a study to evaluate efficacy, safety, and immunogenicity of mrna-1273 vaccine in adults aged 18 years and older to prevent covid-19

Conditions: SARS-CoV-2

Summary: the mrna-1273 vaccine is being developed to prevent covid-19, the disease resulting from severe acute respiratory syndrome coronavirus (sars-cov-2) infection. the study is designed to primarily evaluate the efficacy, safety, and immunogenicity of mrna-1273 to prevent covid-19 for up to 2 years after the second dose of mrna-1273.

this is a 3-part phase 3 study, with part a (blinded phase), part b (open-label observational phase), and part c (booster dose phase). participants in part a are blinded to their treatment assignment, with participants receiving either mrna-1273 vaccine or placebo. part b of the study is designed to offer participants to be unblinded so that participants who received placebo in part a can request 2 doses of open-label mrna-1273 vaccine. additionally, participants who choose to be unblinded and were only able to receive 1 dose of mrna-1273 due to administrative reasons, can choose to receive the second dose of mrna-1273 during part b. in part c, a booster dose will be provided for all eligible participants who choose to receive one. please access www.modernatx.com/cove-study for additional information, such as study overview, participation, and site locations along with contact numbers for each location for the study.

Eligibility criteria:
inclusion criteria: * (part a only) participants who are at high risk of sars-cov-2 infection, defined as adults whose locations or circumstances put them at appreciable risk of exposure to sars-cov-2 and covid-19. * understands and agrees to comply with the study procedures and provides written informed consent. * able to comply with study procedures based on the assessment of the investigator. * female participants of non-childbearing potential may be enrolled in the study. non-childbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥12 consecutive months prior to screening without an alternative medical cause). a follicle-stimulating hormone (fsh) level may be measured at the discretion of the investigator to confirm postmenopausal status. * female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: * has a negative pregnancy test at screening and on the day of the first dose (day 1, open-label day 1, and booster dose day 1). * has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (day 1). * has agreed to continue adequate contraception through 3 months following the last dose (day 29, open-label day 29, and booster dose day 1). * is not currently breastfeeding. * healthy adults or adults with pre-existing medical conditions who are in stable condition. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. * (part c only) is currently enrolled in part b of the current study (mrna-1273-p301). * (part c only) has received at least 1 dose of mrna-1273 in the current study (mrna-1273-p301). exclusion criteria: * is acutely ill or febrile 72 hours prior to or at screening or dosing (part b and part c). fever is defined as a body temperature ≥38.0°celsius/100.4°fahrenheit. participants meeting this criterion may be rescheduled within the relevant window periods. afebrile participants with minor illnesses can be enrolled/dosed at the discretion of the investigator. * is pregnant or breastfeeding. * (part a only) known history of sars-cov-2 infection. * prior (part a) or concurrent (part b and part c) administration of non-study coronavirus (sars-cov, middle east respiratory syndrome \[mers\]-cov) vaccine or current/planned simultaneous participation in another interventional study to prevent or treat covid-19. * (part a only) demonstrated inability to comply with the study procedures. * an immediate family member or household member of this study's personnel. * known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reaction to the vaccine or its excipients. * bleeding disorder considered a contraindication to intramuscular injection or phlebotomy. * has received or plans to receive a vaccine within 28 days prior to the first dose (day 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose of investigational product (ip) (except for seasonal influenza vaccine). * (part a only) has participated in an interventional clinical study within 28 days prior to the day of enrollment. * immunosuppressive or immunodeficient state, including human immunodeficiency virus (hiv) infection, asplenia, and recurrent severe infections. * has received systemic immunosuppressants or immune-modifying drugs for \>14 days in total within 6 months prior to ip dose administration (for corticosteroids ≥20 milligram (mg)/day of prednisone equivalent). * has received systemic immunoglobulins or blood products within 3 months prior to the day of ip dose administration. * has donated ≥450 milliliters (ml) of blood products within 28 days prior to ip dose administration.

Keywords: mrna-1273 mrna-1273 vaccine sars-cov-2 sars-cov-2 vaccine coronavirus virus diseases messenger rna covid-19 covid-19 vaccine moderna