A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of ReCOV, a Vaccine for COVID-19, in Healthy Adult Subjects
Overview
- Phase
- Early Phase 1
- Intervention
- Not specified
- Conditions
- Covid19
- Sponsor
- Jiangsu Rec-Biotechnology Co., Ltd.
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Number of Participants with changes in vital signs from baseline
- Status
- Completed
- 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 different age cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV.
The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and to characterize its immunogenicity.
Detailed Description
A total of 100 participants will receive the following vaccine regime: First, 20 young adult participants (18 to 55 years old) will receive 20μg of ReCOV vaccine on days 0 and 21. Then, 20 young adult participants (18 to 55 years old) will receive 40μg of ReCOV vaccine on days 0 and 21, and 20 old adult participants (56 to 80 years old) will receive 20μg of ReCOV vaccine on days 0 and 21. Finally, 20 old adult participants (56 to 80 years old) will receive 40μg of ReCOV vaccine on days 0 and 21. In the same time, 8 participants for each cohort, total 32 participants will receive 0.5ml of normal saline on days 0 and 21. Safety and immunogenicity data will be collected throughout the study, which concludes at 12 month after the second dose.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects are eligible to be included in the study only if ALL of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and in this protocol.
- •Male or female subjects who are ≥18 years old at the time of Screening (signing the ICF):
- •For the younger adult group: 18 to 55 years, inclusive
- •For the older adult group: ≥56 to \<80 years
- •Have a body mass index (BMI) between 18.5 and 35.0 kg/m
- •Subjects who are of general good health according to the Investigator's assessment, based on a complete medical history without major pathology, and as determined by medical evaluation (including physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory tests). Subjects in the older adult population who have medically stable, well-controlled comorbidities may be enrolled at the discretion of the Investigator.
- •NOTE: All clinical laboratory values should be within reference ranges unless confirmed by Investigator or delegate as not clinically significant. One repeat evaluation of ECG, vital signs, and clinical laboratory tests will be permitted, at the discretion of the Investigator.
- •Subjects who test negative for hepatitis B surface antigen (HBsAg), hepatitis B core antibodies (anti-HBc), anti-hepatitis C virus (HCV) antibodies, and anti-human immunodeficiency virus (HIV) 1 and 2 antibodies at Screening.
- •Subjects who test negative for SARS-Cov-2 infection, based on a reverse transcriptase polymerase chain reaction (RT-PCR) test and serological test for SARS-COV-2 IgM and/or IgG antibodies at Screening.
Exclusion Criteria
- •Subjects are excluded from the study if ANY of the following criteria apply at any time starting from Screening up to Day 1 prior to IP administration:
- •History of clinically significant and uncontrolled hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurologic disease in the opinion of the Investigator within 12 months prior to Screening.
- •Individuals with behavioral or cognitive impairment in the opinion of the Investigator.
- •Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillain-Barré syndrome.
- •Individuals with known or suspected impairment of the immune system, such as:
- •Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days within 60 days prior to Day
- •Use of inhaled, intranasal, or topical corticosteroids is allowed. NOTE: Systemic (oral or parenteral) corticosteroids are also prohibited for 3 weeks after the second dose of the IP.
- •Receipt of cancer chemotherapy within 5 years prior to Day
- •Receipt of immunostimulants or immunosuppressants within 60 days prior to Day
- •Known HIV or acquired immune deficiency syndrome.
Outcomes
Primary Outcomes
Number of Participants with changes in vital signs from baseline
Time Frame: up to 30 days after the second dose
Changes in vital signs from baseline up to 30 days after the second dose
Number of Participants with solicited local and systemic adverse events
Time Frame: up to 7 days after each dose
Incidence of solicited local and systemic adverse events up to 7 days after each dose
Number of Participants with changes in clinical laboratory tests from baseline
Time Frame: up to 7 days after each dose
Changes in clinical laboratory tests from baseline up to 7 days after each dose
Number of Participants with unsolicited adverse events after each dose
Time Frame: up to 30 days after the second dose
Incidence of unsolicited adverse events after each dose up to 30 days after the second dose
Number of Participants with serious adverse events
Time Frame: up to 30 days after the second dose
Incidence of serious adverse events up to 30 days after the second dose
Secondary Outcomes
- Geometric mean titers(GMT)(first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360)
- Seroconversion rates(first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360)
- Number of Participants with adverse events,serious adverse events, and adverse events of special interest(up to 12 months after the second dose)
- Number of Participants with changes in vital signs from baseline(up to 12 months after the second dose)
- Geometric mean fold increase(first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360)
- IFN-γ(first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360)
- Levels of other T cell biomarkers(first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360)