EUCTR2020-003734-20-IT
Active, Not Recruiting
Phase 1
A Phase I/II study to assess the safety and immunogenicity of COVID-eVax, a candidate plasmid DNA vaccine for COVID-19, in healthy adult volunteers. - COVID-eVax
Takis S.r.l.0 sites160 target enrollmentFebruary 15, 2021
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 prevention.
- Sponsor
- Takis S.r.l.
- Enrollment
- 160
- Status
- Active, Not Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Signed and dated informed consent obtained before undergoing any study\-specific procedure
- •2\. Healthy male or female aged \=18 and \= 65 years
- •3\. Body Mass Index \>18\.5 and \=30 kg/m2
- •4\. Vital signs within the following values or ranges:
- •a. Body temperature \= 37,5 °C
- •b. Pulse frequency \=51 and \=100 beats per minute
- •c. Diastolic BP \=60 mmHg, \= 90 mmHg
- •d. Systolic BP \= 90 mmHg, \= 140 mmHg
- •e. Respiratory rate \= 12 breaths per minute, \= 16 breaths per minute
- •5\. ECG at screening normal or with no clinically significant findings (pre\-excitation syndromes, e.g., Wolff\-Parkinson\-White syndrome are absolute exclusion criteria)
Exclusion Criteria
- •1\. History of confirmed infection with SARS\-CoV\-2, by positive nasopharingeal swab or by positive serological test for SARS\-CoV\-2 antibodies
- •2\. Positive serological test for SARS\-CoV\-2 antibodies at screening
- •3\. Subjects at high risk of SARS\-CoV\-2 infection prior or during the trial, including:
- •a. subjects with any known exposure in the 4 weeks before enrolment
- •b. close contacts of suspected or confirmed COVID\-19 or SARS\-CoV\-2 infection cases
- •c. subjects quarantined for any reason
- •d. frontline healthcare professionals working in Emergency departments, ICU and other higher risk healthcare areas
- •4\. Positive serological tests for:
- •a. Hepatitis B surface antigen (HBsAg)
- •b. Hepatitis C antibodies
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, Not Recruiting
Phase 1
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without adjuvant chemo(-radio)therapy, to patients with MAGE-A3-positive Non-Small Cell Lung cancer (stage IB, II or III) - MAGE3-AS15-NSC-001on-Small Cell Lung CancerMedDRA version: 6.1Level: PTClassification code 10061873EUCTR2006-004777-10-ITGlaxoSmithKline Biologicals70
Active, Not Recruiting
Phase 1
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III) - MAGE3-AS15-NSC-001 (ADJ-Chemo)EUCTR2006-004777-10-GBGlaxoSmithKline Biologicals72
Active, Not Recruiting
N/A
A study to assess the safety and immunogenicity of an anti leukemia Antigen-Specific Cancer Immunotherapeutic (ASCI) combined with infusions of T lymphocytes in in vivo regulatory T cells depleted patients as post-consolidation therapy for adult patients with WT1-positive Acute Myeloid Leukemia (AML).EUCTR2011-004144-22-BEInstitut Jules Bordet - Université Libre de Bruxelles
Active, Not Recruiting
N/A
A Phase I/II study to assess the safety and immunogenicity of recMAGE-A3+AS15 cancer immunotherapeutic given as adjuvant therapy, with or without standard adjuvant chemo(-radio)therapy, to patients with MAGE A3-positive Non-Small Cell Lung Cancer (stage IB, II or III) - MAGE3-AS15-NSC-001 (ADJ-Chemo)EUCTR2006-004777-10-DEGlaxoSmithKline Biologicals72
Active, Not Recruiting
Phase 1
Phase I/II study of a new cancer immunotherapeutic in Non-Small Cell Lung Cancer patients.Adult patients with pathologically proven MAGE A3-positive Non-Small Cell Lung Cancer in stage IB, II or III.Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2006-004777-10-BEGlaxoSmithKline Biologicals72