Severe Acute Respiratory Syndrome Coronavirus 2 InfectionPhase 3COVID-19NCT06409663
A Strain Change Study for SARS-CoV-2 rS Vaccines
A Phase 3 study testing NVX-CoV2705 Vaccine in people with Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by Novavax at 2 sites in United States.
Trial summary
The present study aims to investigate the safety and immunogenicity of the Novavax JN.1 subvariant vaccine SARS-CoV-2 rS adjuvanted with Matrix-M (NVX CoV2705) in previously vaccinated adults. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Severe Acute Respiratory Syndrome Coronavirus 2 Infection
- What is being tested?
- NVX-CoV2705 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2024to 17 Apr 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥ 18 years of age at time of study vaccination.
- Previously vaccinated with ≥ 3 doses of an authorized/approved COVID-19 vaccine with the last dose administered ≥ 6 months prior to study vaccination.
- 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 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.
- Condoms (male or female) with spermicide (if acceptable in country)
- Diaphragm with spermicide
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- 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
- 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. Blood pressure must be ≤ 160/100 mmHg; any participant who is otherwise eligible with a blood pressure of ≥ 160/100 mmHg may be retested onsite several times over a 3-hour interval to achieve a lower blood pressure.
- 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.
Who cannot join
- Current participation in research involving receipt of investigational products (drug/biologic/device).
- Received any other vaccine within 28 days prior to study vaccination or plans to receive any other vac-cine within 28 days after study vaccination. Influenza vaccines can be administered up to 14 days before study vaccination.
- Any known history of allergies to products contained in the investigational product in the participant's lifetime.
- Any known history of anaphylaxis to any prior vaccine in the participant's lifetime.
- Known history of myocarditis or pericarditis in the participant's lifetime.
- 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.
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- Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) that requires the use of immune modulators.
- 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). Persons with human immunodeficiency virus are excluded
- Received any prohibited medication, 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 maligna 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.
- 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).
- 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).
- Temperature of > 38°C (oral measurement) or respiratory symptoms in the past 3 days (ie, cough, sore throat, difficulty breathing) leading up to Day 0.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Benchmark Research
Austin, Texas, 78705
Foothills Research Center - CCT Research
Phoenix, Arizona, 85044
About this study
Official title: A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of a JN.1 Subvariant SARS CoV-2 rS Vaccine
The present study aims to investigate the safety and immunogenicity of the Novavax JN.1 subvariant vaccine SARS-CoV-2 rS adjuvanted with Matrix-M (NVX CoV2705) in previously vaccinated adults. A descriptive comparison will be made with participants who received the prior authorized vaccine NVX-CoV2601 in an earlier study (2019nCoV-313).
Read the detailed description
This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of a 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 previously vaccinated adults.
Approximately 60 participants 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 up to 180 days post-vaccination.
- Being tested
- NVX-CoV2705 Vaccine
- Keywords
- coronavirus 2 (SARS-CoV-2)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NVX-CoV2705 VaccineBiological
Also called SARS-CoV-2 rS
All injections will be administered in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant at each injection.
| Study group | Role | What they receive |
|---|---|---|
| NVX-CoV2705 vaccine (5 µg ) | Experimental | NVX-CoV2705 COVID-19 vaccine will contain rS antigen from the JN.1 subvariant of SARS-CoV-2 Receives: Biological: NVX-CoV2705 Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence, duration, and severity of solicited local and systemic adverse events (AEs)
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
Measured: Day 7[ following 1st vaccination]
Incidence, severity, and relationship of any unsolicited AEs
Incidence, severity, and relationship of any unsolicited AEs through 28 days after vaccination.
Measured: Day 28
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs)
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs) through day 180 or end of study (EoS).
Measured: Day 180 or end of study (EoS).
Secondary outcomes (6)
Pseudovirus neutralization titers for the JN.1 subvariant expressed as GMTs
Pseudo virus neutralization antibody responses induced by NVX CoV2705 for the JN.1 subvariant at Day 28 following study vaccination.
Measured: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as GMFR
Pseudovirus neutralization antibody responses of ID50 titers for the JN.1 subvariant of time points (Day 28) from Baseline
Measured: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as SRRs
Pseudovirus neutralization antibody responses of ID50 titers for the JN.1 subvariant of time points (Day 28) from Baseline
Measured: Day 28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as (GMEU)
immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Measured: Day-0 (baseline) to Day 28.
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as GMFR
immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Measured: Frame: Day 0 and Day-28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as SRRs
Immunoglobulin G (IgG) antibody responses for the JN.1 subvariant at relevant time points (Days 0 and 28).
Measured: Frame: Day 0 and Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2024
- Study start14 Oct 2024
- Primary completion15 Oct 2024
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Acute Respiratory Syndrome Coronavirus 2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06409663
- Sponsor's protocol ID
- 2019nCoV-315
- Acronym
- COVID-19
- Status last verified
- Jul 2025
- First submitted
- 8 May 2024
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Alves K, Kouassi A, Nelson J, Plested JS, Kalkeri R, Zhu M, Cloney-Clark S, Cai Z, Ahmed A, McKnight I, Mallory RM, Noriega F. Safety and immunogenicity of a single dose of a JN.1 variant COVID-19 vaccine in previously vaccinated adults: Primary analysis report of a phase 3 open-label trial. Vaccine. 2026 Feb 15;73:128164. doi: 10.1016/j.vaccine.2025.128164. Epub 2025 Dec 26.
PubMed 41455184
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open-Label, Single-Arm Study to Evaluate the Safety and Immunogenicity of a JN.1 Subvariant SARS CoV-2 rS Vaccine
- ClinicalTrials.gov ID
- NCT06409663
- Acronym / sponsor ID
- COVID-19 / 2019nCoV-315
- Keywords
- coronavirus 2 (SARS-CoV-2)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 10 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study aims to investigate the safety and immunogenicity of the Novavax JN.1 subvariant vaccine SARS-CoV-2 rS adjuvanted with Matrix-M (NVX CoV2705) in previously vaccinated adults. A descriptive comparison will be made with participants who received the prior authorized vaccine NVX-CoV2601 in an earlier study (2019nCoV-313).
Detailed description
This is a Phase 3, open-label, single arm study to evaluate the safety and immunogenicity of a single dose of a 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 previously vaccinated adults.
Approximately 60 participants 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 up to 180 days post-vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NVX-CoV2705 vaccine (5 µg ) | Experimental | Biological: NVX-CoV2705 VaccineNVX-CoV2705 COVID-19 vaccine will contain rS antigen from the JN.1 subvariant of SARS-CoV-2 |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adults ≥ 18 years of age at time of study vaccination.
- Previously vaccinated with ≥ 3 doses of an authorized/approved COVID-19 vaccine with the last dose administered ≥ 6 months prior to study vaccination.
- 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 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.
- 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. Blood pressure must be ≤ 160/100 mmHg; any participant who is otherwise eligible with a blood pressure of ≥ 160/100 mmHg may be retested onsite several times over a 3-hour interval to achieve a lower blood pressure.
Key exclusion criteria (14 listed)
- Current participation in research involving receipt of investigational products (drug/biologic/device).
- Received any other vaccine within 28 days prior to study vaccination or plans to receive any other vac-cine within 28 days after study vaccination. Influenza vaccines can be administered up to 14 days before study vaccination.
- Any known history of allergies to products contained in the investigational product in the participant's lifetime.
- Any known history of anaphylaxis to any prior vaccine in the participant's lifetime.
- Known history of myocarditis or pericarditis in the participant's lifetime.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NVX-CoV2705 VaccineAlso: SARS-CoV-2 rSAll injections will be administered in a 0.5 mL injection volume at an antigenic dose of 5 µg with 50 µg Matrix-M adjuvant at each injection. | Biological | NVX-CoV2705 vaccine (5 µg ) |
Primary outcome
Incidence, duration, and severity of solicited local and systemic adverse events (AEs)
Time frame: Day 7[ following 1st vaccination]
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) for 7 days following vaccination.
Incidence, severity, and relationship of any unsolicited AEs
Time frame: Day 28
Incidence, severity, and relationship of any unsolicited AEs through 28 days after vaccination.
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs)
Time frame: Day 180 or end of study (EoS).
Incidence and severity of treatment-related MAAEs, adverse events of special interest and serious adverse events interest (AESIs; predefined list, including PIMMCs, myocarditis and/or pericarditis), and serious adverse events (SAEs) through day 180 or end of study (EoS).
6 secondary outcomes
Pseudovirus neutralization titers for the JN.1 subvariant expressed as GMTs
Time frame: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as GMFR
Time frame: Day 0 to Day 28
Pseudovirus neutralization antibody responses against the JN.1 subvariant Expressed as SRRs
Time frame: Day 28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as (GMEU)
Time frame: Day-0 (baseline) to Day 28.
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as GMFR
Time frame: Frame: Day 0 and Day-28
Anti-S IgG antibody responses for the JN.1 subvariant Expressed as SRRs
Time frame: Frame: Day 0 and Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Derived from this study: PubMed 41455184Alves K, Kouassi A, Nelson J, Plested JS, Kalkeri R, Zhu M, Cloney-Clark S, Cai Z, Ahmed A, McKnight I, Mallory RM, Noriega F. Safety and immunogenicity of a single dose of a JN.1 variant COVID-19 vaccine in previously vaccinated adults: Primary analysis report of a phase 3 open-label trial. Vaccine. 2026 Feb 15;73:128164. doi: 10.1016/j.vaccine.2025.128164. Epub 2025 Dec 26.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing NVX-CoV2705 Vaccine in people with Severe Acute Respiratory Syndrome Coronavirus 2 Infection, run by Novavax at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence, duration, and severity of solicited local and systemic adverse events (AEs) (time frame: Day 7[ following 1st vaccination]). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06409663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.