A Randomised, Double-Blind, Dose-Escalation Phase I Study in Healthy Adults to Assess the Safety, Tolerability and Immunogenicity of Glycovax-002, a Novel Vaccine Candidate Against COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
研究概览
简要总结
Glycovax Pharma has developed a glycoconjugate vaccine candidate called Glycovax-002 to fight the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the origin of COVID-19.
The aim of the study is to assess the safety, reactogenicity and immunogenicity of Glycovax-002 in humans. The study is a phase I, placebo-controlled, dose-escalation study conducted in 36 healthy females and males aged between 18 and 55 years old. The vaccine will be administered three times with a two-week time interval between each dose.
Dose escalation is conducted in three steps. At each step, 9 participants receiving the vaccine will be randomized with 3 participants receiving placebo (normal saline). Progression to next step is conditional to a DSMB's approval.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All the following criteria need to be met for inclusion:
- •Adults in good health as determined by the Principal Investigator or Sub-Investigator between 18 - 55 years old inclusively.
- •Able to provide informed consent and willing to comply with the study procedures.
- •BMI ≥ 18.0 kg/m2 and ≤ 35.0 kg/m2, with weight ≥ 45 kg for female subjects and ≥ 50 kg for male subjects.
- •Vital signs within the following limits: systolic blood pressure (BP) 90 - 140 mmHg, inclusive; diastolic BP 40 - 90 mmHg, inclusive; heart rate 40 - 100 bpm, inclusive; respiratory rate 10 - 22 bpm, inclusive; temperature 35.5 - 37.5 °C, inclusive.
- •Women of child-bearing potential should have a negative serum pregnancy test at Screening and a confirmatory negative urine pregnancy test at Baseline (Day 0, defined as enrolment), one before the second administration (Day 14) and one before the third and last dose administration (Day 28).
- •Agrees to practice acceptable contraception during the study if female of child-bearing potential or male partner of female of child-bearing potential.
- •Physical examination, clinical assessments, and laboratory values within normal limits during Screening, unless assessed as not clinically significant by Investigator or Delegate.
- •Has received a dose or multiple doses, of a registered COVID-19 vaccine, with the last dose more than two months prior to enrolment.
- •Exclusion criteria:
- •Participants will be excluded if any of the following criteria are met:
- •Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator, that could adversely affect the safety of the participant or confound the results of the study. Fully resolved childhood asthma is not exclusionary.
- •History of malignancy, except for non-melanoma skin cancer when excised more than two years ago and cervical intraepithelial neoplasia that has been successfully cured more than two years prior to Screening.
- •Any of the following specific conditions:
- •Autoimmune conditions;
- •Metabolic disorders;
- •Glycosyl transferase disorders (including disorders of fucosyl transferase and fucose metabolism);
- •Tn polyagglutination of erythrocyte syndrome, deficiency of galactosyl transferase, anemia, leukopenia, or thrombocytopenia;
- •Known bacterial infections involving neuraminidase-expressing bacteria.
- •Use of any prescription medication that, in the Investigator's judgment, can interfere with the interpretation of the study tests or in the opinion of the Investigator may be contra-indicated for use with Glycovax-
- •Medications that have been stable in the past 3 months may be allowed, for instance medications for hypertension, hypercholesterolemia, and gastroesophageal reflux disease (e.g. proton pump inhibitors).
- •Receipt of chronic systemic treatment with known immunosuppressant medications, or radiotherapy, within 60 days prior to enrolment.
- •Receipt of chronic systemic immunostimulant therapy (such as interferons or interleukins) within 60 days prior to enrolment.
- •Receipt of systemic corticosteroids (≥20 mg/day of prednisone or equivalent) for ≥14 days within 28 days prior to enrolment.
- •Receipt of blood/plasma products or immunoglobulins within 6 months prior to enrolment.
- •Receipt of any anticoagulation treatment (other than low dose aspirin).
- •History of myocarditis or pericarditis.
- •Presence of any sign or symptom that may suggest an active respiratory infection including COVID-19 at enrolment.
- •Any vaccination other than for influenza within 60 days prior to enrolment, or an influenza vaccination within 30 days prior to enrolment.
- •Planning to receive vaccination within 60 days after enrolment in the study.
- •Positive testing for COVID-19 within 3 months of enrolment or positive PCR testing for COVID-19 at enrolment.
- •Diagnosed with Influenza within 30 days prior to enrolment.
- •Positive for infection with HIV or with hepatitis B or C at Screening.
- •Receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) before study enrolment. For studies involving investigational products that fall within the categories mentioned in other Inclusion Criteria, the respective timelines should be respected.
- •History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis).
- •History of hypersensitivity or allergic reaction to any of the components of GVX-002, including diphtheria toxoid, or squalene-based adjuvants, including Sepivac SWE™ and MF
- •History of drug or alcohol abuse, or positive detection test at Screening or prior to Study Drug administration for alcohol or any illicit drug including cannabis.
- •Current smoking (more than 10 cigarettes/week), current vaping (more than 80 puffs/week), current cannabis use, alcohol abuse (defined as regularly consuming more than 14 units of alcohol per week), or current drug abuse (as tested at Screening), to avoid possible impairment of immune function.
- •Presence of tattoos or scars on the upper arms that would preclude visualising any injection site reactions.
- •Any other reason (e.g., poor venous access) at the Investigator's discretion.
排除标准
- 未提供
研究组 & 干预措施
Step 1 (Low Dose)
A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Low Dose or placebo (ratio 3:1).
干预措施: Glycovax-002 (Biological)
Step 2 (Medium Dose)
A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 Medium Dose or placebo (ratio 3:1).
干预措施: Glycovax-002 (Biological)
Step 3 (High Dose)
A total of 12 participants will receive three injections, spaced by two weeks, of Glycovax-002 High Dose or placebo (ratio 3:1).
干预措施: Glycovax-002 (Biological)
结局指标
主要结局
To assess the overall safety and reactogenicity of the Glycovax-002 conjugated vaccine administered at three different doses in healthy adults.
时间窗: Day 0 - 360
Safety: * Incidence of Adverse Events (AEs) in all participants. * Occurrence of each solicited local and systemic AE, during each 7-day follow-up period after injection. * Occurrence of any AEs until 28 days after the last injection. * Occurrence of serious AEs until one year after the first injection. * Assessment of safety will involve blood tests for biochemistry, hematology, serum chemistry and immunogenicity, urine tests for urinalysis, and participant diaries. Reactogenicity: Reactogenicity will be assessed by the incidence of the following solicited reactions for the first 7 days after each administration: Local: * Swelling at injection site * Erythema at injection site * Pain at injection site General (systemic): * Fever * Fatigue * Chills * Diarrhea * Myalgia * Arthralgia * Headache * Nausea/Vomiting
次要结局
- To assess the virus-neutralizing antibody response induced by Glycovax-002 in healthy adults(Day 0 - 56)
- To assess the immunogenicity induced by Glycovax-002 in healthy adults(Day 0 - 120)