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Virus Therapy
SAM-LNP-S for Coronavirus
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 450
Awards & highlights
Summary
This trial is testing new COVID-19 vaccines on healthy adults to see if they are safe and effective. It includes people who have never been vaccinated and those who have already received a COVID-19 vaccine. The vaccines work by helping the immune system recognize and fight the virus.
Eligible Conditions
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 450
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 450
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Occurrence of Adverse Events of Special Interest (AESIs)
Occurrence of Serious Adverse Events (SAEs)
Occurrence of clinical safety laboratory adverse events by severity grade
+3 moreSecondary study objectives
Geometric mean fold rise from baseline in titer measured by a SARS-CoV-2 neutralization assay
Geometric mean fold rise from baseline in titer of Spike-specific Immunoglobulin G (IgG)
Immunoglobulin G
+11 moreTrial Design
15Treatment groups
Experimental Treatment
Group I: Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 9Experimental Treatment2 Interventions
3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8
Group II: Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 12A,BExperimental Treatment2 Interventions
10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants older than 60 years of age. N=8-12
Group III: Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 11A,BExperimental Treatment2 Interventions
10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12
Group IV: Stage 2 (SAM-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 10A,BExperimental Treatment2 Interventions
6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=8-12
Group V: Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 8A,BExperimental Treatment2 Interventions
10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 57 in participants from 18 to 60 years of age. N=8-12
Group VI: Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 7A,BExperimental Treatment2 Interventions
10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=8-12
Group VII: Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 6Experimental Treatment2 Interventions
6 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10
Group VIII: Stage 2 (SAM-S-TCE Boosts after EUA/licensed mRNA COVID-19 Vaccines) Group 5Experimental Treatment2 Interventions
3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on Day 1 in participants from 18 to 60 years of age. N=10
Group IX: Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 15Experimental Treatment2 Interventions
5 x 10\^11 viral particles of ChAdV68-S-TCE administered through 1.0 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10
Group X: Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 14Experimental Treatment2 Interventions
1 x 10\^11 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 in participants older than 60 years of age. N=7-10
Group XI: Stage 2 (ChAd-S-TCE Boosts after approved/licensed mRNA COVID-19 Vaccines) Group 13Experimental Treatment2 Interventions
5 x 10\^10 viral particles of ChAdV68-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and on or after Day 113 in participants older than 60 years of age. N=7-10
Group XII: Stage 1 (Naïve) Group 4Experimental Treatment2 Interventions
10 mcg of SAM-S-TCE administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-S-TCE administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=3
Group XIII: Stage 1 (Naïve) Group 3BExperimental Treatment2 Interventions
30 mcg SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 3 mcg of SAM-LNP-S administered through 0.25 mL intramuscular injection in the deltoid muscle on or after Day 85 and no later than Day 130 in participants from 18 to 60 years of age. N=7
Group XIV: Stage 1 (Naïve) Group 3AExperimental Treatment2 Interventions
30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=3
Group XV: Stage 1 (Naïve) Group 1Experimental Treatment3 Interventions
5 x 10\^10 viral particles of ChAdV68-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 1 and 30 mcg of SAM-LNP-S administered through 0.5 mL intramuscular injection in the deltoid muscle on Day 29 in participants from 18 to 60 years of age. N=4
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ChAdV68-S
2021
Completed Phase 1
~90
ChAdV68-S-TCE
2021
Completed Phase 1
~90
SAM-LNP-S
2021
Completed Phase 1
~90
SAM-LNP-S-TCE
2021
Completed Phase 1
~90
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Gritstone bio, Inc.Industry Sponsor
8 Previous Clinical Trials
1,266 Total Patients Enrolled
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,302 Previous Clinical Trials
5,501,361 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are 18 years or older, and you are either a man or a non-pregnant woman.You have had a severe allergic reaction in the past, such as anaphylaxis, which could include a reaction to a vaccine.You had surgery, immobility, chronic infection, or head trauma in the last 3 months that could increase the risk of blood clots.You have already received an approved or experimental COVID-19 vaccine, or any other vaccine that could affect the trial's results.You have participated in another study that involved testing a new treatment within the past two months or plan to participate in such a study during this trial.You have a history of angioedema that may be caused by genetic or unknown factors.You have had a serious allergic reaction to any medication in the past.You have had cancer before, except for a type of skin cancer called basal cell carcinoma or a type of cervical cancer called carcinoma in situ.You have had a seizure or received treatment for a seizure disorder in the past three years.You have a history of inflammation in the heart or the sac around the heart.You have a history of Guillain-Barre Syndrome (GBS).You are taking medication that can increase your risk of bleeding or blood clots, such as heparin.If the investigator believes that your health condition may put you at risk or affect the evaluation of the trial vaccine or interpreting the results, you may not be eligible to participate.You have received or plan to receive any live vaccine within 28 days before or after the study vaccination.You cannot have any subunit or killed vaccines 14 days before or after the trial vaccination.You are in generally good health.You have other medical conditions that could make COVID-19 more dangerous for you.You are generally healthy.You have a history of alcohol or drug abuse within the past 5 years.You have been sick with a sudden illness within the past 3 days before the vaccine is given.You do not have any medical conditions that the CDC has identified as increasing the risk of severe COVID-19.You must give written permission before any study procedures can begin.You are able and willing to follow all the study's rules and requirements.
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