Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

GRAd-COV2 Vaccine Against COVID-19

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04528641
Recruitment Status : Active, not recruiting
First Posted : August 27, 2020
Last Update Posted : April 5, 2021
Sponsor:
Collaborator:
Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Information provided by (Responsible Party):
ReiThera Srl

Tracking Information
First Submitted Date  ICMJE August 19, 2020
First Posted Date  ICMJE August 27, 2020
Last Update Posted Date April 5, 2021
Actual Study Start Date  ICMJE August 10, 2020
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
  • Assess the safety, tolerability and reactogenicity of GRAd-COV2: Occurrence of solicited local AE signs and symptoms [ Time Frame: 7 days following the vaccination ]
    Occurrence of solicited local AE signs and symptoms
  • Assess the safety, tolerability and reactogenicity of GRAd-COV2: Occurrence of solicited systemic AE signs and symptoms [ Time Frame: 7 days following the vaccination ]
    Occurrence of solicited systemic AE signs and symptoms
  • Assess the safety, tolerability and reactogenicity of GRAd-COV2: Occurrence of unsolicited AE [ Time Frame: 28 days following the vaccination ]
    Occurrence of unsolicited AE
  • Assess the safety of GRAd-COV2 by laboratory measures: full blood count; blood Biochemistry (Sodium, Potassium, Albumin, Liver Function Tests; Renal function, lactate dehydrogenases (LDH), alkaline phosphatases (ALP)). [ Time Frame: 24 weeks following the vaccination ]
    Change from baseline for safety laboratory measures
  • Assess the safety, tolerability and reactogenicity of GRAd-COV2: Occurrence of serious AE [ Time Frame: 24 weeks following the vaccination ]
    Occurrence of serious AE
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2020)
Immunogenicity [ Time Frame: week 1, 2, 4, 8, 12 and 24 ]
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GRAd-COV2 Vaccine Against COVID-19
Official Title  ICMJE A Phase 1, Dosage-Escalation Study to Assess the Safety and Immunogenicity of a COVID-19 Vaccine GRAd-COV2 in Healthy Adults and Elderly Subjects
Brief Summary RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 Spike protein.
Detailed Description

RT-CoV-2 is a Phase I, open-label, dose escalation multicenter clinical trial to assess safety and immunogenicity of the candidate Coronavirus disease (COVID-19) vaccine GRAd-COV2 in Italian healthy volunteers aged 18-55 years and 65-85 years inclusive. GRAd-COV2 is based on a novel replication defective Gorilla Adenovirus and encodes for SARS-COV-2 full length prefusion stabilized Spike protein. GRAd-COV2 is developed and manufactured by ReiThera Srl.

This study will evaluate a singular intramuscular administration of GRAd-COV2 at 3 dose levels: 5e10, 1e11, 2e11viral particles (vp). There will be 6 study arms for a total of 90 healthy volunteers, divided into 2 cohorts of age, 18-55y and 65-85y, respectively.

Participants will be followed up for 24 weeks after vaccination. Follow up includes safety and immunogenicity assessment. Follow up visits will occur at day2, then 1, 2, 4, 8, 12, 24 weeks after vaccination.

The primary objective is to evaluate the safety and reactogenicity of a single dose vaccination schedule of GRAd-COV2 across 3 dosages in healthy younger and older adults. The secondary objective is to evaluate humoral and cellular immunogenicity.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Phase I, open-label, dose escalation, clinical trial to assess the safety and immunogenicity of the candidate GRAd-COV2 vaccine in 90 healthy volunteers aged 18-55 years and elderly volunteers aged 65-85 years. The vaccine will be administered intramuscularly once in time.
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE COVID-19
Intervention  ICMJE Biological: GRAd-COV2
Single intramuscular administration.
Study Arms  ICMJE
  • Experimental: Arm 1 - Low dose
    Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
    Intervention: Biological: GRAd-COV2
  • Experimental: Arm 2 - Intermediate dose
    Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
    Intervention: Biological: GRAd-COV2
  • Experimental: Arm 3 - High dose
    Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
    Intervention: Biological: GRAd-COV2
  • Experimental: Arm 4 - Low dose
    Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15
    Intervention: Biological: GRAd-COV2
  • Experimental: Arm 5 - Intermediate dose
    Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
    Intervention: Biological: GRAd-COV2
  • Experimental: Arm 6 - High dose
    Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
    Intervention: Biological: GRAd-COV2
Publications * Capone S, Raggioli A, Gentile M, Battella S, Lahm A, Sommella A, Contino AM, Urbanowicz RA, Scala R, Barra F, Leuzzi A, Lilli E, Miselli G, Noto A, Ferraiuolo M, Talotta F, Tsoleridis T, Castilletti C, Matusali G, Colavita F, Lapa D, Meschi S, Capobianchi M, Soriani M, Folgori A, Ball JK, Colloca S, Vitelli A. Immunogenicity of a new gorilla adenovirus vaccine candidate for COVID-19. Mol Ther. 2021 Apr 22. pii: S1525-0016(21)00210-0. doi: 10.1016/j.ymthe.2021.04.022. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 25, 2020)
90
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2021
Estimated Primary Completion Date July 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

A subject must meet all of the following criteria to be eligible to participate in this study:

  1. Provides written informed consent prior to initiation of any study procedures.
  2. Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
  3. Agrees to the collection of venous blood per protocol.
  4. Confirms to have not donated blood three months before the study
  5. Agrees to refrain from blood during the study and until the three months after the end of the study.
  6. Body Mass Index 18-29 kg/m2, inclusive, at screening.
  7. Premenopausal women must agree to use one acceptable primary form of contraception.
  8. Premenopausal women must have a negative urine pregnancy test the day of vaccination and are routinely using - and willing to use up to six months from vaccine administration - an effective method of birth control resulting in a low failure rate (i.e., hormonal contraception, condoms in combination with a spermicidal cream, male partner sterilization-vasectomy or total sexual abstinence).
  9. Oral temperature ≤37.0 degrees Celsius the day of the administration of the vaccine
  10. Pulse no greater than 100 beats per minute.
  11. Systolic blood pressure (BP) is 85 to 139 mmHg, inclusive the day of vaccination.
  12. Should not show laboratory values outside the normal range which may have clinical significance even in absence of specific signs or symptoms.

Exclusion Criteria:

A subject who meets any of the following criteria will be excluded from participation in this study:

  1. Positive serology for anti-HIV-Ab
  2. Positive HbBsAg
  3. Positive anti-HCV-Ab
  4. Positive for SARS-CoV-2 (either anti-S-Ab or anti-N-Ab)
  5. Acute illness, as determined by the site PI or appropriate sub-investigator, the day of vaccination.
  6. Breastfeeding women
  7. Autoimmune and hyper-inflammatory condition
  8. History of atopy (or any IgE associated condition) who had required treatment over the last 6 months;
  9. History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines;
  10. Assumption of any immunomodulatory medication over the last 4 months (including, but not limited to, systemic corticosteroids, allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or other similar or toxic drugs). The use of low dose topical, ophthalmic, inhaled, and intranasal steroid preparations will be permitted.
  11. Presence of self-reported or medically documented significant medical condition
  12. Presence of self-reported or medically documented significant psychiatric condition
  13. Significant cardiovascular disease needing therapy or history of myocarditis or pericarditis or heart surgery. Patients in treatment with Sartans or ACE-Inhibitors and good response to therapy may be included.
  14. 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 or transverse myelitis).
  15. 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.
  16. Primary or secondary immunodeficiency of any cause.
  17. Participated in another investigational study involving vaccination of biologic compounds in the last 12 months.
  18. Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period.
  19. Administration of immunoglobulins and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study.
  20. Has any significant disorder of coagulation.
  21. Has any chronic liver disease, including fatty liver.
  22. Has a history of alcohol abuse or other recreational drug use within 6 months before the first vaccine administration.
  23. Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region).
  24. Received or plans to receive additional vaccination within 4 weeks before or after each vaccination.
  25. Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system
  26. Has any clinical conditions that, in the opinion of the site PI or appropriate sub-investigator, precludes study participation, this includes any acute, subacute, intermittent or chronic medical disease or condition that would place the subject at an unacceptable risk of injury, render the subject unable to meet the requirements of the protocol, or may interfere with the evaluation of responses or the subject's successful completion of this trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04528641
Other Study ID Numbers  ICMJE RT-CoV-2
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party ReiThera Srl
Study Sponsor  ICMJE ReiThera Srl
Collaborators  ICMJE Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani
Investigators  ICMJE
Principal Investigator: Simone Lanini Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS
PRS Account ReiThera Srl
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP