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Dose-finding Study for AdimrSC-2f Vaccine | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Dose-finding Study for AdimrSC-2f Vaccine

A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults

NCT05104489•Adimmune Corporation

View on ClinicalTrials.gov

Summary

AdimrSC-2f is a subunit protein-based vaccine produced using the baculovirus insect cells manufacturing process to prevent Coronavirus disease 2019 (COVID-19). The primary goal of this Phase I/II study is to evaluate the vaccine safety and immunogenicity of AdimrSC-2f in healthy adult individuals, as compared to placebo.

Detailed Description

This will be a Phase I/II, placebo-controlled, randomized, double-blind within dose cohort, dose-finding study to evaluate the safety, tolerability, and immune response of AdimrSC-2f vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in healthy adults aged from 18 to 60. Two hundred forty (240) subjects will be sequentially enrolled from low dose to high dose cohort and then randomized into AdimrSC-2f vaccine group or matched placebo in a 3:1 ratio. Each enrolled subject will receive a total of 3 doses with 3-week apart by 0.5 mL intramuscular (IM) injection to the deltoid region of non-dominant arm preferably. All enrolled subjects will be follow their safety and immune response for six months.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are in good general health in the opinion of the investigator.
•2. At Screening Visit, subjects with a body mass index (BMI) \> 18.5 kg/m2 or ≤ 30.0 kg/m2.
•3. Subjects without known history of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to the first dosing.
•4. Subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures.
•5. Female subjects of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months or documented plasma follicle-stimulating hormone level ≥40 milli-International unit (mIU)/mL\]) must agree to be heterosexually inactive from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing OR agree to consistently use any of the following methods of contraception from at least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks) after the last dosing:
•* Condoms (male or female) with spermicide (if acceptable in country)
•* Diaphragm with spermicide
•* Cervical cap with spermicide
•* Intrauterine device
•* Oral or patch contraceptives
+2 more criteria

Exclusion Criteria

•1. Subjects who are investigational site staff member directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Sponsor employees directly involved in the conduct of the trial.
•2. Any ongoing severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
•3. Subject with positive serology test results for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV) at the Screening Visit (V0).
•4. Subject with positive test result for COVID-19 antigen rapid test at the Screen Visit or V1 prior to the 1st dosing.
•5. Subject with influenza-like illness as defined by any of the following symptoms at the Screening Visit or before randomization: fever (tympanic temperature ≥ 38°C), dry cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia, shortness of breath, muscle and joint pain, or sore throat.
•6. Participation in other studies involving investigational drug(s) and/or device(s) within 90 days prior to the Screening Visit and/or during study participation.
•7. Subject who has received any investigational coronavirus vaccine or has received any medications intended to prevent COVID-19 or plan simultaneous participation in another interventional study to prevent or treat COVID-19.
•8. Subject with any following ongoing disease or medical history in medical chart or by verbal confirmation:
•* Diagnosis of malignancy not in remission for the past 3 years except non-melanoma skin cancer prior to the Screening Visit.
•* Chronic pulmonary disease, asthma or wheezing.
+20 more criteria

Locations (1)

University Gadjah Mada Academic Hospital

Yogyakarta, Indonesia

Key Dates

Start Date

January 3, 2022

Primary Completion Date

December 29, 2022

Completion Date

July 26, 2023

Last Updated

July 28, 2023

Enrollment

241

ACTUAL participants

Conditions

COVID-19

Interventions

AdimrSC-2f

BIOLOGICAL

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RECRUITINGPHASE1

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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: July 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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Dose-finding Study for AdimrSC-2f Vaccine

Inclusion Criteria

Exclusion Criteria

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