Loading clinical trials...

COMPLETEDPHASE1

Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC

Phase 1 Study for the Determination of Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC, Given Twice Intramuscularly to Healthy Volunteers, in a Placebo Controlled Study Design.

NCT04691947•Health Institutes of Turkey

View on ClinicalTrials.gov

Summary

The objective is to determine the safety and immunogenicity of two different strengths (3 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.

Detailed Description

This is a double-blind, double dose, parallel, randomized vaccination study. Each subject will receive in random order a double intramuscular dose of ERUCOV-VAC 3 µg/0.5 ml Vaccine, ERUCOV-VAC 6 µg/0.5 ml Vaccine or 0.5 ml of placebo Vaccine according to a sequence determined by randomization, on Day 0 (1st vaccination) and Day 21 (2nd vaccination).In total 34 healthy subjects of both genders will be monitored for one year in total, after Day 43 the study will be unblinded and the volunteers who took placebo vaccine will be released from the study. The most important evaluation will be performed on Day 43 after the first vaccine dose.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•healthy Caucasian origin
•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
•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 leukocytes are out of the limits ) should be normal/acceptable.
+3 more criteria

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.
•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
+1 more criteria

Locations (1)

Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP)

Kayseri, Turkey (Türkiye)

Key Dates

Start Date

November 5, 2020

Primary Completion Date

November 18, 2021

Completion Date

November 18, 2021

Last Updated

February 14, 2023

Enrollment

ACTUAL participants

Conditions

COVID-19 Vaccine

Interventions

ERUCOV-VAC

BIOLOGICAL

Placebo Vaccine

OTHER

Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health

NCT05553743

BreastfeedingCOVID-19 Infection+3 more

View study

ACTIVE_NOT_RECRUITINGPHASE3

Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial

NCT05556720

HIVOrgan Transplantation+4 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 14, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC

Inclusion Criteria

Exclusion Criteria

Researchers At UC San Diego Are Learning About the Benefits of Human Milk and How It Influences Infant and Child Health

Bringing Optimised COVID-19 Vaccine Schedules To ImmunoCompromised Populations (BOOST-IC): an Adaptive Randomised Controlled Clinical Trial

Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-COVID and EG-COVARo in Healthy Adult Volunteers

A Phase 1/2 Safety and Immunogenicity Trial of COVID-19 Vaccine COVIVAC (Phase 1)

Safety Study About the mRNA Vaccines Against COVID-19 in Children (PEDIVACOV-HCSC)

Immunogenicity Induced by COVID-19 Vaccines in Mexican Population