Official Title
A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of an Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted With Matrix-M
Brief Summary

This study is a Phase 3 trial designed to check the safety and immune response to a newOmicron JN.1 COVID-19 vaccine. Study researchers will give a single dose of this vaccine,called NVX-CoV2705, to approximately 120 participants. This includes adults aged 65 andolder, and individuals aged 12 to 64 who have existing health conditions that put them athigh risk for severe COVID-19. All participants must have received a previous COVID-19vaccine at least 90 days before joining this study. Study researchers will be closelymonitoring participants for their immune response for 28 days and collecting safety datafor 180 days after vaccination.

Detailed Description

This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity
of a single dose of an Omicron JN.1 subvariant severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine
(SARS-CoV-2 rS) adjuvanted with Matrix-M® (NVX-CoV2705) in participants ≥ 65 years of age
and participants 12 through 64 years of age who have at least one underlying condition
that puts them at high risk for severe outcomes from coronavirus disease 2019 (COVID 19)
previously vaccinated with a COVID-19 vaccine ≥ 90 days prior to study vaccination. The
goal will be to enroll a similar number of participants in the 2 age cohorts (≥ 65 years
and 12 through 64 years) and in the 12 through 64 years age cohort, an effort will be
made to enroll a similar number of participants in the 2 age subcohorts (12 through 17
years and 18 through 64 years).

Approximately 120 participants, approximately 60 participants in each age cohort and
approximately 30 participants in each age subcohort, will be enrolled to receive a single
dose of NVX-CoV2705 on Day 0 and remain on study for immunogenicity until Day 28 and
safety data collection through 180 days post-vaccination.

Not yet recruiting
COVID-19
SARS-CoV-2 Infection

Biological: NVX-CoV2705

Intramuscular (deltoid) injection at an antigenic dose of 5 µg with 50 µg Matrix-M
adjuvant.
Other Name: Omicron JN.1 Subvariant SARS-CoV-2 rS Vaccine Adjuvanted with Matrix-M

Eligibility Criteria

Inclusion Criteria:

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

1. Participants ≥ 65 years of age and participants 12 through 64 years who have at
least one underlying condition that puts them at high risk of severe outcomes
from COVID-19 at time of study vaccination. In each instance, the
investigator's judgment may be exercised and other eligibility criteria must be
respected.

2. Previously vaccinated with a COVID-19 vaccine with the last dose administered ≥
90 days prior to study vaccination (written or verbal confirmation by
participant).

3. Participant and parent(s)/caregiver(s) or legally acceptable representative
willing and able to give informed consent and assent prior to study enrollment
and to comply with study procedures.

4. 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.

1. Condoms (male or female) with spermicide (if acceptable in country)

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, sympto-thermal, post-ovulation methods) and withdrawal are not
acceptable methods of contraception.

5. 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. Vital signs must be within medically acceptable ranges
prior to study vaccination. If the individual has a diagnosis of hypertension,
it must be stable and controlled with necessary medication.

6. Agrees not to 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.

Exclusion Criteria:

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

1. Current participation in research involving receipt of investigational products
(drug/biologic/device).

2. Received any other vaccine (except for a licensed seasonal influenza vaccine or
rabies vaccine [if medically indicated]) within 28 days prior to study
vaccination. For the influenza vaccine, a participant is eligible as long as
the vaccine was administered ≥ 14 days prior to study vaccination.

3. Any known history of allergies to products contained in the investigational
product in the participant's lifetime.

4. Any known history of anaphylaxis to any prior vaccine in the participant's
lifetime.

5. Known history of myocarditis or pericarditis in the participant's lifetime.

6. 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.

7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital)
that requires the use of immune modulators.

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

8. Chronic administration (defined as > 14 continuous days) of immunosuppressant,
systemic glucocorticoids, 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, inhaled or
intranasal glucocorticoids is permitted. Topical tacrolimus and ocular
cyclosporin are permitted.

9. Received any prohibited medication (see Section 7.3), immunoglobulin,
blood-derived products, or immunosuppressant drugs within 90 days prior to
study vaccination (Day 0).

10. Active cancer (malignancy) on chemotherapy within 3 years prior to 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).

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

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).

14. Temperature of > 38°C/≥ 100.4°F (oral measurement) or respiratory symptoms in
the past 3 days (ie, cough, sore throat, difficulty breathing) leading up to
Day 0.

Eligibility Gender
All
Eligibility Age
Minimum: 12 Years ~ Maximum: 90 Years
Locations

Not Provided

Not Provided

NCT Number
Keywords
Covid-19
MeSH Terms
COVID-19
Vaccines