NCT05366296
Withdrawn
Phase 1
A Randomized, Observer-Blinded, Placebo-Controlled Phase I Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of One Dose Booster by A Lyophilized COVID-19 mRNA Vaccine in Adults Aged 18 to 60 Years
Wuhan Recogen Biotechnology Co., Ltd.0 sitesJuly 2022
ConditionsCOVID-19 Pandemic
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- COVID-19 Pandemic
- Sponsor
- Wuhan Recogen Biotechnology Co., Ltd.
- Primary Endpoint
- The occurrence of unsolicited AEs within 28 days after the booster vaccination.
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
Brief Summary
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19), which is spreading all over the world. This virus can cause acute respiratory distress syndrome (ARDS) with a high fatality rate. In this phase I first-in-human clinical trial, healthy volunteers in two dose cohorts will be vaccinated Lyophilized COVID-19 mRNA Vaccine (RH109) The aim of the study is to assess the safety, reactogenicity and Immunogenicity of the candidate vaccine and to characterize its immunogenicity.
Detailed Description
Participants will be enrolled into 2 ascending dose (RH109 low-dose 25 μg, high-dose 50 μg) cohorts randomly. Approximately 24 eligible participants, 12 for each cohort, will be randomized with a 3:1 ratio (RH109 : Placebo). The study will progress in a sequential manner, with the low-dose cohort being enrolled and dosed first. Dose escalation from low-dose to high-dose cohort is contingent on a review of safety data of the low-dose cohort through to 7 days following the vaccination by a Safety Monitoring Committee (SMC)
Investigators
Eligibility Criteria
Inclusion Criteria
- •Aged 18 to 60 years (included) at screening.
- •Have a body mass index (BMI) between 18.5 and 35.0 kg/m2 (included)
- •Able and willing to comply with all study requirements.
- •Willing to allow the Investigator to discuss the volunteers'participant's medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures.
- •Participants who are of general good health, or with medically stable, well-controlled comorbidities according to the Investigator's assessment, based on medical history at the time of screening and clinical evaluations.
- •Have completed three doses vaccination by any mRNA COVID-19 vaccine 3\~12 months (90\~365 days, included) prior to the study vaccination.
- •Females of childbearing potential who are involved in heterosexual sexual activity, must be willing to practice continuous effective contraception until 90 days after the study vaccination and have negative pregnancy tests before study vaccination.
- •Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for ≥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status.
- •The effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc.
- •Males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after the study vaccination.
Exclusion Criteria
- •Laboratory confirmed SARS-CoV-2 infection (history), defined by the result of SARS-CoV-2 RT-PCR assay is positive, and/or SARS-CoV-2 nucleocapsid protein antibody is positive.
- •Documented medical history of COVID-19 disease.
- •Fever (oral temperature ≥ 37.5°C / axillary temperature ≥ 37.3°C) on the day of vaccination. Or having fever within 72 hours before the vaccination.
- •Having abnormal results of clinical laboratory testing during screening, which is judged by the Investigator to be clinically significant, including hematology, clinical chemistry, urinalysis, and coagulation.
- •History of severe allergic disease or reactions likely to be exacerbated by any component of investigational vaccine, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local hypersensitive necrosis reaction (Arthus reaction), prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema.
- •Having malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ), immune disease (e.g., documented human immunodeficiency virus \[HIV\] infection, systemic lupus erythematosus, rheumatoid arthritis, alienia or splenectomy, and other immune disease that may influence immune response at the Investigator's discretion).
- •Having severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease (including history of myocarditis or pericarditis), respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. Mild/moderate well-controlled comorbidities are allowed to participate.
- •Having bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture.
- •Received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before the study vaccination. Local administration of immunosuppressant or immunomodulator is allowed (e.g., ointment, eye drops, inhalation, or nasal spray). Drugs for local administration should not be given at a dose over the recommended level in package insert or participants should have no signs of systemic exposure.
- •Administration of immunoglobulin and/or blood product within 3 months before the study vaccination or plan to use that during the study.
Outcomes
Primary Outcomes
The occurrence of unsolicited AEs within 28 days after the booster vaccination.
Time Frame: Time Frame: within 28 days after the booster vaccination
The occurrence of serious adverse events (SAEs) and adverse events of special interest (AESIs) until 6 months after the booster vaccination
Time Frame: Until 6 months after the booster vaccination
The occurrence of solicited local and systemic adverse events (AEs) within 7 days after the booster vaccination
Time Frame: Within 7days after each does
Secondary Outcomes
- The GMI of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination(At 14 days, 28 days, 3 months and 6 months after the booster vaccination.)
- The GMT of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination.(At 14 days, 28 days, 3 months and 6 months after the booster vaccination.)
- The SCR of anti-N-terminal domain (NTD) and anti-receptor binding domain (RBD) specific IgG at 14 days, 28 days, 3 months and 6 months after the booster vaccination.(At 14 days, 28 days, 3 months and 6 months after the booster vaccination.)
- Seroconversion rate (SCR) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype(At 14 days, 28 days, 3 months and 6 months after the booster vaccination.)
- Geometric mean titer (GMT) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype(At 14 days, 28 days, 3 months, and 6 months after the booster vaccination.)
- Geometric mean increase (GMI) of live-virus neutralizing antibody against SARS-CoV-2 Omicron variant (e.g., BA.1 and BA.2) and SARS-CoV-2 prototype(At 14 days, 28 days, 3 months, and 6 months after the booster vaccination.)
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