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The main purpose of this study is to test an investigational drug known as VYD2311, which is being developed to lower the risk of getting COVID-19. VYD2311 is a monoclonal antibody that attaches to the virus that causes COVID-19 and helps block it from entering your cells. It is being tested in adults and adolescents at least 12 years old. Participants in this study will be given a "study drug" that will be either VYD2311 or placebo.
The study drug will be given as a shot into the muscle in the participant's upper thigh or upper arm once a month with a total of 3 shots during the study.
This study will help researchers see how well VYD2311 works to prevent COVID-19 during the 90 days after the first shot. The study will also look at the safety and tolerability of VYD2311, how the study drug is processed by the body (pharmacokinetics), how the immune system reacts to the study drug (immunogenicity), and how well VYD2311 can block the virus from infecting cells (neutralization). To do these tests, your blood will be drawn at certain times during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VYD2311-SD (single dose) | Active Comparator | VYD2311 administered via IM injection on Day 1, followed by placebo injection (0.9% sodium chloride [normal saline]) on Day 30 and Day 60 |
|
| VYD2311-MD (multidose) | Active Comparator | VYD2311 administered via IM injection on Day 1, Day 30, and Day 60 |
|
| Placebo | Placebo Comparator | Normal saline administered by IM injection on Day 1, Day 30, and Day 60 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VYD2311-SD | Drug | VYD2311-SD (single-dose arm): Intramuscular injection dosing on Day 1 with VYD2311 and Intramuscular injection dosing Placebo (normal saline) on Day 30 and Day 60 |
| Measure | Description | Time Frame |
|---|---|---|
| RT-PCR-confirmed symptomatic COVID-19 through Day 90 | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of safety based on treatment-emergent adverse events, injection site reactions, and hypersensitivity reactions through Day 90 | 90 days | |
| Serum concentrations of VYD2311 through Day 90 | 90 days |
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Inclusion Criteria:
Participants are eligible to be included in the study only if all the following criteria apply:
Is an adult aged ≥18 years or an adolescent aged 12 to <18 years weighing at least 40 kg at the time of Screening. Note: Adolescent enrollment is allowed only if permitted by the local health authorities and local ethics committees.
Has uninterrupted access to a device (eg, mobile phone, tablet) enabled to receive study reminders (eg, SMS text messages). The parent/guardian of adolescent participants will receive the study reminders.
Provides written documentation of informed consent by signing a current IEC/IRB-approved ICF at the time of Screening. In the case of adolescents, parental informed consent and adolescent assent must also be obtained.
Is able to understand and comply with study requirements/procedures (if applicable, with assistance by a caregiver, surrogate, or LAR) based on the assessment of the Investigator.
For participants assigned female sex at birth:
Note: Pregnant participants will be eligible for enrollment after iDMC review of safety data only upon Sponsor communication to sites and only in regions permitted by local health authorities and local ethics committees. If pregnant participants are eligible for enrollment, this criterion is no longer applicable.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
NOTE: Other protocol defined inclusion/exclusion criteria apply
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Invivyd Investigative Site | Long Beach | California | 90806 | United States | ||
| Inviviyd Investigative Site |
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| VYD2311-MD | Drug | VYD2311-MD (multi-dose): Intramuscular injection dosing on Day 1, Day 30, and Day 60 with VYD2311 |
|
| Placebo | Drug | Intramuscular injection dosing on Day 1, Day 30, and Day 60 with Placebo (Normal Saline) |
|
| Incidence of ADAs against VYD2311 through Day 90 | 90 days |
| Calculated sVNA titers (VYD2311 serum concentration/variant IC50) against relevant SARS-CoV-2 variants through Day 90 | 90 days |
| San Diego |
| California |
| 92103 |
| United States |
| Invivyd Investigative Site | Orlando | Florida | 32819 | United States |
| Invivyd Investigative Site | Hinesville | Georgia | 31313 | United States |
| Invivyd Investigative Site | Melrose Park | Illinois | 60160 | United States |
| Invivyd Investigative Site | Lenexa | Kansas | 66219 | United States |
| Invivyd Investigative Site | Silver Spring | Maryland | 20904 | United States |
| Invivyd Investigative Site | Burlington | Massachusetts | 01803 | United States |
| Invivyd Investigative Site | Southfield | Michigan | 48034 | United States |
| Invivyd Investigative Site | Maplewood | Minnesota | 55109 | United States |
| Invivyd Investigative Site | Independence | Missouri | 64055 | United States |
| Invivyd Investigative Site | Jersey City | New Jersey | 07306 | United States |
| Invivyd Investigative Site | The Bronx | New York | 10455 | United States |
| Invivyd Investigative Site | Philadelphia | Pennsylvania | 19107 | United States |
| Invivyd Investigative Site | Myrtle Beach | South Carolina | 29572 | United States |
| Invivyd Investigative Site | Goodlettsville | Tennessee | 37072 | United States |
| Invivyd Investigative Site | Houston | Texas | 77065 | United States |
| Invivyd Investigative Site | Houston-2 | Texas | 77065 | United States |
| Invivyd Investigative Site | Irving | Texas | 75061 | United States |
| Invivyd Investigative Site | Sugar Land | Texas | 46254 | United States |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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