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| Column | Value |
|---|---|
| Trial registration number | NCT05435027 |
|
Full text link
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
|
|
First author
Last imported at : March 17, 2023, 8 a.m. Source : ClinicalTrials.gov |
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Contact
Last imported at : March 17, 2023, 8 a.m. Source : ClinicalTrials.gov |
Not reported |
|
Registration date
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
2022-06-28 |
|
Recruitment status
Last imported at : March 14, 2024, 4 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Non-randomized |
|
Design
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Parallel |
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Masking
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
multi-center |
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Study aim
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Prevention |
|
Inclusion criteria
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
inclusion criteria: male or non-pregnant female at least 18 years and no more than 65 years of age at enrollment (parts a, b, and c only). no previous sars-cov-2 infection or recovered. hiv-negative status confirmed by laboratory testing. additional inclusion criteria for plwh: serum positive hiv test or history of hiv infection. on anti-retroviral therapy for at least 3 months before screening and clinically stable. additional inclusion criteria for part d (grt-r918): male or non-pregnant female between 18 and <60 years of age at enrollment. male or non-pregnant female greater than or equal to 60 years of age at enrollment. received any authorized sars-cov-2 vaccine series at least 2 months prior to study vaccine. |
|
Exclusion criteria
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
current active infection with covid-19. positive for sars-cov-2 by nasal swab polymerase chain reaction (pcr) at screening. currently receiving treatment or prevention agents with activity against sars-cov-2. breastfeeding, pregnant, or planning to become pregnant during the course of the study. received or plans to receive any non-study provided sars-cov-2 vaccine (including boost) during the study period (except for part d). received or plans to receive any live, attenuated vaccine within 28 days before or after study vaccination. received or plans to receive any subunit or killed vaccine within 14 days before or after vaccination. received or plans to receive immunoglobulins and/or any blood products within the 3 months preceding the planned administration of first study vaccination or at any time during the study. currently active viral infection of hepatitis b virus or hepatitis c virus. additional exclusion criteria for plwh: screening cd4+ t cell count ≤200 cells/mcl. viral load ≥10,000 virus particles/ml. history of opportunistic illness indicative of stage 3 hiv infection. acute febrile illness within 4 weeks before the first vaccination. additional exclusion criterion for part d (grt-r918) cohorts d3, d4, d7, and d8: - received last dose of any authorized sars-cov-2 vaccine series within 2 months prior to study vaccine. |
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Number of arms
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
4 |
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Funding
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Gritstone bio, Inc. |
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Inclusion age min
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
65 |
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Countries
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
South Africa |
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Type of patients
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
High risk patients |
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Severity scale
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : March 17, 2023, 8 a.m. Source : ClinicalTrials.gov |
342 |
|
primary outcome
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Number of Participants with One or More Serious Adverse Events;Number of Participants with One or More Solicited Local Reactogenicity Signs and Symptoms;Number of Participants with One or More Solicited Systemic Reactogenicity Signs and Symptoms;Number of Participants with Unsolicited Adverse Events |
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Notes
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
Phase 1 |
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Arms
Last imported at : June 29, 2022, 10 p.m. Source : ClinicalTrials.gov |
[{"arm_notes": "HIV negative", "treatment_id": 2550, "treatment_name": "Samrna-spikebeta-tce9", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "HIV negative", "treatment_id": 2551, "treatment_name": "Samrna-spikebeta-tce11", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "People Living with HIV", "treatment_id": 2551, "treatment_name": "Samrna-spikebeta-tce11", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "nan", "treatment_id": 2552, "treatment_name": "Samrna-spikeomicron-n-tce11", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}] |