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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04818801




Registration number
NCT04818801
Ethics application status
Date submitted
19/03/2021
Date registered
26/03/2021
Date last updated
27/09/2022

Titles & IDs
Public title
Safety, Reactogenicity and Immunogenicity Study of ReCOV
Scientific title
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
Secondary ID [1] 0 0
CT61101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Covid19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Recombinant two-component COVID-19 vaccine (CHO cell)
Other interventions - Placebo

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

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


Other interventions: Recombinant two-component COVID-19 vaccine (CHO cell)
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.

Other interventions: Placebo
Normal saline (0.9% sodium chloride solution),
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with solicited local and systemic adverse events
Timepoint [1] 0 0
up to 7 days after each dose
Primary outcome [2] 0 0
Number of Participants with unsolicited adverse events after each dose
Timepoint [2] 0 0
up to 30 days after the second dose
Primary outcome [3] 0 0
Number of Participants with serious adverse events
Timepoint [3] 0 0
up to 30 days after the second dose
Primary outcome [4] 0 0
Number of Participants with changes in clinical laboratory tests from baseline
Timepoint [4] 0 0
up to 7 days after each dose
Primary outcome [5] 0 0
Number of Participants with changes in vital signs from baseline
Timepoint [5] 0 0
up to 30 days after the second dose
Secondary outcome [1] 0 0
Number of Participants with adverse events,serious adverse events, and adverse events of special interest
Timepoint [1] 0 0
up to 12 months after the second dose
Secondary outcome [2] 0 0
Number of Participants with changes in vital signs from baseline
Timepoint [2] 0 0
up to 12 months after the second dose
Secondary outcome [3] 0 0
Geometric mean titers(GMT)
Timepoint [3] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [4] 0 0
Seroconversion rates
Timepoint [4] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [5] 0 0
Geometric mean fold increase
Timepoint [5] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [6] 0 0
IFN-?
Timepoint [6] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [7] 0 0
Geometric mean titers(GMT)
Timepoint [7] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [8] 0 0
Seroconversion rates
Timepoint [8] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [9] 0 0
Geometric mean fold increase
Timepoint [9] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360
Secondary outcome [10] 0 0
Levels of other T cell biomarkers
Timepoint [10] 0 0
first dose day 21, second dose day 14, , day 30, day 90, day 180 and day 360

Eligibility
Key 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:

1. 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.

2. Male or female subjects who are =18 years old at the time of Screening (signing the
ICF):

1. For the younger adult group: 18 to 55 years, inclusive

2. For the older adult group: =56 to <80 years

3. Have a body mass index (BMI) between 18.5 and 35.0 kg/m2.

4. 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.

5. 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.

6. 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.

7. Female subjects are eligible to participate if not pregnant, not breastfeeding, and at
least 1 of the following conditions applies:

1. 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.

2. 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.

8. 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:

1. Are abstinent from penile-vaginal intercourse as their usual and preferred
lifestyle (abstinent on a long-term and persistent basis) and agree to remain
abstinent.

2. Agree to use a male condom and have their partner use of a contraceptive method
with a failure rate of <1% per year when having penile-vaginal intercourse with a
WOCBP who is not currently pregnant.

3. Male subjects with a pregnant or breastfeeding partner must agree to remain
abstinent from penile-vaginal intercourse or use a male condom during each
episode of penile penetration.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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:

1. 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.

2. Individuals with behavioral or cognitive impairment in the opinion of the
Investigator.

3. Individuals with any progressive or severe neurologic disorder, seizure disorder,
or history of Guillain-Barré syndrome.

4. Individuals with known or suspected impairment of the immune system, such as:

1. 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.

2. Receipt of cancer chemotherapy within 5 years prior to Day 1.

3. Receipt of immunostimulants or immunosuppressants within 60 days prior to
Day 1.

4. Known HIV or acquired immune deficiency syndrome.

5. Subjects with active or prior documented autoimmune disorder (such as
potential immune mediated diseases [pIMDs]).

6. 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.

7. Being treated for tuberculosis.

5. History of allergic disease or reactions associated with previous vaccinations or
likely to be exacerbated by any component of the IP.

6. Individuals who have had a previous confirmed or suspected illness caused by
SARS-CoV-1, SARS-CoV-2, or MERS-CoV.

7. 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).

8. History of urticaria within 1 year prior to Screening.

9. History of hereditary angioneurotic edema or acquired angioneurotic edema.

10. History of asplenia or functional asplenia.

11. History of platelet disorder or other bleeding diathesis or condition associated
with prolonged bleeding that would, in the opinion of the Investigator,
contraindicate intramuscular injection.

12. Current febrile illness or body temperature =38.0°C or other moderate to severe
illness within 24 hours of IP administration on Day 1. This condition is
considered to be temporary or self-limiting, and a subject may be vaccinated once
the condition has resolved if no other exclusion criteria is met.

13. Any current active infections, including localized infections, or any recent
history (within 1 week prior to IP administration) of active infections or cough;
or a history of recurrent or chronic infections (>3 infections/year).

14. Individuals with a history of drug or alcohol abuse (with an average intake
exceeding 10 drinks/week for women and 15 drinks/week for men: 1 drink = 360 mL
of beer, 150 mL of wine, or 45 mL of spirits) or drug addiction (including soft
drugs like cannabis products) within the past 2 years.

15. Current heavy smoker, defined as smoking =20 cigarettes/day (1 pack or
equivalent), or a former heavy smoker who was an active smoker within the past 1
year prior to Screening.

16. Individuals who faint at the sight of blood or needles.

17. Participation in another interventional clinical study (including a
bioequivalence study) with an investigational drug within 30 days or 5 half-lives
of the drug (whichever is longer) prior to the first dose of the IP.

18. Individuals who have received any prior investigational or approved vaccine
against a coronavirus, including but not limited to SARS-CoV-1, SARS-CoV-2, and
MERS-CoV.

19. Individuals who have received any other licensed vaccines within 14 days (for
inactivated vaccines) or 30 days (for live or attenuated vaccines) prior to
enrollment in this study, or those who are planning to receive any vaccine within
30 days before the first dose of IP or during the study, with the exception of
the seasonal influenza vaccine.

20. Individuals must not have donated blood for 30 days prior to Day 1 and must agree
to not donate blood for 6 months after Day 1 (receipt of first dose of the IP).

21. Individuals with any condition that, in the opinion of the Investigator, would
interfere with the study objectives or pose additional subject risk.

22. Any persons who are:

1. An employee of the study site, Investigator, contract research organization
(CRO) or Sponsor.

2. A first-degree relative of an employee of the study site, the Investigator,
CRO, or the Sponsor.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 0
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/05/2022
Sample size
Target
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Jiangsu Rec-Biotechnology Co., Ltd.
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Iqvia Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04818801
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries