Safety, Reactogenicity and Immunogenicity Study of ReCOV

NCT04818801 | Completed Early Phase 1 DMC

• 1 other identifier: CT61101
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

Covid19

Outcome Measures

Primary Outcomes (5)

• Number of Participants with solicited local and systemic adverse events

  Incidence of solicited local and systemic adverse events up to 7 days after each dose

  up to 7 days after each dose

• Number of Participants with unsolicited adverse events after each dose

  Incidence of unsolicited adverse events after each dose up to 30 days after the second dose

  up to 30 days after the second dose

• Number of Participants with serious adverse events

  Incidence of serious adverse events up to 30 days after the second dose

  up to 30 days after the second dose

• Number of Participants with changes in clinical laboratory tests from baseline

  Changes in clinical laboratory tests from baseline up to 7 days after each dose

  up to 7 days after each dose

• Number of Participants with changes in vital signs from baseline

  Changes in vital signs from baseline up to 30 days after the second dose

  up to 30 days after the second dose

Secondary Outcomes (10)

• 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 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

• Geometric mean fold increase

  first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360

Study Arms (2)

Recombinant two-component COVID-19 vaccine (CHO cell)

EXPERIMENTAL

Participants received Recombinant two-component COVID-19 vaccine (CHO cell) 0.5ml reconstituted by adjuvant solution, 2 shots at a interval 21 days, intramuscular injection

Biological: Recombinant two-component COVID-19 vaccine (CHO cell)

Placebo

PLACEBO COMPARATOR

Participants received placebo of 0.5ml normal saline (0.9% sodium chloride solution), 2 shots at a interval 21 days, intramuscular injection

Other: Placebo

Interventions

Recombinant two-component COVID-19 vaccine (CHO cell) BIOLOGICAL

The spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies.

Also known as: ReCOV

Recombinant two-component COVID-19 vaccine (CHO cell)

Placebo OTHER

Normal saline (0.9% sodium chloride solution),

Also known as: Normal saline

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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/m2.
• 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.
• Female subjects are eligible to participate if not pregnant, not breastfeeding, and at least 1 of the following conditions applies:
• Is not a woman of childbearing potential (WOCBP), defined as:
• Surgically sterile (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy, as confirmed by review of the subject's medical records, medical examination, or medical history interview), or Postmenopausal (defined as no menses for 12 months without an alternative medical cause. A high follicle-stimulating hormone \[FSH\] level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy \[HRT\]. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient). Female subjects on HRT and whose menopausal status is in doubt will be required to use 1 of the non estrogen hormonal highly effective contraception methods from Day 1 until at least 6 months after the second dose of IP if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of postmenopausal status before study enrollment.
• Is a WOCBP who agrees to use a highly effective method of contraception consistently and correctly from Day 1 until at least 6 months after the second dose of IP.
• Nonsterilized male subjects with female partners of childbearing potential are eligible to participate if they agree to ONE of the following from Day 1 until at least 6 months after the second dose of IP and refrain from donating sperm during this period:

You may not qualify if:

• 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 1. 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 1.
• Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.
• Known HIV or acquired immune deficiency syndrome.
• Subjects with active or prior documented autoimmune disorder (such as potential immune mediated diseases \[pIMDs\]).
• Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Day 1 or planned during the full length of the study.
• Being treated for tuberculosis.
• History of allergic disease or reactions associated with previous vaccinations or likely to be exacerbated by any component of the IP.
• Individuals who have had a previous confirmed or suspected illness caused by SARS-CoV-1, SARS-CoV-2, or MERS-CoV.
• Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder within the past 5 years from the first dose of the IP (Day 1).

Sponsors & Collaborators

• Jiangsu Rec-Biotechnology Co., Ltd.: lead
• Iqvia Pty Ltd: collaborator

Study Sites (2)

Auckland Clinical Studies

Auckland, New Zealand

Location

Christchurch Clinical Studies Trust

Christchurch, New Zealand

Location

Related Publications (1)

• Wynne C, Balgos A, Li J, Hamilton P, Tirador L, Jaen AM, Mo C, Yue Z, Ma Y, Wang Q, Wen R, Yao Z, Yu J, Yao W, Zhang J, Zheng H, Hong K, Zhu F, Liu Y. Safety and Immunogenicity of a Recombinant Two-Component SARS-CoV-2 Protein Vaccine: Randomized, Double-Blind, Placebo-Controlled Phase I and Phase II Studies. Infect Dis Ther. 2024 Jan;13(1):57-78. doi: 10.1007/s40121-023-00896-w. Epub 2023 Dec 16.

  PMID: 38103161 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 26, 2021
• Study Start: June 18, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 5, 2022
• Last Updated: September 27, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (2)