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About
This is a study to evaluate the effectiveness and safety of a coronavirus disease 2019 (COVID-19) vaccine called SARS-CoV-2 rS with Matrix-M1 adjuvant in a minimum of approximately 2,960 to a maximum of approximately 4,164 healthy HIV-negative (HIV-) adult participants and in approximately 240 medically stable HIV-positive (HIV+) adult participants in up to 15 sites across South Africa. A vaccine causes the body to have an immune response that may help prevent the infection or reduce the severity of symptoms. An adjuvant is something that can make a vaccine work better. This study will look at the protective effect, body's immune response, and safety of SARS-CoV-2 rS with Matrix-M1 adjuvant in these study populations. Participants in the study will randomly be assigned to receive SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo. Each participant in the study will receive a total of 2 intramuscular injections over the course of the study.
Enrollment
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Inclusion criteria
All subjects:
HIV-negative subjects only:
HIV-positive subjects only:
Exclusion criteria
Any current acute illness requiring medical or surgical care, or chronic illness (excluding HIV in HIV-positive subjects) that requires changes in medication in the past 2 months indicating that chronic illness/disease is not stable.
Chronic disease, including:
Participation in research involving an investigational product (drug/biologic/device) within 45 days prior to first study vaccination.
Prior receipt of investigational or approved COVID-19 vaccine at any time.
History of a diagnosis of suspected or confirmed COVID-19.
Received influenza (flu) vaccination within 14 days prior to first study vaccination; or any other vaccine within 4 weeks prior to first study vaccination; or planned vaccination with 5 weeks after first study vaccination.
Any autoimmune or immunodeficiency disease/condition (excluding HIV in HIV-positive patients).
Chronic (more than 14 days continuous) administration of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 90 days prior to first study vaccination (excluding HAART in HIV-positive subjects). NOTE: An immunosuppressant dose of glucocorticoid is defined as a systemic dose ≥ 10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted.
Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination (excluding HAART in HIV-positive subjects).
Acute respiratory and/or non-respiratory illness consistent with potential COVID-19, concurrent with or within 14 days prior to first study vaccination, or documented temperature of > 38°C during this period.
Known blood clotting disorder.
Active cancer (malignancy) within 3 years prior to first study vaccination (with the exception of adequately treated non-melanoma skin cancers, as assessed by the investigator).
Any known allergies to products contained in the investigational product, or latex allergy, or any history of anaphylaxis in relation to any previous vaccination.
Women who are breastfeeding or who are pregnant at the time of screening, or plan to become pregnant within the first 6 months of the study.
History of alcohol abuse or drug addiction within 2 years prior to the first study vaccination.
Any condition (other than HIV in HIV-positive subjects) that, in the opinion of the investigator, would pose a health risk to the subject if they participate in the study, or could interfere with evaluation of the study vaccine or interpretation of study results.
Study team member or first-degree relative of any study member.
Other protocol-defined inclusion/exclusion criteria may apply
Primary purpose
Allocation
Interventional model
Masking
4,422 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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