UNAIR Inactivated COVID-19 Vaccine

Safety and Immunogenicity of UNAIR Inactivated COVID-19 Vaccine in Healthy Populations Aged 18 Years and Above (Phase I/II)

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.

Study Overview

• Status: Recruiting
• Conditions: Vaccine Reaction; COVID-19 Pandemic
• Intervention / Treatment: Biological: UNAIR Inactivated COVID-19 Vaccine; Biological: CoronaVac Biofarma COVID-19 Vaccine

• Study Type: Interventional
• Enrollment (Estimated): 495
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Dominicus Husada, MD; Phone Number: +6281232266377; Email: dominicushusada@yahoo.com
• Study Contact Backup: Name: Damayanti Tinduh, MD; Phone Number: +6281703293335; Email: damayanti.tinduh@fk.unair.ac.id

Study Locations

• Indonesia
  • East Java
    • Surabaya, East Java, Indonesia, 67161
      • Recruiting
      • Dr. Soetomo General Hospital
      • Sub-Investigator: Dwiyanti Puspitasari, MD
      • Sub-Investigator: Yudi H Oktaviano, MD
      • Contact: Dominicus Husada, MD; Phone Number: +6281232266377; Email: dominicushusada@yahoo.com
      • Contact: Damayanti Tinduh, MD; Phone Number: +6281703293335; Email: damayanti.tinduh@fk.unair.ac.id
      • Principal Investigator: Dominicus Husada, MD
      • Sub-Investigator: Damayanti Tinduh, MD
      • Sub-Investigator: Gatot Soegiarto, MD
      • Sub-Investigator: Leny Kartina, MD
      • Sub-Investigator: Aryati Aryati, MD
      • Sub-Investigator: Jusak Nugraha, MD
      • Sub-Investigator: Munawaroh Fitriah, MD
      • Sub-Investigator: Maria I Lusida, MD
      • Sub-Investigator: Eko B Khoendori, MD
      • Sub-Investigator: Neneng D Kurniati, MD
      • Sub-Investigator: Fierly Hayati, MD
      • Sub-Investigator: Budi Utomo, MD
      • Sub-Investigator: Novira Widajanti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. 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.
2. Subjects have been informed properly regarding the study and signed the informed consent form
3. Subject will commit to comply with the instructions of the investigator and the schedule of the trial
4. 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.
5. 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.
6. Participants must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

Exclusion Criteria:

1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
2. 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)
3. Known history of allergy to any component of the vaccines
4. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
5. Any autoimmune or immunodeficiency disease/condition
6. 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.
7. Chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine
8. Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
9. Individuals who previously receive any vaccines against Covid-19
10. Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
11. 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
12. 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.
13. History of alcohol or substance abuse
14. HIV patients.
15. Malignancy patients within 5 years prior to first study vaccination.
16. Any neurological disease or history of significant neurological disorder such as meningitis, encephalitis, Guillain-Barre Syndrome, multiple sclerosis, etc
17. Vital sign abnormalities and clinical laboratory abnormalities as decided by the investigators. Vital sign measurements and clinical laboratory testing may be repeated before the final decision.
18. Women who are pregnant, breastfeeding, or who plan to become pregnant during the study.
19. Participant has major psychiatric problem or illness
20. Participant cannot communicate reliably with the investigator
21. Participant has contraindication to intramuscular injection and blood draws, such as bleeding disorders or phobia.
22. Participant had major surgery within 12 weeks before vaccination which will not be fully recovered, or has major surgery planned during the time participant is expected to participate in the study or within 6 months after the last dose of study vaccine administration.
23. Any condition that in the opinion of the investigators would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine or interpretation of the study results
24. Study team members.
25. Subject planning to move from the study area before the end of study period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: UNAIR Inactivated COVID-19 Vaccine 3 microgram	Biological: UNAIR Inactivated COVID-19 Vaccine; 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.
Experimental: UNAIR Inactivated COVID-19 Vaccine 5 microgram	Biological: UNAIR Inactivated COVID-19 Vaccine; 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.
Active Comparator: CoronaVac Biofarma COVID-19 Vaccine	Biological: CoronaVac Biofarma COVID-19 Vaccine; Control vaccine in this study is existing CoronaVac-BioFarma inactivated COVID-19 vaccine which has been used widely in Indonesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited clinical (local and systemic), laboratory, and unsolicited adverse events	The number of adverse events occur among participants.	3, 6, and 12 months after the first vaccination
SARS-CoV-2 neutralization antibodies	The level of SARS-CoV-2 neutralization antibodies in participants.	3, 6, and 12 months after the first vaccination
SARS-CoV-2 binding antibodies	The level of SARS-CoV-2 binding antibodies in participants.	3, 6, and 12 months after the first vaccination
Th1 and Th2	Th1 and Th2 levels in participants.	3, 6, and 12 months after the first vaccination

Collaborators and Investigators

• Sponsor: Dr. Soetomo General Hospital
• Collaborators: Indonesia-MoH; Universitas Airlangga; Biotis Pharmaceuticals, Indonesia
• Investigators: Principal Investigator: Dominicus Husada, MD, Dr. Soetomo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2022
• Primary Completion (Actual): April 6, 2023
• Study Completion (Estimated): July 6, 2023

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: COVID-19; Immunogenicity; Indonesia; Inactivated COVID-19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: UNAIR-MP-INAKTIF-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: There is not yet plan to share IPD with other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No