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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 a phase 1 study to test the safety, tolerability, and immunogenicity of two investigational ChAd vaccines and two investigational SAM vaccines for COVID-19 in healthy adults in the US. The study will enroll 17 subjects in Stage 1 and up to 118 subjects in Stage 2. Subjects will be monitored for exposure and infection to SARS-CoV-2 throughout the study and followed for 12 months after their last vaccination.

Eligible Conditions
  • Coronavirus

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 450
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through day 450 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more
Secondary outcome measures
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 more

Trial 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
SAM-LNP-S
2021
Completed Phase 1
~90
SAM-LNP-S-TCE
2021
Completed Phase 1
~90
ChAdV68-S
2021
Completed Phase 1
~90
ChAdV68-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
3,283 Previous Clinical Trials
5,498,851 Total Patients Enrolled

Media Library

ChAdV68-S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04776317 — Phase 1
~19 spots leftby Jul 2025