NVX-CoV2705 Vaccine for COVID-19

(COVID-19 Trial)

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

60 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the NVX-CoV2705 Vaccine treatment for COVID-19?

The NVX-CoV2373 vaccine, similar to NVX-CoV2705, showed about 90% effectiveness in preventing COVID-19 after the second dose, and it also produced strong immune responses against different virus variants. ^{1 2 3 4 5}

Is the NVX-CoV2705 Vaccine safe for humans?

The NVX-CoV2373 vaccine, which is similar to NVX-CoV2705, has been shown to be safe in several studies with over 31,000 participants. Common side effects included tenderness and pain at the injection site, fatigue, muscle pain, headache, and nausea, but it was generally well-tolerated. ^{1 3 5 6 7}

How is the NVX-CoV2705 vaccine different from other COVID-19 treatments?

The NVX-CoV2705 vaccine is unique because it is a recombinant spike protein nanoparticle vaccine, which means it uses a piece of the virus's spike protein to stimulate an immune response. This is different from mRNA vaccines, which use genetic material to instruct cells to produce the spike protein. Additionally, it includes an adjuvant (a substance that enhances the body's immune response) called Matrix-M, which helps boost its effectiveness. ^{1 2 3 8 9}

What is the purpose of this trial?

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).

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. United States 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. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

NVX-CoV2373-induced cellular and humoral immunity towards parental SARS-CoV-2 and VOCs compared to BNT162b2 and mRNA-1273-regimens. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. [2023]

7. Netherlands 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trial. [2022]