Study of a Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS-CoV-2) Adjuvanted Inactivated Vaccine in Healthy Adults

NCT04866069 | Terminated Phase 1 DMC

• 1 other identifier: ISV2AOH3ODN
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I study is designed as double-blinded, randomised, placebo controlled, three-armed study composed of two different dose arms of protective adjuvanted inactivated vaccine against SARS-CoV-2 in dose escalations (first low dose group, followed by high dose group) and placebo arm.

Conditions

Covid19

Keywords

SARS-CoV-2; Adjuvanted inactivated vaccine

Outcome Measures

Primary Outcomes (3)

• Acute adverse events (AEs)

  Frequency of acute adverse events in all dosage groups

  24 hours

• Solicited local and systemic adverse events (AEs)

  Frequency of local and systemic AEs in all dosage groups

  15 days

• Unsolicited local and systemic adverse events (AEs)

  Frequency of local and systemic AEs in all dosage groups

  28 days

Secondary Outcomes (2)

• Neutralizing antibody response

  Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.

• Cellular immune response

  Before first dose administration, on Day 21-28-35 and Month 3 and Month 6 after first dose administration.

Study Arms (3)

Low-Dose Group (Group A)

EXPERIMENTAL

20 participants will receive 10 µg-3M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine

Biological: SARS-CoV-2 vaccine

High-Dose Group (Group B)

EXPERIMENTAL

20 participants will receive 20 µg-6M inactivated virus + 1 mg Al(OH)3 + 300 µg CpGODN adjuvanted vaccine

Biological: SARS-CoV-2 vaccine

Placebo Group

PLACEBO COMPARATOR

10 participants will receive 1 ml of 0.9% sodium chloride (NaCl)

Biological: Placebo

Interventions

SARS-CoV-2 vaccine BIOLOGICAL

Adjuvanted inactivated vaccine

High-Dose Group (Group B); Low-Dose Group (Group A)

Placebo BIOLOGICAL

0.9% NaCl

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible for the study, each participant must satisfy all the following criteria:
• Healthy participants between 18-45 years of age,
• Sign an informed consent document,
• Negative immunoglobulin G (IgG) and immunoglobulin M (IgM) antibody for COVID-19,
• Negative quantitative polymerase chain reaction (qPCR) SARS-CoV-2 results of nasopharyngeal/sputum samples,
• Able to comply with the study protocol during the study period,
• Negative tests for Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV),
• Body temperature \<37.2 C and no signs of active infection,
• Body mass index 18-35 kg/m2,
• Normal laboratory levels of whole blood count, alanine transaminase (ALT), aspartate transaminase (AST), total bilirubin, urea, creatinine, and fasting blood glucose, or abnormal finding detected in any laboratory parameter which is not greater than Grade 1 according to the investigator's evaluation,
• Good general health (no known disease in the history and physical examination within 14 days prior to the enrolment),
• Female and male participants who will be able to have appropriate contraception methods within 30 days prior to vaccine injection and within 6 months after vaccination,

You may not qualify if:

• Participants with any of the following criteria will be excluded:
• History of seizure, encephalopathy, or psychosis,
• History of allergic reactions to any known vaccine or to any component of the study vaccine,
• Pregnant, breastfeeding, or positive pregnancy test or planning to conceive within 6 months,
• History of SARS-CoV-2 infection,
• Severe cardiovascular disorders (arrhythmia, conduction disorders, history of myocardial infarction, uncontrolled hypertension),
• Severe chronic disorders (asthma, diabetes mellitus, thyroid disorders…etc),
• Congenital or acquired angioedema,
• Diagnosis of immunodeficiency,
• Diagnosis of bleeding diathesis,
• Use of immunosuppressive treatment, anti-allergic treatment, cytotoxic treatment, inhaler corticosteroids (allergic rhinitis or topical steroid ointments are excluded),
• Those who received blood and blood product transfusions in the last 6 months,
• Those on any vaccine program or experimental medication within 1 month prior to the study,
• History of any vaccination against SARS-CoV-2 within 1 month prior to the study,
• Use of active tuberculosis treatment,

Sponsors & Collaborators

• Osman ERGANIS, PhD, Prof: lead
• The Scientific and Technological Research Council of Turkey: collaborator
• VETAL Inc.: collaborator
• MonitorCRO: collaborator

Study Sites (1)

Ankara City Hospital Phase I Drug Research Center

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19

Interventions

COVID-19 Vaccines

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Oguz Akbas, MD

  MonitorCRO

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Prof

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: April 29, 2021
• Study Start: April 25, 2021
• Primary Completion: September 5, 2021
• Study Completion: September 5, 2021
• Last Updated: April 18, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)