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                    <a href="?cresstrial=15843&amp;modal=1&amp;valnames=exclusion_criteria&amp;order=created_at">Created at</a>
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                <th scope="col">Source</th>
                
                <th scope="col">Raw Value</th>
                <th scope="col">Validated value</th>
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                <td>April 8, 2022, 3:30 p.m.</td>
                <td>oms</td>
                
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        <p class="exclusion_criteria">
            Participants with any of the following criteria will be excluded:
1. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness of moderate or severe grade including HIV Stage III/IV or chronic illness/disease that is not stable (at the discretion of the investigator). Acute illness is a temporary exclusion for which the participant may be re-evaluated once they improve or recover.
2. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine).
3. Unstable or Severe Chronic disease inclusive of:
a. Hypertension (elevated blood pressure [SBP&gt;155mmHg or DBP&gt;100mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.b. Congestive heart failure (CHF) stage 3 or greater or diagnosed cardiovascular disease that is not controlled using medication in the past 6 months.
c. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbations repeated in the past 2 years. Note: If participant has been stable the last 6 months and are not Gold stage 3 or greater, they may be included.
d. Asthma stage 4 and/or unstable cases with asthma therapy adjustments in the past that 2 months.
e. Type 1 or any type 2 diabetes (adult onset) with an HbA1c &gt; 8.5 in the last 6 months. Any participant with diabetes is required to have an AIC value in last 6 months. Adolescents may not be diabetic.
f. Chronic kidney disease requiring dialysis or GFR &lt;30 (may use associated creatinine based on age and gender)
g. Chronic hepatic disease with evidence of hepatic compromise. Includes known Hepatitis B or C.
h. Chronic or serious neurological diseases (e.g. cerebrovascular disease (including transient ischemic attacks), autoimmune disorders, neurologic deterioration (including dementia), Guillain Barre syndrome)
4. Cognitive impairment – congenital or acquired
5. Participation in research involving an investigational product (drug/biologic/device) within 30 days prior to first study vaccination. Exception is if participant in a follow up safety phase and the investigation product has been given &gt; 6months previously.
6. Prior receipt of an Ebola vaccine i.e., Ad26.ZEBOV/MVA-BN-Filo vaccines.
7. Received any other vaccine within 4 weeks prior to first study vaccination or planned vaccination within 2 weeks after study vaccination (exception for mass vaccination campaigns). Participants may be revaluated after the window has passed.
8. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital), excluding HIV. Note: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic), including stable diabetes are allowed.
9. Chronic administration (&gt;14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 60 days prior to first study vaccination, excluding HAART. 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.10. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination, excluding HAART.
11. Temporary exclusion: Acute respiratory and/or non-respiratory illness consistent with po
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        <p class="exclusion_criteria validated">
            Participants with any of the following criteria will be excluded:
1. Any ongoing, symptomatic acute illness requiring medical or surgical care or chronic illness of moderate or severe grade including HIV Stage III/IV or chronic illness/disease that is not stable (at the discretion of the investigator). Acute illness is a temporary exclusion for which the participant may be re-evaluated once they improve or recover.
2. Use of a heterologous COVID-19 primary series at the platform level (mRNA, Adenovector and inactivated vaccine).
3. Unstable or Severe Chronic disease inclusive of:
a. Hypertension (elevated blood pressure [SBP&gt;155mmHg or DBP&gt;100mmHg]). Note that participants can be retested once after resting or return on another day for retesting. Participants may also have anti-hypertensive medication adjusted and may be reassessed after at least 2 weeks.b. Congestive heart failure (CHF) stage 3 or greater or diagnosed cardiovascular disease that is not controlled using medication in the past 6 months.
c. Chronic obstructive pulmonary disease (COPD) with a history of an acute exacerbations repeated in the past 2 years. Note: If participant has been stable the last 6 months and are not Gold stage 3 or greater, they may be included.
d. Asthma stage 4 and/or unstable cases with asthma therapy adjustments in the past that 2 months.
e. Type 1 or any type 2 diabetes (adult onset) with an HbA1c &gt; 8.5 in the last 6 months. Any participant with diabetes is required to have an AIC value in last 6 months. Adolescents may not be diabetic.
f. Chronic kidney disease requiring dialysis or GFR &lt;30 (may use associated creatinine based on age and gender)
g. Chronic hepatic disease with evidence of hepatic compromise. Includes known Hepatitis B or C.
h. Chronic or serious neurological diseases (e.g. cerebrovascular disease (including transient ischemic attacks), autoimmune disorders, neurologic deterioration (including dementia), Guillain Barre syndrome)
4. Cognitive impairment – congenital or acquired
5. Participation in research involving an investigational product (drug/biologic/device) within 30 days prior to first study vaccination. Exception is if participant in a follow up safety phase and the investigation product has been given &gt; 6months previously.
6. Prior receipt of an Ebola vaccine i.e., Ad26.ZEBOV/MVA-BN-Filo vaccines.
7. Received any other vaccine within 4 weeks prior to first study vaccination or planned vaccination within 2 weeks after study vaccination (exception for mass vaccination campaigns). Participants may be revaluated after the window has passed.
8. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital), excluding HIV. Note: Stable endocrine disorders that have a confirmed autoimmune etiology (e.g., thyroid, pancreatic), including stable diabetes are allowed.
9. Chronic administration (&gt;14 continuous days) of immunosuppressant, systemic glucocorticosteroids, or other immune-modifying drugs within 60 days prior to first study vaccination, excluding HAART. 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.10. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination, excluding HAART.
11. Temporary exclusion: Acute respiratory and/or non-respiratory illness consistent with po
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