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COVID-19Phase 1NCT04528641

Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine

A Phase 1 study testing GRAd-COV2 in people with COVID-19, run by ReiThera Srl at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
COVID-19
What is being tested?
GRAd-COV2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
98 participants
Where
2 sitesItaly
Study dates
10 Aug 2020to 19 May 2021
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • A subject must meet all of the following criteria to be eligible to participate in this study:
  • Provides written informed consent prior to initiation of any study procedures.
  • Be able to understand and agrees to comply with planned study procedures and be available for all study visits.
  • Agrees to the collection of venous blood per protocol.
  • Confirms to have not donated blood three months before the study
  • Agrees to refrain from blood during the study and until the three months after the end of the study.
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  • Body Mass Index 18-29 kg/m2, inclusive, at screening.
  • Premenopausal women must agree to use one acceptable primary form of contraception.
  • 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).
  • Oral temperature ≤37.0 degrees Celsius the day of the administration of the vaccine
  • Pulse no greater than 100 beats per minute.
  • Systolic blood pressure (BP) is 85 to 139 mmHg, inclusive the day of vaccination.
  • Should not show laboratory values outside the normal range which may have clinical significance even in absence of specific signs or symptoms.

Who cannot join

  • A subject who meets any of the following criteria will be excluded from participation in this study:
  • Positive serology for anti-HIV-Ab
  • Positive HbBsAg
  • Positive anti-HCV-Ab
  • Positive for SARS-CoV-2 (either anti-S-Ab or anti-N-Ab)
  • Acute illness, as determined by the site PI or appropriate sub-investigator, the day of vaccination.
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  • Breastfeeding women
  • Autoimmune and hyper-inflammatory condition
  • History of atopy (or any IgE associated condition) who had required treatment over the last 6 months;
  • History of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any previous licensed or unlicensed vaccines;
  • 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.
  • Presence of self-reported or medically documented significant medical condition
  • Presence of self-reported or medically documented significant psychiatric condition
  • 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.
  • 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).
  • 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.
  • Primary or secondary immunodeficiency of any cause.
  • Participated in another investigational study involving vaccination of biologic compounds in the last 12 months.
  • Currently enrolled in or plans to participate in another clinical trial with an investigational agent that will be received during the study-reporting period.
  • 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.
  • Has any significant disorder of coagulation.
  • Has any chronic liver disease, including fatty liver.
  • Has a history of alcohol abuse or other recreational drug use within 6 months before the first vaccine administration.
  • 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).
  • Received or plans to receive additional vaccination within 4 weeks before or after each vaccination.
  • Has been reported as a case (confirmed or probable) of COVID-19 from the regional health system
  • 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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

  • INMI Spallanzani

    Rome, 00149

  • Centro Ricerche Cliniche

    Verona, 37134

Other trials in Italy

About this study

Official title: 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

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.

Read the 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.

Conditions
COVID-19
Being tested
GRAd-COV2
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GRAd-COV2Biological

    Single intramuscular administration.

Study groups in NCT04528641
Study groupRoleWhat they receive
Arm 1 - Low doseExperimentalArm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
Receives: Biological: GRAd-COV2
Arm 2 - Intermediate doseExperimentalArm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
Receives: Biological: GRAd-COV2
Arm 3 - High doseExperimentalArm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
Receives: Biological: GRAd-COV2
Arm 4 - Low doseExperimentalArm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
Receives: Biological: GRAd-COV2
Arm 5 - Intermediate doseExperimentalArm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
Receives: Biological: GRAd-COV2
Arm 6 - High doseExperimentalArm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
Receives: Biological: GRAd-COV2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination

    Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.

    Measured: 7 days following the vaccination

  2. Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination

    Participants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.

    Measured: 7 days following the vaccination

  3. Occurrence of Unsolicited AE 28 Days Following the Vaccination

    Occurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as "Any AE" occurring 28 days following the vaccination.

    Measured: 28 days following the vaccination

  4. Occurrence of Serious AE 24 Weeks Following the Vaccination

    Occurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)

    Measured: 24 weeks following the vaccination

  5. Change in Leucocytes From Baseline

    Measured: baseline, Weeks 1,2,4,8,12, and 24

  6. Change in Basophils From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  7. Change in Eosinophils From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  8. Change in Neutrophils From Baseline

    Change from baseline was calculated as the value at each week minus the value at the baseline.

    Measured: Weeks 1,2,4,8,12, and 24

  9. Change in Monocytes From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  10. Change in Lymphocytes From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  11. Change in Erythrocytes From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  12. Change in Hematocrit From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  13. Change in Platelets From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  14. Change in Hemoglobin From Baseline

    Measured: Weeks 1,2,4,8,12, and 24

  15. Change in Sodium From Baseline

    Measured: week 1,2,4,8,12, and 24

  16. Change in Potassium From Baseline

    Measured: week 1,2,4,8,12, and 24

  17. Change in Alkaline Phosphatase From Baseline

    Measured: week 1,2,4,8,12, and 24

  18. Change in Alanine Aminotransferase From Baseline

    Measured: week 1,2,4,8,12, and 24

  19. Change in Aspartate Aminotransferase From Baseline

    Measured: week 1,2,4,8,12, and 24

  20. Change in Direct Bilirubin Form Baseline

    Measured: week 1,2,4,8,12, and 24

  21. Change in Bilirubin From Baseline

    Measured: week 1,2,4,8,12, and 24

  22. Change in Albumin Form Baseline

    Measured: week 1,2,4,8,12, and 24

  23. Change in Creatinine Form Baseline

    Measured: week 1,2,4,8,12, and 24

  24. Change in Lactate Dehydrogenase From Baseline

    Measured: week 1,2,4,8,12, and 24

  25. Change in Urea Nitrogen From Baseline

    Measured: week 1,2,4,8,12, and 24

Secondary outcomes (4)

  1. Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody

    To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine

    Immunogenicity Result: Seroconversion for Anti-S Antibody

    Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.

    Measured: week 1, 2, 4, 8, 12, and 24

  2. Number of Participants With Positive, Negative Anti-n Antibody

    To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine

    cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline

    Measured: week 1, 2, 4, 8, 12 and 24

  3. Number of Participants With Positive, Negative for Micro Neutralization Test

    To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test

    Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline

    Measured: week 4 and week 24

  4. Immunogenicity - T-cell Response

    To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated.

    T-cells were evaluated on frozen and fresh (week2) samples

    Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints

    Unit: spot-forming cells [SFC]/1 × 10^6 peripheral blood mononuclear cell [PBMC]

    Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.

    Measured: baseline, week 2, week 4, week 8, week 12, week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Aug 2020
  2. Study start10 Aug 2020
  3. Primary completion19 May 2021
  4. Study completion19 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Sequential
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)
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04528641
Sponsor's protocol ID
RT-CoV-2
Status last verified
Jan 2022
First submitted
19 Aug 2020
Last updated
8 Feb 2022
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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 Aug 4;29(8):2412-2423. doi: 10.1016/j.ymthe.2021.04.022. Epub 2021 Apr 23.

    PubMed 33895322

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GRAd-COV2 in people with COVID-19, run by ReiThera Srl at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination (time frame: 7 days following the vaccination). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04528641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.

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