Dose-finding Study for AdimrSC-2f Vaccine

NCT05104489 | Completed Phase 1 DMC

• 1 other identifier: ADPCT21013I
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• SARS-CoV-2 neutralizing antibody tiers

  21 days after the 3rd dosing

• Incidence of adverse events and clinically significant changes in clinical and laboratory evaluations.

  Day 1 to 24 weeks after the last dosing

Secondary Outcomes (2)

• SARS-CoV-2 neutralizing antibody tiers

  Day 1, Day 22, Day 43, 21 days after the last dosing, and 24 weeks after the last dosing

• Number of subjects with SARS-CoV-2 infection

  21 days after the 3rd dosing to 24 weeks after the last dosing

Study Arms (4)

Low Dose

EXPERIMENTAL

50 mcg of antigen with 250 mcg of Al(OH)3

Biological: AdimrSC-2f

Median Dose

EXPERIMENTAL

100 mcg of antigen with 250 mcg of Al(OH)3

Biological: AdimrSC-2f

High Dose

EXPERIMENTAL

100 mcg of antigen with 500 mcg of Al(OH)3

Biological: AdimrSC-2f

Placebo

PLACEBO COMPARATOR

250 mcg of Al(OH)3

Biological: AdimrSC-2f

Interventions

AdimrSC-2f BIOLOGICAL

IM injection

High Dose; Low Dose; Median Dose; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• At Screening Visit, subjects with a body mass index (BMI) \> 18.5 kg/m2 or ≤ 30.0 kg/m2.
• 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.
• Subjects are willing and able to give informed consent prior to any screening procedure conducting and to comply with study procedures.
• 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
• Norplant®, Depo-Provera®, or other in country regulatory-approved contraceptive method that is designed to protect against pregnancy
• Abstinence, as a form of contraception, is acceptable

You may not qualify if:

• 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.
• 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.
• 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).
• Subject with positive test result for COVID-19 antigen rapid test at the Screen Visit or V1 prior to the 1st dosing.
• 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.
• 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.
• 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.
• 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.
• Chronic liver disease or suspected active hepatitis.
• Clinically significant cardiovascular disease such as arrhythmia, coronary artery disease or heart failure.
• Personal or family history of immune disorders, including systemic lupus erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, and Type 1 diabetes.
• Any confirmed or suspected abnormal immune function, immunosuppressive, or immunodeficiency.
• Personal or family history of Guillain-Barré Syndrome.

Sponsors & Collaborators

• Adimmune Corporation: lead

Study Sites (1)

University Gadjah Mada Academic Hospital

Yogyakarta, 55281, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2021
• First Posted: November 3, 2021
• Study Start: January 3, 2022
• Primary Completion: December 29, 2022
• Study Completion: July 26, 2023
• Last Updated: July 28, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)