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COVID-19'a karşı geliştirilen yerli aşının klinik faz çalışmalarına katılan gönüllüler ile anket çalışması

Yıl 2025, Cilt: 8 Sayı: 5, 765 - 769, 16.09.2025
https://doi.org/10.32322/jhsm.1733877

Öz

Amaç:
Bu çalışma, Türkiye’nin ilk yerli COVID-19 aşısı olan Turkovac’ın Faz 1 ve Faz 2 klinik araştırmalarına katılan gönüllülerin sosyodemografik özelliklerini, katılım motivasyonlarını ve deneyimlerini değerlendirmeyi amaçlamaktadır.
Yöntem:
Araştırmaya toplam 230 gönüllü katılmıştır. Katılımcıların demografik bilgileri ve klinik araştırmalara ilişkin görüşleri yapılandırılmış bir anket formu kullanılarak toplanmıştır.
Bulgular:
Gönüllülerin büyük çoğunluğu erkektir (%76,1) ve şehir merkezlerinde yaşamaktadır (%87,8). Katılımcıların %91,7’si Faz 2 çalışmasına, %8,3’ü ise Faz 1 çalışmasına katılmıştır. Gönüllülerin çoğu, katılım motivasyonlarının yerli aşıya duydukları güvenden kaynaklandığını belirtmiştir. Ayrıca, önemli bir kısmı klinik araştırma deneyimini olumlu değerlendirmiş ve gelecekteki çalışmalara katılmaya istekli olduklarını ifade etmiştir.
Sonuç:
Bu çalışmanın bulguları, gelecekte yapılacak klinik araştırmaların planlanmasında ve gönüllü katılımını artırmaya yönelik etkili stratejilerin geliştirilmesinde yol gösterici olabilir.

Kaynakça

  • Lin Y, Hu Z, Zhao Q, Alias H, Danaee M, Wong LP. Understanding COVID-19 vaccine demand and hesitancy: a nationwide online survey in China. PLoS Negl Trop Dis. 2020;14(12):e0008961. doi:10.1371/journal.pntd.0008961
  • Vaccines and immunization: what is vaccination? https://www.who.int/news-room/questions-and-answers/item/vaccines-and-immunization-what-is-vaccination (Updated 01.04.2025).
  • Schmid P, Rauber D, Betsch C, Lidolt G, Denker ML. Barriers of influenza vaccination intention and behavior-a systematic review of influenza vaccine hesitancy, 2005-2016. PLoS One. 2017;12(1):e0170550. doi:10.1371/journal.pone.0170550
  • Ozdarendeli A, Sezer Z, Pavel STI, et al. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023;41(2):380-390. doi:10.1016/ j.vaccine.2022.10.093.
  • Sezer Z. COVID-19 aşı klinik araştırmaları. Klinik araştırmalar. Editörler , Özet A, Tunçok Y, Özdemir N, Yazıcı O. 1. Baskı. Ankara: Turkiye Klinikleri; 2022. p.169-74.
  • Kochhar S, Salmon DA. Planning for COVID-19 vaccines safety surveillance. Vaccine. 2020;38(40):6194-6198. doi:10.1016/j.vaccine.2020. 07.013
  • Mazıcıoğlu MM, Göğüsten B, Erenmemişoğlu A. İlaç biyoeşdeğerlik çalışmalarında katılımcı profili. Turk Klin J Med Sci. 2004;24(4):328-331.
  • Erdoğdu Y, Koçoğlu F, Sevim C. COVID-19 pandemisi sürecinde anksiyete ile umutsuzluk düzeylerinin psikososyal ve demografik değişkenlere göre incelenmesi. Klin Psikiyatr Derg. 2020:23. doi:10.5505/kpd.2020.35403
  • Karlsson LC, Soveri A, Lewandowsky S, et al. Fearing the disease or the vaccine: the case of COVID-19. Personal Individ Differ. 2021;172:110590. doi:10.1016/j.paid.2020.110590
  • Lin Y, Hu Z, Zhao Q, Alias H, Danaee M, Wong LP. Understanding COVID-19 vaccine demand and hesitancy: a nationwide online survey in China. PLoS Neglect Tropic Dis. 2020;14(12):e0008961. doi:10.1371/journal.pntd.0008961
  • Freeman D, Loe BS, Chadwick A, et al. COVID-19 vaccine hesitancy in the UK: the Oxford coronavirus explanations, attitudes, and narratives survey (Oceans) II. Psychol Med. 2022;52(14):3127-3141. doi: 10.1017/S0033291720005188
  • Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Int Med. 2007;167(9):905-912. doi:10.1001/archinte.167.9.905
  • van Diemen J, Verdonk P, Chieffo A, et al. The importance of achieving sex- and gender-based equity in clinical trials: a call to action. Eur Heart J. 2021;42(31):2990-2994. doi:10.1093/eurheartj/ehab457
  • Lobato L, Bethony JM, Pereira FB, Grahek SL, Diemert D, Gazzinelli MF. Impact of gender on the decision to participate in a clinical trial: a cross-sectional study. BMC Public Health. 2014;14:1156. doi:10.1186/1471-2458-14-1156
  • Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation? Eur J Clin Pharmacol. 2007;63(11):1085-1094. doi:10.1007/s00228-007-0368-3
  • Bigorra J, Baños JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443-446. doi:10.1007/bf02336681
  • Hassar M, Pocelinko R, Weintraub M, Nelson D, Thomas G, Lasagna L. Free-living volunteer’s motivations and attitudes toward pharmacologic studies in man. Clin Pharmacol Ther. 1977;21(5):515-519. doi:10.1002/cpt 1977215515
  • Hermann R, Heger-Mahn D, Mahler M, et al. Adverse events and discomfort in studies on healthy subjects: the volunteer’s perspective. A survey conducted by the German Association for Applied Human Pharmacology. Eur J Clin Pharmacol. 1997;53(3-4):207-214. doi:10.1007/s002280050364
  • Halpern SD. Financial incentives for research participation: empirical questions, available answers and the burden of further proof. Am J Med Sci. 2011;342(4):290-293. doi:10.1097/MAJ.0b013e3182297925
  • Dubé È, Ward JK, Verger P, MacDonald NE. Vaccine hesitancy, acceptance, and anti-vaccination: trends and future prospects for public health. Annu Rev Public Health. 2021;42:175-191. doi:10.1146/annurev-publhealth-090419-102240
  • Oliveira IS, Cardoso LS, Ferreira IG, et al. Anti-vaccination movements in the world and in Brazil. Rev Soc Bras Med Trop. 2022;55:e05922021. doi:10.1590/0037-8682-0592-2021
  • Mills MC, Salisbury D. The challenges of distributing COVID-19 vaccinations. E Clin Med. 2020 (8);31:100674. doi: 10.1016/j.eclinm.2020. 100674
  • Barrett JS, Yang SY, Muralidharan K, et al. Considerations for addressing anti-vaccination campaigns: how did we get here and what can we do about it? Clin Transl Sci. 2022;15(6):1380-1386. doi:10.1111/cts.13273
  • Fasce A, Schmid P, Holford DL, Bates L, Gurevych I, Lewandowsky S. A taxonomy of anti-vaccination arguments from a systematic literature review and text modelling. Nat Hum Behav. 2023;7(9):1462-1480. doi:10.1038/s41562-023-01644-3
  • Harapan H, Wagner AL, Yufika A, et al. Acceptance of a COVID-19 vaccine in Southeast Asia: a cross-sectional study in Indonesia. Front Public Health. 2020;8:381. doi:10.3389/fpubh.2020.00381

Survey study on volunteers participating in clinical phase trials of the national vaccine developed against COVID-19

Yıl 2025, Cilt: 8 Sayı: 5, 765 - 769, 16.09.2025
https://doi.org/10.32322/jhsm.1733877

Öz

Aims: This study aimed to evaluate the sociodemographic characteristics, motivations for participation, and experiences of volunteers who took part in the phase 1 and phase 2 clinical trials of Turkovac, the first national COVID-19 vaccine developed in Turkiye.
Methods: A total of 230 volunteers participated in the study. Data on their demographics and perspectives on clinical research were collected using a structured questionnaire.
Results: The majority of the volunteers were male (76.1%) and residing in urban areas (87.8%). Of all participants, 91.7% were involved in the phase 2 trial and 8.3% in the phase 1 trial. Most volunteers reported that their motivation for participation was based on trust in the national vaccine. Furthermore, a significant part of the participants evaluated their clinical trial experience positively and expressed willingness to participate in future studies.
Conclusion: The findings of this study may provide valuable insights for the planning of future clinical trials and the development of effective strategies to increase volunteer participation.

Etik Beyan

Approval was received for this study from the Erciyes University Non-Interventional Clinical Research Ethics Committee (Approval No: 2021/149).

Teşekkür

We would like to thank all our volunteers who contributed to the national vaccine study and our team for their efforts.

Kaynakça

  • Lin Y, Hu Z, Zhao Q, Alias H, Danaee M, Wong LP. Understanding COVID-19 vaccine demand and hesitancy: a nationwide online survey in China. PLoS Negl Trop Dis. 2020;14(12):e0008961. doi:10.1371/journal.pntd.0008961
  • Vaccines and immunization: what is vaccination? https://www.who.int/news-room/questions-and-answers/item/vaccines-and-immunization-what-is-vaccination (Updated 01.04.2025).
  • Schmid P, Rauber D, Betsch C, Lidolt G, Denker ML. Barriers of influenza vaccination intention and behavior-a systematic review of influenza vaccine hesitancy, 2005-2016. PLoS One. 2017;12(1):e0170550. doi:10.1371/journal.pone.0170550
  • Ozdarendeli A, Sezer Z, Pavel STI, et al. Safety and immunogenicity of an inactivated whole virion SARS-CoV-2 vaccine, TURKOVAC, in healthy adults: interim results from randomised, double-blind, placebo-controlled phase 1 and 2 trials. Vaccine. 2023;41(2):380-390. doi:10.1016/ j.vaccine.2022.10.093.
  • Sezer Z. COVID-19 aşı klinik araştırmaları. Klinik araştırmalar. Editörler , Özet A, Tunçok Y, Özdemir N, Yazıcı O. 1. Baskı. Ankara: Turkiye Klinikleri; 2022. p.169-74.
  • Kochhar S, Salmon DA. Planning for COVID-19 vaccines safety surveillance. Vaccine. 2020;38(40):6194-6198. doi:10.1016/j.vaccine.2020. 07.013
  • Mazıcıoğlu MM, Göğüsten B, Erenmemişoğlu A. İlaç biyoeşdeğerlik çalışmalarında katılımcı profili. Turk Klin J Med Sci. 2004;24(4):328-331.
  • Erdoğdu Y, Koçoğlu F, Sevim C. COVID-19 pandemisi sürecinde anksiyete ile umutsuzluk düzeylerinin psikososyal ve demografik değişkenlere göre incelenmesi. Klin Psikiyatr Derg. 2020:23. doi:10.5505/kpd.2020.35403
  • Karlsson LC, Soveri A, Lewandowsky S, et al. Fearing the disease or the vaccine: the case of COVID-19. Personal Individ Differ. 2021;172:110590. doi:10.1016/j.paid.2020.110590
  • Lin Y, Hu Z, Zhao Q, Alias H, Danaee M, Wong LP. Understanding COVID-19 vaccine demand and hesitancy: a nationwide online survey in China. PLoS Neglect Tropic Dis. 2020;14(12):e0008961. doi:10.1371/journal.pntd.0008961
  • Freeman D, Loe BS, Chadwick A, et al. COVID-19 vaccine hesitancy in the UK: the Oxford coronavirus explanations, attitudes, and narratives survey (Oceans) II. Psychol Med. 2022;52(14):3127-3141. doi: 10.1017/S0033291720005188
  • Ding EL, Powe NR, Manson JE, Sherber NS, Braunstein JB. Sex differences in perceived risks, distrust, and willingness to participate in clinical trials: a randomized study of cardiovascular prevention trials. Arch Int Med. 2007;167(9):905-912. doi:10.1001/archinte.167.9.905
  • van Diemen J, Verdonk P, Chieffo A, et al. The importance of achieving sex- and gender-based equity in clinical trials: a call to action. Eur Heart J. 2021;42(31):2990-2994. doi:10.1093/eurheartj/ehab457
  • Lobato L, Bethony JM, Pereira FB, Grahek SL, Diemert D, Gazzinelli MF. Impact of gender on the decision to participate in a clinical trial: a cross-sectional study. BMC Public Health. 2014;14:1156. doi:10.1186/1471-2458-14-1156
  • Almeida L, Azevedo B, Nunes T, Vaz-da-Silva M, Soares-da-Silva P. Why healthy subjects volunteer for phase I studies and how they perceive their participation? Eur J Clin Pharmacol. 2007;63(11):1085-1094. doi:10.1007/s00228-007-0368-3
  • Bigorra J, Baños JE. Weight of financial reward in the decision by medical students and experienced healthy volunteers to participate in clinical trials. Eur J Clin Pharmacol. 1990;38(5):443-446. doi:10.1007/bf02336681
  • Hassar M, Pocelinko R, Weintraub M, Nelson D, Thomas G, Lasagna L. Free-living volunteer’s motivations and attitudes toward pharmacologic studies in man. Clin Pharmacol Ther. 1977;21(5):515-519. doi:10.1002/cpt 1977215515
  • Hermann R, Heger-Mahn D, Mahler M, et al. Adverse events and discomfort in studies on healthy subjects: the volunteer’s perspective. A survey conducted by the German Association for Applied Human Pharmacology. Eur J Clin Pharmacol. 1997;53(3-4):207-214. doi:10.1007/s002280050364
  • Halpern SD. Financial incentives for research participation: empirical questions, available answers and the burden of further proof. Am J Med Sci. 2011;342(4):290-293. doi:10.1097/MAJ.0b013e3182297925
  • Dubé È, Ward JK, Verger P, MacDonald NE. Vaccine hesitancy, acceptance, and anti-vaccination: trends and future prospects for public health. Annu Rev Public Health. 2021;42:175-191. doi:10.1146/annurev-publhealth-090419-102240
  • Oliveira IS, Cardoso LS, Ferreira IG, et al. Anti-vaccination movements in the world and in Brazil. Rev Soc Bras Med Trop. 2022;55:e05922021. doi:10.1590/0037-8682-0592-2021
  • Mills MC, Salisbury D. The challenges of distributing COVID-19 vaccinations. E Clin Med. 2020 (8);31:100674. doi: 10.1016/j.eclinm.2020. 100674
  • Barrett JS, Yang SY, Muralidharan K, et al. Considerations for addressing anti-vaccination campaigns: how did we get here and what can we do about it? Clin Transl Sci. 2022;15(6):1380-1386. doi:10.1111/cts.13273
  • Fasce A, Schmid P, Holford DL, Bates L, Gurevych I, Lewandowsky S. A taxonomy of anti-vaccination arguments from a systematic literature review and text modelling. Nat Hum Behav. 2023;7(9):1462-1480. doi:10.1038/s41562-023-01644-3
  • Harapan H, Wagner AL, Yufika A, et al. Acceptance of a COVID-19 vaccine in Southeast Asia: a cross-sectional study in Indonesia. Front Public Health. 2020;8:381. doi:10.3389/fpubh.2020.00381
Toplam 25 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Klinik Farmakoloji ve Terapötikler, Tıbbi Farmakoloji
Bölüm Orijinal Makale
Yazarlar

Zafer Sezer 0000-0003-4858-3906

Ahmet İnal 0000-0002-5917-3729

Seda Caymaz Yılmaz 0009-0009-4854-2048

Yayımlanma Tarihi 16 Eylül 2025
Gönderilme Tarihi 3 Temmuz 2025
Kabul Tarihi 21 Temmuz 2025
Yayımlandığı Sayı Yıl 2025 Cilt: 8 Sayı: 5

Kaynak Göster

AMA Sezer Z, İnal A, Caymaz Yılmaz S. Survey study on volunteers participating in clinical phase trials of the national vaccine developed against COVID-19. J Health Sci Med /JHSM /jhsm. Eylül 2025;8(5):765-769. doi:10.32322/jhsm.1733877

Üniversitelerarası Kurul (ÜAK) Eşdeğerliği:  Ulakbim TR Dizin'de olan dergilerde yayımlanan makale [10 PUAN] ve 1a, b, c hariç  uluslararası indekslerde (1d) olan dergilerde yayımlanan makale [5 PUAN]

Dahil olduğumuz İndeksler (Dizinler) ve Platformlar sayfanın en altındadır.

Not:
Dergimiz WOS indeksli değildir ve bu nedenle Q olarak sınıflandırılmamıştır.

Yüksek Öğretim Kurumu (YÖK) kriterlerine göre yağmacı/şüpheli dergiler hakkındaki kararları ile yazar aydınlatma metni ve dergi ücretlendirme politikasını tarayıcınızdan indirebilirsiniz. https://dergipark.org.tr/tr/journal/2316/file/4905/show 


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