IRCT20230131057293N1
Completed
Phase 1
Phase I, Randomized, Double Blind, Placebo-controlled, Study of the Safety and Immunogenicity of mRNA-based COVID-19 Vaccine (COReNAPCIN) Produced by ReNAP Co. as Booster Dose in Healthy Population Aged 18-50 Years
ReNAP Company0 sites30 target enrollmentTBD
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19.
- Sponsor
- ReNAP Company
- Enrollment
- 30
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Provides written informed consent prior to initiation of any study procedures
- •Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits
- •Agrees to perform all study procedures, including the collection of venous blood per protocol
- •18 to 50 years of age, inclusive
- •Body Mass Index 18\-35 kg/m2
- •Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration
- •Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after
- •Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after
- •In good health as determined by medical history and physical examination and the opinion of the principal investigator
- •Has received 3 doses of inactivated Sinopharm or COVIran Barekat vaccine and the time interval from receiving the last dose of vaccine to receiving clinical study intervention at least 90 days and maximum 18 months, vaccination history must be checked and approved through the vaccination record
Exclusion Criteria
- •Positive pregnancy test either at screening or just prior to intervention administration
- •Female subject who is breastfeeding or plans to breastfeed from the time of intervention through 60 days after
- •Has any medical disease or condition that, in the opinion of the principal investigator, precludes study participation
- •Presence of self\-reported or medically documented significant medical (including respiratory, cardiovascular, neurological, autoimmune, Immunodeficiency, and kidney diseases...) or psychiatric condition
- •Has an acute illness within 2 weeks prior to injection, with or without fever \[temperature \=38\.0°C], runny nose or eyes, shortness of breath, cough, weakness, and diarrhea, that in the opinion of the principal investigator, precludes study participation
- •Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies
- •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 intervention administration
- •Currently enrolled in or plans to participate in another clinical trial during the study period
- •Has previously participated in an investigational study involving lipid nanoparticles (LNPs)
- •Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any components of the study product, any previous licensed or investigational vaccines or medication, and to any food or cosmetics
Outcomes
Primary Outcomes
Not specified
Similar Trials
Completed
Phase 1
Phase I, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenous APL-9 in Healthy VolunteersIschaemic strokeStroke - IschaemicACTRN12617001308381Clinical Network Services Pty Ltd34
Completed
Phase 1
Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Intravenous APL-2 in Healthy VolunteersACTRN12616000700437Clinical Network Services Pty Ltd25
Terminated
Phase 1
Phase 1, Double-blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Subcutaneous APL-9 in Healthy VolunteersParoxysmal nocturnal hemoglobinuria (PNH)Blood - Haematological diseasesACTRN12616000862448Clinical Network Services Pty Ltd6
Completed
Not Applicable
Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled).hepatitis-C infections10047438NL-OMON30518Janssen-Cilag60
Not yet recruiting
Phase 1
Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RPH-203 Following a Single Dose in Healthy Male VolunteersBone MetastasisOsteoporosisCancer - BoneMusculoskeletal - OsteoporosisACTRN12613000651785ucleus Network Limited48