Immuno-bridging Study of COVID-19 Protein Subunit Recombinant Vaccine

NCT05433285 | Completed Phase 3 DMC

• 1 other identifier: CoV2-IB-0322
• Study Type: interventional
• Target: 4,050
• Locations: 1 country
• Sites: 4

Brief Summary

Observer-blind, randomized, active-controlled prospective intervention study

Conditions

COVID-19

Keywords

COVID-19 vaccine; healthy population; naive participants

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of the candidate vaccine

  Geometric Mean Titers (GMT) of neutralizing antibody

  14 days after the last dose

• Seroconversion rate of the candidate vaccine

  Seroconversion rate of neutralizing 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

  12 months after the last dose

• Persistence neutralizing antibody of vaccine candidate

  28 days, 3 months, 6 months and 12 months after the last dose

• Persistence Immunoglobulin G (IgG) antibody of vaccine candidate

  14 days, 28 days, 3 months, 6 months and 12 months after the last dose

Other Outcomes (1)

• Cellular immunity of candidate vaccine

  14 days, 6 months and 12 months after two-dose primary series.

Study Arms (2)

COVID-19 Protein Subunit Recombinant Vaccine

EXPERIMENTAL

2 doses of COVID-19 Protein Subunit Recombinant Vaccine administered with 28 days interval (0.5 mL per dose)

Biological: COVID-19 Protein Subunit Recombinant Vaccine

Active Comparator

ACTIVE COMPARATOR

2 doses of Covovax® - recombinant spike protein Nanoparticle Vaccine, administered with 28 days interval (0.5 mL per dose)

Biological: Active Comparator

Interventions

COVID-19 Protein Subunit Recombinant Vaccine BIOLOGICAL

SARS-CoV-2 RBD subunit recombinant protein, manufactured by PT. Bio Farma

COVID-19 Protein Subunit Recombinant Vaccine

Active Comparator BIOLOGICAL

Covovax® COVID-19 vaccine is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of the SARS-CoV-2 betacoronavirus

Active Comparator

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, 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 in the previous 4 weeks received a treatment likely to alter the immune response (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
• Fakultas Kedokteran Universitas Indonesia: collaborator
• Faculty of Medicine Universitas Diponegoro: collaborator
• Faculty of Medicine Universitas Andalas: collaborator
• Faculty of Medicine Universitas Hassanudin: collaborator

Study Sites (4)

Faculty of Medicine Diponegoro University

Semarang, Central Java, Indonesia

Location

Fakultas Kedokteran Universitas Indonesia

Jakarta, Greater Jakarta, Indonesia

Location

Faculty of Medicine Universitas Hassanudin

Makassar, South Sulawesi, Indonesia

Location

Faculty of Medicine Universitas Andalas

Padang, West Sumatera, Indonesia

Location

Related Publications (1)

• Nurdin A, Movieta Nency Y, Maddeppungeng M, Sekartini R, Mulia Sari R, Surachman F, Fitry Yani F, Raveinal, Anggrainy F, Hafiz A, Linosefa, Machmud R, Awaliyah Deza P, Rujiana V, Bella Rahimi M, Farhanah N, Gundi Pramudo S, Hapsari R, Tri Anantyo D, Mulyono, Mahati E, Maharani N, Darma S, Husni Esa Darussalam A, Shakinah S, Nasrum Massi M, Soedjatmiko. Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial. Vaccine. 2024 Apr 30;42(12):3009-3017. doi: 10.1016/j.vaccine.2024.03.077. Epub 2024 Apr 4.

  PMID: 38575433 DERIVED

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 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Vaccine candidate and active comparator are masking, lot number is masking
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 27, 2022
• Study Start: June 7, 2022
• Primary Completion: August 5, 2022
• Study Completion: August 31, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (4)