COVID-19Phase 1SphinxNCT05218070
Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of COVID-19 Infection
A Phase 1 study testing EgyVax Vaccine Candidate in people with COVID-19, run by Eva Pharma at 1 site in Egypt.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- EgyVax Vaccine Candidate
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Feb 2022to Jun 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Provides proven legal identity.
- Provides written informed consent prior to initiation of any study procedures.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Agrees to the collection of venous blood per protocol.
- Male or non-pregnant female subjects, 18-55 years of age at the time of enrollment.
- Male or female of childbearing potential must agree to use or have practiced true abstinence or use at least two acceptable primary form of contraception from first vaccination until 60 days after the last vaccination.
Show all 13Show fewer
- Women of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each vaccination.
- Healthy subjects who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study.
- Oral temperature is less than 37.5 °C.
- Pulse less than 100 beats per minute.
- Blood pressure (BP) less than 140/90 mm Hg, inclusive. (Appendix I)
- Clinical screening laboratory evaluations (white blood cell (WBC), hemoglobin (Hgb), platelets (PLTs), alanine transaminase (ALT), aspartate transaminase (AST), creatinine (Cr), alkaline phosphatase (ALP), total bilirubin (T. Bili), prothrombin time (PT), partial thromboplastin time (PTT) and HbA1c) are within acceptable normal reference ranges at the clinical laboratory being used.
- Must agree to refrain from donating blood or plasma during the study (outside of this study).
Who cannot join
- 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:
- Type 1 diabetes (T1D), or type 2 diabetes (T2D) that cannot be controlled by drugs
- Hypertension that cannot be controlled by drugs
- Current smoking
Show all 30Show fewer
- History of chronic smoking within the prior year
- BMI is ≤ 18 kg/m2 or ≥ 40 kg/m2
- Resident in a long-term facility
- 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).
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University Hospitals (Al-Manial Specialized University Hospital)
Cairo
Dr. Amal S Hassan, Professor
About this study
Official title: Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of Severe Acute Respiratory Syndrome (SARS) - Coronavirus 2 (CoV-2) Infection (COVID-19)
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).
Read the detailed 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:
- 35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects)
- 70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects)
- Placebo for both injections at day 0 and day 14 (Placebo, 15 subjects)
For easier reference, refer to the below definitions of each study group:
- Cohort 1: first three subjects of the low dose vaccination group plus two subjects from the control group
- Cohort 2: second three subjects of the low dose vaccination group plus one subject from the control group
- Cohort 3: remaining nine subjects of the low dose vaccination group plus two subjects from the control group
- Cohort 4: first three subjects of the high dose vaccination group plus two subjects from the control group.
- Cohort 5: second three subjects of the high dose vaccination group plus one subject from the control group
- Cohort 6: remaining nine subjects of the high dose vaccination group plus two subjects from the control 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
- Conditions
- COVID-19
- Being tested
- EgyVax Vaccine Candidate, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EgyVax Vaccine CandidateDrug
EgyVax Inactivated SARS-CoV-2 vaccine candidate, equivalent to 70 mcg inactivated SARS-CoV-2 total protein. Alum adjuvant 2% 50 µl (equivalent to 0.5 mg AlOH). Equivalent volume of Saline 0.9% to each vaccine dose. Each vial contains 0.5 ml representing one dose 70 mcg of inactivated SARS-CoV-2 virus with alum adjuvant or two doses of 35 mcg of inactivated SARS-CoV-2 virus with alum adjuvant
PlaceboDrug
0.5ml Saline (0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Vaccine | Experimental | 35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects) Receives: Drug: EgyVax Vaccine Candidate |
| High Dose Vaccine | Experimental | 70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects) Receives: Drug: EgyVax Vaccine Candidate |
| Placebo | Placebo comparator | Placebo for both injections at day 0 and day 14 (Placebo, 15 subjects) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of EgyVax Vaccine after 1 month from the first vaccination dose
To evaluate the recorded adverse events (AEs) following vaccine administration
Measured: Up to 1 month of the first vaccination dose
Safety of EgyVax Vaccine up to 6 months of the first vaccination dose
To evaluate and follow up the Serious AEs (SAEs) following vaccine administration
Measured: Up to 6 months of the first vaccination dose
Secondary outcomes (3)
Evaluation of Neutralizing antibodies (NAB) response following vaccine administration
To measure the NAB levels following vaccine administration
Measured: Up to 6 month of the first vaccination dose
Dose Selection
To recommend dose for phase II clinical trials, in terms of safety and NAB response
Measured: After 3 months of the first vaccination dose
Safety of EgyVax Vaccine
To evaluate the recorded AEs following vaccine administration
Measured: Up to 1 year of the first vaccination dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start6 Feb 2022
- Primary completionOct 2022 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eva Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veterinary Serum & Vaccine Research Institute (VSVRI), Egypt, The Supreme Council of University Hospitals, Egypt, Ministry of Higher Education and Scientific Research, Egypt
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218070
- Sponsor's protocol ID
- SPHINX22122020
- Acronym
- Sphinx
- Status last verified
- Jan 2022
- First submitted
- 25 Jan 2022
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
World Health Organization. WHO Director-General's opening remarks at the media briefing on COVID-19. Available from: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 World Health Organization. Coronavirus disease 2019 (COVID-19) situation report - 70. In: Data as reported by national authorities by 10:00 CET 30 March 2020. Geneva, Switzerland: World Health Organization; 2020. Rauch S, Jasny E, Schmidt KE, et al. New vaccine technologies to combat outbreak situations. Front Immunol 2018;9:1963. Saad MA, Saleh AA, Islam Ryan MA, Saleh MS, Abdulaal T, Hassan WA, et al. Preliminary Step towards COVID-19 Inactivated Vaccine Development in Egypt. Archives of Clinical Trials. 2021 Jul 28;1(1). Ali AA, Saad MA, Ryan I, Amin M, Shindy MI, Hassan WA, et al. Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 In Mice As Emerging Vaccine Development In Egypt. bioRxiv. 2021 Jan 1. US Food and Drug Administration. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Rockville, MD: Center for Biologics Evaluation and Research; September 2007. Hobohm L, Becattini C, Ebner M, et al. Definition of tachycardia for risk stratification of pulmonary embolism. European Journal of Internal Medicine. 2020 Dec 1;82:76-82. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European heart journal. 2018 Sep 1;39(33):3021-104.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of EgyVax Vaccine Candidate for Prophylaxis of Severe Acute Respiratory Syndrome (SARS) - Coronavirus 2 (CoV-2) Infection (COVID-19)
- ClinicalTrials.gov ID
- NCT05218070
- Acronym / sponsor ID
- Sphinx / SPHINX22122020
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Eva PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Veterinary Serum & Vaccine Research Institute (VSVRI), Egypt, The Supreme Council of University Hospitals, Egypt, Ministry of Higher Education and Scientific Research, Egypt
- Study start
- 6 Feb 2022 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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:
- 35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects)
- 70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects)
- Placebo for both injections at day 0 and day 14 (Placebo, 15 subjects)
For easier reference, refer to the below definitions of each study group:
- Cohort 1: first three subjects of the low dose vaccination group plus two subjects from the control group
- Cohort 2: second three subjects of the low dose vaccination group plus one subject from the control group
- Cohort 3: remaining nine subjects of the low dose vaccination group plus two subjects from the control group
- Cohort 4: first three subjects of the high dose vaccination group plus two subjects from the control group.
- Cohort 5: second three subjects of the high dose vaccination group plus one subject from the control group
- Cohort 6: remaining nine subjects of the high dose vaccination group plus two subjects from the control 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Vaccine | Experimental | Drug: EgyVax Vaccine Candidate35 mcg dose for both vaccinations at day 0 and day 14 (low dose, 15 subjects) |
| High Dose Vaccine | Experimental | Drug: EgyVax Vaccine Candidate70 mcg dose for both vaccinations at day 0 and day 14 (high dose, 15 subjects) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo for both injections at day 0 and day 14 (Placebo, 15 subjects) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Provides proven legal identity.
- Provides written informed consent prior to initiation of any study procedures.
- Willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
- Agrees to the collection of venous blood per protocol.
- Male or non-pregnant female subjects, 18-55 years of age at the time of enrollment.
Key exclusion criteria (30 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EgyVax Vaccine CandidateEgyVax Inactivated SARS-CoV-2 vaccine candidate, equivalent to 70 mcg inactivated SARS-CoV-2 total protein. Alum adjuvant 2% 50 µl (equivalent to 0.5 mg AlOH). Equivalent volume of Saline 0.9% to each vaccine dose. Each vial contains 0.5 ml representing one dose 70 mcg of inactivated SARS-CoV-2 virus with alum adjuvant or two doses of 35 mcg of inactivated SARS-CoV-2 virus with alum adjuvant | Drug | High Dose Vaccine, Low Dose Vaccine |
| Placebo0.5ml Saline (0.9%) | Drug | Placebo |
Primary outcome
Safety of EgyVax Vaccine after 1 month from the first vaccination dose
Time frame: Up to 1 month of the first vaccination dose
To evaluate the recorded adverse events (AEs) following vaccine administration
Safety of EgyVax Vaccine up to 6 months of the first vaccination dose
Time frame: Up to 6 months of the first vaccination dose
To evaluate and follow up the Serious AEs (SAEs) following vaccine administration
3 secondary outcomes
Evaluation of Neutralizing antibodies (NAB) response following vaccine administration
Time frame: Up to 6 month of the first vaccination dose
Dose Selection
Time frame: After 3 months of the first vaccination dose
Safety of EgyVax Vaccine
Time frame: Up to 1 year of the first vaccination dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- BackgroundWorld Health Organization. WHO Director-General's opening remarks at the media briefing on COVID-19. Available from: https://www.who.int/dg/speeches/detail/who-director-general-s-opening-remarks-at-the-media-briefing-on-covid-19---11-march-2020 World Health Organization. Coronavirus disease 2019 (COVID-19) situation report - 70. In: Data as reported by national authorities by 10:00 CET 30 March 2020. Geneva, Switzerland: World Health Organization; 2020. Rauch S, Jasny E, Schmidt KE, et al. New vaccine technologies to combat outbreak situations. Front Immunol 2018;9:1963. Saad MA, Saleh AA, Islam Ryan MA, Saleh MS, Abdulaal T, Hassan WA, et al. Preliminary Step towards COVID-19 Inactivated Vaccine Development in Egypt. Archives of Clinical Trials. 2021 Jul 28;1(1). Ali AA, Saad MA, Ryan I, Amin M, Shindy MI, Hassan WA, et al. Safety and Immunogenicity Evaluation of Inactivated whole-virus-SARS-COV-2 In Mice As Emerging Vaccine Development In Egypt. bioRxiv. 2021 Jan 1. US Food and Drug Administration. Guidance for industry: toxicity grading scale for healthy adult and adolescent volunteers enrolled in preventive vaccine clinical trials. Rockville, MD: Center for Biologics Evaluation and Research; September 2007. Hobohm L, Becattini C, Ebner M, et al. Definition of tachycardia for risk stratification of pulmonary embolism. European Journal of Internal Medicine. 2020 Dec 1;82:76-82. Williams B, Mancia G, Spiering W, et al. 2018 ESC/ESH Guidelines for the management of arterial hypertension: The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). European heart journal. 2018 Sep 1;39(33):3021-104.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing EgyVax Vaccine Candidate in people with COVID-19, run by Eva Pharma at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameera Ezzat, MD (+201001551576, samira.ezzat@evapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of EgyVax Vaccine after 1 month from the first vaccination dose (time frame: Up to 1 month of the first vaccination dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05218070, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.