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

COMPLETEDPHASE2

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

COVID-19: A Phase 2a, Partially Observer-blind, Multicenter, Controlled, Dose-confirmation Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults >60 Years of Age and 18 to 60 Years of Age

NCT04515147•CureVac

View on ClinicalTrials.gov

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.

Detailed Description

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Healthy male and female participants ≥18 years of age. A healthy participant is defined as an individual who is in good general health, according to the Investigator's assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
•Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
•Participants are able to understand and willing to provide informed consent.
•Physical examination without clinically significant findings according to the Investigator's assessment.
•Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2.
•Female participants of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for female participants presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before).
•Female participants of childbearing potential must use highly effective methods of birth control from 2 weeks before the first administration of the trial vaccine until 3 months following the last administration. The following methods of birth control are considered highly effective when used consistently and correctly:
•* Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal);
•* Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable);
•* Intrauterine devices;
+5 more criteria

Exclusion Criteria

•Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
•Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration (primary dose or booster dose).
•Receipt of any investigational or licensed/authorized SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
•Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
•Use of hormonal therapy for gender reassignment.
•Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection.
•History of immune-mediated or autoimmune disease.
•History of angioedema (known C1 inhibitor deficiency).
•History of anaphylaxis or allergy to any component of CVnCoV or aminoglycoside antibiotics.
•History of or current alcohol and/or drug abuse.
+15 more criteria

Locations (2)

Centro de vacunación internacional - CEVAXIN Panama Clinic

Panama City, Panama

Instituto de Investigación Nutricional

Lima, Peru

Key Dates

Start Date

September 21, 2020

Primary Completion Date

February 21, 2022

Completion Date

February 21, 2022

Last Updated

September 28, 2023

Enrollment

668

ACTUAL participants

Conditions

CoronavirusCovid19SARS-CoV-2Severe Acute Respiratory Syndrome

Interventions

CVnCoV 6 μg

BIOLOGICAL

CVnCoV 12 μg

BIOLOGICAL

Hepatitis A vaccine

BIOLOGICAL

Pneumococcal vaccine

BIOLOGICAL

CVnCoV 12μg

BIOLOGICAL

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NCT06631287

Long COVIDSars-CoV-2 Infection+2 more

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RECRUITINGPHASE1

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

NCT05141058

SARS-CoV-2 Infection

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Randomized Double-Blind Placebo-Controlled Trial EValuating Baricitinib on PERSistent NEurologic and Cardiopulmonary Symptoms of Long COVID

T Cell Therapy Opposing Novel COVID-19 Infection in Immunocompromised Patients

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