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A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine

A Randomized, Single Center, Open-label, Dose-finding, Phase I Study to Evaluate the Safety and Immunogenicity of Pandemic Virus Vaccine, AdimrSC-2f (SARS-CoV-2), in Healthy Volunteers

NCT04522089•Adimmune Corporation

View on ClinicalTrials.gov

Summary

This study aims to evaluate the safety and immunogenicity of the preventative vaccine, AdimrSC-2f, in healthy volunteers aged from 20 to 60 years old.

Detailed Description

The objectives of this phase I study are: 1. to evaluate the safety profile of the AdimrSC-2f vaccine, and 2. to assess the immunogenicity of the AdimrSC-2f vaccine.

Eligibility

Age

20 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Male or non-pregnant female, aged 20 to 60 years old (inclusive).
•2. Subject who is physically and mentally capable of participating the study and are willing to adhere to study procedures.
•3. Subject with no clinically significant abnormal findings in medical history, physical examination, vital signs, or clinical laboratory results at the Screening visit based on the investigator's judgment.
•4. Subject with negative test result in SARS-CoV-2 antibody (IgG and IgM) rapid test at the Screening visit.
•5. Subject with negative serology test results for human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, and hepatitis C antibody at the Screening visit.
•6. Subjects' clinical laboratory test results are in the normal range or with abnormal values without clinical significance as judged by the investigator.
•7. Female subject with childbearing potential must have negative result in urine pregnancy test at the Screening visit.
•8. Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
•1. Intrauterine device plus one barrier method
•2. Oral, implantable, or injectable contraceptives plus one barrier method; or
+3 more criteria

Exclusion Criteria

•1. Subject with a body mass index (BMI) \< 18.5 kg/m2 (underweight) or ≥ 35 kg/m2 (greater than Class I obesity) at the Screening Visit.
•2. Subject with history of cancer (except localized skin cancer without metastases) within 5 years prior to the Screening visit.
•3. Subject has ongoing or medical history of hypertension or diabetes mellitus.
•4. Subject has ongoing use of tobacco or nicotine-containing products (nicotine patch included) or e-cigarette devices or with history of using nicotine-containing product as documented in medical chart or by verbal confirmation at screening.
•5. Subject with documented history of substance or alcohol abuse in the medical chart or by verbal confirmation within 6 months (approximately 180 days) prior to the Screening visit.
•6. Subject who received any vaccine (live, inactivated, or bacterial) within 1 month (approximately 30 days) prior to the Screening visit.
•7. Subject with hypersensitivity to the ingredients of AdimrSC-2f (including aluminum).
•8. Subject with personal or family history of Guillain-Barré Syndrome.
•9. Subject who has travelled abroad within 3 months (approximately 90 days) prior to the Screening visit.
•10. Subject with influenza-like illness as defined by any of the following symptoms at Screening visit: fever (tympanic temperature ≥ 38℃), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
+9 more criteria

Locations (1)

National Taiwan University Hospital

Taipei, Taiwan

Key Dates

Start Date

August 24, 2020

Primary Completion Date

November 20, 2020

Completion Date

May 6, 2021

Last Updated

May 24, 2022

Enrollment

ACTUAL participants

Conditions

COVID-19

Interventions

AdimrSC-2f

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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: May 24, 2022Data 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 Study to Evaluate the Safety and Immunogenicity of COVID-19 (AdimrSC-2f) Vaccine

Inclusion Criteria

Exclusion Criteria

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