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| Name | Class |
|---|---|
| Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Low dose | Experimental | Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 |
|
| Arm 2 - Intermediate dose | Experimental | Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 |
|
| Arm 3 - High dose | Experimental | Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 |
|
| Arm 4 - Low dose | Experimental | Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 |
|
| Arm 5 - Intermediate dose | Experimental | Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 |
|
| Arm 6 - High dose | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GRAd-COV2 | Biological | Single intramuscular administration. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | week 1, 2, 4, 8, 12, and 24 |
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Inclusion Criteria:
A subject must meet all of the following criteria to be eligible to participate in this study:
Exclusion Criteria:
A subject who meets any of the following criteria will be excluded from participation in this study:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Lanini | Istituto Nazionale per le Malattie Infettive "Lazzaro Spallanzani" IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| INMI Spallanzani | Rome | 00149 | Italy | |||
| Centro Ricerche Cliniche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33895322 | Derived | 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. |
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a total of 180 subjects were screened and 98 subjects were enrolled in the study. seven out of 98 enrolled subjects were not administered vaccine because of withdrawal by subjects (3 subjects) and because the protocol allowed Screening period 21 days passed (4 subjects). a total of 91 subjects were administered vaccine.
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 - Low Dose | Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration. |
| FG001 | Arm 2 - Intermediate Dose | Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| FG002 | Arm 3 - High Dose | Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| FG003 | Arm 4 - Low Dose | Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration. |
| FG004 | Arm 5 - Intermediate Dose | Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| FG005 | Arm 6 - High Dose | Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 - Low Dose | Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration. |
| BG001 | Arm 2 - Intermediate Dose |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 7 days following the vaccination |
|
Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences.
Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 - Low Dose | Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15 GRAd-COV2: Single intramuscular administration. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA v. 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Reithera | 06 99775 | 352 | roberto.camerini@reithera.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 30, 2020 | Jan 17, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 23, 2021 | Jan 17, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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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.
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Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 |
|
| 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 |
| 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 | 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 | 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. | baseline, week 2, week 4, week 8, week 12, week 24 |
| Verona |
| 37134 |
| Italy |
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
| BG002 | Arm 3 - High Dose | Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| BG003 | Arm 4 - Low Dose | Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration. |
| BG004 | Arm 5 - Intermediate Dose | Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| BG005 | Arm 6 - High Dose | Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Demographic - weight | Mean | Standard Deviation | kg |
|
| Demographic - Height | Mean | Standard Deviation | cm |
|
| Demographic - BMI | Mean | Standard Deviation | Kg/m^2 |
|
| OG002 | Arm 3 - High Dose | Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| OG003 | Arm 4 - Low Dose | Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration. |
| OG004 | Arm 5 - Intermediate Dose | Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
| OG005 | Arm 6 - High Dose | Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. |
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 7 days following the vaccination |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 28 days following the vaccination |
|
|
|
| Primary | 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) | Posted | Count of Participants | Participants | 24 weeks following the vaccination |
|
|
|
| Primary | Change in Leucocytes From Baseline | Posted | Mean | Standard Deviation | 10^9 leucocytes /L | baseline, Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Basophils From Baseline | Posted | Mean | Standard Deviation | 10^9 basophils/L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Eosinophils From Baseline | Posted | Mean | Standard Deviation | 10^9 eosinophils /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Neutrophils From Baseline | Change from baseline was calculated as the value at each week minus the value at the baseline. | Posted | Mean | Standard Deviation | 10^9 Neutrophils /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Monocytes From Baseline | Posted | Mean | Standard Deviation | 10^9 Monocytes /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Lymphocytes From Baseline | Posted | Mean | Standard Deviation | 10^9 Lymphocytes /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Erythrocytes From Baseline | Posted | Mean | Standard Deviation | 10^12 Erythrocytes /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Hematocrit From Baseline | Posted | Mean | Standard Deviation | percentage of Total | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Platelets From Baseline | Posted | Mean | Standard Deviation | 10^9 Platelets /L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Hemoglobin From Baseline | Posted | Mean | Standard Deviation | g/L | Weeks 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Sodium From Baseline | Posted | Mean | Standard Deviation | mmol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Potassium From Baseline | Posted | Mean | Standard Deviation | mmol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Alkaline Phosphatase From Baseline | Posted | Mean | Standard Deviation | U/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Alanine Aminotransferase From Baseline | Posted | Mean | Standard Deviation | U/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Aspartate Aminotransferase From Baseline | Posted | Mean | Standard Deviation | U/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Direct Bilirubin Form Baseline | Posted | Mean | Standard Deviation | umol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Bilirubin From Baseline | Posted | Mean | Standard Deviation | umol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Albumin Form Baseline | Posted | Mean | Standard Deviation | g/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Creatinine Form Baseline | Posted | Mean | Standard Deviation | umol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Lactate Dehydrogenase From Baseline | Posted | Mean | Standard Deviation | U/L | week 1,2,4,8,12, and 24 |
|
|
|
| Primary | Change in Urea Nitrogen From Baseline | Posted | Mean | Standard Deviation | mmol/L | week 1,2,4,8,12, and 24 |
|
|
|
| Secondary | 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. |
| Posted | Count of Participants | Participants | week 1, 2, 4, 8, 12, and 24 |
|
|
|
| Secondary | 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 |
| Posted | Count of Participants | Participants | week 1, 2, 4, 8, 12 and 24 |
|
|
|
| Secondary | 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 | number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period. | Posted | Count of Participants | Participants | week 4 and week 24 |
|
|
|
| Secondary | 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. | number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period. | Posted | Median | Inter-Quartile Range | SFC/1x10^6 PBMC | baseline, week 2, week 4, week 8, week 12, week 24 |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 12 |
| 15 |
| EG001 | Arm 2 - Intermediate Dose | Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. | 0 | 15 | 0 | 15 | 14 | 15 |
| EG002 | Arm 3 - High Dose | Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. | 0 | 15 | 0 | 15 | 14 | 15 |
| EG003 | Arm 4 - Low Dose | Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16 GRAd-COV2: Single intramuscular administration. | 0 | 16 | 0 | 16 | 13 | 16 |
| EG004 | Arm 5 - Intermediate Dose | Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15 GRAd-COV2: Single intramuscular administration. | 0 | 15 | 0 | 15 | 9 | 15 |
| EG005 | Arm 6 - High Dose | Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15 GRAd-COV2: Single intramuscular administration. | 0 | 15 | 0 | 15 | 9 | 15 |
| injection site pain | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Chills | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Injection Site Erithema | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Injection Site swelling | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Injection Site hematoma | General disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Muscle contracture | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Spinal Pain | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Abdominal Pain | Gastrointestinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Faeces Soft | Gastrointestinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Neutropoenia | Blood and lymphatic system disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Muscle injury | Injury, poisoning and procedural complications | MedDRA v. 23.0 | Systematic Assessment |
|
| Muscle Strain | Injury, poisoning and procedural complications | MedDRA v. 23.0 | Systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA v. 23.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA v. 23.0 | Systematic Assessment |
|
| Oral Herpes | Infections and infestations | MedDRA v. 23.0 | Systematic Assessment |
|
| Tooth Abscess | Infections and infestations | MedDRA v. 23.0 | Systematic Assessment |
|
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Premenstrual Syndrome | Reproductive system and breast disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Chalazion | Eye disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Aspartate Aminotransferase increased | Investigations | MedDRA v. 23.0 | Systematic Assessment |
|
| Hyperkaliemia | Metabolism and nutrition disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Hot Flush | Vascular disorders | MedDRA v. 23.0 | Systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA v. 23.0 | Systematic Assessment |
|
Publication of the results will be agreed between ReiThera SRL and Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani. If one of the parties is interested in proceeding with a scientific publication, it must give written and electronic communication to the other party. Any impediments to publication must be communicated electronically within 30 days. If a party deems it inappropriate to publish, it will try to provide written changes to the text that could allow its publication.
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Fatigue |
|
| Pyrexia |
|
| Myalgia |
|
| Chills |
|
| Nausea |
|
| Neutropeonia |
|
| Abdominal Pain |
|
| Diarrhoea |
|
| Arthralgia |
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| Back Pain |
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| Cough |
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| Faeces Soft |
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| Hot flush |
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| Hyperkalaemia |
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| Muscle injury |
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| Muscle strain |
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| Tooth fracture |
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| Dyspnoea |
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| Oropharyngeal pain |
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| Ecchymosis |
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| Tooth abscess |
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| Chalazion |
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| Lymphadenopathy |
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| week 1 - any AE : Moderate |
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| week 1 - any AE : Severe |
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| week 2 - any AE: mild |
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| week 2 - any AE: moderate |
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| week 2 - any AE: severe |
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| week 3 - Any AE: mild |
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| week 3 - any AE: moderate |
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| week 3 - any AE: severe |
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| week 4 - any AE: mild |
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| week 4 - any AE: moderate |
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| week 4 - any AE: severe |
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| Any treatment-emergent SAE |
|
| week 2 |
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| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
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| week 8 |
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| week 12 |
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| week 24 |
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| week 2 |
|
| week 4 |
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| week 8 |
|
| week 12 |
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| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
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| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
| week 2 |
|
| week 4 |
|
| week 8 |
|
| week 12 |
|
| week 24 |
|
|
| week 2 |
|
|
| week 4 |
|
|
| week 8 |
|
|
| week 12 |
|
|
| week 24 |
|
|
|
| week 2 |
|
|
| week 4 |
|
|
| week 8 |
|
|
| week 12 |
|
|
| week 24 |
|
|
|
| Negative week 4 |
|
|
| Positive week 24 |
|
|
| Negative week 24 |
|
|
|
| T-cell response week 2 (fresh samples) |
|
|
| T-cell response week 2 (frozen samples) |
|
|
| T-cell response week 4 |
|
|
| T-cell response week 8 |
|
|
| T-cell response week 12 |
|
|
| T-cell response week 24 |
|
|
| negative |
|
| indeterminate |
|
| negative |
|
| indeterminate |
|
| negative |
|
| indeterminate |
|
| negative |
|
| indeterminate |
|
| negative |
|
| indeterminate |
|
| negative |
|
| negative |
|
| negative |
|
| negative |
|
| negative |
|