Phase 3 Study to Evaluate a Single Booster of the NVX-CoV2373 COVID19 Vaccine in Adults

• Status: Not yet recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an observer-blinded Phase 3 study to evaluate the safety and immunogenicity of a single booster dose of the Novavax severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with Matrix-MTM (NVX-CoV2373) in adults previously vaccinated with the BBIBP-CorV vaccine. The study will enroll approximately1,000 participants >18 years of age. All participants will be randomized in a 1:1 ratio to receive a single booster dose of NVX-CoV2373 or the BBIBP-CorV vaccine. All participants will receive the booster dose on Day 0 and remain on study for immunogenicity and safety data collection through Day 180. An interim analysis will be performed of safety and immunogenicity data gathered through Day 28.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Cogna Technology Solutions LLC
• Collaborator: Novavax

Criteria

Inclusion Criteria:

1. Adults ≥ 18 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 3 months after the last vaccination OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through 3 months after the last vaccination.

1. Condoms (male or female)

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 NOTE: Periodic abstinence (eg, calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.

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 as determined by the investigator 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.

NOTE: For participants who become hospitalized with COVID-19, participation in investigational treatment studies is permitted.

6. Has previously received a documented complete two dose series of the BBIBP-CorV vaccine with the second dose having been given at least 180 days prior to study vaccination.

Exclusion Criteria:

If an individual meets any of the following criteria, he or she is ineligible for this study:

1. Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to first study vaccination.

2. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine (including COVID-19) within 30 days prior to first study vaccination.

3. Any known allergies to products contained in the investigational product

4. Any history of anaphylaxis to any prior vaccine.

5. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.

NOTE: Stable endocrine disorders (eg, thyroiditis, pancreatitis), including stable diabetes mellitus with no history of diabetic ketoacidosis are NOT excluded.

6. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.

NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical or intranasal glucocorticoids is permitted. Topical tacrolimus and ocular cyclosporin are permitted. Use of inhaled glucocorticoids is prohibited.

7. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.

8. 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).

9. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.

10. 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.

11. 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).

12. Study team member or immediate family member of any study team member (inclusive of Sponsor, CRO, and study site personnel involved in the conduct or planning of the study).