Clinical trial NCT05463068: Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Official title: A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: COVID-19
SARS-CoV-2 Infection
Keywords: Coronavirus
COVID-19
Lead sponsor: Novavax
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 911
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMEUs
timeFrame: Day 29
Secondary outcomes:
measure: Serum IgG antibody levels expressed as seroconversion rate (SCR)
timeFrame: Day 29
measure: MN50 geometric mean titers (GMTs) to the SARS-CoV-2 expressed as GMTs
timeFrame: Day 29
measure: MN50 GMTs to the SARS-CoV-2 expressed as SCR
timeFrame: Day 29
measure: Human Angiotensin-Converting Enzyme 2 (hACE2) inhibition assay titers GMT to the SARS-CoV-2 expressed as GMT
timeFrame: Day 29
measure: hACE2 inhibition assay titers to the SARS-CoV-2 expressed as SCR
timeFrame: Day 29
measure: Incidence and severity of MAAEs
timeFrame: Day 0 to Day 29
measure: Incidence and severity of AESIs
timeFrame: Day 0 to Day 29
measure: Incidence and relationship of SAEs
timeFrame: Day 0 to Day 29
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Clinical Trial Services Inc.
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: DeLand
country: United States
facility: Accel Clinical Research
state: Florida
city: Hollywood
country: United States
facility: Research Centers of America
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Lake City
country: United States
facility: Multi-Specialty Research Associates, Inc.
state: Florida
city: Atlanta
country: United States
facility: Cen/Excel ACMR
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Stockbridge
country: United States
facility: CRA Headlands
state: Georgia
city: Boise
country: United States
facility: Velocity Clinical Research
state: Idaho
city: Sioux City
country: United States
facility: Meridian Clinical Research
state: Iowa
city: Baton Rouge
country: United States
facility: Meridian Clinical Research
state: Louisiana
city: Gulfport
country: United States
facility: MedPharmics
state: Mississippi
city: Saint Louis
country: United States
facility: Sundance Clinical Research
state: Missouri
city: Norfolk
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Omaha
country: United States
facility: Meridian Clinical Research
state: Nebraska
city: Endwell
country: United States
facility: Meridian Clinical Research
state: New York
city: Rochester
country: United States
facility: Rochester Clinical Research
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC
state: North Carolina
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Cleveland
country: United States
facility: Velocity Clinical Research
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Yukon
country: United States
facility: Tekton Research
state: Oklahoma
city: Grants Pass
country: United States
facility: Velocity Clinical Research
state: Oregon
city: East Greenwich
country: United States
facility: Velocity Clinical Research
state: Rhode Island
city: Austin
country: United States
facility: Benchmark Research
state: Texas
city: Austin
country: United States
facility: Tekton Research
state: Texas
city: Houston
country: United States
facility: Benchmark Research
state: Texas
city: Plano
country: United States
facility: Research Your Health
state: Texas
city: San Antonio
country: United States
facility: Tekton Research
state: Texas
Study officials:
affiliation: Novavax, Inc.
name: Clinical Development
role: STUDY_DIRECTOR
References: