Phase 2 Study for the Determination of Efficacy, Immunogenicity and Safety of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, in a Placebo Controlled, Randomized, Double Blind Study Design.

Health Institutes of Turkey1 site in 1 country250 target enrollmentFebruary 10, 2021

ConditionsCOVID-19

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: COVID-19
Sponsor: Health Institutes of Turkey
Enrollment: 250
Locations: 1
Primary Endpoint: Serum IgG antibody levels specific for the SARS-CoV- 2 rS protein antigen(s)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective is to determine the efficacy, immunogenicity and safety of two different strengths (3 µg and 6 µg) of an inactivated COVID 19 Vaccine compared to placebo so that to demonstrate the efficacy and safety in prophylaxis of COVID-19. A 3rd application will be performed to approximately the half of the volunteers who were administered 3 μg/0.5 ml and who accept to be vaccinated for a 3rd time, on their month 4 visit.

Registry

clinicaltrials.gov

Start Date

February 10, 2021

End Date

March 30, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Health Institutes of Turkey

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•healthy Caucasian origin
•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 and respiratory rate should be normal/acceptable.
•laboratory examination (blood/serum examination: sodium, potassium, calcium, total protein, albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, haemoglobin, haematocrit, erythrocytes, Ieukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab should be normal/acceptable.

Exclusion Criteria

•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