Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05313035 | Completed Phase 2 DMC

• 1 other identifier: CoV2-020322
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

Brief Summary

This trial is observer-blind, comparative, randomized, placebo-controlled phase 2 study. The population is healthy subjects aged 18 and above

Conditions

COVID-19

Keywords

COVID-19 vaccine; healthy population

Outcome Measures

Primary Outcomes (1)

• Immunogenicity of the candidate vaccine

  seroconversion rate of antibody (IgG and neutralization antibody)

  14 days after the last dose

Secondary Outcomes (4)

• Safety of the candidate vaccine

  28 days after each dose

• Serious Adverse Event (SAE) of the vaccine

  6 months after the last dose

• Persistence antibody of vaccine candidate

  14 days, 28 days, 3 months, 6 months after the last dose

• Persistence antibody of vaccine candidate

  14 days, 28 days, 3 months, 6 months after the last dose

Study Arms (3)

Vaccine Candidate Formula 1

EXPERIMENTAL

2 doses of vaccine candidate formula 1 administered with 28 days interval (0.5 mL per dose)

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Vaccine Candidate Formula 2

EXPERIMENTAL

2 doses of vaccine candidate formula 2 administered with 28 days interval (0.5 mL per dose)

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Control

PLACEBO COMPARATOR

2 doses of placebo administered with 28 days interval (0.5 mL per dose)

Biological: placebo

Interventions

SARS-CoV-2 protein subunit recombinant vaccine BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula 1; Vaccine Candidate Formula 2

placebo BIOLOGICAL

the placebo is NaCl injection manufactured by PT. Bio Farma

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically healthy subjects aged 18 years and above.
• Subjects have been informed properly regarding the study and signed the informed consent form.
• Subjects will commit to comply with the instructions of the investigator and the schedule of the trial.

You may not qualify if:

• Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
• History of vaccination with any COVID-19 vaccine.
• History of COVID-19 within 1 month (for mild-moderate disease) or 3 months (for severe disease) prior to enrollment.
• Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
• Women who are pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
• History of uncontrolled asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
• History of blood disorders contraindicating intramuscular injection.
• Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives.
• History of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immuneresponse (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
• History of uncontrolled epilepsy or other progressive neurological disorders, such as Guillain-Barre syndrome.
• Subjects receive any vaccination (other than COVID-19 vaccine) within 1 month before and after IP immunization.
• Subjects plan to move from the study area before the end of study period.

Sponsors & Collaborators

• PT Bio Farma: lead
• Indonesia University: collaborator
• Faculty of Medicine, Diponegoro University, Semarang: collaborator
• Faculty of Medicine, Universitas Andalas, Padang: collaborator
• Faculty of Medicine, Universitas Hassanudin, Makassar: collaborator

Study Sites (3)

Faculty of Medicine, Diponegoro University, Semarang

Semarang, Central Java, Indonesia

Location

Faculty of Medicine Universitas Hassanudin

Makassar, South Sulawesi, Indonesia

Location

Faculty of Medicine, Universitas Andalas, Padang

Padang, West Sumatera, 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 Officials

• Prof. Dr. Soedjatmiko SpA(K), MSi, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vaccine candidate and placebo are masking, lot number is masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 6, 2022
• Study Start: April 13, 2022
• Primary Completion: July 22, 2022
• Study Completion: February 28, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

ID (3)