RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

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)

Quick Facts

Study Start:2025-09-04

Study Completion:2027-01-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07128615

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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

* 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
* 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

Contacts and Locations

Study Contact

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479

information.center@astrazeneca.com

Study Locations (Sites)

Research Site

Long Beach, California, 90815

United States

Research Site

Rolling Hills Estates, California, 90274

United States

Research Site

Hialeah, Florida, 33012

United States

Research Site

Stockbridge, Georgia, 30281

United States

Research Site

Chicago, Illinois, 60640

United States

Research Site

Lenexa, Kansas, 66219

United States

Research Site

Kansas City, Missouri, 64114

United States

Research Site

Omaha, Nebraska, 68134

United States

Research Site

Las Vegas, Nevada, 89119

United States

Research Site

Cincinnati, Ohio, 45212

United States

Research Site

Edmond, Oklahoma, 73013

United States

Research Site

North Charleston, South Carolina, 29405

United States

Research Site

Austin, Texas, 78745

United States

Research Site

West Jordan, Utah, 84088

United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-04

Study Completion Date2027-01-07

Study Record Updates

Study Start Date2025-09-04

Study Completion Date2027-01-07

Terms related to this study

Keywords Provided by Researchers

Avian Influenza A
mRNA Vaccine
Pandemic Influenza
VLP
H5N1
H7N9
AstraZeneca

Additional Relevant MeSH Terms

Influenza A