CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 185 enrolled
Drug / intervention
CV0501 (3 μg) +6 morebiological
Likely dose
CV0501 3–200 μg intramuscular single injection (dose-escalation study)AI-extracted
Key inclusion· 5
  • Age ≥18 years
  • Received ≥2 prior doses of Comirnaty or Moderna COVID-19 vaccine (Spikevax), with last dose ≥6 months before screening
  • Negative SARS-CoV-2 RT-PCR at screening
  • Healthy or medically stable with normal labs, vitals, and physical exam
Key exclusion· 16
  • Positive pregnancy test or breastfeeding
  • Fever (≥38.0°C or ≥100.4°F) within 72 hours before vaccination or suspected COVID-19 symptoms
  • History of SARS-CoV-2 infection or COVID-19 within 6 months before screening
  • HIV, hepatitis B, or hepatitis C (documented history or positive test at screening)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05477186
NCT05477186Phase 1Completed

A Phase 1, Open-label, Safety and Immunogenicity Study of a Booster Dose of the Investigational CV0501 mRNA COVID-19 Vaccine in Adults at Least 18 Years Old

GlaxoSmithKline·interventional·Posted Jul 28, 2022·Updated Feb 21, 2025

In Brief

A Phase 1 clinical trial evaluating CV0501 (3 μg), CV0501 (6 μg), and 5 other interventions for COVID-19 and SARS-CoV-2. Completed, enrolled 185 participants across 17 sites in 3 countries.

Detailed Summary

Prevention of COVID-19 caused by SARS-CoV-2.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOVID-19, SARS-CoV-2
CountriesAustralia, Philippines, United States
Collaborators--

Timeline

Phase 1CompletedFinished
2023202420252026
First PostedJul 28, 2022
Enrollment StartAug 12, 2022
Primary CompletionAug 18, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 3.9 years ago

Interventions

CV0501 (3 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (6 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (12 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (25 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (50 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (100 μg)biological

Study vaccine was administered as a single intramuscular injection.

CV0501 (200 μg)biological

Study vaccine was administered as a single intramuscular injection.