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mRNA Vaccine

CV2CoV (2 µg) 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1, 8, 15, 29, 85, and 180
Awards & highlights

Study Summary

This trial is testing if a vaccine can prevent COVID-19 caused by the SARS-CoV-2 virus.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1, 8, 15, 29, 85, and 180
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 1, 8, 15, 29, 85, and 180 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of participants with adverse events of special interest (AESIs) from study vaccination through the end of the study
Percentage of participants with each solicited systemic AEs up to 7 days after study vaccination
Percentage of participants with medically attended adverse events (MAAEs) from study vaccination through the end of the study
+3 more
Secondary outcome measures
GMI from baseline of binding IgG against SARS CoV-2 S protein and RBD at each collection time point
GMTs of binding Immunoglobulin G (IgG) against SARS CoV-2 S protein and Receptor-Binding Domain (RBD) at each collection time point.
Geometric Mean Increase (GMI) from baseline of neutralizing antibody titers against pseudovirus bearing spike protein from SARS CoV 2 WT at each collection time point
+2 more

Trial Design

5Treatment groups
Experimental Treatment
Group I: CV2CoV Dose Cohort 5 (20 µg)Experimental Treatment1 Intervention
Cohort 5 will receive CV2CoV dose level 20 µg Enrollment into Cohort 5 will begin after the SRT has reviewed safety data from all participants in the previous dose cohort.
Group II: CV2CoV Dose Cohort 4 (16 µg)Experimental Treatment1 Intervention
Cohort 4 will receive CV2CoV dose level 16 µg Enrollment into Cohort 4 will begin after the SRT has reviewed safety data from all participants in the previous dose cohort.
Group III: CV2CoV Dose Cohort 3 (12 µg)Experimental Treatment1 Intervention
Cohort 3 will receive CV2CoV dose level 12 µg Enrollment into Cohort 3 will begin after the SRT has reviewed safety data from 2 sentinel participants from the previous dose cohort.
Group IV: CV2CoV Dose Cohort 2 (8 µg)Experimental Treatment1 Intervention
Cohort 2 will receive CV2CoV dose level 8 µg Enrollment into Cohort 2 will begin after the Safety Review Team (SRT) has reviewed safety data from 2 sentinel participants from the previous dose cohort.
Group V: CV2CoV Dose Cohort 1 (2µg or 4µg)Experimental Treatment2 Interventions
Group 1a will receive CV2CoV dose level 2 µg Group 1b will receive CV2CoV dose level 4 µg
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CV2CoV (2 µg)
2022
Completed Phase 1
~100
CV2CoV (4 µg)
2022
Completed Phase 1
~100
CV2CoV (8 µg)
2022
Completed Phase 1
~100
CV2CoV (16 µg)
2022
Completed Phase 1
~100
CV2CoV (20 µg)
2022
Completed Phase 1
~100
CV2CoV (12 µg)
2022
Completed Phase 1
~100

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CureVacIndustry Sponsor
24 Previous Clinical Trials
46,403 Total Patients Enrolled
8 Trials studying COVID-19
43,802 Patients Enrolled for COVID-19
GlaxoSmithKlineLead Sponsor
4,755 Previous Clinical Trials
8,070,718 Total Patients Enrolled
23 Trials studying COVID-19
25,521 Patients Enrolled for COVID-19
CureVac AGIndustry Sponsor
21 Previous Clinical Trials
44,456 Total Patients Enrolled
7 Trials studying COVID-19
43,127 Patients Enrolled for COVID-19

Frequently Asked Questions

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

To what extent is participation being facilitated in this clinical research?

"Affirmative. Clinicaltrials.gov states that this research endeavor is currently accepting participants, having been first published on March 24th 2022 and revised as of July 21st 2022. 210 patients will be enrolled from 18 medical sites for the study's duration."

Answered by AI

What potential risks could be associated with CV2CoV (2 µg) exposure?

"Since this is an early stage clinical trial, CV2CoV (2 µg) received a score of 1 due to the lack of concrete data confirming its safety and efficacy."

Answered by AI

Is the enrollment window for this clinical experiment still open?

"Based on the information provided by clinicaltrials.gov, this research is presently taking applications from potential participants. The trial was initially published on March 24th 2022 while its most recent edit occurred July 21st of that year."

Answered by AI

Are there any North American locations in which this trial is currently being conducted?

"This trial is available at 18 different medical sites, including Velocity Clinical Research - Salt Lake City - Jordan Valley-ERN-PPDS in West Jordan, CTMD research Inc - Palm Springs Hunt PPDS in Palm Springs, and Global Medical Research - M3 WR - ERN - PPDS in Dallas."

Answered by AI

Who else is applying?

What state do they live in?
Arizona
How old are they?
18 - 65
What site did they apply to?
Velocity Clinical Research - San Diego
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants
2022. "Safety, Reactogenicity, and Immunogenicity Trial of CV2CoV mRNA Vaccine Against SARS-CoV-2 in Seropositive Adult Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05260437.
~32 spots leftby Apr 2025
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