Trial Review

Technical difficulties have been reported by some users of the search function and is being investigated by technical staff. Thank you for your patience and apologies for any inconvenience caused.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04893512




Registration number
NCT04893512
Ethics application status
Date submitted
14/05/2021
Date registered
19/05/2021
Date last updated
20/04/2023

Titles & IDs
Public title
First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
Scientific title
First-In-Human Study Of Orally Administered CoV2-OGEN1 In Healthy Subjects
Secondary ID [1] 0 0
CoV2-OGEN1-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
SARS-CoV-2 (COVID-19) 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Orally Suspension of CoV2-OGEN1

Experimental: Orally administered CoV2-OGEN1- 2 dose schedule - 50mcg,100mcg and 200mcg will be tested as single oral dose on day 1 and day 15. The dose will be in the form of oral suspension.


Treatment: Drugs: Orally Suspension of CoV2-OGEN1
CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
To evaluate the safety of 2-dose vaccination schedule of orally administered CoV2-OGEN1 by following local and systemic adverse events
Timepoint [1] 0 0
Non serious AE are to assessed for 21-28 days after each study vaccination while serious AE are to be followed for atleast 6 months after completion of all study vaccinations
Secondary outcome [1] 0 0
To evaluate geometric mean fold rise (GMFR)
Timepoint [1] 0 0
From baseline on day 43
Secondary outcome [2] 0 0
To evaluate geometric mean fold rise (GMFR)
Timepoint [2] 0 0
From baseline on day 43
Secondary outcome [3] 0 0
To evaluate geometric mean fold rise (GMFR)
Timepoint [3] 0 0
From baseline on day 43
Secondary outcome [4] 0 0
To evaluate geometric mean titer (GMT)
Timepoint [4] 0 0
On day 43
Secondary outcome [5] 0 0
To evaluate geometric mean titer (GMT)
Timepoint [5] 0 0
On day 43
Secondary outcome [6] 0 0
To evaluate percentage of subjects
Timepoint [6] 0 0
On day 43

Eligibility
Key inclusion criteria
Participants must fulfil all of the following criteria to be eligible for the study:

1. Capable of giving personal signed informed consent, which includes compliance with the
requirements and restrictions listed in this protocol and be available for all study
visits.

2. Must agree to collection of nasal wash, oral rinse, and venous blood per protocol and
agree to have samples stored for secondary research.

3. Male or non-pregnant female, >/= to 18 years and </= 56 years of age at time of
enrollment.

4. Body Mass Index (BMI) 18-35 kg/m^2 at screening.

5. Women of childbearing potential must agree to use or have practiced true abstinence or
use at least one acceptable primary form of contraception. Not of childbearing
potential - post-menopausal females (defined as having a history of amenorrhea for at
least one year) or a documented status as being surgically sterile (hysterectomy,
bilateral oophorectomy, tubal ligation/salpingectomy, or Essure(R) placement).

6. Male subjects of childbearing potential: use of condoms to ensure effective
contraception with a female partner of childbearing potential from first vaccination
until 90 days after the last vaccination.

7. Male subjects agree to refrain from sperm donation from the time of first vaccination
until 90 days after the last vaccination.

8. In good health as determined by medical history and physical examination to evaluate
acute or ongoing chronic medical diagnoses/conditions that have been present for at
least 90 days, which would affect the assessment of safety of subjects. (Note: Chronic
medical diagnoses/conditions/medications should be stable for the last 60 days (no
hospitalizations, emergency room (ER), or urgent care for condition or need for
supplemental oxygen)).

9. Oral temperature is less than 100.0 degrees Fahrenheit (37.8 degrees Celsius).

10. Pulse no greater than 100 beats per minute.

11. Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.

12. Clinical screening laboratory evaluations (Basic Metabolic Panel, White blood cell
(WBC), Hemoglobin (Hgb), Hematocrit (HCT), RBC count, Mean Corpuscular Volume (MCV),
Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC),
platelets (PLTs), Total Neutrophils - Absolute (NEUT#), Eosinophils - Absolute (EO#),
Monocytes - Absolute (MONO#), Basophils - Absolute (BASO#), Lymphocytes - Absolute
(LYMPH#), alanine transaminase (ALT), aspartate transaminase (AST), alkaline
phosphatase (ALP), total bilirubin (T. Bili), Lipase, prothrombin time (PT), and
partial thromboplastin time (PTT)) are within the acceptable normal reference ranges
of the clinical laboratory. Subjects with out of range values may be included if the
clinical laboratory or PI deem the out of range value to be clinically insignificant.

13. The subject must agree to refrain from donating blood or plasma during the study
(outside of this study).
Minimum age
18 Years
Maximum age
56 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria

Participants will be excluded from participation in the study if any of the following
criteria are met at screening:

1. Positive pregnancy test either at screening or just prior to the first vaccine
administration.

2. Participants who is breastfeeding or planning on breastfeeding from the time of the
first vaccination through 60 days after the last vaccination.

3. Has any medical disease or condition that, in the opinion of the site PI or
appropriate sub-investigator, precludes study participation.

4. Acute or chronic gastrointestinal conditions such as Crohn's, Ulcerative Colitis,
gastritis, proctitis, IBS, or any other inflammatory bowel disease.

5. Currently taking Histamine-2 (H2) Blocker, Proton Pump Inhibitor (PPI), Promotility
Agent, or any chronic antacids.

6. Presence of self-reported or medically documented significant medical or psychiatric
condition(s).

7. Significant cardiovascular disease (e.g., congestive heart failure, cardiomyopathy,
ischemic heart disease), uncontrolled hypertension, history of myocarditis or
pericarditis as an adult, myocardial infarction (MI) within past 6 months, coronary
artery bypass surgery or stent placement, or uncontrolled cardiac arrhythmia.

8. Neurological or neurodevelopmental conditions (e.g., history of migraines in the past
5 years, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal
neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis,
stroke or transient ischemic attack, multiple sclerosis, Parkinson's disease,
amyotrophic lateral sclerosis, Creutzfeldt-Jakob disease, or Alzheimer's disease).

9. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding
basal cell and squamous cell carcinoma of the skin, which are allowed.

10. Active autoimmune disease or any history of autoimmune disease determined by hx or
lab/physical examination.

11. Individuals at high risk for severe COVID-19, including those with any of the
following risk factors:

1. T2DM

2. Asthma

3. Respiratory conditions (including emphysema or COPD)

4. Tobacco use (vaping, smoking, chew) within 1 year

12. Chronic kidney disease, estimated glomerular filtration rate (eGFR) <60
mL/min/1.73m^2.

13. Immunocompromised individuals with known or suspected immunodeficiency, as determined
by medical history or lab/physical examination.

14. Acute illness, as determined by the site PI or appropriate sub-investigator, with or
without fever [oral temperature >/= 38.0 degrees Celsius (100.4 degrees Fahrenheit)]
within 72 hours prior to each vaccination.

15. History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV).

16. Participation in another investigational study involving any investigational product
within 60 days, or 5 half-lives, whichever is longer, before the first vaccine
administration.

17. Participation in another clinical trial with an investigational agent that will be
received during the study-reporting period.

18. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,
generalized urticaria, angioedema, other significant reaction) to any previous
licensed or unlicensed vaccines.

19. Chronic use (more than 14 continuous days) or anticipated use within the next 6 months
of any medications that may be associated with impaired immune responsiveness.
Including, but not limited to the following excluded drugs: systemic or inhaled
corticosteroids, allergy injections, immunoglobulin, interferon, immunomodulators,
cytotoxic drugs, or other similar or toxic drugs during the preceding 6-month period
prior to vaccine administration (Day 1). The use of low dose topical, ophthalmic,
otic, and intranasal steroid preparations will be permitted.

20. Anticipating the need for immunosuppressive treatment within the next 6 months.

21. Receipt of immunoglobulin and/or any blood or blood products within the 4 months
before the first vaccine administration or at any time during the study.

22. Blood dyscrasias or significant disorder of coagulation, based on history or abnormal
laboratory results.

23. Chronic liver disease, including fatty liver.

24. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use
within 6 months before the first vaccine administration.

25. Received or plans to receive a licensed, live vaccine within 4 weeks before or after
each vaccination.

26. Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or
after each vaccination.

27. Receipt of any other SARS-CoV-2, MERS, SARS-CoV-1 or other experimental coronavirus
vaccine at any time prior to or during the study.

28. Close contact of anyone known to have COVID-19 infection within 30 days prior to
vaccine administration.

29. Confirmed or suspected positive COVID-19 test results via diagnostic or antibody test.

30. Current treatment with investigational agents for prophylaxis of COVID-19.

31. Current use of any prescription or over-the-counter medications within 7 days prior to
vaccination, unless approved by the investigator or necessary to manage a chronic
condition.

32. Plans to travel outside the participating country from enrollment through 28 days
after the second vaccination.

33. Healthcare worker at high risk of contracting SARS-CoV-2

34. Reside in a skilled nursing home, have a requirement for skilled nursing care, and/or
non-ambulatory.

35. Medical or psychiatric condition including recent (with the past year) or active
suicidal ideation/behavior or abnormality, self-reported or medically documented, that
may increase the risk of study participation or make the participant inappropriate for
the study based on the Investigator's judgement.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
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
30/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/11/2022
Sample size
Target
Accrual to date
Final
45
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Syneos Health
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
US Specialty Formulations, LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
To evaluate the safety of 2 dose vaccination schedule of orally administered CoV2-OGEN1 In
healthy subjects
Trial website
https://clinicaltrials.gov/ct2/show/NCT04893512
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