Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study: Study Understanding Pre-Exposure pRophylaxis of NOVel Antibodies (SUPERNOVA) Sub-study

NCT ID: NCT05648110

Last Updated: 2025-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 3882 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-16
• Study Completion Date: 2025-02-11

Brief Summary

AZD3152, a single mAb, is being developed to have broad neutralizing activity across known SARS-CoV-2 variants of concern for pre-exposure prophylaxis of COVID-19.

The aim of the Phase I/III study (Parent Study) will be to evaluate the safety, efficacy and neutralizing activity of AZD3152 compared with comparator for pre exposure prophylaxis of COVID-19, and separately evaluate the safety and PK of AZD5156, a combination of AZD3152 and AZD1061.

Sub-study:

This Phase II sub-study of SUPERNOVA will assess the safety, PK, and predicted neutralizing activity of AZD3152 compared with EVUSHELD for pre-exposure prophylaxis of COVID-19.

Detailed Description

In the Parent study, the Phase I Sentinel Safety Cohort will assess the safety of AZD5156 (a combination of 2 mAbs, AZD1061 [cilgavimab, a component of AZD7442 (EVUSHELD)] and AZD3152) in healthy adults and the Phase III Main Cohort will assess the safety, efficacy, PK, and neutralizing activity of two doses of AZD3152 compared with two doses of comparator given at a 6-month interval in adults and adolescents 12 years of age or older (weighing at least 40 kg) with conditions causing immune impairment, who are less likely to mount an adequate protective immune response after vaccination and thus are at higher risk of developing severe COVID-19 in 18 countries.

Sub-study:

This Phase II sub-study of SUPERNOVA is operating in USA only, and it will assess the safety, PK, and predicted neutralizing activity of AZD3152 in adults 18 years of age or older (weighing at least 40 kg) with conditions causing immune impairment who are less likely to mount an adequate protective immune response after vaccination as well as individuals who are immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Conditions

COVID-19, SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156

The Sentinel Safety Cohort of the Parent Study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: EXPERIMENTAL

AZD5156 (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: PLACEBO_COMPARATOR

Placebo (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

single dose of Placebo (3 mL + 2 mL) IM

Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: EXPERIMENTAL

AZD5156 (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: PLACEBO_COMPARATOR

Placebo (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

single dose of Placebo (3 mL + 2 mL) IM

Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: EXPERIMENTAL

AZD5156 (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: PLACEBO_COMPARATOR

Placebo (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

single dose of Placebo (3 mL + 2 mL) IM

Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: EXPERIMENTAL

AZD5156 (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo

The Sentinel Safety Cohort of the Parent study will enroll 56 healthy adults, 18 to 55 years of age, who will be randomized to receive AZD5156 (40 participants) or placebo (16 participants). Participants will be randomized to receive study intervention IM either in the gluteal or the anterolateral thigh. Dosing within the Sentinel Safety Cohort will be staggered, with participants allocated sequentially to 4 subcohorts (1a, 1b, 2a, and 2b).

Group Type: PLACEBO_COMPARATOR

Placebo (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

single dose of Placebo (3 mL + 2 mL) IM

Parent study Main Cohort - AZD3152

The Main Cohort of the Parent study will enroll approximately 3200 participants. Dosing in the Main Cohort will be staggered, so that it starts with adult participants aged 18 years and older, with no adolescent participants dosed in the Main Cohort until safety data from Visit 2a (Day 8) and Visit 2b (Day 15) have been reviewed by the DSMB for at least 80 adult Main Cohort participants (which will include at least 40 participants who have received AZD3152). Participants in the Main Cohort will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.

Group Type: EXPERIMENTAL

Placebo (Parent study Sentinel Safety Cohort)

Intervention Type: BIOLOGICAL

single dose of Placebo (3 mL + 2 mL) IM

AZD3152 (Parent study Main Cohort)

Intervention Type: BIOLOGICAL

300 mg AZD3152 at 150 mg/mL

1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181

Parent study Main Cohort - EVUSHELD™

Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.

At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.

Group Type: ACTIVE_COMPARATOR

EVUSHELD™ (Parent study Main Cohort)

Intervention Type: BIOLOGICAL

600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL

2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181

Parent study Main Cohort - Placebo

Participants in the Main Cohort of the Parent study will be randomized 1:1 to receive AZD3152 300 mg or comparator administered IM in the anterolateral thigh on Day 1. Participants will receive a second dose of their original randomized study intervention (ie, active treatment or comparator) 6 months after Visit 1.

At the request of regulatory authorities the active comparator will be changed to placebo. As the comparator is given on two occasions, this means that a participant randomized to the comparator arm may receive (a) two doses of EVUSHELD, (b) a dose of EVUSHELD and a dose of placebo, or (c) two doses of placebo.

Group Type: PLACEBO_COMPARATOR

Placebo (Parent study Main Cohort)

Intervention Type: BIOLOGICAL

Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181

Sub-study - AZD3152

This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Group Type: EXPERIMENTAL

AZD3152 (Sub-study)

Intervention Type: BIOLOGICAL

Single dose of 1200 mg IV at Visit 1 Day 1

Sub-study - AZD7442 (EVUSHELD™)

This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Group Type: ACTIVE_COMPARATOR

AZD7442 - EVUSHELD™ (Sub-study)

Intervention Type: BIOLOGICAL

Single dose 300 mg IM administered on Visit 1 Day 1

Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV

This sub-study will enroll approximately 450 participants, ≥ 18 years of age with a minimum weight of 40 kg. An initial Sentinel Safety Cohort will include 12 healthy volunteers; all other participants in the study will be either immunocompromised or immunocompetent (including healthy participants) with all degrees of SARS-CoV-2 infection risk.

Group Type: EXPERIMENTAL

AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152

Intervention Type: BIOLOGICAL

Single dose of AZD7442 (EVUSHELD™) 300 mg IM

Interventions

AZD5156 (Parent study Sentinel Safety Cohort)

600 mg AZD5156 consisting of 300 mg AZD1061 at 100 mg/mL and 300 mg AZD3152 at 150 mg/mL

3 mL of AZD1061 2 mL of AZD3152 IM on Visit 1 Day 1

Intervention Type: BIOLOGICAL

Placebo (Parent study Sentinel Safety Cohort)

single dose of Placebo (3 mL + 2 mL) IM

Intervention Type: BIOLOGICAL

EVUSHELD™ (Parent study Main Cohort)

600 mg EVUSHELD™/AZD7442 consisting of 300 mg AZD1061 and 300 mg AZD8895, both at 100 mg/mL

2 IM injections (thigh) of 3 mL each IM on Visit 1 Day 1 and on Visit 5 Day 181

Intervention Type: BIOLOGICAL

AZD3152 (Parent study Main Cohort)

300 mg AZD3152 at 150 mg/mL

1 IM injection (thigh) of 2 mL of AZD3152 on Visit 1 Day 1 and on Visit 5 Day 181

Intervention Type: BIOLOGICAL

Placebo (Parent study Main Cohort)

Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181

Intervention Type: BIOLOGICAL

AZD3152 (Sub-study)

Single dose of 1200 mg IV at Visit 1 Day 1

Intervention Type: BIOLOGICAL

AZD7442 - EVUSHELD™ (Sub-study)

Single dose 300 mg IM administered on Visit 1 Day 1

Intervention Type: BIOLOGICAL

AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152

Single dose of AZD7442 (EVUSHELD™) 300 mg IM

Intervention Type: BIOLOGICAL

Other Intervention Names

EVUSHELD™

Eligibility Criteria

Inclusion Criteria

• Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, with no concomitant disease or concomitant medication (except for medication specifically permitted by the protocol).
• Age 18 to 55 years at the time of signing the informed consent.
• Negative rapid antigen test at Visit 1.
• Weight ≥ 45 kg and ≤ 110 kg at screening.

• Participant must be 12 years of age or older at the time of signing the informed consent.
• Negative rapid antigen test prior to dosing at Visit 1.
• Weight ≥ 40 kg at screening.
• Participants must satisfy at least 1 of the following risk factors at enrollment:

• Have solid tumor cancer and be on active immunosuppressive treatment
• Have hematologic malignancy
• Transplant participants must satisfy at least one of the following:

1. Have had a solid organ transplant within 2 years and / or

2. Had a hematopoietic stem cell transplant within 2 years and / or

3. Who have chronic graft-versus-host disease

4. Participants who previously had a solid organ transplant or hematopoietic stem cell transplant more than 2 years prior to Visit 1 may also be eligible based on the inclusion criterion for immunosuppressive treatment

• Are actively taking immunosuppressive medicines (eg, are using corticosteroids [ie, ≥ 20 mg prednisone or equivalent per day when administered for ≥ 2 weeks], high dose alkylating agents, antimetabolites, transplant-related immunosuppressive drugs, cancer chemotherapeutic agents classified as severely immunosuppressive [eg, Bruton's tyrosine kinase inhibitors], tumor-necrosis blockers, or other immunosuppressive or immunomodulatory biologic agents (eg, for rheumatic diseases)
• Received chimeric antigen receptor T cell therapy
• Within 1 year of receiving B-cell depleting therapies (eg, rituximab, ocrelizumab, ofatumumab, alemtuzumab)
• Have a moderate or severe primary (eg, DiGeorge syndrome) or secondary (eg, hemodialysis) immunodeficiency
• Advanced or untreated HIV infection (people with HIV and CD4 cell counts < 200/mm3 within 6 months of Visit 1, history of an AIDS-defining illness without immune reconstitution, or clinical manifestations of symptomatic HIV)
• Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent CV event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
• Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), including those at Illness Visits, based on the assessment of the Investigator.

• Healthy, defined according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the Investigator.
• Participants must be 18 to 55 years at the time of signing the informed consent.
• Weight ≥ 45 kg and ≤ 110 kg at screening.

• Immunocompromised or immunocompetent, including healthy participants, with all degrees of SARS-CoV-2 infection risk, will be enrolled following completion of Sentinel Safety Cohort enrolment.
• Participants must be 18 years of age or older at the time of signing the informed consent.
• Weight ≥ 40 kg at screening.

• 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.
• Negative rapid antigen test for SARS-CoV-2 prior to dosing at Visit 1.
• Medically stable defined as disease not requiring significant change in maintenance therapy or hospitalization for worsening disease or any recent cardiovascular event (eg, acute myocardial infarction, thromboembolic event) during the 1 month prior to enrollment, with no acute change in condition at the time of study enrollment as judged by the Investigator and no expected changes at the time of the enrollment.
• Able to understand and comply with all study requirements/procedures (if applicable, with assistance by caregiver, surrogate, or legally authorized representative or equivalent representative as locally defined), based on the assessment of the Investigator.

Exclusion Criteria

• Women 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 study intervention administration and until at least 6 months after study intervention administration.
• Known hypersensitivity to any component of the study intervention.
• Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves within the screening period or may be rescreened once.
• Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• Receipt of immunoglobulin (non-COVID related) or blood products within 6 months prior to Visit 1.
• Previous receipt of a mAb against SARS-CoV-2.
• Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• Receipt of a COVID-19 antiviral for prophylaxis within 3 months prior to Visit 1
• COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
• Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study.
• Known or suspected congenital or acquired immunodeficiency, or receipt of immunosuppressive therapy, including any course of glucocorticoid therapy exceeding 2 weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6 months prior to screening.
• Active infection with hepatitis B or C.
• Serum creatinine, AST, or ALT above 1.5 × ULN at screening
• History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.

Parent study - Main Cohort Participants (Phase III):

• Women 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 study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential.
• Known hypersensitivity to any component of the study intervention.
• Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
• Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• Receipt of IV or SC immunoglobulin within 6 months prior to Visit 1 or expected to receive IV or SC immunoglobulin 6 months after dosing.
• Receipt of convalescent COVID-19 plasma treatment within 6 months prior to Visit 1.
• Previous receipt of a mAb against SARS-CoV-2 within 6 months prior to Visit 1.
• Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
• COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory testing or a rapid test [including at home testing]).
• Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study except where the participant ceased IMP treatment >90 days and is in the follow-up period of the study and not expected to receive further IMP).

• Active infection with hepatitis B or C.
• Serum creatinine, AST, or ALT above 1.5 × ULN at screening.
• History of malignancy other than treated non-melanoma skin cancers or locally-treated cervical cancer in previous 5 years.

• Receipt of EVUSHELD (AZD7442) within 12 months prior to Visit 1.
• Women 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 study intervention administration and until at least 6 months after study intervention administration. Note: female participants aged > 12 years will be considered to be a woman of childbearing potential.
• Known hypersensitivity to any component of the study intervention.
• Previous hypersensitivity or severe adverse reaction following administration of a mAb.
• Acute (time-limited) or febrile (temperature ≥ 38.0°C [100.4ºF]) illness/infection on day prior to or day of planned dosing; participants excluded for transient acute illness may be dosed if illness resolves and may be rescreened for enrollment once.
• Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days prior to Visit 1.
• Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.
• Has human immunodeficiency virus infection.
• Receipt of IV or SC immunoglobulin or blood products within 6 months prior to Visit 1 and expected to receive IV or SC immunoglobulin or blood products 6 months after dosing.
• Receipt of a COVID-19 vaccine within 3 months prior to Visit 1.
• Receipt of a COVID-19 antiviral for prophylaxis within at least 2 weeks prior to Visit 1.
• COVID-19 within 3 months prior to Visit 1 (confirmed either by laboratory RT-PCR testing or a rapid antigen test [including at-home testing]).
• Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the period of study follow-up, or concurrent participation in another interventional study (except where the participant ceased IMP treatment > 90 days and is in the follow-up period of the study and not expected to receive further IMP).

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 130 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Research Site

Birmingham, Alabama, United States

Research Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Mesa, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Colton, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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Sacramento, California, United States

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Tustin, California, United States

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Westminster, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Fort Collins, Colorado, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Coral Gables, Florida, United States

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Fleming Island, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Lake Worth, Florida, United States

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Largo, Florida, United States

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Lauderdale Lakes, Florida, United States

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Leesburg, Florida, United States

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Medley, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Miami Springs, Florida, United States

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North Miami Beach, Florida, United States

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Orlando, Florida, United States

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Ormond Beach, Florida, United States

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Port Orange, Florida, United States

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St. Petersburg, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Boise, Idaho, United States

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Burr Ridge, Illinois, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Gurnee, Illinois, United States

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Evansville, Indiana, United States

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Evansville, Indiana, United States

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South Bend, Indiana, United States

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West Des Moines, Iowa, United States

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Overland Park, Kansas, United States

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Wichita, Kansas, United States

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Bowling Green, Kentucky, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Lake Charles, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Methuen, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Farmington Hills, Michigan, United States

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Grand Rapids, Michigan, United States

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Novi, Michigan, United States

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Saint Clair Shores, Michigan, United States

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Minneapolis, Minnesota, United States

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Jefferson City, Missouri, United States

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Kansas City, Missouri, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Missoula, Montana, United States

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Lincoln, Nebraska, United States

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Las Vegas, Nevada, United States

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Portsmouth, New Hampshire, United States

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Hackensack, New Jersey, United States

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Albuquerque, New Mexico, United States

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Buffalo, New York, United States

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Ridgewood, New York, United States

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Rochester, New York, United States

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Rochester, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Monroe, North Carolina, United States

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Morehead City, North Carolina, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Westlake, Ohio, United States

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Allentown, Pennsylvania, United States

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Duncansville, Pennsylvania, United States

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Harrisburg, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Providence, Rhode Island, United States

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Myrtle Beach, South Carolina, United States

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North Charleston, South Carolina, United States

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Rock Hill, South Carolina, United States

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Spartanburg, South Carolina, United States

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Knoxville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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Mesquite, Texas, United States

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San Angelo, Texas, United States

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San Antonio, Texas, United States

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Shenandoah, Texas, United States

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Layton, Utah, United States

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Salt Lake City, Utah, United States

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Annandale, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Olympia, Washington, United States

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Seattle, Washington, United States

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Madison, Wisconsin, United States

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Melbourne, , Australia

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Melbourne, , Australia

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Murdoch, , Australia

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Parkville, , Australia

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Raymond Terrace, , Australia

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Sippy Downs, , Australia

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West Perth, , Australia

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Alken, , Belgium

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Liège, , Belgium

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Aalborg, , Denmark

Research Site

Aarhus, , Denmark

Research Site

Hvidovre, , Denmark

Research Site

Roskilde, , Denmark

Research Site

Svendborg, , Denmark

Research Site

Dijon, , France

Research Site

La Roche-sur-Yon, , France

Research Site

Lille, , France

Research Site

Nantes, , France

Research Site

Nîmes, , France

Research Site

Paris, , France

Research Site

Paris, , France

Research Site

Poitiers, , France

Research Site

Saint-Etienne, , France

Research Site

Strasbourg, , France

Research Site

Toulouse, , France

Research Site

Tours, , France

Research Site

Cologne, , Germany

Research Site

Essen, , Germany

Research Site

Hamburg, , Germany

Research Site

Hanover, , Germany

Research Site

Mainz, , Germany

Research Site

Petah Tikva, , Israel

Research Site

Ramat Gan, , Israel

Research Site

Kuala Lumpur, , Malaysia

Research Site

Kuala Lumpur, , Malaysia

Research Site

Kuching, , Malaysia

Research Site

Seberang Jaya, , Malaysia

Research Site

Sunway City, , Malaysia

Research Site

Krakow, , Poland

Research Site

Skórzewo, , Poland

Research Site

Singapore, , Singapore

Research Site

Singapore, , Singapore

Research Site

Singapore, , Singapore

Research Site

Gyeonggi-do, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Seoul, , South Korea

Research Site

Badalona, , Spain

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

Barcelona, , Spain

Research Site

Córdoba, , Spain

Research Site

Madrid, , Spain

Research Site

Madrid, , Spain

Research Site

Madrid, , Spain

Research Site

Marbella (Málaga), , Spain

Research Site

Mérida, , Spain

Research Site

Pozuelo de Alarcón, , Spain

Research Site

Valladolid, , Spain

Research Site

Vigo, , Spain

Research Site

Taichung, , Taiwan

Research Site

Taipei, , Taiwan

Research Site

Bangkok, , Thailand

Research Site

Bangkok, , Thailand

Research Site

Khon Kaen, , Thailand

Research Site

Muang, , Thailand

Research Site

Muang, , Thailand

Research Site

Abu Dhabi, , United Arab Emirates

Research Site

Abu Dhabi, , United Arab Emirates

Research Site

Bristol, , United Kingdom

Research Site

Edinburgh, , United Kingdom

Research Site

Harrow, , United Kingdom

Research Site

Leeds, , United Kingdom

Research Site

Liverpool, , United Kingdom

Research Site

London, , United Kingdom

Research Site

London, , United Kingdom

Research Site

Manchester, , United Kingdom

Research Site

Oxford, , United Kingdom

Research Site

Sheffield, , United Kingdom

Research Site

Torpoint, , United Kingdom

Research Site

Truro, , United Kingdom

Research Site

Hanoi, , Vietnam

Research Site

Hochiminh City, , Vietnam

Countries

United States; Australia; Belgium; Canada; Denmark; France; Germany; Israel; Malaysia; Poland; Singapore; South Korea; Spain; Taiwan; Thailand; United Arab Emirates; United Kingdom; Vietnam

References

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Cai Y, Diallo S, Rosenthal K, Ren K, Flores DJ, Dippel A, Oganesyan V, van Dyk N, Chen X, Cantu E, Choudhary R, Sulikowski M, Adissu H, Chawla B, Kar S, Liu C, Dijokaite-Guraliuc A, Mongkolsapaya J, Rajan S, Loo YM, Beavon R, Webber C, Chang LJ, Thomas S, Clegg L, Zhang H, Screaton GR, Philbin N, Harre M, Selim A, Martinez-Alier N, Uriel A, Cohen TS, Perez JL, Esser MT, Blair W, Francica JR. AZD3152 neutralizes SARS-CoV-2 historical and contemporary variants and is protective in hamsters and well tolerated in adults. Sci Transl Med. 2024 Jun 26;16(753):eado2817. doi: 10.1126/scitranslmed.ado2817. Epub 2024 Jun 26.

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Other Identifiers

2024-512554-15-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

2022-002378-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D7000C00001

Identifier Type: -

Identifier Source: org_study_id