AZD4117 + AZD5315 Vaccines for Flu

(PANDA Trial)

Recruiting at 13 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: AstraZeneca

Must not be taking: Immunosuppressants, mRNA vaccines

Disqualifiers: Autoimmune conditions, Immunodeficiency, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two new vaccines, AZD4117 and AZD5315, designed to protect against certain bird flu strains, specifically H5N1 and H7N9. The main goal is to determine the safety of these vaccines and their ability to trigger an immune response. Participants will be divided into groups to receive varying doses of the vaccines or a placebo, a harmless substance used for comparison. Individuals who have been medically stable for the past three months may be suitable for this trial. As a Phase 1 and Phase 2 trial, this research aims to understand how the vaccines work in people and measure their effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking medical advancements.

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 immune-modifying drugs, 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 shows that AZD4117 and AZD5315 are being tested for safety and effectiveness against certain bird flu strains. Other studies have found that flu vaccines are generally well-tolerated, with serious side effects occurring in about 1-2 cases per million doses.

Specific safety data for these two vaccines is not yet available, but their presence in early testing suggests they are considered safe enough for human trials at this stage. This likely indicates they have passed initial safety tests in labs and on animals.

In summary, although detailed safety information for AZD4117 and AZD5315 is not yet available, ongoing studies aim to confirm their safety for people. Participation in these trials will help gather important information about human responses to these vaccines. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about AZD4117 and AZD5315 vaccines for flu because they offer new approaches to flu prevention compared to traditional vaccines. Unlike standard flu vaccines that often rely on inactivated or live attenuated viruses, these treatments may utilize advanced adjuvant systems or novel antigens to boost immune response. This could lead to enhanced protection, particularly in older adults who typically have weaker immune responses to conventional vaccines. Additionally, these vaccines might offer broader protection against multiple flu strains, reducing the need for annual updates.

What evidence suggests that this trial's vaccines could be effective against avian Influenza A?

This trial will evaluate the effectiveness of two vaccines, AZD4117 and AZD5315, in preventing flu infections. Studies have shown that vaccines like AZD4117 can greatly reduce the risk of flu. In one study, only 2.2% of those who received the vaccine got sick, compared to 7.1% of those who received a placebo, demonstrating that AZD4117 is 69% effective in preventing flu infections. Meanwhile, researchers are studying AZD5315 for its ability to protect against certain flu strains. Both vaccines strengthen the body's immune system to fight the flu, especially targeting bird flu strains like H5N1 and H7N9. Early research suggests they could be promising in lowering the risk of flu. Participants in this trial will receive either AZD4117 or AZD5315, with different dosage levels tested across various age groups. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are medically stable, meaning no hospital stays or major treatment changes in the last 3 months. It's not for those with certain heart conditions, nerve disorders, allergies to vaccine ingredients, recent blood product recipients, or participants in other trials. Pregnant women and those not using effective birth control are excluded.

Inclusion Criteria

Written informed consent and any locally required authorization (eg, HIPAA in the US) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations

Participants who are medically stable such that hospitalization within the study period is not anticipated and the participant appears likely to be able to remain on study through the end of protocol-specified follow-up. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months prior to enrollment

I am 18 years old or older.

Exclusion Criteria

History of hypersensitivity to any component of the IMP

I have had myocarditis, pericarditis, Guillain-Barré syndrome, or a similar condition.

I haven't had a flu shot within 14 days before or won't for 28 days after my trial medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either AZD4117, AZD5315, or placebo to assess safety and immunogenicity

8 weeks

Multiple visits for vaccine administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

48 weeks

Regular follow-up visits to assess immunogenicity

What Are the Treatments Tested in This Trial?

Interventions

• AZD4117
• AZD5315

Trial Overview

The PANDA study tests two vaccines (AZD4117 and AZD5315) against avian flu strains H5N1 and H7N9. Participants will either receive one of these vaccines or a placebo to compare safety and immune responses.

How Is the Trial Designed?

Group I: Arm 8: DL2 of AZD5315 >= 65 years of age Experimental Treatment 1 Intervention

Participants will receive DL2 AZD5315.

Group II: Arm 7: DL1 of AZD5315 >= 65 years of age Experimental Treatment 1 Intervention

Participants will receive DL1 AZD5315.

Group III: Arm 6: DL2 of AZD5315 18 to 64 years of age Experimental Treatment 1 Intervention

Participants will receive DL2 AZD5315.

Group IV: Arm 5: DL1 of AZD5315 18 to 64 years of age Experimental Treatment 1 Intervention

Participants will receive DL1 AZD5315.

Group V: Arm 4: DL2 of AZD4117 >= 65 years of age Experimental Treatment 1 Intervention

Participants will receive DL2 AZD4117.

Group VI: Arm 3: DL1 of AZD4117 >= 65 years of age Experimental Treatment 1 Intervention

Participants will receive DL1 AZD4117.

Group VII: Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age Experimental Treatment 1 Intervention

Participants will receive DL2 AZD4117.

Group VIII: Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age Experimental Treatment 1 Intervention

Participants will receive DL1 AZD4117.

Group IX: Arm 9: placebo 18 to 64 years of age Placebo Group 1 Intervention

Participants will receive placebo.

Group X: Arm 10: placebo >= 65 years of age Placebo Group 1 Intervention

Participants will receive placebo.

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Biomedical Advanced Research and Development Authority

Collaborator

Trials

108

Recruited

574,000+

Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB)

Collaborator

Trials

1

Recruited

20+

Citations

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clinicaltrials.gov/study/NCT07128615

NCT07128615 | A Phase I/II Study on Safety AND ...

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain ...

2.

withpower.com

withpower.com/trial/phase-2-influenza-a-virus-infection-8-2025-b4c45

AZD4117 + AZD5315 Vaccines for Flu (PANDA Trial)

The PANDA medical study, being run by AstraZeneca, is evaluating whether AZD4117 and AZD5315 will have tolerable side effects & efficacy for patients with Flu.

3.

ichgcp.net

ichgcp.net/clinical-trials-registry/549473-a-phase-iii-study-on-safety-and-immunogenicity-of-azd4117-and-azd5315-vaccines-panda

PANDA Influenza Vaccine Clinical Trial: AZD4117 ... - ICH GCP

This study is specifically designed to protect against Influenza A, a serious respiratory illness that causes seasonal outbreaks and can lead to ...

4.

cdc.gov

cdc.gov/mmwr/volumes/74/wr/mm7406a2.htm

Interim Estimates of 2024–2025 Seasonal Influenza ...

Effectiveness against influenza A(H3N2) was 51% (IVY) against influenza-associated hospitalization but was not statistically significant in the ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8168527/

Influenza Vaccine Effectiveness: New Insights and ...

With febrile illness as the clinical end point, the attack rate was 2.2% in the vaccine group and 7.1% in the placebo group (69% efficacy). This was perhaps the ...

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astrazenecaclinicaltrials.com

astrazenecaclinicaltrials.com/study/D8500C00001/

A Phase I/II Study on Safety AND Immunogenicity ...

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains ...

7.

theglobeandmail.com

theglobeandmail.com/investing/markets/stocks/AZN/pressreleases/34506043/astrazenecas-new-vaccine-study-targets-avian-influenza/

AstraZeneca's New Vaccine Study Targets Avian Influenza

' The study aims to evaluate the safety and immune response of two investigational vaccines, AZD4117 and AZD5315, designed to protect against ...

8.

withpower.com

withpower.com/clinical-trials/for-flu?page=1

Top Flu Clinical Trials | Power

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains ...