Efficacy Study of COVID-19 mRNA Vaccine in Regions With SARS-CoV-2 Variants of Concern

Prior treatment

• Acutely ill 72 hours prior to or at screening. Participants meeting this criterion may be rescheduled within the relevant window periods. Participants with minor illnesses can be enrolled at the discretion of the investigator.
• Prior receipt of a SARS-CoV-2 vaccine.
• Live attenuated vaccines received within 30 days before first vaccination (eg, measles, mumps, and rubella \[MMR\]; oral polio vaccine \[OPV\]; varicella; yellow fever; live attenuated influenza vaccine, live attenuated zoster vaccine).
• Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, human papilloma virus (HPV), pneumococcal, Hepatitis A or B).
• Blood products, systemic immunoglobulins, or monoclonal antibodies (including against SARS-CoV-2) received within 90 days before first vaccination.

Other illness

• History of angioedema or anaphylaxis.
  • Vaccines and other injections

Lab values

• History of severe allergic reaction to any ingredient of this vaccine (lipids (SM-102, polyethylene glycol \[PEG\] 2000 dimyristoyl glycerol \[DMG\], cholesterol, and 1,2-distearoyl-sn-glycero-3-phosphocholine \[DSPC\]), tromethamine, tromethamine hydrochloride, acetic acid, sodium acetate trihydrate, and sucrose).

Other

• General

• General and Demographic Criteria
• Age ≥ 18 years if participant self-reports living with HIV or another comorbidity known to be associated with severe COVID-19, for example (CDC.gov for exhaustive list):
  • Hypertension
  • Type 2 diabetes mellitus
  • Overweight, obese, or severely obese (ie, body mass index \[BMI\] ≥ 25 kg/m2)
  • Heart conditions, such as heart failure, coronary artery disease, or cardiomyopathies
  • Chronic kidney disease
  • COPD (chronic obstructive pulmonary disease)
  • Cancer
  • Non-HIV immunocompromised state (weakened immune system) or solid organ transplant
  • Pregnancy
  • Sickle cell disease
  • Smoking
• Willingness to be followed and remain in the catchment area for the planned duration of the study.
• Ability and willingness to provide informed consent.
• Willingness to discuss HIV infection status, undergo related testing/monitoring labs, and receive counseling and referrals to minimize HIV acquisition/improve HIV care as appropriate based on their infection status.
• Assessment of Understanding (AoU): Participant demonstrates understanding of this study; completes a questionnaire prior to first vaccination with demonstration of understanding of all questionnaire items answered incorrectly.
• Agrees not to enroll in another interventional study of an investigational research agent until after the study is completed and all the data has been obtained. Enrollment in studies of investigational research agents for the treatment of COVID-19 is allowed for participants who develop COVID-19 disease.