← Back to Search

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
Are in good health*
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 450
Awards & highlights

Study 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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are in generally good health.

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
ChAdV68-S-TCE
2021
Completed Phase 1
~90
ChAdV68-S
2021
Completed Phase 1
~90
SAM-LNP-S-TCE
2021
Completed Phase 1
~90
SAM-LNP-S
2021
Completed Phase 1
~90

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,261 Previous Clinical Trials
5,483,021 Total Patients Enrolled
Gritstone bio, Inc.Industry Sponsor
8 Previous Clinical Trials
1,266 Total Patients Enrolled

Media Library

ChAdV68-S (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04776317 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria must individuals meet in order to be eligible for this clinical experiment?

"This clinical study is seeking 81 participants with an age range between 18 and 99 years old, who have contracted COVID-19. Enrollment requires written consent from the patient as well as being male or nonpregnant women of good health* determined by absence of significant medical conditions that would increase risk for severe coronavirus disease (COVID-19). *As defined by Centers for Disease Control and Prevention (CDC) guidelines."

Answered by AI

Does this research trial include participants of any age below 60?

"This study is inviting volunteers who are above the age of majority and below 99 years old to take part."

Answered by AI

Does the Food and Drug Administration recognize SAM-LNP-S as a safe, legitimate product?

"Based on our team's assessment, the safety of SAM-LNP-S has been given a score of 1. This is reasonable as this drug trial is still in its early stages and lacks evidence to confirm both efficacy and safety."

Answered by AI

What is the exact number of institutions that are deploying this clinical experiment?

"Currently, this trial is accepting patients from 5 clinical sites; Seattle, Decatur and Saint Louis are three of these locations. To reduce your need to travel, you should select the closest centre if you decide to participate in the study."

Answered by AI

Are new participants being recruited for this clinical experiment currently?

"According to clinicaltrials.gov, the recruitment for this medical trial has concluded as of November 3rd 2022; however, there are still numerous other studies actively enrolling patients at this time with 1,018 trials in total."

Answered by AI

What are the main goals of this research endeavor?

"Per the trial sponsor, Gritstone bio, Inc., this clinical study will assess a range of primary and secondary outcomes over a Day 1-Day 450 interval. The principal outcome being assessed is Occurrence of solicited local reactogenicity adverse events (AEs). Secondary outcomes that are under evaluation include Rate of spot-forming cell per million cells by peptide pool as determined by interferon gamma Enzyme Linked Immunospot Assay (ELISpot), Geometric mean fold rise from baseline in titer measured by SARS-CoV-2 neutralization assay for wild type virus/emergent viral strains,"

Answered by AI

Who else is applying?

What site did they apply to?
Baylor College of Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I am always looking for ways to volunteer to help with medical research, especially if it pays well.
PatientReceived 2+ prior treatments
~20 spots leftby Mar 2025