Turkovac / Health Institutes of Turkey - LARVOL DELTA

Which type of vaccine is more beneficial for reducing the risk of deep vein thrombosis, CoronaVac, BNT162b2, or TURKOVAC? (PubMed, Sci Prog) - "Deep vein thrombosis was least common in patients who received only BNT162b2. Although the frequency of deep vein thrombosis was similar in the groups, we found that the lowest rate of deep vein thrombosis was in the group that received TURKOVAC after BNT162b2."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Thrombosis • Venous Thromboembolism

Evaluation of the Impact of COVID-19 Vaccines on Renal Function in Chronic Kidney Disease (CKD) Patients (ERA 2025) - "This study aimed to assess the effects of three COVID-19 vaccines (Sinovac, Biontech, Turkovac) on renal function... The comparison of trends suggests that COVID-19 vaccines, particularly Biontech, did not adversely affect renal function. This highlights the safety of vaccination for CKD patients, but continued monitoring of renal health remains critical, especially with aging populations.Figure-1. Boxplot showing the monthly creatinine changes for pre- and post-vaccination periods."

Clinical • Chronic Kidney Disease • Infectious Disease • Nephrology • Novel Coronavirus Disease • Renal Disease

Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine(TURKOVAC) in Healthy Population of 18 and 64 Years of Age (Both Inclusive):a Randomized, Double-blind, Phase IIb Clinical Trial (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: Health Institutes of Turkey | Phase classification: P2b ➔ P2 | N=200 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Phase classification • Trial withdrawal • Infectious Disease • Novel Coronavirus Disease

Vaccination with inactivated SARS-CoV-2 vaccine TURKOVAC induces durable humoral and cellular immune responses up to 8 months. (PubMed, Front Med (Lausanne)) - "TURKOVAC vaccination induces durable immune responses, with spike-specific B cells persisting up to 8 months and T cell responses peaking at 4 months before declining. These findings suggest that TURKOVAC contributes to long-term immune protection against SARS-CoV-2."

Journal • Cognitive Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • CD4 • IL2 • LAMP1

Relative effectiveness of COVID-19 vaccine booster doses in people aged 65 and older-a retrospective cohort study in Türkiye. (PubMed, Ther Adv Vaccines Immunother) - "The vaccines were mostly administered as CoronaVac for the first and second doses (81.4% and 82.2%, respectively) and BNT162b2 for the third and fourth doses (61.8% and 73.1%, respectively). Turkovac was administered only in booster doses (third dose 0.6%, fourth dose 4.8%)...In two booster doses receipts, the adjusted rVE was found to be 45.4% (95% CI 13.8-65.4) in three doses of inactivated and one dose mRNA vaccine schedule and 43.0% (95% CI 20.5-59.2) in two doses of inactivated and two doses of mRNA vaccines schedule compared to the two homolog boosters with CoronaVac primary vaccine schedule. In this study, the effectiveness of the mRNA vaccine as a booster dose was higher than that of the homologous boosters in participants receiving the CoronaVac primary series for those aged 65 and over."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

The impact of previous SARS-CoV-2 infection on post-vaccine adverse events in individuals vaccinated with TURKOVAC or CoronaVac -inactivated COVID-19 vaccines. (PubMed, Hum Vaccin Immunother) - "The frequencies of local and systemic AEs after the second dose were similar between those with and without a COVID-19 history. The TURKOVAC and CoronaVac showed similar frequencies of local and systemic AEs in the first 30 minutes after vaccination."

Adverse events • Clinical • Journal • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Observational National Vaccine Study (clinicaltrials.gov) - P=N/A | N=200 | Completed | Sponsor: Health Institutes of Turkey | Active, not recruiting ➔ Completed | N=4000 ➔ 200 | Trial primary completion date: Jan 2024 ➔ Nov 2023

Enrollment change • Trial completion • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent (clinicaltrials.gov) - P2 | N=1 | Completed | Sponsor: Health Institutes of Turkey | Active, not recruiting ➔ Completed | N=644 ➔ 1

Enrollment change • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine (clinicaltrials.gov) - P3 | N=1290 | Completed | Sponsor: Health Institutes of Turkey | Trial completion date: Apr 2023 ➔ Feb 2024

Trial completion date • Infectious Disease • Novel Coronavirus Disease

Phase 3 Booster Vaccination Against COVID-19 (clinicaltrials.gov) - P3 | N=4340 | Completed | Sponsor: Health Institutes of Turkey | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Long-Term Immunogenicity and Safety of a Homologous Third Dose Booster Vaccination with TURKOVAC: Phase 2 Clinical Study Findings with 32-Week Post-Booster Follow-Up. (PubMed, Vaccines (Basel)) - "Nine participants (20.9%) tested positive for SARS-CoV-2 RT-PCR between weeks 8 and 32 of booster vaccination; none of them were hospitalized or died. These findings suggest that boosting with TURKOVAC can provide effective protection against COVID-19 for at least 8 weeks and reduce the severity of the disease."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Evaluation of local and systemic side effects of Turkovac vaccine in adults. (PubMed, Turk J Med Sci) - "Our study revealed that Turkovac is a generally well-tolerated vaccine and had no side effects. More studies are required to evaluate Turkovac's side effects in other populations."

Adverse events • Journal • Cough • Dermatology • Fatigue • Immunology • Infectious Disease • Musculoskeletal Diseases • Musculoskeletal Pain • Novel Coronavirus Disease • Orthopedics • Pain • Respiratory Diseases • Urticaria

Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent (12-18 Years) (clinicaltrials.gov) - P2 | N=644 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Phase classification: P2b ➔ P2

Phase classification • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Phase 3 Booster Vaccination Against COVID-19 (clinicaltrials.gov) - P3 | N=4340 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Trial completion date: Jun 2023 ➔ Dec 2023

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IFNG • IL2 • TNFA

Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19 (clinicaltrials.gov) - P2 | N=65 | Completed | Sponsor: Health Institutes of Turkey | Active, not recruiting ➔ Completed | Phase classification: P2b ➔ P2 | N=1034 ➔ 65

Enrollment change • Phase classification • Trial completion • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent (12-18 Years) (clinicaltrials.gov) - P2b | N=644 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Trial completion date: Jul 2023 ➔ Nov 2023

Trial completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine (clinicaltrials.gov) - P3 | N=1290 | Completed | Sponsor: Health Institutes of Turkey | Active, not recruiting ➔ Completed | Trial completion date: Aug 2023 ➔ Apr 2023

Trial completion • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Long-Term Results of Immunogenicity of Booster Vaccination against SARS-CoV-2 (Hybrid COV-RAPEL TR Study) in Turkiye: A Double-Blind, Randomized, Controlled, Multicenter Phase 2 Clinical Study. (PubMed, Vaccines (Basel)) - P2 | "This study aimed to present the long-term (Day 84) immunogenicity results of the double-blind, randomized, controlled, phase II Hybrid COV-RAPEL TR Study (NCT04979949), in which the TURKOVAC or CoronaVac vaccines were used as a booster after the second dose of primary vaccination with CoronaVac...A single booster dose, after the completion of the primary vaccination, increases antibody positivity on Day 28 which persists until Day 84 with a slight decrease. However, an additional booster dose may be required thereafter, since the decrease in antibody titer may be faster over time."

Journal • P2 data • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Observational National Vaccine Study (clinicaltrials.gov) - P=N/A | N=4000 | Active, not recruiting | Sponsor: Health Institutes of Turkey

New trial • Infectious Disease • Novel Coronavirus Disease

Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye. (PubMed, Ann Med) - "Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines."

Adverse events • Journal • Fatigue • Infectious Disease • Novel Coronavirus Disease • Pain • Respiratory Diseases

Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19 (clinicaltrials.gov) - P2b | N=1034 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Recruiting ➔ Active, not recruiting | Trial completion date: Jan 2023 ➔ May 2023 | Trial primary completion date: Oct 2022 ➔ Feb 2023

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Self-Reported Allergic Adverse Events Following Inactivated SARS-CoV-2 Vaccine (TURKOVAC™) among General and High-Risk Population. (PubMed, Vaccines (Basel)) - "A known history of allergy increased the risk of having an allergic experience by approximately six times following vaccination. As a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, with a low allergic reaction-related adverse event profile, can be an alternative to other COVID-19 vaccines."

Adverse events • Journal • Allergy • Immunology • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Efficacy, Immunogenicity, and Safety of the Inactivated COVID-19 Vaccine (TURKOVAC) Versus the CoronaVac Vaccine (clinicaltrials.gov) - P3 | N=1290 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Trial primary completion date: Jan 2022 ➔ May 2023

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

Efficacy, Immunogenicity, and Safety of TURKOVAC Vaccine Versus the CoronaVac Vaccine Against COVID-19 in Healthy Adolescent (12-18 Years) (clinicaltrials.gov) - P2b | N=644 | Active, not recruiting | Sponsor: Health Institutes of Turkey | Recruiting ➔ Active, not recruiting | Trial primary completion date: Jan 2023 ➔ May 2023

Enrollment closed • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases

Safety and Immunogenicity of Two Different Strengths of the Inactivated COVID-19 Vaccine ERUCOV-VAC (clinicaltrials.gov) - P1 | N=44 | Completed | Sponsor: Health Institutes of Turkey | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • IL2 • TNFA