Status:
COMPLETED
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
Lead Sponsor:
Novavax
Conditions:
COVID-19
Eligibility:
All Genders
18-54 years
Phase:
PHASE2
PHASE3
Brief Summary
This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) p...
Detailed Description
Novavax, Inc. developed a recombinant prototype COVID-19 vaccine constructed from the full-length ancestral (Wuhan) SARS CoV-2 S glycoprotein (GP) adjuvanted with the saponin-based Matrix-M adjuvant (...
Eligibility Criteria
Inclusion
- Adults ≥ 18 years of age at time of study vaccination.
- Part 1: Previously vaccinated with ≥ 3 doses of the Moderna and/or Pfizer /BioNTech prototype monovalent and/or BA.4/5 containing bivalent COVID-19 vaccines with the last dose administered ≥ 90 days prior to study vaccination.
- Part 2: Clinical history of COVID-19-like disease during the previous year.
- Willing and able to give informed consent prior to study enrollment and to comply with study procedures.
- 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 in-active 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.
- Condoms (male or female) with spermicide (if acceptable in country)
- Diaphragm with spermicide
- Cervical cap with spermicide
- Intrauterine device
- Oral or patch contraceptives
- Norplant®, Depo-Provera®, or other in country regulatory approved contraceptive method that is designed to protect against pregnancy.
- Abstinence, as a form of contraception, is acceptable if in line with the participant's lifestyle NOTE: Periodic abstinence (eg, calendar, ovulation, sympto-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Is medically stable, as determined by the investigator (based on review of health status, vital signs \[to include body temperature\], medical history, and physical examination \[to include body weight\]). Vital signs must be within medically acceptable ranges prior to study vaccination.
- Agrees to not participate in any research involving receipt of investigational products (drug/biologic/device) including 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.
Exclusion
- Received COVID-19 vaccines other than Moderna and/or Pfizer-BioNTech in the past, inclusive of clinical trial COVID-19 vaccines.
- Participation in research involving receipt of investigational products (drug/biologic/device) within 90 days prior to study vaccination (Day 0).
- Received influenza vaccination within 14 days prior to study vaccination, or any other vaccine within 30 days prior to study vaccination.
- Any known allergies to products contained in the investigational product.
- Any history of anaphylaxis to any prior vaccine.
- 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.
- Chronic administration (defined as \> 14 continuous days) of immunosuppressant, systemic glucocorti-coids, or other immune-modifying drugs within 90 days prior to study vaccination (Day 0).
- 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.
- Received any prohibited medication (see Section 7.4.1), immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to study vaccination (Day 0).
- Active cancer (malignancy) on chemotherapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo malign and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
- Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
- Suspected or known history of alcohol abuse or drug addiction within 2 years prior to study vaccination that, in the opinion of the investigator, might interfere with protocol compliance.
- 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 (includ-ing neurologic or psychiatric conditions likely to impair the quality of safety reporting).
- 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).
- Known history of myocarditis or pericarditis.
- Respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing).
- Temperature of \> 38°C within 24 hours of planned study vaccination (site measured or participant meas-ured).
- Blood pressure of ≥ 160/100 mmHg.
Key Trial Info
Start Date :
September 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2024
Estimated Enrollment :
660 Patients enrolled
Trial Details
Trial ID
NCT05975060
Start Date
September 7 2023
End Date
May 20 2024
Last Update
May 30 2024
Active Locations (30)
Enter a location and click search to find clinical trials sorted by distance.
1
AMR
Mobile, Alabama, United States, 36608
2
Benchmark Research
Sacramento, California, United States, 95864
3
Lynn Institute of the Rockies
Colorado Springs, Colorado, United States, 80918
4
AMR LLC-Miami
Coral Gables, Florida, United States, 33134