NVX-CoV2705 Vaccine for COVID-19

(COVID-19 Trial)

No longer recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novavax

Must not be taking: Immunosuppressants, Glucocorticoids

Disqualifiers: Autoimmune, Immunodeficiency, Cancer, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates a new COVID-19 vaccine, NVX-CoV2705, to determine its safety and ability to trigger an immune response in individuals already vaccinated. Researchers will compare its effects to those of a previously studied vaccine. The trial seeks adults who have received at least three doses of any COVID-19 vaccine, with the last dose administered at least six months ago. This opportunity may suit individuals interested in contributing to COVID-19 research and meeting the vaccination criteria. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially pivotal moment in vaccine development.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on immunosuppressants or certain immune-modifying drugs, you may need to stop them 90 days before joining the study.

Is there any evidence suggesting that the NVX-CoV2705 vaccine is likely to be safe for humans?

Research shows that the Novavax COVID-19 vaccine is generally well-tolerated, often causing mild side effects like arm pain or fatigue. Some studies suggest a small risk of heart inflammation (myocarditis and pericarditis) after vaccination. These cases are rare but important to consider.

The vaccine has already been approved for preventing COVID-19, having passed thorough safety checks. This new trial tests a slightly different version of the vaccine, based on the same foundation. Overall, past research suggests the vaccine is mostly safe, though some risks exist. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The NVX-CoV2705 vaccine is unique because it targets the JN.1 subvariant of SARS-CoV-2, featuring a recombinant spike (rS) antigen specifically designed to address this variant. Unlike most current vaccines that were developed based on earlier strains of the virus, NVX-CoV2705 offers a tailored approach to the evolving virus landscape. Researchers are excited about this treatment because it could potentially provide more effective protection against newer variants, enhancing our ability to manage and control COVID-19's spread in the community.

What evidence suggests that the NVX-CoV2705 vaccine might be an effective treatment for COVID-19?

Research has shown that the Novavax COVID-19 vaccine, similar to the NVX-CoV2705 vaccine studied in this trial, effectively prevents COVID-19. Studies have found that it triggers a strong immune response in people of various ages and backgrounds. The closely related Nuvaxovid vaccine has been approved for use and proven safe and effective. This suggests that the NVX-CoV2705 vaccine, which participants in this trial will receive, might also work well against the JN.1 subvariant of the virus. Overall, the available data provides confidence in its potential effectiveness. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 who have had at least 3 doses of an approved COVID-19 vaccine, with the last dose given more than 6 months ago. They must be medically stable and not involved in other research that could affect results. Women able to have children must avoid pregnancy or use contraception during the study.

Inclusion Criteria

I agree not to join other research studies involving new treatments or devices while in this study.

I am willing and able to follow the study's procedures.

I've had 3 or more COVID-19 vaccine doses, with the last one over 6 months ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of the NVX CoV2705 vaccine on Day 0

1 day

1 visit (in-person)

Immunogenicity Monitoring

Participants are monitored for immunogenicity until Day 28

4 weeks

1 visit (in-person) at Day 28

Safety Follow-up

Participants are monitored for safety data collection up to 180 days post-vaccination

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NVX-CoV2705 Vaccine

Trial Overview The trial is testing NVX-CoV2705, a new Novavax vaccine targeting a SARS-CoV-2 subvariant, for safety and immune response in adults previously vaccinated with NVX-CoV2601 or another authorized COVID-19 vaccine.

How Is the Trial Designed?

Group I: NVX-CoV2705 vaccine (5 µg ) Experimental Treatment 1 Intervention

NVX-CoV2705 COVID-19 vaccine will contain rS antigen from the JN.1 subvariant of SARS-CoV-2

Who Is Running the Clinical Trial?

Novavax

Lead Sponsor

Trials

51

Recruited

111,000+

Published Research Related to This Trial

The NVX-CoV2373 COVID-19 vaccine induces a strong CD4+ T-cell response, particularly after two doses, with a significant majority (93.5%) of recipients showing interferon-γ responses, indicating robust immune activation.

This vaccine elicits a Th1-biased immune response that is cross-reactive to various SARS-CoV-2 variants, including Omicron, suggesting it may provide broad protection against different strains of the virus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strong CD4+ T-Cell Responses to Ancestral and Variant Spike Proteins Are Established by NVX-CoV2373 Severe Acute Respiratory Syndrome Coronavirus 2 Primary Vaccination. Fries, L., Formica, N., Mallory, RM., et al.[2023]

The NVX-CoV2373 vaccine, evaluated in over 31,000 participants across five clinical studies, demonstrated high efficacy against COVID-19 and a well-tolerated safety profile, with common side effects including injection site pain and fatigue.

A booster dose administered six months after the initial two doses significantly increased antibody levels against COVID-19 variants, reinforcing the vaccine's effectiveness and supporting its use in both primary and booster vaccination regimens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brighton Collaboration standardized template with key considerations for a benefit/risk assessment for the Novavax COVID-19 Vaccine (NVX-CoV2373), a recombinant spike protein vaccine with Matrix-M adjuvant to prevent disease caused by SARS-CoV-2 viruses. Wilkinson, B., Patel, KS., Smith, K., et al.[2023]

The NVX-CoV2373 Covid-19 vaccine demonstrated a strong safety profile and was effective in preventing Covid-19 infection, as shown in a clinical trial with a significant number of participants.

The study provided evidence that the vaccine elicited a robust immune response, contributing to its efficacy in reducing the incidence of Covid-19 among vaccinated individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Novavax vaccine had 90% efficacy against COVID-19 ≥7 d after the second dose. Sacks, HS.[2021]

The NVX-CoV2373 COVID-19 vaccine demonstrated high efficacy rates of 89.7-90.4% in clinical trials, indicating it is effective in preventing COVID-19 in adults aged 18 and older.

The vaccine has an acceptable safety profile, with most adverse reactions being mild to moderate, and serious adverse events occurring at similar low rates in both NVX-CoV2373 and placebo groups, suggesting it is safe for use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. Smith, K., Hegazy, K., Cai, MR., et al.[2023]

In a phase 3 trial with 15,187 participants, the NVX-CoV2373 vaccine demonstrated an impressive efficacy of 89.7% in preventing SARS-CoV-2 infections, with no hospitalizations or deaths reported in the vaccinated group.

The vaccine showed high efficacy against the B.1.1.7 (alpha) variant at 86.3% and an even higher efficacy of 96.4% against non-B.1.1.7 variants, while side effects were generally mild and similar to those in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. Heath, PT., Galiza, EP., Baxter, DN., et al.[2023]

Citations

1. ema.europa.eu ema.europa.eu/en/medicines/human/EPAR/nuvaxovid

Nuvaxovid | European Medicines Agency (EMA) Taken together, the results of the two studies show that Nuvaxovid was effective at preventing COVID-19 in both adults and adolescents. The original strain of ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0264410X2500074X

Efficacy, immunogenicity, and safety of the Novavax COVID ... Overall, the Novavax COVID-19 vaccine was immunogenic and had a tolerable safety profile across diverse populations of IIC; some outcomes varied ...

3. ir.novavax.com ir.novavax.com/press-releases/2025-08-27-Novavaxs-Nuvaxovid-TM-2025-2026-Formula-COVID-19-Vaccine-Approved-in-the-U-S

Novavax's Nuvaxovid™ 2025-2026 Formula COVID-19 ... Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19. Both clinical and ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06409663

NCT06409663 | A Strain Change Study for SARS-CoV-2 rS ... 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 ...

5. pro.campus.sanofi pro.campus.sanofi/us/products/nuvaxovid/efficacy

Clinical Trial Results and Study Designs | NUVAXOVID™ Explore the efficacy of NUVAXOVID™ (COVID-19 Vaccine, Adjuvanted) for individuals 65+ and those 12-64 with an underlying condition that puts them at high ...

6. dailymed.nlm.nih.gov dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a20513c-d255-46d7-8e6b-294cec4b44f4

DailyMed - NUVAXOVID COVID-19 VACCINE, ADJUVANTED Clinical trials data provide evidence for increased risks of myocarditis and pericarditis following administration of NUVAXOVID. There have been postmarketing ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06409663

A Strain Change Study for SARS-CoV-2 rS Vaccines 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 ...

8. ir.novavax.com ir.novavax.com/press-releases/2025-05-19-U-S-FDA-Approves-BLA-for-Novavaxs-COVID-19-Vaccine

U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine The BLA approval was based on pivotal Phase 3 clinical trial data that showed Nuvaxovid was safe and effective for the prevention of COVID-19.