 29 | Number of participants Medically Attended Adverse Event(s) (MAAEs), Adverse event(s) of Special Interest (AESIs), and Serious Adverse Event(s) (SAEs) |
| Incidence and Severity of MAAEs Through Day 29 | Day 29 | Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose) |
| Number of Participants With Unsolicited Treatment-Emergent Adverse Events by COVID-19 | Day 29 | Number of Participants with Unsolicited Treatment-Emergent Adverse Events by COVID-19 throughout the study at Day 29 |
Countries
United States
Contacts
STUDY_DIRECTORClinical Development
Novavax, Inc.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 36.4 years STANDARD_DEVIATION 8.39 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 143 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 248 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 10 Participants |
| PCR, n (%) Missing | 7 Participants |
| PCR, n (%) Negative | 288 Participants |
| PCR, n (%) Positive | 6 Participants |
| Previous SARS-CoV-2 infection, n (%) | 17 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 3 Participants |
| Race/Ethnicity, Customized Asian | 30 Participants |
| Race/Ethnicity, Customized Black or African American | 51 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not reported/specified | 9 Participants |
| Race/Ethnicity, Customized Other | 9 Participants |
| Race/Ethnicity, Customized White or Caucasian | 670 Participants |
| Sex: Female, Male Female | 526 Participants |
| Sex: Female, Male Male | 123 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 298 | 0 / 303 | 0 / 304 |
| other Total, other adverse events | 7 / 298 | 3 / 303 | 4 / 304 |
| serious Total, serious adverse events | 0 / 298 | 1 / 303 | 1 / 304 |
Outcome results
None listed