TITLE: Study Population (Part 4 of Phase 3 study of Vaccine Candidate for COVID-19)
AUTHORS: Chris Ockenhouse, Chris Gast, Renee Holt, Jorge Flores

[DESCRIPTION]
<div class = "text-blocks"><div class = "text-block"><span>This is Part 4 of "Phase 3 randomized, double-blinded, placebo-controlled trial to evaluate the safety, immunogenicity, and efficacy of </span><span style = "font-weight:bold;">Vaccine Candidate</span><span> against COVID-19 in adults > 18 years of age"</span></div><div class = "text-block">This generic Phase 3 protocol was developed by the PATH team with support of the Bill and Melinda Gates Foundation. The aim of the collection is to share recommended best practices in designing and implementing a Phase 3 study of a COVID-19 vaccine candidate. As Phase 3 trials of different Vaccine Candidates  proceed around the world, following the same protocols will ensure consistency and comparability of the Phase 3 trial results.</div><div class = "text-block"><span style = "font-weight:bold;">Please note</span><span> that this is an evolving document, to be versioned and updated, based on community feedback and new data.</span></div></div>

[STEPS]
?. [Participant inclusion criteria]
Willingness to provide a signed, printed, and dated informed consent form.
?. [Participant inclusion criteria]
Stated willingness to comply with all study procedures and availability for the duration of the study.
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Be a male or female 18 years of age or older.
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Be at high risk of SARS-CoV-2 infection due to location, profession, or activities.
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For females (unless the sponsor has performed DART and Phase 1/2 safety studies): Be of non-childbearing potential or willing to use appropriate contraceptive measures for 30 days prior to vaccination through two months after completion of the vaccine series. Non-childbearing potential means being surgically sterilized or at least one year post-menopausal. Appropriate measures to prevent pregnancy include abstinence or adequate contraceptive precautions (i.e. intrauterine or implantable contraceptive device; oral contraceptives; diaphragm or condom in combination with contraceptive jelly, cream or foam).
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For healthy participants with pre-existing medical conditions: Be in stable condition that hasn’t worsened over the three months before enrollment to require hospitalization or significant changes in therapy.
?. [Participant exclusion criteria]
An individual who meets any of the criteria in this sections will be excluded from participation in this study.
Investigators should use good clinical judgment in considering a participant’s overall fitness for inclusion in the trial. Some participants may not be appropriate for the study, even if they meet all the eligibility criteria. In addition, the participants should reside within reasonable proximity to the study site, without plans to leave the area prior to the end of the study.
?. [Participant exclusion criteria]
Planned administration/administration of a vaccine not foreseen by the study protocol from within 30 days before the first dose of study vaccine.
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History of COVID-19 disease.
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History of allergic reactions or anaphylaxis to previous immunizations or allergies to any components of the vaccine.
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Fever (oral >38.0 C) within the past 24 hours.
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Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the study vaccine.
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History of bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular (IM) injections or venipuncture.
?. [Participant exclusion criteria]
Being pregnant (i.e. a positive pregnancy test) or lactating during the immunization phase of the study. If a woman becomes pregnant after all vaccinations are complete, she will not be excluded from the remainder of the studybut will be followed through delivery.
?. [Participant exclusion criteria]
Planning to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase through two months after the second immunization.
?. [Participant exclusion criteria]
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose (for corticosteroids, this means prednisone or equivalent, ≥ 0.5 mg/kg/day; inhaled and topical steroids are allowed).
?. [Participant exclusion criteria]
Compromised immune system diseases including cancer (except basal cell carcinoma), congenital or acquired immune deficiencies and uncontrolled autoimmune diseases, as per case history and/or physical examination.
?. [Participant exclusion criteria]
Indications of drug abuse or excessive use of alcohol as deemed by the investigator to confound safety assessments or render the participant unable or unlikely to adhere to protocol requirements or provide accurate safety reports.
?. [Participant exclusion criteria]
History of asplenia.
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Unavailable for the entire trial period.
?. [Participant exclusion criteria]
Any other findings the investigator feels would increase the risk of having an adverse outcome from participation in the trial.