COVID-19 Vaccine for Coronavirus

(COVID-19 Trial)

Not currently recruiting at 98 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and safety of a new single-dose COVID-19 vaccine, NVX-CoV2705, for adults. Participants will receive either the actual vaccine or a placebo (a harmless substance resembling the vaccine) to compare outcomes. The trial targets generally healthy individuals aged 50 to under 65 who are either unvaccinated or vaccinated at least 90 days prior. It suits those interested in contributing to COVID-19 research and who meet these basic criteria. Researchers will monitor participants for 180 days to gather comprehensive results. As a Phase 4 trial, this research helps to understand how the already FDA-approved and effective vaccine benefits more patients.

Do I have to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are taking immunosuppressants or systemic glucocorticoids for more than 14 days, you may not be eligible to participate.

What is the safety track record for the NVX-CoV2705 vaccine?

Research has shown that the NVX-CoV2705 COVID-19 vaccine is generally safe. Studies have found that most people tolerate it well, with common side effects being mild, such as a sore arm or slight fatigue. Serious side effects have been rare in trials. The vaccine triggers a strong immune response against the Omicron variant of COVID-19, suggesting it works effectively. As this is a Phase 4 trial, the vaccine has already received approval for use, indicating it has passed earlier safety tests.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about NVX-CoV2705 because it offers a new approach to COVID-19 vaccination. Unlike many existing vaccines that use mRNA technology, NVX-CoV2705 is a protein-based vaccine, which could appeal to individuals seeking alternatives to mRNA vaccines like Pfizer-BioNTech and Moderna. This treatment involves a single intramuscular injection, potentially simplifying the vaccination process and improving compliance. Additionally, protein-based vaccines have a long history of use in other diseases, which might reassure those concerned about newer vaccine technologies.

What is the effectiveness track record for the NVX-CoV2705 COVID-19 vaccine?

Research has shown that the NVX-CoV2705 COVID-19 vaccine, which participants in this trial may receive, effectively prevents COVID-19. Studies have found it to be about 90% effective at preventing symptomatic infection. Data also suggest it offers strong protection against various virus variants. Real-world studies have confirmed its effectiveness, demonstrating that it helps prevent severe outcomes like hospitalizations. Overall, the NVX-CoV2705 vaccine has proven to be a reliable choice for COVID-19 prevention. Participants in this trial may also receive a placebo, which consists of a single intramuscular injection of normal saline.678910

Who Is on the Research Team?

CD

Clinical Development

Principal Investigator

Novavax, Inc.

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 50 to under 65 who are not at high risk for severe COVID-19. Participants can be unvaccinated or have had their last COVID-19 vaccine at least 90 days ago. Women of childbearing age must use birth control or avoid sex during the study.

Inclusion Criteria

I am using a long-term birth control method.
I am between 50 and 64 years old and not at high risk for severe COVID-19.
I have not been vaccinated for COVID-19 or my last COVID-19 vaccine was over 90 days ago.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single intramuscular injection of NVX-CoV2705 or placebo on Day 0

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

180 days
Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • NVX-CoV2705

Trial Overview

The study tests a single dose of the NVX-CoV2705 Omicron JN.1 COVID-19 vaccine versus a placebo in about 6,500 people, with participants randomly assigned to each group and followed for six months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: NVX-CoV2705Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novavax

Lead Sponsor

Trials
51
Recruited
111,000+

Sanofi

Industry Sponsor

Trials
2,246
Recruited
4,085,000+
Paul Hudson profile image

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico profile image

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

Comparing the COVID-19 Vaccines: How Are They Different?

It's important to keep up with how well the updated vaccines are performing. We mapped out a comparison of the COVID vaccines in the United States.

Vaccine Effectiveness | COVID-19

Assessing real-world COVID-19 vaccine effectiveness in key populations and against key outcomes. Providing timely data to evaluate effectiveness ...

Real-world effectiveness of COVID-19 vaccines - PMC - NIH

Objective. To estimate the coronavirus disease 2019 (COVID-19) vaccine effectiveness (VE) against concerned outcomes in real-world settings.

What doctors wish patients knew about the Novavax ...

“The study data submitted to FDA says, overall, it was about 90% effective at preventing COVID,” said Dr. Fryhofer. “However, it did not seem to ...

Comparing the differences between COVID-19 vaccines

Find out how the COVID-19 vaccines work, how many doses are needed, possible side effects and who shouldn't get the vaccine.

Safety and immunogenicity of a single dose of a JN.1 ...

NVX-CoV2705 was well tolerated, with an acceptable safety profile, following single dose administration. At the time of this report, the Novavax ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41455184/

Safety and immunogenicity of a single dose of a JN.1 ...

A single dose of NVX-CoV2705 induced a rapid and robust anti-SARS-CoV-2 immune response against the Omicron JN.1 and other circulating ...

Package Insert and Patient Package Insert - NUVAXOVID

COVID-19 Vaccine, Adjuvanted (2023-2024 Formula). 76. Safety data accrued in Studies 1, 5, 6, and 7 are relevant to NUVAXOVID because the vaccines. 77.

Press Release: ESCMID: Sanofi's Nuvaxovid COVID-19 ...

ESCMID: Sanofi's Nuvaxovid COVID-19 vaccine showed better tolerability than mNEXSPIKE in head-to-head study First head-to-head, double-blind ...

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

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 ...