Safety and Immunogenicity Study of COVID-19 Protein Subunit Recombinant Vaccine Adjuvanted With Alum+CpG 1018

NCT05228613 | Completed Phase 1 DMC

• 1 other identifier: CoV2-0122
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 2

Brief Summary

The study is an observer-blind, randomized, controlled prospective intervention study of Phase I. The primary objective is to evaluate the safety and immunogenicity of the SARS-CoV-2 protein subunit recombinant vaccine adjuvanted with Alum+CpG1018

Conditions

COVID-19

Keywords

COVID-19 vaccine; healthy population

Outcome Measures

Primary Outcomes (1)

• Safety of the vaccine within 7 days after each dose

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

  7 days after each dose

Secondary Outcomes (9)

• safety of the vaccine within 28 days after each dose

  28 days after each dose

• Serious Adverse Event (SAE) of the vaccine

  6 months after the last dose

• Comparison of safety between vaccine and active control

  28 days after each dose and 6 months after the last dose

• Deviation of laboratory evaluation

  7 days after the first dose and 14 days after the last dose

• Inflammatory factor evaluation

  7 days after the first dose and 14 days after the last dose

Other Outcomes (1)

• Cellular immunity evaluation

  14 days after the last dose

Study Arms (5)

Vaccine Candidate Formula A

EXPERIMENTAL

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

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Vaccine Candidate Formula B

EXPERIMENTAL

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

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Vaccine Candidate Formula C

EXPERIMENTAL

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

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Vaccine Candidate Formula D

EXPERIMENTAL

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

Biological: SARS-CoV-2 protein subunit recombinant vaccine

Active Control

ACTIVE COMPARATOR

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

Biological: SARS-CoV-2 inactivated vaccine

Interventions

SARS-CoV-2 protein subunit recombinant vaccine BIOLOGICAL

candidate vaccine manufactured by PT. Bio Farma

Vaccine Candidate Formula A; Vaccine Candidate Formula B; Vaccine Candidate Formula C; Vaccine Candidate Formula D

SARS-CoV-2 inactivated vaccine BIOLOGICAL

active control manufactured by Sinovac Life Sciences Co.Ltd

Active Control

Eligibility Criteria

• Age: 18 Years - 70 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 investigational product against COVID-19 (based on anamnesis)
• Subjects who have history of COVID-19 (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 RT-PCR test for SARS-CoV-2 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 (for main study subset).
• 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 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, Diponegoro University, Semarang: collaborator

Study Sites (2)

Faculty of Medicine, Diponegoro University, Semarang

Semarang, Central Java, Indonesia

Location

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

• Yetty Movieta Nency, MD

  Faculty of Medicine, Diponegoro University, Semarang

  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: February 7, 2022
• First Posted: February 8, 2022
• Study Start: February 16, 2022
• Primary Completion: August 2, 2022
• Study Completion: January 24, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

ID (2)