Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

COVID-19 Clinical Trial

Official title:

A Randomized, Observer-Blinded, Phase 3 Study to Compare the Immunogenicity and Safety of 3 Lots of NVX-CoV2373 in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05463068
• Other study ID #: 2019nCoV-307
• Status: Completed
• Phase: Phase 3
• Start date: July 11, 2022
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2023
• Source: Novavax
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: September 1, 2022
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Drug:
• NVX-Cov2373
Intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL) on Day 1

Locations

Country	Name	City	State
United States	Cen/Excel ACMR	Atlanta	Georgia
United States	Benchmark Research	Austin	Texas
United States	Tekton Research	Austin	Texas
United States	Meridian Clinical Research	Baton Rouge	Louisiana
United States	Velocity Clinical Research	Boise	Idaho
United States	OnSite Clinical Solutions, LLC	Charlotte	North Carolina
United States	CTI Clinical Research Center	Cincinnati	Ohio
United States	Velocity Clinical Research	Cleveland	Ohio
United States	Accel Clinical Research	DeLand	Florida
United States	Velocity Clinical Research	East Greenwich	Rhode Island
United States	Meridian Clinical Research	Endwell	New York
United States	Velocity Clinical Research	Grants Pass	Oregon
United States	MedPharmics	Gulfport	Mississippi
United States	Research Centers of America	Hollywood	Florida
United States	Benchmark Research	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Multi-Specialty Research Associates, Inc.	Lake City	Florida
United States	Long Beach Clinical Trial Services Inc.	Long Beach	California
United States	Meridian Clinical Research	Norfolk	Nebraska
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Meridian Clinical Research	Omaha	Nebraska
United States	Research Your Health	Plano	Texas
United States	Rochester Clinical Research	Rochester	New York
United States	Benchmark Research	Sacramento	California
United States	Sundance Clinical Research	Saint Louis	Missouri
United States	Tekton Research	San Antonio	Texas
United States	Meridian Clinical Research	Savannah	Georgia
United States	Meridian Clinical Research	Sioux City	Iowa
United States	CRA Headlands	Stockbridge	Georgia
United States	Tekton Research	Yukon	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Novavax

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Immunoglobulin G (IgG) Antibody Levels Expressed as GMEUs	IgG geometric mean ELISA unit concentrations (GMEU/mL) to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.	Day 29
Secondary	Serum IgG antibody levels expressed as seroconversion rate (SCR)	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.	Day 29
Secondary	MN50 geometric mean titers (GMTs) to the SARS-CoV-2 expressed as GMTs	MN50 geometric mean titers to the SARS-CoV-2 spike protein at Day 29 in each treatment arm.	Day 29
Secondary	MN50 GMTs to the SARS-CoV-2 expressed as SCR	Proportion of participants in each treatment arm who achieve seroconversion (= 4-fold increase from baseline) in MN50 titers to the SARS-CoV-2 spike protein at Day 29.	Day 29
Secondary	Human Angiotensin-Converting Enzyme 2 (hACE2) inhibition assay titers GMT to the SARS-CoV-2 expressed as GMT	hACE2 inhibition assay titers (geometric mean titer [GMTs]) at Day 29 in each treatment arm.	Day 29
Secondary	hACE2 inhibition assay titers to the SARS-CoV-2 expressed as SCR	Proportion of participants in each treatment arm who achieve seroconversion (= 4-fold increase from baseline) in hACE2 titers concentrations to the SARS-CoV-2 spike protein at Day 29.	Day 29
Secondary	Incidence and severity of MAAEs	Incidence, duration, severity, and relationship of MAAEs through Day 29 (ie, 28 days after vaccine dose).	Day 0 to Day 29
Secondary	Incidence and severity of AESIs	Incidence, duration, severity, and relationship of AESIs (including myocarditis and/or pericarditis) through Day 29 (ie, 28 days after vaccine dose).	Day 0 to Day 29
Secondary	Incidence and relationship of SAEs	Incidence and relationship of SAEs throughout the study	Day 0 to Day 29