UNAIR Inactivated COVID-19 Vaccine

NCT05226429 | Unknown Phase 1 DMC

• 1 other identifier: UNAIR-MP-INAKTIF-001
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, observer blind, controlled phase I/II study to evaluate the Safety, Reactogenicity, and Immunogenicity of UNAIR Inactivated Covid-19 Vaccine in Healthy Populations Aged 18 Years and Above. UNAIR Inactivated Covid-19 Vaccine is an inactivated vaccine developed by Airlangga University (Universitas Airlangga / UNAIR) made of SARS-CoV-2 virus isolated from a patient in Surabaya, Indonesia, composed with aluminium hydroxy gel, tween 80, and L-histidine. This study will be the first in human.

Conditions

COVID-19 Pandemic; Vaccine Reaction

Keywords

Inactivated COVID-19 Vaccine; Immunogenicity; Indonesia; COVID-19

Outcome Measures

Primary Outcomes (5)

• Solicited clinical (local and systemic), laboratory, and unsolicited adverse events

  The number of adverse events occur among participants.

  7 days each vaccination

• Solicited clinical (local and systemic), laboratory, and unsolicited adverse events

  The number of adverse events occur among participants.

  28 days after each vaccination

• SARS-CoV-2 neutralization antibodies

  The level of SARS-CoV-2 neutralization antibodies in participants.

  28 days after the second vaccination

• SARS-CoV-2 binding antibodies

  The level of SARS-CoV-2 binding antibodies in participants.

  28 days after the second vaccination

• Th1 and Th2

  Th1 and Th2 levels in participants.

  28 days after the second vaccination

Secondary Outcomes (4)

• Solicited clinical (local and systemic), laboratory, and unsolicited adverse events

  3, 6, and 12 months after the first vaccination

• SARS-CoV-2 neutralization antibodies

  3, 6, and 12 months after the first vaccination

• SARS-CoV-2 binding antibodies

  3, 6, and 12 months after the first vaccination

• Th1 and Th2

  3, 6, and 12 months after the first vaccination

Study Arms (3)

UNAIR Inactivated COVID-19 Vaccine 3 microgram

EXPERIMENTAL

Biological: UNAIR Inactivated COVID-19 Vaccine

UNAIR Inactivated COVID-19 Vaccine 5 microgram

EXPERIMENTAL

Biological: UNAIR Inactivated COVID-19 Vaccine

CoronaVac Biofarma COVID-19 Vaccine

ACTIVE COMPARATOR

Biological: CoronaVac Biofarma COVID-19 Vaccine

Interventions

UNAIR Inactivated COVID-19 Vaccine BIOLOGICAL

UNAIR Inactivated Covid-19 Vaccine contains S protein of SARS-CoV-2 virus, Aluminium hydroxide gel, 10 mM L-Histidine buffer, 0.005% Tween Polysorbate 80, and 0.9% Sodium chloride. Vaccine will be prepared in vial (1 ml per vial). One vial will be used for one injection only. The vial should be shaken well before injection.

UNAIR Inactivated COVID-19 Vaccine 3 microgram; UNAIR Inactivated COVID-19 Vaccine 5 microgram

CoronaVac Biofarma COVID-19 Vaccine BIOLOGICAL

Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.

CoronaVac Biofarma COVID-19 Vaccine

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 have been informed properly regarding the study and signed the informed consent form
• Subject will commit to comply with the instructions of the investigator and the schedule of the trial
• Female subjects of childbearing potential must agree to consistently use any methods of contraception (except the periodic abstinence) from at least 21 days prior to enrollment and through 6 months after the last vaccination.
• Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
• Participants must be willing to provide verifiable identification, has 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 trial.
• Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5 degree Celcius or more) concurrent or within 7 days prior to first 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 has 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 steroid will be permitted. Inhaled glucocorticoids is prohibited.
• Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
• Individuals who previously receive any vaccines against Covid-19
• Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
• Individuals who have a previously ascertained Covid-19 in the period of 3 months before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19
• Positive test for SARS-CoV-2 (Antigen or PCR) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
• History of alcohol or substance abuse
• HIV patients.
• Malignancy patients within 5 years prior to first study vaccination.

Sponsors & Collaborators

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

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 67161, Indonesia

RECRUITING

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

• Dominicus Husada, MD

  Dr. Soetomo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominicus Husada, MD

CONTACT

‭+6281232266377‬; dominicushusada@yahoo.com

Damayanti Tinduh, MD

CONTACT

‭+6281703293335‬; damayanti.tinduh@fk.unair.ac.id

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In this clinical trial, the experimental vaccine and the control vaccine will have different packages. In order to maintain the blinding process, the unblinded team will be appointed to place the vaccine in the syringe. The injection team (other team members) will later inject the vaccines according to the random group that has been selected. The unblinded team consists mostly of pharmacists and they will also have responsibilities to taking care of the vaccines and all of related documents. The injection team does not know what kind of vaccine is in the syringe. The injection team is also different from the observer team (those who will observe the subjects after the injection). This observer team does not know what kind of vaccine that already be given to the subjects.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair of Institutional Review Board

Model Details: There will be 3 groups in phase I. Two adult groups (18 year old and above) with two different doses (3 and 5 μg) and 1 control group using Coronavac-BioFarma vaccine. There will be the same 3 groups in phase II. Two treatment groups of adult will use 2 kind of doses as in phase I. The other group is for control (Coronavac-BioFarma vaccine). The vaccines will be administered with 2-dose schedule, intramuscularly. All cohorts will be followed for 12 months.

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 7, 2022
• Study Start: February 8, 2022
• Primary Completion: April 6, 2023
• Study Completion: July 6, 2023
• Last Updated: June 15, 2023

Record last verified: 2023-06

Locations

ID (1)