UNAIR Inactivated COVID-19 Vaccine as Homologue Booster (Immunobridging Study)

NCT06259578 | Recruiting Early Phase 1 DMC

• 1 other identifier: UNAIR-MP-INAKTIF-BO-009
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this open-label clinical trial is to evaluate the safety and immunogenicity of INAVAC (Vaksin Merah Putih - UNAIR SARS-CoV-2 (Vero Cell Inactivated)) Vaccine as Homologue Booster in Adult Subjects in Indonesia. The main question it aims to answer is: "To evaluate the humoral immunogenicity profile at 28 days following vaccination with INAVAC vaccine as homolog booster administered intramuscularly in healthy adults age 18 years and above". Participants will be administered one dose of vaccination for the third dose (booster vaccination) intramuscularly.

Conditions

COVID-19 Pandemic; COVID-19 Vaccines; COVID-19 Virus Disease

Keywords

Inactivated COVID-19 Vaccine; Immunogenicity; Safety; COVID-19; Indonesia; Immunobridging study; Booster; INAVAC

Outcome Measures

Primary Outcomes (1)

• Humoral Immune Reponse

  1. SARS-CoV-2 Neutralization: SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above 2. IgG RBD SARS-CoV-2 antibodies measured by CLIA: analysis of antibodies binding to the SARS-CoV-2 S-protein, at 28 days following vaccination with INAVAC vaccine as homologue booster administered intramuscularly in healthy adults age 18 year and above

  28 days following vaccination

Secondary Outcomes (3)

• Incidence of Adverse Events

  7 days, 28 days, 3 months and 6 months following vaccination

• Humoral Immune Reponse

  3 and 6 months following vaccination

• Exploratory Endpoints

  Through study completion, an average of 6 months after the study product administration

Study Arms (1)

INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg

EXPERIMENTAL

The study product is provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) once.

Biological: INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg

Interventions

INAVAC (Vaksin Merah Putih - UA- SARS CoV-2 (Vero Cell Inactivated) 5 μg BIOLOGICAL

1 dose of 0.5 ml containing inactivated SARS-CoV-2 virus (5 μg ), Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride

INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 μg

Eligibility Criteria

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

You may qualify if:

• Healthy adults and elderly, males and females, 18 years of age and above. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
• Subjects already received 2 (two) doses of INAVAC vaccines (5 ug), mostly during the phase I/II/III clinical trial of this vaccine. The interval between the second primary injection and the booster is 12-18 months.
• 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
• Female subjects of childbearing potential must agree to postpone pregnancy from at least 21 days before enrollment and through 6 months after the vaccination.
• Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the vaccine.
• Participants must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study.

You may not qualify if:

• Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial
• Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrently or within 7 days before study vaccination. This includes respiratory or constitutional symptoms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
• Known history of allergy to any component of the vaccines
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
• Any autoimmune or immunodeficiency disease/condition
• Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood-derived products, long-term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroids will be permitted. Inhaled glucocorticoids are prohibited.
• Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, and diabetes requiring the use of medicine. The final decision regarding this condition will be made by the attending field clinicians or investigators.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
• Individuals who previously received any vaccines against Covid-19, other than INAVAC.
• Subjects already immunized with any other vaccines within 4 weeks prior and expect to receive other vaccines within 60 days following the booster dose
• Individuals who have a previously ascertained COVID-19 in 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe COVID-19) before the first recruit of this study, or in close contact in the last 14 days with a confirmed case of Covid-19.
• Positive test for SARS-CoV-2 (Antigen or PCR) at screening before the vaccination. Testing may be repeated during the screening period if exposure to a positive confirmed case of SARS-CoV-2 is suspected, at the discretion of the investigator.
• History of alcohol or substance abuse
• HIV patients.
• Malignancy patients within 3 years before study vaccination.

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Universitas Airlangga: collaborator
• Bioxis Pharmaceuticalls: collaborator
• Indonesia-MoH: collaborator

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 67161, Indonesia

RECRUITING

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Related Links

• New York Vaccine Tracker. Accessed 30 April 2022.
• Badan POM Republik Indonesia. Accessed 11 October 2021.
• Worldometer coronavirus cases. Accessed 30 March 2023.
• Our world in Data. Accessed 30 April 2022.
• CNN. Accessed 11 October 2021.
• World Health Organization. Accessed 11 October 2021.
• Badan POM Republik Indonesia. Accessed 11 April 2022.
• CNN Indonesia. Accessed 11 October 2021.
• Suara.com. Accessed 11 October 2021.

MeSH Terms

Conditions

COVID-19

Interventions

vaksin merah putih - UA SARS-CoV-2 COVID-19 vaccine

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: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: February 14, 2024
• Study Start: January 29, 2024
• Primary Completion: August 29, 2024
• Study Completion: December 29, 2024
• Last Updated: February 14, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)