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Cancer Vaccine

Part B, Condition 2: Intermediate storage for COVID-19

Phase 2

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 29, 91 and 181

Awards & highlights

Study Summary

This trial is divided into two parts. In Part A, researchers are testing the immune response and safety of an experimental COVID-19 vaccine booster in healthy adults, comparing it to a control vaccine. In

Who is the study for?

Healthy adults over 18, including those with stable pre-existing conditions and women not of childbearing potential. Participants must have completed an mRNA COVID-19 vaccine series at least 3 months prior to the study and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing booster doses of new COVID-19 mRNA vaccines (monovalent and bivalent in various doses) against a control vaccine. It will assess immune response and safety under different storage conditions for each vaccine type.See study design

What are the potential side effects?

While specific side effects are not listed, typical reactions to vaccines may include soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea or swelling.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ days 29, 91 and 181

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~days 29, 91 and 181

This trial's timeline: 3 weeks for screening, Varies for treatment, and days 29, 91 and 181 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part A: Percentage of participants with adverse events of special interest (AESIs)

Part A: Percentage of participants with medically attended adverse events (MAAEs)

Part A: Percentage of participants with serious adverse events (SAEs)

+10 more

Secondary outcome measures

Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XX spike protein

Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing Omicron subvariant XZ spike protein

Part A: Geometric mean increase of the fold increase from baseline of serum neutralization titers against pseudovirus bearing SARS-CoV-2 strain XY spike protein

+6 more

Trial Design

8Treatment groups

Experimental Treatment

Active Control

Group I: Part B, Condition 3: Maximum storage conditionsExperimental Treatment1 Intervention

Participants receive one dose of CV0801.

Group II: Part B, Condition 2: Intermediate storageExperimental Treatment1 Intervention

Participants receive one dose of CV0801.

Group III: Part B, Condition 1: Baseline-controlExperimental Treatment1 Intervention

Participants receive one dose of CV0801.

Group IV: Part A, Group D: CV0601 High doseExperimental Treatment1 Intervention

Participants receive high dose of CV0601.

Group V: Part A, Group C: CV0701 Low doseExperimental Treatment1 Intervention

Participants receive low dose of CV0701.

Group VI: Part A, Group B: CV0701 Medium doseExperimental Treatment1 Intervention

Participants receive medium dose of CV0701.

Group VII: Part A, Group A: CV0701 High doseExperimental Treatment1 Intervention

Participants receive high dose of CV0701.

Group VIII: Part A, Group E: Control vaccineActive Control1 Intervention

Participants receive control vaccine.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,758 Previous Clinical Trials

8,103,455 Total Patients Enrolled

23 Trials studying COVID-19

24,944 Patients Enrolled for COVID-19

CureVacIndustry Sponsor

24 Previous Clinical Trials

45,813 Total Patients Enrolled

8 Trials studying COVID-19

43,212 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.

How prevalent is the participation of medical centers in this trial within the United States?

"There are 18 active sites participating in this research, including Benchmark Research - Sacramento - HyperCore - PPDS in Sacramento, Research Centers of America - CenExel - PPDS in Hollywood, and AES - DRS - Optimal Research Illinois - Peoria in Creve Coeur. Additionally, there are another 15 locations involved."

Answered by AI

Has Part A, Group A: CV0701 High dose received official approval from the FDA?

"In this Phase 2 trial, Part A, Group A: CV0701 High dose is assigned a safety score of 2 by our team at Power. This reflects existing safety data but lacks evidence for efficacy."

Answered by AI

Is the enrollment phase for this investigation currently ongoing?

"Based on information from clinicaltrials.gov, this particular study is currently not accepting new participants. Despite being posted on 8/1/2023 and last updated on 3/13/2024, there are numerous other trials actively seeking candidates with a total of 569 open opportunities for enrollment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

2023. "A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05960097.