Evidence map›Paper›PMID 36366373›Full record

ArticleVaccines2022

Efficacy, Immunogenicity, and Safety of the Two-Dose Schedules of TURKOVAC versus CoronaVac in Healthy Subjects: A Randomized, Observer-Blinded, Non-Inferiority Phase III Trial.

Mine Durusu Tanriover, Ozlem Altuntas Aydin, Rahmet Guner, Orhan Yildiz, Ilhami Celik, Hamdi Levent Doganay, Sukran Kose, Sila Akhan, Emin Halis Akalin, Zafer Sezer and 3 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Vaccines, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04942405 (Efficacy, Immunogenicity, and Safety of the Two-Dose Inactivated COVID-19 Vaccine), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04942405 phase3completednot on this map

Efficacy, Immunogenicity, and Safety of the Two-Dose Inactivated COVID-19 Vaccine (TURKOVAC) Versus the Two-Dose CoronaVac (Sinovac) Vaccine in Healthy Subjects: A Randomized, Observer-Blinded, Phase III Clinical Trial

TypeinterventionalSponsorHealth Institutes of TurkeyRan2021 to 2024Enrolled1,290ConditionsCovid19ArmsTURCOVAC, CoronaVac
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Assessing the robustness of COVID-19 vaccine efficacy trials: systematic review and meta-analysis, January 2023.Euro surveillance : bulletin Europeen sur les maladies transmissibles = European communicable disease bulletin · 2023
    Pooled it
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 9 institutions in 3 countries.

Mine Durusu TanrioverDepartment of Internal Medicine, Hacettepe University Faculty of Medicine, 06230 Ankara, Türkiye.ORCID 0000-0001-9565-4389
Ozlem Altuntas AydinDepartment of Infectious Diseases and Clinical Microbiology, University of Health Sciences, Başaksehir Cam and Sakura City Hospital, 34480 Istanbul, Türkiye.
Rahmet GunerInfectious Diseases and Clinical Microbiology Clinic, Ankara Yildirim Beyazit University, Ankara City Hospital, 06800 Ankara, Türkiye.
Orhan YildizDepartment of Infectious Diseases and Clinical Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye.
Ilhami CelikDepartment of Infectious Diseases and Clinical Microbiology, Kayseri City Training and Research Hospital, 38080 Kayseri, Türkiye.ORCID 0000-0002-2604-3776
Hamdi Levent DoganayDepartment of Gastroenterology, Medical Park Pendik Hospital, 34899 Istanbul, Türkiye.
Sukran KoseInfectious Diseases Clinic, University of Health Sciences, Izmir Tepecik Training and Research Hospital, 35020 Izmir, Türkiye.
Sila AkhanDepartment of Infectious Diseases and Clinical Microbiology, Kocaeli University Faculty of Medicine, 41001 Kocaeli, Türkiye.
Emin Halis AkalinDepartment of Infectious Diseases and Clinical Microbiology, Bursa Uludag University Faculty of Medicine, 16059 Bursa, Türkiye.ORCID 0000-0001-7530-1279
Zafer SezerDepartment of Medical Pharmacology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye.
Aykut OzdarendeliDepartment of Microbiology, Erciyes University Faculty of Medicine, 38030 Kayseri, Türkiye.
Serhat UnalVaccine Institute, Hacettepe University, 06230 Ankara, Türkiye.ORCID 0000-0003-1184-4711
On Behalf Of The Turkovac Study Group
Erciyes University · TRHacettepe University · TRAnkara Yıldırım Beyazıt University · TRBahçeşehir University · TRBursa Uludağ Üni̇versi̇tesi̇ · TRIzmir University · TRKayseri Eğitim ve Araştırma Hastanesi · TRKocaeli Üniversitesi · TRSağlık Bilimleri Üniversitesi · TR

Funding

THE HEALTH INSTITUTES OF TÜRKIYE (TUSEB). TSB-11568-VAC-COV-TUR-F3.01
6 · The paper itself

Abstract

We present the interim results of the efficacy, immunogenicity, and safety of the two-dose schedules of TURKOVAC versus CoronaVac. This was a randomized, observer-blinded, non-inferiority trial (NCT04942405). Volunteers were 18-55 years old and randomized at a 1:1 ratio to receive either TURKOVAC or CoronaVac at Day 0 and Day 28, both of which are 3 μg/0.5 mL of inactivated severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) adsorbed to aluminum hydroxide. The primary efficacy outcome was the prevention of polymerase chain reaction (PCR)-confirmed symptomatic coronavirus disease 2019 (COVID-19) at least 14 days after the second dose in the modified per-protocol (mPP) group. Safety analyses were performed in the modified intention-to-treat (mITT) group. Between 22 June 2021 and 7 January 2022, 1290 participants were randomized. The mITT group consisted of 915 participants, and the mPP group consisted of 732 participants. During a median follow-up of 90 (IQR 86-90) days, the relative risk reduction with TURKOVAC compared to CoronaVac was 41.03% (95% CI 12.95-60.06) for preventing PCR-confirmed symptomatic COVID-19. The incidences of adverse events (AEs) overall were 58.8% in TURKOVAC and 49.7% in CoronaVac arms (

Indexed as

CoronaVacCOVID-19efficacysafetySARS-CoV-2 vaccinesTURKOVACvaccinationvaccinevaccine immunogenicity

Identifiers

PMID36366373
PMCPMC9698857
OpenAlexW4308209212

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.