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.
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
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
98
Single intramuscular administration.
INMI Spallanzani
Rome, Italy
Centro Ricerche Cliniche
Verona, Italy
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.
Time frame: 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.
Time frame: 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.
Time frame: 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)
Time frame: 24 weeks following the vaccination
Change in Leucocytes From Baseline
Time frame: baseline, Weeks 1,2,4,8,12, and 24
Change in Basophils From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Eosinophils From Baseline
Time frame: 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.
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Time frame: Weeks 1,2,4,8,12, and 24
Change in Monocytes From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Lymphocytes From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Erythrocytes From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Hematocrit From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Platelets From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Hemoglobin From Baseline
Time frame: Weeks 1,2,4,8,12, and 24
Change in Sodium From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Potassium From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Alkaline Phosphatase From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Alanine Aminotransferase From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Aspartate Aminotransferase From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Direct Bilirubin Form Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Bilirubin From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Albumin Form Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Creatinine Form Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Lactate Dehydrogenase From Baseline
Time frame: week 1,2,4,8,12, and 24
Change in Urea Nitrogen From Baseline
Time frame: week 1,2,4,8,12, and 24
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.
Time frame: week 1, 2, 4, 8, 12, and 24
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
Time frame: week 1, 2, 4, 8, 12 and 24
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
Time frame: week 4 and week 24
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.
Time frame: baseline, week 2, week 4, week 8, week 12, week 24