mRNA Vaccines for Influenza

MD
Overseen ByMeagan Deming
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests new mRNA vaccines designed to protect against various strains of the influenza A virus. Researchers aim to determine if these vaccines are safe and elicit a strong immune response. Participants will receive one or two injections, depending on their study group. The trial seeks healthy adults who have maintained good health for at least the past two months and have not experienced major health issues recently. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial does not specifically require you to stop taking your current medications. However, if you are on medications that affect the immune system or have had recent changes in your prescription, it might affect your eligibility. It's best to discuss your specific medications with the trial team to ensure they don't pose any additional risks.

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

Studies have shown that the mRNA vaccines being tested for the flu are safe. Previous research on similar vaccines indicates they are well-tolerated by people. Recipients of these vaccines experienced mild side effects, such as temporary soreness at the injection site or a mild fever. No serious side effects were reported in these studies.

For example, trials of the cH8/1N1 mRNA vaccine revealed no major safety concerns. The cH5/1N1 vaccine also demonstrated a good safety record in trials. Similarly, the cH15/3 and cH4/3 vaccines did not cause any serious problems.

Since this trial is in its early phase, it primarily focuses on safety. Researchers closely monitor the treatment's safety to identify any potential issues early. Overall, previous studies have shown the vaccines to be safe.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these mRNA vaccines for influenza because they use cutting-edge mRNA technology to stimulate an immune response. Unlike traditional flu vaccines, which often use inactivated or weakened virus particles, these vaccines use snippets of genetic material to teach the body to recognize and attack the influenza virus. This approach allows for faster development and potentially broader protection against various flu strains. Moreover, mRNA vaccines can be quickly adapted to tackle emerging flu variants, offering a significant advantage over current seasonal flu vaccines.

What evidence suggests that this trial's treatments could be effective for influenza?

Research has shown that mRNA vaccines for the flu, like those in this trial, hold promise. Participants will receive different combinations of these vaccines. For instance, the cH8/1N1 vaccine triggered strong immune responses in mice, protecting them against various flu strains. Similarly, the cH5/1N1 vaccine enhanced specific immune responses in humans, targeting key parts of the flu virus. The cH15/3 and cH4/3 vaccines are designed to offer broad protection against various flu types by stimulating specific antibodies. Overall, these mRNA vaccines aim to provide a wider and more effective defense against flu viruses compared to traditional vaccines.24678

Are You a Good Fit for This Trial?

This trial is for healthy men and non-pregnant, non-breastfeeding women aged 18 to 59. Participants should not have major health issues or be taking part in other studies. Pregnant or breastfeeding women cannot join.

Inclusion Criteria

I am not pregnant, as confirmed by recent pregnancy tests.
Provision of signed and dated informed consent form before initiation of any study procedures
Willingness to comply with all study procedures and availability for the duration of the study
See 9 more

Exclusion Criteria

History of any medical disease or condition contraindicating study participation as judged by site PI or sub-investigator
Any abnormality or permanent body art interfering with observation of local injection site reactions
I have received or plan to receive a live vaccine within 4 weeks of the study treatment.
See 25 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one or two doses of monovalent or bivalent mRNA chimeric hemagglutinin vaccines

8 weeks
2 visits (in-person)

Follow-up

Participants are monitored for safety and immunogenicity after receiving the vaccine doses

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • cH15/3 mRNA chimeric hemagglutinin vaccine
  • cH4/3 mRNA chimeric hemagglutinin vaccine
  • cH5/1N1 mRNA chimeric hemagglutinin vaccine
  • cH8/1N1 mRNA chimeric hemagglutinin vaccine

Trial Overview

Researchers are testing new mRNA flu vaccines (various combinations of cH8/1, cH5/1N1, cH15/3, and cH4/3) given as one or two shots. Some groups get a placebo (saline). The study checks safety and how well the vaccines trigger an immune response.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Group I: Cohort 2, Arm6Experimental Treatment4 Interventions
Group II: Cohort 2, Arm5Experimental Treatment3 Interventions
Group III: Cohort 2, Arm4Experimental Treatment3 Interventions
Group IV: Cohort 1, Arm3Experimental Treatment4 Interventions
Group V: Cohort 1, Arm2Experimental Treatment2 Interventions
Group VI: Cohort 1, Arm1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Citations

Chimeric hemagglutinin split vaccines elicit broadly cross ...

The vaccine effectiveness (VE) of commercially available influenza vaccines is in the range of 10 to 60%, being generally lower for H3N2 in comparison to H1N1

Chimeric hemagglutinin and M2 mRNA vaccine for broad ...

Moreover, Fluaxe immunization inhibited the inflammatory response induced by influenza infection. In summary, we conclude that Fluaxe can elicit broad cross- ...

Universal Influenza Vaccine Technology Landscape

Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates Formulations: cH15/3 RNA, Results not yet reported

Determination of the optimal challenge dose of group 2 ...

The H3 stalk-based chimeric HA influenza virus vaccine induces cross-protection against H7N9 challenge. Three protective protection via cellular immunity 2 ...

Structural characterization of influenza group 1 chimeric ...

Chimeric hemagglutinins (cHA) appear to be promising for the design and development of universal influenza vaccines. Influenza A group 1 ...

Safety and Immunogenicity of Chimeric Hemagglutinin ...

This is a Phase 1, randomized, controlled, dose-ranging clinical trial to assess the safety and immunogenicity of novel influenza A Group 1 ...

Chimeric hemagglutinin and M2 mRNA vaccine for broad ...

We developed a novel cocktail mRNA vaccine encoding chimeric HAs (cH5/1-BV, cH7/3) and intact M2 (termed Fluaxe), which confers broad protection against major ...

Assessment of critical bioprocess parameters for broadly ...

We previously showed that chimeric hemagglutinin (cHA) virus vaccines are an effective strategy to elicit cross-protective immune responses to ...