Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as AZD5156 (Parent study Sentinel Safety Cohort)
AZD5156 · 1 trial · 1 indication
Primary: (Main Cohort) Occurrence of AEs collected through approximately 90 days after each IMP administration; SAEs, MAAEs, and AESIs collected through Day 451
(Sub-study) Occurrence of AEs collected through 29 days after IMP administration. SAEs, MAAEs, and AESIs collected through Day 451 (ie, end of study).
AZD3152 Day 29 predicted nAb titer for BA.2.86 variant = AZD3152 serum PK conc. (ng/mL)/(3.8 ng/mL), where 3.8 ng/mL is AZD3152 BA.2.86 IC50. AZD7442 Day 29 predicted nAb titer for Alpha variant = AZD7442 serum PK conc. (ng/mL)/(2.1 ng/mL), where 2.1 ng/mL is AZD7442 Alpha IC50. This table only shows AZD3152 and AZD7442 concentration at Day 29.
(Main Cohort) Confirmed symptomatic COVID-19 case at Primary Analysis.
(Main Cohort) Confirmed symptomatic COVID-19 case attributable to matched variants at Primary Analysis.
Primary: (Sentinel Cohort) Occurrence of AEs, SAEs, MAAEs, and AESIs collected through Day 461
| Arm | Type | Description |
|---|---|---|
| Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - AZD5156 | EXPERIMENTAL | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 1a Gluteal - Placebo | PLACEBO_COMPARATOR | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - AZD5156 | EXPERIMENTAL | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 1b Thigh - Placebo | PLACEBO_COMPARATOR | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal- AZD5156 | EXPERIMENTAL | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 2a Gluteal - Placebo | PLACEBO_COMPARATOR | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - AZD5156 | EXPERIMENTAL | 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). |
| Parent study Sentinel Safety Cohort - Subcohort 2b Thigh - Placebo | PLACEBO_COMPARATOR | 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). |
| Parent study Main Cohort - AZD3152 | EXPERIMENTAL | 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. |
| Parent study Main Cohort - EVUSHELD™ | ACTIVE_COMPARATOR | 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. |
| Parent study Main Cohort - Placebo | PLACEBO_COMPARATOR | 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. |
| Sub-study - AZD3152 | EXPERIMENTAL | 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. |
| Sub-study - AZD7442 (EVUSHELD™) | ACTIVE_COMPARATOR | 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. |
| Sub-study - AZD7442 (EVUSHELD™) Immunocompromised participants offered AZD3152 1200mg IV | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| AZD5156 (Parent study Sentinel Safety Cohort) | 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 |
| Placebo (Parent study Sentinel Safety Cohort) | BIOLOGICAL | single dose of Placebo (3 mL + 2 mL) IM |
| EVUSHELD™ (Parent study Main Cohort) | 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 |
| AZD3152 (Parent study Main Cohort) | 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 |
| Placebo (Parent study Main Cohort) | BIOLOGICAL | Single doses of 0.9% sodium chloride 2 mL IM for injection on Visit 1 Day 1 and Visit 5 Day 181 |
| AZD3152 (Sub-study) | BIOLOGICAL | Single dose of 1200 mg IV at Visit 1 Day 1 |
| AZD7442 - EVUSHELD™ (Sub-study) | BIOLOGICAL | Single dose 300 mg IM administered on Visit 1 Day 1 |
| AZD7442 (EVUSHELD™) (Sub-study) Immunocompromised participants offered AZD3152 | BIOLOGICAL | Single dose of AZD7442 (EVUSHELD™) 300 mg IM |
Parent study - Sentinel Safety Cohort Participants (Phase I): Parent study - Sentinel Cohort Inclusion Criteria: * Healthy participants according to medical history, physical examination, baseline safety laboratory tests, and screening parameters, according to the judgment of the investigator, wit...