Status and phase
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About
This is a phase I, prospective, three-arm, open-label, randomized, first in human (FIH) clinical trial to assess the safety and immunogenicity of EgyVax vaccine candidate for prophylaxis of SARS-CoV-2 infection (COVID-19).
Full description
Study subjects will receive one dose of study intervention as assigned at each vaccination visit (Visits 1 and 4) via intramuscular (IM) injection in the upper arm approximately 14 days apart. Study interventions should be administered into the deltoid muscle, preferably of the nondominant arm .
Each subject will be assigned to receive either:
For easier reference, refer to the below definitions of each study group:
Step 1 (Day 0): Cohort 1 will receive their initial dose of vaccine.
Step 2 (Day 7): After 7 days from step 1, Cohort 2 will receive their initial dose of vaccine.
Step 3 (Day 14): After 7 days from step 2; Cohort 1 will receive their second dose of vaccine, and Cohort 3 & 4 will randomly receive their initial dose of vaccine.
Step 4 (Day 21): After 7 days from step 3, Cohort 2 will receive their second dose of vaccine, and Cohort 5 will receive their initial dose of vaccine
Step 5 (Day 28): After 7 days from step 4, Cohort 3 & 4 will receive their second dose of vaccine, and Cohort 6 will receive their initial dose of vaccine
Step 6 (Day 35): After 7 days from step 5, Cohort 5 will receive their second dose of vaccine
Step 7 (Day 42): After 7 days from step 6, Cohort 6 will receive their second dose of vaccine.
The Data Monitoring Committee (DMC) will periodically review trial data including safety data. Subjects will also be asked to provide blood samples at specified time points, which investigators will test in the laboratory to detect and measure the immune response to the vaccine candidate
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Positive pregnancy test either at screening or just prior to each vaccine administration.
Female subject who is breastfeeding or plans to breastfeed from the time of the first vaccination through 60 days after the last vaccination.
Individuals at high risk for severe COVID-19, including those with any of the following risk factors:
Have any other medical disease/condition or psychiatric condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation. (Appendix II)
History of recent COVID-19 diagnosis; within 6 months prior to enrollment . This should be confirmed with chest computed tomography (CT) scan and or polymerase chain reaction (PCR).
Has an acute illness, as determined by the participating site PI or appropriate sub-investigator, with or without fever (oral temperature of 37.8 °C or above) within 72 hours prior to each vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the participating site PI or appropriate sub-investigator, the residual symptoms will not interfere with the ability to assess safety parameters as required by the protocol.
Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
Has participated in another investigational study involving any investigational product (study drug, biologic or device) within 60 days, or 5 half-lives, whichever is longer, before the first vaccine administration.
Currently enrolled in or plans to participate in another clinical study with an investigational agent that will be received during the study-reporting period.
Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines.
Exposure to radiotherapy or chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness. Including, but not limited to, systemic corticosteroids exceeding ≥20 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar drugs during the preceding 6-month period prior to vaccine administration (Day 0). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
Anticipating the need for radiotherapy or immunosuppressive treatment within the next 6 months. Including, but not limited to, systemic corticosteroids ≥20 mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar drugs during the preceding 6-month period prior to vaccine administration (Day 0). The use of low dose topical, ophthalmic, inhaled and intranasal steroid preparations will be permitted.
Received immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
Has any blood dyscrasias or clinically significant disorder of coagulation (in the opinion of the investigator). The use of ≤325 mg of aspirin per day as prophylaxis is permitted, but the use of other platelet aggregation inhibitors, thrombin inhibitors, Factor Xa inhibitors, or warfarin derivatives is exclusionary, regardless of bleeding history.
Has any liver disease or impairment, including fatty liver.
Has a history of alcohol abuse or other recreational drug use within 6 months before the first vaccine administration.
Has a positive test result for drugs of abuse at screening or before the first vaccine administration.
Has any abnormality that would interfere with the ability to observe local reactions at the injection site.
Received or plans to receive a licensed, live vaccine within 4 weeks before or after each vaccination. For example: Yellow fever, Tuberculosis (BCG), Influenza live attenuated.
Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after each vaccination.
Receipt of any other SARS-CoV-2 or other experimental coronavirus vaccine at any time prior to or during the study.
Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to vaccine administration. If exposure is suspected, subjects may be enrolled with subsequent documentation of a negative test for SARS-CoV-2, at the discretion of the investigator.
On current treatment with investigational agents for prophylaxis of COVID-19.
Currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g., healthcare worker, emergency response personnel).
Primary purpose
Allocation
Interventional model
Masking
45 participants in 3 patient groups, including a placebo group
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Central trial contact
Sameera Ezzat, MD; Ahmed Ramadan, MSc
Data sourced from clinicaltrials.gov
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