A Phase 2/3 interventional study of GRAd-COV2 and Placebo in Covid19, sponsored by ReiThera Srl. Completed at 26 sites in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-03-29.
Sponsored by ReiThera Srl · Phase 2/3, Interventional, and Prevention
Multicenter Study assessing the safety, efficacy, and immunogenicity of the candidate vaccine GRAd-COV2, compared to placebo, for the prevention of COVID-19. Participants will be adults ≥ 18 years of age who are healthy or have medically stable chronic diseases and are at increased risk for SARS-CoV-2 acquisition and COVID-19. In the phase II part approximately 900 participants will be randomized in a 1:1:1 ratio to receive i) 2 repeated (21 days apart) intramuscular (IM) doses of GRAd-COV2 at 1x10\^11 viral particle (vp) (n = approximately 300 subjects) ii) 1 single IM dose of GRAd-COV2 at 2x10\^11 vp plus 1 dose of placebo after 21 days (n= approximately 300 subject) or 2 doses of placebo (n = approximately 300 subjects) on day 1 and day 22. There will be 3 strata for randomization: ≥ 65 years, \< 65 years and categorized to be at increased risk ("at risk") for the complications of COVID-19, and \< 65 years "not at risk". Risk will be defined referring to the study participants' relevant past and current medical history. An independent Data Safety Monitoring Board will provide oversight, to ensure safe and ethical conduct of the Study; a Steering Committee will revise safety data (collected for 900 participants 1 week after dosing) and immunogenicity data (collected for 450 participants 5 weeks after the first dosing) generated in phase II part. Jointly DSMB and SC will recommend the expansion to phase III and the best regimen to be used.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 10,300 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →ReiThera Srl is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 single IM dose of GRAd-COV2 2 x 10\^11 vp plus 1 dose of saline placebo after 21 days
Biological: GRAd-COV2
2 repeated (21 days apart) IM dose of GRAd-COV2 1 x 10\^11
Biological: GRAd-COV2
Two doses of saline placebo on day 1 and day 22
Other: Placebo
GRAd-COV2 is a replication-defective gorilla adenoviral vector (GRAd) encoding the SARS-CoV-2 surface glycoprotein (S, Spike) antigen under the control of CMV immediate early promoter. The encoded Spike antigen is stabilized in pre-fusion conformation by introducing 2 proline residues
Saline solution
Number of participants with symptomatic laboratory confirmed COVID-19
A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs ≥ 28 days post first dose or ≥ 7 days after the second dose of study intervention (depending on the selected regimen).
Time frame: FROM > 28 DAYS POST FIRST DOSE (DAY 1) UP TO DAY 360
Incidence of AEs, SAEs, MAAEs, and AESI
1. Incidence of AEs for 28 days post each dose of study intervention. 2. Incidence of SAEs, MAAEs, and AESIs from Day 1 post treatment through Day 360.
Time frame: 28 DAYS POST EACH DOSE FOR AEs and FROM RANDOMIZATION UP TO DAY 360 FOR SAEs, MAAEs, and AESI
Incidence of local and systemic solicited AEs
Incidence of local and systemic solicited AEs
Time frame: 7 DAYS POST EACH DOSE OF STUDY INTERVENTION
Post-treatment GMTs in SARS-CoV2 S and/or RBD antibodies
Post-treatment GMTs from day of dosing baseline value to 35 days post first dose in SARS-CoV-2 S and/or RBD antibodies.
Time frame: from day 1 to day 36
Post-treatment GMFRs in SARS-CoV2 S and/or RBD antibodies
Post-treatment GMFRs from day of dosing baseline value to 35 days post first dose in SARS-CoV-2 S and/or RBD antibodies.
Time frame: from day 1 to day 36
Proportion of participants with post-treatment seroresponse (> 4-fold rise in titers) to the S and/or RBD antigens of GRAd-COV2
Proportion of participants with post-treatment seroresponse (\> 4-fold rise in titers) to the S and/or RBD antigens of GRAd-COV2.
Time frame: from day 1 to day 36
Time to first SARS-CoV2 RT-PCR positive severe or critical symptomatic illness
Time to first SARS-CoV-2 RT-PCR-positive severe or critical symptomatic illness occurring ≥ 28 days post first dose or ≥ 7 days after second dose of study intervention
Time frame: FROM > 28 DAYS POST FIRST DOSE (DAY 1) UP TO DAY 360
Proportion of participants who have a post-treatment response for SARS-COV2 Nucleocapside antibodies
Proportion of participants who have a post-treatment response (negative at baseline to positive post treatment with study intervention) for SARS-CoV-2 Nucleocapsid antibodies over time.
Time frame: from Day 1 up to day 360
Time to first case of SARS-COV2 RT-PCR positive symptomatic illness using CDC criteria
Time to first case of SARS-CoV-2 RT-PCR- positive symptomatic illness occurring ≥ 28 days post first dose or \> 7 days after second dose of study intervention using CDC criteria.
Time frame: FROM > 28 DAYS POST FIRST DOSE (DAY 1) UP TO DAY 360
Time to first COVID-19 related Emergency Department admission
Time to first COVID-19-related Emergency Department admission occurring ≥ 28 days post single dose or ≥ 7 days post second dose of study intervention.
Time frame: FROM > 28 DAYS POST FIRST DOSE (DAY 1) UP TO DAY 360
Time to COVID-19 related death
Time to COVID-19 related death
Time frame: FROM > 28 DAYS POST FIRST DOSE (DAY 1) UP TO DAY 360
Post-treatment GMTs in SARS-CoV-2 S and/or RBD antibodies
Post-treatment GMTs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 S and/or RBD antibodies
Time frame: from day of dosing baseline value to 35 days after first dose
Post-treatment GMFRs in SARS-CoV-2 S and/or RBD antibodies
Post-treatment GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 S and/or RBD antibodies
Time frame: from day of dosing baseline value to 35 days after first dose
Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers) in S and/or RBD antigens of GRAd-COV2.
The proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to the S and/or RBD antigens of GRAd-COV2.
Time frame: from day 1 to day 36
Post-treatment GMTs in SARS-CoV2 S neutralizing antibodies
Post-treatment GMTs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 neutralizing antibodies.
Time frame: from day of dosing baseline value to 35 days after first dose
Post-treatment GMFRs in SARS-CoV2 S neutralizing antibodies
Post-treatment GMFRs from day of dosing baseline value to 35 days post first dose (14 days post second dose) in SARS-CoV-2 neutralizing antibodies.
Time frame: from day of dosing baseline value to 35 days after first dose
Proportion of participants with post-treatment seroresponse (> 4-fold rise in titers) in SARS-COV2 neutralizing antibodies
Proportion of participants who have a post-treatment seroresponse (≥ 4-fold rise in titers from day of dosing baseline value to 35 days post first dose) to GRAd-COV2 as measured by SARS-CoV-2 neutralizing antibodies.
Time frame: from day 1 to day 36
This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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