MedTrace Logo

A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19

NCT04515147 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 668

Last updated 2023-09-28

Study results available
· View outcomes & findings →

Summary

This study aims to evaluate the safety and reactogenicity profile after 1 and 2 dose administrations of investigational SARS-CoV-2 mRNA vaccine (CVnCoV) at different dose levels and to evaluate the humoral immune response after 1 and 2 dose administrations of CVnCoV.

Conditions

  • Coronavirus
  • Covid19
  • SARS-CoV-2
  • Severe Acute Respiratory Syndrome

Interventions

BIOLOGICAL

CVnCoV 6 μg

Participants will receive an intramuscular injection by needle in the deltoid area.

BIOLOGICAL

CVnCoV 12 μg

Participants will receive an intramuscular injection by needle in the deltoid area.

BIOLOGICAL

Hepatitis A vaccine

Participants will receive an intramuscular injection by needle in the deltoid area.

BIOLOGICAL

Pneumococcal vaccine

Participants will receive an intramuscular injection by needle in the deltoid area.

BIOLOGICAL

CVnCoV 12μg

Participants will receive an intramuscular injection by needle in the deltoid area.

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV

  • CureVac

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-09-21
Primary Completion
2022-02-21
Completion
2022-02-21

Countries

  • Panama
  • Peru

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515147 on ClinicalTrials.gov