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Influenza APhase 1/2PANDANCT07128615

A Phase I/II Study on Safety AND Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

A Phase 1/2 study testing AZD4117 and AZD5315 in people with Influenza A, run by AstraZeneca at 14 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes). Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza A
What is being tested?
AZD4117 and AZD5315
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
405 participants
Where
14 sitesUnited States
Study dates
4 Sep 2025to 29 Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adults, ≥ 18 years of age at the time of signing the informed consent
  • Participants who are medically stable such that, according to the judgement of the Investigator, 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
  • 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

Who cannot join

  • History of hypersensitivity to any component of the IMP
  • History of hypersensitivity to penicillin and its derivatives
  • History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis associated with a vaccine
  • Known or suspected congenital or acquired immunodeficiency
  • Abnormal findings on screening laboratory tests
  • Previous history of myocarditis, pericarditis, Guillain-Barré syndrome or any other demyelinating condition
Show all 17Show fewer
  • Known or suspected autoimmune conditions as determined by history and/or physical examination
  • Receipt of any other type of seasonal influenza vaccination from 14 days before the first dose until 28 days after the administration of the last dose of IMP
  • Receipt of an mRNA vaccine within 28 days before administration of IMP
  • Receipt or expected receipt of any other type of licensed or investigational vaccine within 28 days prior to Visit 1 (D1) or Visit 5 (D58)
  • Receipt of immunoglobulin or blood products within 6 months prior to administration of study intervention or expected receipt during the study
  • Receipt of immune-modifying drugs or immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy within 6 months prior to enrollment (or expected receipt during study), or long-term systemic corticosteroid therapy (prednisolone or equivalent at a dose of ≥ 20 mg daily for more than 2 consecutive weeks) within 6 months prior to enrollment or expected receipt during study. Topical/inhaled steroids or short-term oral steroids are permitted
  • Participation in another trial, or receiving interventional Study IMP, in the preceding 90 days or expected receipt of another study intervention (or participation in another trial) during the period of study follow-up
  • Acute (time-limited) or febrile (temperature ≥ 38.0 °C [100.4 °F]) illness/infection within 3 days of intended IMP administration
  • Individuals who have had a previous confirmed or suspected illness from influenza caused by an H5N1 or H7N9 virus
  • Individuals who had household contact with and/or intimate exposure to an individual with laboratory confirmed H5N1 infection, exposure to infected household poultry/ wild birds/cattle or contaminated environments with sick and dead poultry or wild birds or cattle, within 60 days prior to enrollment
  • Female participants who are pregnant, lactating, or of childbearing potential and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to IMP administration and until at least 6 months after IMP administration

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Research Site

    Austin, Texas, 78745

  • Research Site

    Chicago, Illinois, 60640

  • Research Site

    Cincinnati, Ohio, 45212

  • Research Site

    Edmond, Oklahoma, 73013

  • Research Site

    Kansas City, Missouri, 64114

  • Research Site

    Las Vegas, Nevada, 89119

  • Research Site

    Lenexa, Kansas, 66219

  • Research Site

    Long Beach, California, 90815

  • Research Site

    Miami Lakes, Florida, 33016

  • Research Site

    North Charleston, South Carolina, 29405

  • Research Site

    Omaha, Nebraska, 68134

  • Research Site

    Rolling Hills Estates, California, 90274

  • Research Site

    Stockbridge, Georgia, 30281

  • Research Site

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Phase I/II, Double-blinded, Randomized, Placebo-Controlled, Dose Selection Study in Adults to Assess the Safety and Immunogenicity of AZD4117 and AZD5315 Vaccines (PANDA)

The purpose of this study is to evaluate the safety and immunogenicity of two investigational vaccines, AZD4117 and AZD5315 to protect against certain strains of avian Influenza A (H5N1 and H7N9 subtypes).

Conditions
Influenza A
Being tested
AZD4117, AZD5315, Placebo
Keywords
Avian Influenza A, mRNA Vaccine, Pandemic Influenza, VLP, H5N1, H7N9, AstraZeneca

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AZD4117Biological

    Intramuscular (IM) injection

  • AZD5315Biological

    IM injection

  • PlaceboOther

    IM injection

Study groups in NCT07128615
Study groupRoleWhat they receive
Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of ageExperimentalParticipants will receive DL1 AZD4117.
Receives: Biological: AZD4117
Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of ageExperimentalParticipants will receive DL2 AZD4117.
Receives: Biological: AZD4117
Arm 3: DL1 of AZD4117 >= 65 years of ageExperimentalParticipants will receive DL1 AZD4117.
Receives: Biological: AZD4117
Arm 4: DL2 of AZD4117 >= 65 years of ageExperimentalParticipants will receive DL2 AZD4117.
Receives: Biological: AZD4117
Arm 5: DL1 of AZD5315 18 to 64 years of ageExperimentalParticipants will receive DL1 AZD5315.
Receives: Biological: AZD5315
Arm 6: DL2 of AZD5315 18 to 64 years of ageExperimentalParticipants will receive DL2 AZD5315.
Receives: Biological: AZD5315
Arm 7: DL1 of AZD5315 >= 65 years of ageExperimentalParticipants will receive DL1 AZD5315.
Receives: Biological: AZD5315
Arm 8: DL2 of AZD5315 >= 65 years of ageExperimentalParticipants will receive DL2 AZD5315.
Receives: Biological: AZD5315
Arm 9: placebo 18 to 64 years of agePlacebo comparatorParticipants will receive placebo.
Receives: Other: Placebo
Arm 10: placebo >= 65 years of agePlacebo comparatorParticipants will receive placebo.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants with immediate unsolicited adverse events (AE)

    Measured: Within 30 minutes after dosing

  2. Percentage of participants with injection site and systemic solicited adverse reactions (AR)

    Measured: Through 7 days after dosing

  3. Percentage of participants with unsolicited AE

    Measured: Through 28 days after the last dose

  4. Percentage of participants with serious adverse events (SAE)

    Measured: Through 12 months after the last dose

  5. Percentage of participants with medically attended adverse events (MAAE)

    Measured: Through 12 months after the last dose

  6. Percentage of participants with adverse events of special interest (AESI)

    Measured: Through 12 months after the last dose

  7. Proportion of participants achieving ≥ 1:40 HAI titer post-IMP administration

    A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.

    Measured: Day 58

  8. Proportion of participants achieving seroconversion post-IMP administration

    Seroconversion status, defined as either a pre-IMP administration HAI titer < 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.

    Measured: Day 58

Secondary outcomes (4)

  1. Geometric mean titer (GMT) of HAI antibody

    Measured: Days 1 to 389

  2. Geometric mean fold-rise (GMFR) of HAI antibody titers from baseline

    The fold rise is calculated as the ratio of the post-dose titer to the pre-dose titer.

    Measured: Days 29 to 389

  3. Proportion of participants achieving a ≥1:40 HAI titer post-IMP administration

    A binary endpoint, defined as ≥ 1:40 HAI titer post-IMP administration.

    Measured: Days 29 to 389

  4. Proportion of participants achieving seroconversion post-IMP administration

    Seroconversion status, defined as either a pre-IMP administration HAI titer < 1:10 and a post-IMP administration HAI titer ≥ 1:40, or a pre-IMP administration titer ≥ 1:10 and 4-fold increase in post-IMP administration titer.

    Measured: Days 29 to 389

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2025
  2. Study start4 Sep 2025
  3. Primary completion28 Jan 2026
  4. Study completion29 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
405 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128615
Sponsor's protocol ID
D8500C00001
Acronym
PANDA
Status last verified
Oct 2026
First submitted
5 Aug 2025
Last updated
9 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing AZD4117 and AZD5315 in people with Influenza A, run by AstraZeneca at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with immediate unsolicited adverse events (AE) (time frame: Within 30 minutes after dosing). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07128615.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.

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