Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine

NCT05067894 | Completed Phase 1 DMC

• 1 other identifier: CoV2-010221
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is To evaluate the safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose.

Conditions

Covid19

Keywords

covid19 vaccine

Outcome Measures

Primary Outcomes (1)

• Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose

  percentage of subjects with solicited and unsolicited Adverse Events (AE)

  7 days after each dose

Secondary Outcomes (6)

• safety of the SARS-CoV-2 protein subunit recombinant vaccine within 28 days after each dose

  28 days after each dose

• Comparison of AE/ Serious Adverse Events (SAE) between intervention vaccine and active control

  28 days after each dose

• Deviation of laboratory evaluation

  28 days after the first dose

• Deviation of laboratory evaluation

  7 days after whole schedule dose

• Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after second dose

  28 days after each dose

Study Arms (4)

Adult - Vaccine candidate

EXPERIMENTAL

50 µg dose, adult group (18-59 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine

Adult - Control

ACTIVE COMPARATOR

SARS-CoV-2 inactivated vaccine, adult group (18-59 years)

Biological: SARS-CoV-2 Inactivated Vaccine

Elderly - Vaccine candidate

EXPERIMENTAL

50 µg dose, elderly group (\> 60 years)

Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine

Elderly - Control

ACTIVE COMPARATOR

SARS-CoV-2 inactivated vaccine, elderly group (\> 60 years)

Biological: SARS-CoV-2 Inactivated Vaccine

Interventions

SARS-CoV-2 Protein Subunit Recombinant Vaccine BIOLOGICAL

intramuscular injection

Adult - Vaccine candidate; Elderly - Vaccine candidate

SARS-CoV-2 Inactivated Vaccine BIOLOGICAL

intramuscular injection

Adult - Control; Elderly - 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 within the following age groups: adults (18-59 years) and elderly (60 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 investigational product against Covid-19 during or 6 months prior to enrollment.
• Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or other examinations).
• Evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun).
• The result of rapid antigen test is positive.
• Women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results).
• Abnormality hematology and biochemical test results.
• History of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
• History of uncontrolled coagulopathy or 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.
• Subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)).
• Subjects who have 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 Investigational Product (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
• National Institute of Health Research and Development, Ministry of Health Republic of Indonesia: collaborator

Study Sites (1)

Fakultas Kedokteran Universitas Indonesia

Jakarta, Greater Jakarta, 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. Rini Sekartini, MD

  Fakultas Kedokteran Universitas Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Observer blind: Investigational Product and Active Comparator are masking. Lot number is masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2021
• First Posted: October 5, 2021
• Study Start: December 10, 2021
• Primary Completion: April 11, 2022
• Study Completion: August 6, 2022
• Last Updated: August 9, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)