60 Participants Needed

NVX-CoV2705 Vaccine for COVID-19

(COVID-19 Trial)

Recruiting at 1 trial location
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial

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.12345

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.13567

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.12389

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.
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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
1Treatment groups
Experimental Treatment
Group I: NVX-CoV2705 vaccine (5 µg )Experimental Treatment1 Intervention
NVX-CoV2705 COVID-19 vaccine will contain rS antigen from the JN.1 subvariant of SARS-CoV-2

Find a Clinic Near You

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

References

The Novavax vaccine had 90% efficacy against COVID-19 ≥7 d after the second dose. [2021]
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]
NVX-CoV2373-induced cellular and humoral immunity towards parental SARS-CoV-2 and VOCs compared to BNT162b2 and mRNA-1273-regimens. [2022]
Immunogenicity and safety of NVX-CoV2373 as a booster: A phase 3 randomized clinical trial in adults. [2023]
Safety of the NVX-CoV2373 COVID-19 vaccine in randomized placebo-controlled clinical trials. [2023]
Safety and Efficacy of NVX-CoV2373 Covid-19 Vaccine. [2023]
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]
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico. [2023]
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]
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