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SAM-LNP-S for Coronavirus
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.
- Coronavirus
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
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- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
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,"
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
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