Safety and Immunogenicity of the Inactivated Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine Compared to Placebo

NCT04838080 | Unknown Phase 1 DMC

• 1 other identifier: ALP-2020-FZ-01-PK-537-2
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to determine the safety and immunogenicity of two different strengths (4 µg and 6 µg) of an inactivated COVID-19 Vaccine compared to placebo so that to demonstrate the safety and efficacy in prophylaxis of COVID-19

Conditions

COVID-19 Vaccine

Keywords

COVID-19; Vaccine; Inactive; Phase 1

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Questioning adverse events and examination of laboratory safety data

  From day 0 until the end of follow up period (6 months)

Secondary Outcomes (3)

• Serum immunoglobulin G (IgG) antibody levels

  From screening until the end of follow up period (6 months)

• Neutralizing antibodies

  From screening until the end of follow up period (6 months)

• Blood levels of cytokines

  From screening until the end of follow up period

Study Arms (3)

Low dose vaccine

EXPERIMENTAL

Inactivated COVID-19 Vaccine 4 µg/0.5 ml

Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine

High Dose Vaccine

EXPERIMENTAL

Inactivated COVID-19 Vaccine 6 µg/0.5 ml

Biological: Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine

Placebo

PLACEBO COMPARATOR

0.9 % NaCl

Biological: Placebo

Interventions

Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine BIOLOGICAL

Two applications on Days 0 and 21

Low dose vaccine

Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine BIOLOGICAL

Two applications on Days 0 and 21

High Dose Vaccine

Placebo BIOLOGICAL

Two applications on Days 0 and 21

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Non-pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• healthy Caucasian origin
• male or female
• age between 18 and 55 years
• accepting not to participate in another COVID-19 vaccine study until the end of the study
• volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or IUD used by the partner) during the study for at least 1 year
• female participants of childbearing potential (defined as any female who has experienced menarche and who is NOT surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination OR agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination.
• male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination
• participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination
• the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial);
• life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable
• body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ECG should be normal/acceptable.
• physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, Lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable
• laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, BUN, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, HDL, LDL), AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Leukocytes, platelet count, prothrombin time (PT) and activated partial thromboplastin time (aPTT); HBsAg, HIV-Ab, HCV-Ab; urine examination: urine color, appearance, specific gravity, pH, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable.
• antiSARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
• drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates)

You may not qualify if:

• women with a positive blood (β-HCG) pregnancy test
• lactating women
• history of COVID-19 infection or showing COVID-19 infection symptoms
• having had contact to people with known COVID-19 infection in the last 14 days
• having fever (\> 37.4oC in the last 24 hours), dry cough or feeling tired and having aches and pains, nasal congestion, runny nose, sore throat and diarrhea.
• positive real time RT-PCR COVID-19 test.
• leukemia or neoplasm in history.
• persons with autoimmune diseases
• allergic diathesis or any clinically significant allergic disease (i.e. asthma)
• any condition that might impair the immune response
• recent or current immunosuppressive medication
• any other vaccine application 30 days before the first dose
• presence or a history of clinically significant cardiovascular, renal, hepatic, pulmonary, metabolic, endocrine, haematological, gastrointestinal, neurological, psychiatric or other major diseases;
• disruption of platelets or other blood clotting disorders, which may cause contraindications to intramuscular administration
• clinically significant illness within 4 weeks before the start of the study. Especially any acute or chronic illness seizures.

Sponsors & Collaborators

• Kocak Farma: lead

Study Sites (1)

Yeditepe AR-GE ve Analiz Merkezi İyi Klinik Uygulamaları Merkezi (Center for GCP)

Istanbul, 34718, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

COVID-19; Sedentary Behavior

Interventions

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; Behavior

Intervention Hierarchy (Ancestors)

Biological Products; Complex Mixtures

Study Officials

• Aydin Erenmemisoglu, Prof.

  Legal representative

  STUDY DIRECTOR

• Turgay Celik, Prof.

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Turgay Celik, Prof.

CONTACT

+ 90 (216) 578 0000; turgay.celik@yeditepe.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 8, 2021
• Study Start: March 19, 2021
• Primary Completion: June 1, 2021
• Study Completion: October 20, 2021
• Last Updated: April 13, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)