Combination Vaccine for COVID-19 and Flu

Recruiting at14 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Sanofi

Must not be taking: Immunosuppressants, Anticoagulants

Disqualifiers: Immunodeficiency, Bleeding disorder, Stroke, others

Stay on Your Current Meds

No Placebo Group

Trial Summary

What is the purpose of this trial?

Study VBT00002 is planned to be a Phase 1/2, randomized, modified double-blind, active-controlled, multi-center study to be conducted in approximately 980 adults aged 50 years and older in the United States. The purpose of the study is to assess the safety and immunogenicity of recombinant influenza vaccine (RIV) + adjuvanted recombinant COVID-19 vaccine (rC19) vaccine comprised of RIV combined with different recombinant Spike (rS) antigen levels of rC19 compared to RIV alone, rC19 (dose 1) alone, and RIV and rC19 (dose 1) (coadministered in opposite arms). Placebo will be coadministered in the RIV alone, rC19 (dose 1) alone, and RIV + rC19 study groups to control for the number of injections and to maintain observer blinding. Thus, each participant will receive two injections at enrollment, one in each deltoid muscle. Study details include: * The study duration will be approximately 12 months * Study intervention will be administered via a single intramuscular (IM) injection into the right and left deltoid muscles on Day(D) 01 * Dose escalation with sequential enrollment (sentinel cohort followed by main cohort for a given dose) * The visit frequency for participants will be D01 and D30, and D09-D366 (telephone call) Number of Participants: Approximately 980 participants are expected to be randomized.

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 immunosuppressive therapy or long-term systemic corticosteroids, you may not be eligible to participate.

What data supports the effectiveness of the combination vaccine for COVID-19 and flu?

The Novavax COVID-19 vaccine, known as Nuvaxovid, has shown high effectiveness rates of 89.7-90.4% in preventing COVID-19 and has been found to boost immune responses against various virus strains, including new variants, without increasing side effects. ^{1 2 3 4 5}

Is the combination vaccine for COVID-19 and flu safe for humans?

The NVX-CoV2373 vaccine, also known as Nuvaxovid or the Novavax COVID-19 Vaccine, has been shown to be safe in humans based on several clinical trials. Common side effects include tenderness and pain at the injection site, fatigue, muscle pain, headache, and nausea, but these were generally mild and not severe. ^{2 3 4 5 6}

How is the combination vaccine for COVID-19 and flu different from other treatments?

The combination vaccine uses the Novavax COVID-19 vaccine, which is unique because it is a protein-based vaccine that includes a special ingredient called an adjuvant to boost the immune response. This vaccine is stable at regular refrigerator temperatures, making it easier to store and distribute compared to some other COVID-19 vaccines. ^{1 2 4 7 8}

Research Team

Eligibility Criteria

This trial is for adults aged 50 or older in the U.S. who can get shots in both arms, have completed their initial COVID-19 vaccine series plus a booster, and are either not able to have children or agree to use contraception. They should be healthy or with stable pre-existing conditions.

Inclusion Criteria

Informed consent form has been signed and dated

I am 50 years old or older.

I am not pregnant or breastfeeding and follow specific birth control guidelines.

Exclusion Criteria

I haven't had recent vaccines or received immune globulins/blood products.

Known systemic hypersensitivity to study intervention components or history of life-threatening reactions to study interventions

I have a weak immune system due to a condition or treatment.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two intramuscular injections on Day 01, one in each deltoid muscle, with dose escalation and sequential enrollment

1 day

1 visit (in-person) on Day 01

Follow-up

Participants are monitored for safety and immunogenicity, with visits on Day 30 and telephone follow-ups from Day 09 to Day 366

12 months

1 visit (in-person) on Day 30, multiple telephone calls from Day 09 to Day 366

Long-term follow-up

Participants are monitored for adverse events and immunogenicity up to 12 months following the last study vaccination

12 months

Treatment Details

Interventions

• rC19 (dose 1) (Cancer Vaccine)
• RIV + rC19 (dose 1) (Cancer Vaccine)
• RIV + rC19 (dose 2) (Cancer Vaccine)
• RIV + rC19 (dose 3) (Cancer Vaccine)
• RIV + rC19 (dose 4) (Cancer Vaccine)

Trial Overview The study tests a combination vaccine of recombinant influenza (RIV) and different levels of adjuvanted recombinant COVID-19 (rC19) vaccines against RIV alone, rC19 alone, and placebo. Participants will receive two injections on Day 1 and follow-ups over approximately one year.

Participant Groups

Group I: Group 7: RIV + rC19 (dose 4) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group II: Group 6: RIV + rC19 (dose 3) (in right or left deltoid) and placebo Experimental Treatment 2 Interventions

two IM injections on D01

Group III: Group 5: RIV + rC19 (dose 2) (in right or left deltoid) and placebo Experimental Treatment 2 Interventions

two IM injections on D01

Group IV: Group 4: RIV + rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group V: Group 3: RIV (in right or left deltoid) and rC19 (dose 1) (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group VI: Group 2: rC19 (dose 1) (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

Group VII: Group 1: RIV (in right or left deltoid) and placebo (in opposite deltoid) Experimental Treatment 2 Interventions

two IM injections on D01

rC19 (dose 1) is already approved in Canada, Japan for the following indications:

Approved in Canada as Nuvaxovid for:

• Prevention of COVID-19

Approved in Japan as Nuvaxovid for:

• Prevention of COVID-19

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

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

Findings from Research

The Nuvaxovid™ vaccine, which uses a recombinant spike protein nanoparticle combined with the Matrix-M adjuvant, has been authorized for use in the EU and Great Britain, highlighting its safety and efficacy in generating immune responses against SARS-CoV-2.

This vaccine is notable for its stability, with a shelf life of 9 months at standard refrigeration temperatures, making it easier to distribute and store compared to some other COVID-19 vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants. Parums, DV.[2022]

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]

OVX836, a recombinant influenza vaccine, demonstrated a favorable safety profile up to a dose of 480 μg, with mild local and systemic reactions, indicating it is well tolerated by healthy adults.

The vaccine elicited significant dose-dependent immune responses, including increased nucleoprotein-specific CD4 and CD8 T-cell responses, suggesting it may provide effective protection against influenza A and warrants further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial. Leroux-Roels, I., Willems, P., Waerlop, G., et al.[2023]

The substudy involving 431 participants demonstrated that co-administering the COVID-19 vaccine NVX-CoV2373 with seasonal influenza vaccines was generally safe, with no serious adverse events or anaphylaxis reported, although reactogenicity (like tenderness and fatigue) was higher in the co-vaccination group.

The efficacy of NVX-CoV2373 in the substudy was 87.5%, which is comparable to the main study's efficacy of 89.8%, indicating that co-administration does not significantly compromise the effectiveness of the COVID-19 vaccine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. Toback, S., Galiza, E., Cosgrove, C., et al.[2022]

References

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

Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Immunogenicity and safety of a fourth homologous dose of NVX-CoV2373. [2023]

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

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

5. Singapore pubmed.ncbi.nlm.nih.gov

Immunogenicity and safety of heterologous booster with protein-based COVID-19 vaccine (NVX-CoV2373) in healthy adults: A comparative analysis with mRNA vaccines. [2023]

6. 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]

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

Immunogenicity, safety, and preliminary efficacy evaluation of OVX836, a nucleoprotein-based universal influenza A vaccine candidate: a randomised, double-blind, placebo-controlled, phase 2a trial. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial. [2022]