Status:
COMPLETED
Study of a Severe Acute Respiratory Syndrome CoV-2 (SARS-CoV-2) Virus-like Particle (VLP) Vaccine in Healthy Adults
Lead Sponsor:
Ihsan GURSEL, PhD, Prof.
Collaborating Sponsors:
Dr Abdurrahman Yurtaslan Ankara Oncology Training and Research Hospital
The Scientific and Technological Research Council of Turkey
Conditions:
Covid19
Eligibility:
All Genders
18-59 years
Phase:
PHASE1
Brief Summary
This is a VLP SARS-CoV-2 vaccine study of a vaccine developed in Turkey and manufactured according to Good Manufacturing Practices (GMP) requirements. Preclinical toxicology studies on experimental an...
Detailed Description
This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective VLP vaccine (harboring M, N, E, and hexapro modifi...
Eligibility Criteria
Inclusion
- To be eligible for the study, each participant must satisfy all the following criteria:
- Healthy participants between 18-59 years of age,
- Sign an informed consent document,
- Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
- Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
- Able to comply with the study protocol during the study period,
- Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
- Body temperature \<37.2 C,
- Body mass index 18-35 kg/m2,
- Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose,
- Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
- Female participants who are not pregnant or who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,
- Male participants who will be able to have appropriate contraception methods for 6 months after vaccination,
Exclusion
- Participants with any of the following criteria will be excluded:
- History of seizure, encephalopathy or psychosis,
- History of allergic reactions to any known vaccine or to any component of the study vaccine,
- Pregnant, breastfeeding or positive pregnancy test or planning to conceive within 6 months,
- Active infection signs or body temperature \>37.2 C,
- History of SARS-CoV-2 infection,
- Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
- Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
- Congenital or acquired angioedema,
- Diagnosis of immunodeficiency,
- Diagnosis of bleeding diathesis,
- Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
- Those who received blood and blood product transfusions in the last 6 months,
- Those on any vaccine program or experimental medication within 1 month prior to the study,
- History of any live vaccine administration within 1 month prior to the study,
- History of any inactive vaccine administration within 1 month prior to the study,
- Use of active tuberculosis treatment,
- According to the investigator's evaluation, those who have any condition (medical, psychological, social, etc.) that may impair the patient's compliance with the study will be excluded from the study.
Key Trial Info
Start Date :
March 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04818281
Start Date
March 27 2021
End Date
December 29 2021
Last Update
May 25 2022
Active Locations (1)
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1
Dr. Abdurahman Yurtaslan Ankara Oncology Training and Research Hospital Phase I Clinical Study Center
Ankara, Turkey (Türkiye), 06200