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

NCT07128615 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: D8500C00001
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 14

Brief 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).

Conditions

Influenza A

Keywords

Avian Influenza A; mRNA Vaccine; Pandemic Influenza; VLP; H5N1; H7N9; AstraZeneca

Outcome Measures

Primary Outcomes (8)

• Percentage of participants with immediate unsolicited adverse events (AE)

  Within 30 minutes after dosing

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

  Through 7 days after dosing

• Percentage of participants with unsolicited AE

  Through 28 days after the last dose

• Percentage of participants with serious adverse events (SAE)

  Through 12 months after the last dose

• Percentage of participants with medically attended adverse events (MAAE)

  Through 12 months after the last dose

• Percentage of participants with adverse events of special interest (AESI)

  Through 12 months after the last dose

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

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

  Day 58

• 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.

  Day 58

Secondary Outcomes (4)

• Geometric mean titer (GMT) of HAI antibody

  Days 1 to 389

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

  Days 29 to 389

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

  Days 29 to 389

• Proportion of participants achieving seroconversion post-IMP administration

  Days 29 to 389

Study Arms (10)

Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age

EXPERIMENTAL

Participants will receive DL1 AZD4117.

Biological: AZD4117

Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age

EXPERIMENTAL

Participants will receive DL2 AZD4117.

Biological: AZD4117

Arm 3: DL1 of AZD4117 >= 65 years of age

EXPERIMENTAL

Participants will receive DL1 AZD4117.

Biological: AZD4117

Arm 4: DL2 of AZD4117 >= 65 years of age

EXPERIMENTAL

Participants will receive DL2 AZD4117.

Biological: AZD4117

Arm 5: DL1 of AZD5315 18 to 64 years of age

EXPERIMENTAL

Participants will receive DL1 AZD5315.

Biological: AZD5315

Arm 6: DL2 of AZD5315 18 to 64 years of age

EXPERIMENTAL

Participants will receive DL2 AZD5315.

Biological: AZD5315

Arm 7: DL1 of AZD5315 >= 65 years of age

EXPERIMENTAL

Participants will receive DL1 AZD5315.

Biological: AZD5315

Arm 8: DL2 of AZD5315 >= 65 years of age

EXPERIMENTAL

Participants will receive DL2 AZD5315.

Biological: AZD5315

Arm 9: placebo 18 to 64 years of age

PLACEBO COMPARATOR

Participants will receive placebo.

Other: Placebo

Arm 10: placebo >= 65 years of age

PLACEBO COMPARATOR

Participants will receive placebo.

Other: Placebo

Interventions

AZD4117 BIOLOGICAL

Intramuscular (IM) injection

Arm 1: Dosage Level 1 (DL1) of AZD4117 18 to 64 years of age; Arm 2: Dosage Level 2 (DL2) of AZD4117 18 to 64 years of age; Arm 3: DL1 of AZD4117 >= 65 years of age; Arm 4: DL2 of AZD4117 >= 65 years of age

AZD5315 BIOLOGICAL

IM injection

Arm 5: DL1 of AZD5315 18 to 64 years of age; Arm 6: DL2 of AZD5315 18 to 64 years of age; Arm 7: DL1 of AZD5315 >= 65 years of age; Arm 8: DL2 of AZD5315 >= 65 years of age

Placebo OTHER

IM injection

Arm 10: placebo >= 65 years of age; Arm 9: placebo 18 to 64 years of age

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• AstraZeneca: lead
• Biomedical Advanced Research and Development Authority: collaborator
• Joint Program Executive Office (JPEO) Chemical, Biological, Radiological, and Nuclear Defense (CBRND) Enabling Biotechnologies (EB): collaborator

Study Sites (14)

Research Site

Long Beach, California, 90815, United States

Location

Research Site

Rolling Hills Estates, California, 90274, United States

Location

Research Site

Hialeah, Florida, 33012, United States

Location

Research Site

Stockbridge, Georgia, 30281, United States

Location

Research Site

Chicago, Illinois, 60640, United States

Location

Research Site

Lenexa, Kansas, 66219, United States

Location

Research Site

Kansas City, Missouri, 64114, United States

Location

Research Site

Omaha, Nebraska, 68134, United States

Location

Research Site

Las Vegas, Nevada, 89119, United States

Location

Research Site

Cincinnati, Ohio, 45212, United States

Location

Research Site

Edmond, Oklahoma, 73013, United States

Location

Research Site

North Charleston, South Carolina, 29405, United States

Location

Research Site

Austin, Texas, 78745, United States

Location

Research Site

West Jordan, Utah, 84088, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking will be secured to the syringe after preparation by unblinded personnel
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2025
• First Posted: August 19, 2025
• Study Start: September 4, 2025
• Primary Completion: January 28, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

US (14)