mRNA Vaccine for Flu

Not currently recruiting at 12 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Immunosuppressants, Corticosteroids, Anticoagulants, others

Disqualifiers: Immunodeficiency, Myocarditis, Guillain-Barré, others

Compensation: Varies

Number of Visits: 9

Duration: 3 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mRNA vaccine designed to protect against a specific type of flu that could cause a pandemic. Researchers aim to determine the vaccine's safety and its effectiveness in helping the body fight the virus. Different vaccine doses will be tested to identify the most effective one. Generally healthy individuals who have not recently received flu shots or other vaccines might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new vaccine, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the pandemic flu H5 HA mRNA SD2 vaccine has been tested in other studies, focusing on its safety. In one study with 507 participants who received the vaccine, about 20.3% experienced side effects. However, these side effects were usually mild and not serious. Other research on similar mRNA vaccines found no serious health problems or deaths related to the vaccine over six months. This suggests that while some side effects might occur, they are generally not serious.

The vaccine tested in this trial is a second-generation mRNA vaccine, improved from earlier versions to enhance safety and efficacy. The current trial aims to determine the best dose for future use, ensuring minimal side effects while effectively protecting against the flu. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment?

Researchers are excited about the pandemic flu H5 HA mRNA SD2 vaccine because it represents a novel approach to flu prevention by using mRNA technology. Unlike traditional flu vaccines, which typically use inactivated viruses or viral proteins, this vaccine uses mRNA to instruct cells to produce a piece of the virus, prompting an immune response. This method not only speeds up vaccine production but also allows for rapid updates in response to new viral strains. With multiple dosing groups—low, medium, and high—researchers aim to optimize efficacy and safety, potentially leading to a more versatile and quicker-to-develop flu vaccine.

What evidence suggests that this trial's mRNA vaccine treatments could be effective for pandemic flu?

Studies have shown that mRNA vaccines can trigger a strong immune response against flu viruses. Research indicates that mRNA vaccines, such as the Pandemic flu H5 HA mRNA SD2 vaccine tested in this trial, have been effective against various types of influenza A. Early results suggest these vaccines might offer better protection than some current flu vaccines. Although data on the H5 strain remains limited, the mechanism of mRNA vaccines has shown promise in similar cases. This type of vaccine helps the body learn to recognize and fight the virus effectively. Participants in this trial will receive different doses of the vaccine or a placebo to evaluate its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults aged 18 and older who can't get pregnant or agree to use contraception. Women of childbearing potential must test negative for pregnancy. It's not suitable for those unable to follow the study schedule.

Inclusion Criteria

I agree to use effective birth control or abstain from sex starting 4 weeks before until 12 weeks after the last treatment.

I am a woman who can have children and have tested negative for pregnancy recently.

I am not able to have children because I am postmenopausal or have been surgically sterilized.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive two injections of placebo or pandemic flu H5 mRNA vaccine 21 days apart at high, medium, and low doses

3 weeks

2 visits (in-person)

Short-term Follow-up

Short-term follow-up visits occur 8 and 21 days after each injection to monitor safety and immunogenicity

6 weeks

4 visits (in-person)

Long-term Follow-up

Participants are followed up at 3, 6, and 12 months after the second injection for safety and immunogenicity

12 months

3 visits (in-person), 1 call (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Pandemic flu H5 HA mRNA SD2 vaccine

Trial Overview The trial tests a new mRNA vaccine against pandemic flu H5 strain at three different doses. Participants will receive two shots, 21 days apart, and be monitored over approximately 13 months with visits and blood samples.

How Is the Trial Designed?

Group I: Group 3: Pandemic flu H5 HA mRNA SD2 vaccine (High dose) Experimental Treatment 1 Intervention

Participants will receive two injections of high dose pandemic flu H5 HA mRNA SD2 vaccine

Group II: Group 2: Pandemic flu H5 HA mRNA SD2 vaccine (Medium dose) Experimental Treatment 1 Intervention

Participants will receive two injections of medium dose pandemic flu H5 HA mRNA SD2 vaccine

Group III: Group 1: Pandemic flu H5 HA mRNA SD2 vaccine (Low dose) Experimental Treatment 1 Intervention

Participants will receive two injections of low dose pandemic flu H5 HA mRNA SD2 vaccine

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive two injections of placebo

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

Published Research Related to This Trial

In a study of 507 vaccinated individuals, 20.3% experienced complications after receiving pandemic influenza vaccines, indicating that adverse events were more common than reported in spontaneous reporting systems.

The spontaneous reporting rate of adverse events was significantly lower (322-fold) than the rates identified through systematic follow-up, suggesting that formal observation studies may provide a more accurate assessment of vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events associated with pandemic influenza vaccines: comparison of the results of a follow-up study with those coming from spontaneous reporting. Carvajal, A., Ortega, PG., Sáinz, M., et al.[2010]

A quadrivalent mRNA vaccine targeting four seasonal influenza virus strains was shown to induce strong antibody responses in mice, with effective protection against illness even at low doses (as low as 1 μg per antigen).

The mRNA vaccine demonstrated the ability to prevent weight loss and protect against morbidity and mortality from influenza, highlighting its potential as a promising alternative to traditional influenza vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seasonal quadrivalent mRNA vaccine prevents and mitigates influenza infection. Kackos, CM., DeBeauchamp, J., Davitt, CJH., et al.[2023]

mRNA vaccines for influenza have been shown to induce strong and long-lasting immunity in both very young and very old mice, demonstrating their potential effectiveness across age groups.

These vaccines not only provide protection against influenza A virus but also target multiple viral antigens, suggesting they could serve as cross-protective vaccines, similar in efficacy to licensed vaccines in larger animals like pigs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protective efficacy of in vitro synthesized, specific mRNA vaccines against influenza A virus infection. Petsch, B., Schnee, M., Vogel, AB., et al.[2021]

In a retrospective study of 66 individuals who received the H1N1 vaccine during a 2010 mass vaccination campaign in São Paulo, the most common adverse events reported were mild symptoms such as fever, headache, myalgia, and injection site pain.

Importantly, no serious adverse events were reported, indicating that the H1N1 vaccine was generally safe for those vaccinated at this center.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spontaneous reporting of adverse events following pandemic influenza A (H1N1) immunization in a reference center in the State of São Paulo, Brazil. Oliveira, DS., Lara, AN., Luiz, AM., et al.[2022]

Citations

1. withpower.com withpower.com/trial/phase-2-pandemic-influenza-immunization-3-2025-4866c

mRNA Vaccine for Flu · Info for Participants In a study of 507 vaccinated individuals, 20.3% experienced complications after receiving pandemic influenza vaccines, indicating that adverse events were more ...

2. guidelinecentral.com guidelinecentral.com/clinical-trial/?id=NCT06907511

Study Details Group 2: Pandemic flu H5 HA mRNA SD2 vaccine (Medium dose): Participants will receive two injections of medium dose pandemic flu H5 HA mRNA SD2 vaccine.

3. cidrap.umn.edu cidrap.umn.edu/influenza-vaccines/moderna-announces-promising-efficacy-results-mrna-flu-vaccine-trial

Moderna announces promising efficacy results from mRNA ... In a press release, the company said its candidate flu vaccine, called mRNA 1010, showed superior results, with an rVE of 26.6% in the overall ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11970786/

An mRNA-based seasonal influenza vaccine in adults The efficacy profile of mRNA-1010 was generally reflective of immunogenicity findings, with higher immune responses against influenza A strains ...

5. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/es/listing/313019/study-to-evaluate-safety-2/

Study on mRNA Vaccine for Pandemic Flu This study investigates a vaccine for the H5 strain of pandemic flu, which is a type of influenza virus. The purpose is to find the right ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12216828/

Immunogenicity and safety of mRNA-based seasonal ... Through 6 months, no deaths or serious adverse events were related to vaccination with mRNA-1020 or mRNA-1030 at any dose. These findings ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800082029

Pandemic flu H5 HA mRNA SD2 vaccine - Sanofi - AdisInsight The Pandemic flu H5 hemagglutinin (HA) mRNA SD2 vaccine is a second-generation, structurally designed (SD2) mRNA vaccine being developed by ...

8. trial.medpath.com trial.medpath.com/clinical-trial/e2c569a6bfc83ee7/nct06907511-h5-ha-mrna-vaccine-safety-immunogenicity

Study to Evaluate the Safety and the Immunogenicity of a ... Study to evaluate the safety and the immunogenicity of a second generation structurally designed mRNA vaccine candidate against pandemic influenza H5 HA strain.