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Virus Therapy
mRNA Vaccine Doses for COVID-19
Phase 1
Waitlist Available
Research Sponsored by GlaxoSmithKline
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is a male or nonpregnant female of 18 to 49 years, inclusive, at screening
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to month 6
Awards & highlights
Study Summary
This trial studies the safety and effectiveness of a SARS-CoV-2 vaccine in people who already had a vaccination.
Who is the study for?
Healthy adults aged 18-49 who've had their primary and booster mRNA COVID-19 vaccines at least 6 months prior can join. They must not be pregnant, plan to become pregnant soon, or have a history of severe allergies to vaccines. Participants should not have any immune system issues or serious health conditions that could affect the trial.Check my eligibility
What is being tested?
The study tests different doses (10μg, 30μg, and 100μg) of an mRNA vaccine called mRNA-CR-04 against COVID-19 in comparison with a placebo. The goal is to assess safety and how well the body responds by producing immunity.See study design
What are the potential side effects?
Possible side effects include pain at the injection site, fatigue, headache, muscle pain, chills, fever, nausea. These are common reactions seen with other similar vaccines but may vary based on dose.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 49 years old and not pregnant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to month 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of participants reporting Unsolicited Adverse Events (AEs)
Number of participants reporting medically attended adverse events (MAAEs)
Number of participants with adverse events of special interest (AESIs)
+4 moreSecondary outcome measures
Geometric mean ratio (GMR) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains
Geometric mean titers (GMTs) of neutralizing antibody (Ab) against pseudovirus bearing S protein from vaccine encoded SARS-CoV-2 and Wild Type (WT) strains
Number of participants reporting MAAEs
+3 moreTrial Design
6Treatment groups
Experimental Treatment
Placebo Group
Group I: Part B: mRNA CR-04 3 µgExperimental Treatment1 Intervention
mRNA 3 µg administered on day 1.
Group II: Part B: mRNA CR-04 10 µgExperimental Treatment1 Intervention
mRNA 10µg administered on day 1.
Group III: Part A, Group 3: mRNA CR-04 100 µg +PlaceboExperimental Treatment2 Interventions
mRNA 100µg or placebo administered on day 1.
Group IV: Part A, Group 2: mRNA CR-04 30 µg +PlaceboExperimental Treatment2 Interventions
mRNA 30µg or placebo administered on day 1.
Group V: Part A, Group 1: mRNA CR-04 10 µg +PlaceboExperimental Treatment2 Interventions
mRNA 10 micrograms (µg) or placebo administered on day 1.
Group VI: Part B: PlaceboPlacebo Group1 Intervention
Placebo administered on day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
GlaxoSmithKlineLead Sponsor
4,751 Previous Clinical Trials
8,067,400 Total Patients Enrolled
22 Trials studying COVID-19
24,697 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 49 years old and not pregnant.You must have a negative COVID-19 test within 7 days before getting the study vaccine.I haven't taken strong immune system affecting drugs regularly for the past 6 months.I plan to get a COVID-19 booster during the study or by Day 31 if recommended.I have a history of serious heart conditions or conditions that could affect my heart.I have a condition like kidney disease or liver disease that increases my risk for severe COVID-19.I have new or stable mild lab test abnormalities.You have had a serious allergic reaction to a vaccine or any part of the study vaccine in the past.I have a significant health condition like heart disease, severe asthma, or uncontrolled high blood pressure.I have had a fever of 100.4°F or higher in the last 3 days.I have not received, nor plan to receive any vaccines, except the flu shot, around my study vaccination dates.I had COVID-19 or tested positive for it within the last 6 months.I am not planning to become pregnant or stop using birth control within a month after getting the study vaccine.I haven't received and don't plan to receive any blood products or immunoglobulins 90 days before and during the study.You have been in close contact with someone who had a confirmed COVID-19 infection within the two weeks before the study's vaccination.I have received a non-mRNA COVID-19 vaccine.I agree not to donate blood or plasma from the start of the study until 6 months after vaccination.You have a condition that weakens your immune system, as confirmed by your medical history and physical examination. No lab tests are needed for this.Your body mass index is higher than 40 kg/m^2.I have completed the primary and booster doses of Pfizer or Moderna COVID-19 vaccine 6-18 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: mRNA CR-04 10 µg
- Group 2: Part B: Placebo
- Group 3: Part A, Group 3: mRNA CR-04 100 µg +Placebo
- Group 4: Part B: mRNA CR-04 3 µg
- Group 5: Part A, Group 2: mRNA CR-04 30 µg +Placebo
- Group 6: Part A, Group 1: mRNA CR-04 10 µg +Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research encompass individuals 35 years of age or older?
"For this research, only those who are above the age of majority and below 49 years old may be considered for inclusion."
Answered by AI
Is this experiment now enrolling participants?
"Clinicaltrials.gov data display that, though this trial was initially posted on August 7th 2023 and last modified on August 1st 2023, it is not presently seeking participants. However, there are several other studies in progress which are actively recruiting patients at present."
Answered by AI
In how many sites can one access this clinical trial?
"Currently, there are 4 clinics running this medical trial. These sites can be found in Melbourne, Peoria and Austin to name a few. When signing up for the study, it is advised that participants choose the closest site to reduce travelling time commitments."
Answered by AI
Is participation in this research protocol open to me?
"Candidates who wish to be admitted into this clinical trial must meet two criteria: they must possess a confirmed coronavirus diagnosis and have an age range between 18-49. This investigation is currently recruiting 72 individuals in total."
Answered by AI
Has the FDA accepted mRNA-CR-04 vaccine 10μg as a valid treatment?
"Preliminary data from Phase 1 of the trial suggests a limited understanding of mRNA-CR-04 vaccine 10μg's safety and efficacy, thus earning it a score of 1."
Answered by AI
Who else is applying?
What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Did not meet criteria
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