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

NCT04528641 | Completed Phase 1 Results

• 1 other identifier: RT-CoV-2
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (25)

• 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.

  7 days following the vaccination

• 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.

  7 days following the vaccination

• 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.

  28 days following the vaccination

• 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)

  24 weeks following the vaccination

• Change in Leucocytes From Baseline

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

• Change in Basophils From Baseline

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

• Change in Eosinophils From Baseline

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

• Change in Neutrophils From Baseline

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

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

• Change in Monocytes From Baseline

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

• Change in Lymphocytes From Baseline

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

• Change in Erythrocytes From Baseline

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

• Change in Hematocrit From Baseline

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

• Change in Platelets From Baseline

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

• Change in Hemoglobin From Baseline

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

• Change in Sodium From Baseline

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

• Change in Potassium From Baseline

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

• Change in Alkaline Phosphatase From Baseline

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

• Change in Alanine Aminotransferase From Baseline

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

• Change in Aspartate Aminotransferase From Baseline

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

• Change in Direct Bilirubin Form Baseline

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

• Change in Bilirubin From Baseline

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

• Change in Albumin Form Baseline

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

• Change in Creatinine Form Baseline

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

• Change in Lactate Dehydrogenase From Baseline

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

• Change in Urea Nitrogen From Baseline

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

Secondary Outcomes (4)

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

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

• Number of Participants With Positive, Negative Anti-n Antibody

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

• Number of Participants With Positive, Negative for Micro Neutralization Test

  week 4 and week 24

• Immunogenicity - T-cell Response

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

Study Arms (6)

Arm 1 - Low dose

EXPERIMENTAL

Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15

Biological: GRAd-COV2

Arm 2 - Intermediate dose

EXPERIMENTAL

Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15

Biological: GRAd-COV2

Arm 3 - High dose

EXPERIMENTAL

Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15

Biological: GRAd-COV2

Arm 4 - Low dose

EXPERIMENTAL

Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16

Biological: GRAd-COV2

Arm 5 - Intermediate dose

EXPERIMENTAL

Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15

Biological: GRAd-COV2

Arm 6 - High dose

EXPERIMENTAL

Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15

Biological: GRAd-COV2

Interventions

GRAd-COV2 BIOLOGICAL

Single intramuscular administration.

Arm 1 - Low dose; Arm 2 - Intermediate dose; Arm 3 - High dose; Arm 4 - Low dose; Arm 5 - Intermediate dose; Arm 6 - High dose

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• ReiThera Srl: lead
• Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS: collaborator

Study Sites (2)

INMI Spallanzani

Rome, 00149, Italy

Location

Centro Ricerche Cliniche

Verona, 37134, Italy

Location

Related Publications (1)

• 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.

  PMID: 33895322 DERIVED

MeSH Terms

Conditions

COVID-19

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

Results Point of Contact

• Title: Medical Director
• Organization: Reithera

roberto.camerini@reithera.com

06 99775

Study Officials

• Simone Lanini

  Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 27, 2020
• Study Start: August 10, 2020
• Primary Completion: May 19, 2021
• Study Completion: May 19, 2021
• Last Updated: February 8, 2022
• Results First Posted: February 8, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)