Phase 3 Boosting Study for the SARS-CoV-2 rS Vaccine

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, randomized, observer blinded study to evaluate the safety and immunogenicity of 2 booster doses of the Omicron variant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine adjuvanted with Matrix-M™ adjuvant (NVX-CoV2515) in previously vaccinated adults. In total, the study will enroll approximately 980 participants, ≥18 and ≤ 64 years of age. Approximately 490 participants will receive study vaccine for the Omicron variant (NVX-CoV2515) and 490 participants will receive study vaccine for the prototype Wuhan strain (NVX-CoV2373).

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

Details

• Lead Sponsor: Novavax

Criteria

Inclusion Criteria:

To be included in this study, each individual must satisfy all the following criteria:

1. Adults ≥ 18 and ≤ 64 years of age at screening.

2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.

3. 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.

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 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. Have previously received 2 homologous doses of either the Moderna or Pfizer-BioNTech COVID-19 prototype vaccines with the last dose having been given ≥ 180 days prior to first study booster or 3 homologous doses of either the Moderna 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:

1. Received COVID-19 vaccines other than Moderna or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.

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

3. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.

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

5. Any history of anaphylaxis to any prior vaccine.

6. 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.

7. 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.

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

9. 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).

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

11. 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.

12. 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).

13. 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).