Kuntjoro Harimurti
DIvisi Geriatri, Kelompok Staf Medis Ilmu Penyakit Dalam, Fakultas Kedokteran Universitas Indonesia - RSUPN Dr Cipto Mangunkusumo

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Journal : eJournal Kedokteran Indonesia

Evaluation of Safety and Anti-RBD IgG Sars Cov-2 after Indovac Administration in Depok Kuntjoro Harimurti; Harningtyas Jasmin; Rini Sekartini; Muhammad Aini; Irene Yuniar; Wahyuni Indawati; Angga Wirahmadi
eJournal Kedokteran Indonesia Vol. 11 No. 2 - Agustus 2023
Publisher : Faculty of Medicine Universitas Indonesia

Show Abstract | Download Original | Original Source | Check in Google Scholar | DOI: 10.23886/ejki.11.393.118-25

Abstract

The WHO declared the COVID-19 pandemic on March 11, 2020, then several centres developed Covid-19 vaccines. The Indovac vaccine contains SARS-CoV-2 RBD antigen adjuvanted with Alum and CpG1018. This article reported Jakarta Centre Phase 1 trial results of the safety and immunogenicity of Indovac in Kota Depok. This study is a randomised, observer-blinded, active-control (Sinovac) clinical trial. The study included 175 healthy adults aged 18–70 and 75 participants were enrolled by the Jakarta centre. Two vaccine doses were given 28 days apart. Four vaccine formulas were tested. Safety evaluations included solicited and unsolicited adverse events (AE) up to 28 days post-injection. SARS-CoV-2 anti-RBD IgG was tested before, 14, and 28 days after second injection to determine immunogenicity. Most solicited AEs were injection site pain. Local pain was highest in the RLCL group after the first dose (38.62%) and RHCH after the second dose (23.08%). 13.33% and 6.67% of control group subjects experienced local pain after the first and second injections, respectively. RHCL has the highest seroconversion (100%) after two injections. Anti-RBD IgG responses increased (p<0.005) in all groups and plateaued 28 days after the second dose injection. In conclusion, Indovac was safe and immunogenic in Jakarta.
Co-Authors . Andriansjah A. Harryanto Achmad Fauzy, Achmad Adityo Susilo, Adityo Agus Joko Susanto, Agus Joko Agus Siswanto Agus Susanto Kosasih, Agus Susanto Andhika Rachman Andra Aswar Andra Aswar, Andra Andri Sanityoso Sulaiman Anis Karuniawati Anna Mira Lubis Antono, Akbarbudhi Ario Perbowo Putra Ario Perbowo Putra, Ario Perbowo Aru W Sudoyo Aru W Sudoyo Aulia Rizka Aulia Rizka, Aulia Birry Karim Bonar, Maruhum Bonar H C Martin Rumende C Martin Rumende C Martin Rumende C Rinaldi A Lesmana C. Martin Rumende, C. Martin Ceva W. Pitoyo Chyntia Olivia Maurine Cleopas M Rumende, Cleopas M Cleopas Martin Rumende Cleopas Martin Rumende Czeresna Heriawan Soejono Dedy G Sudrajat Dedy G Sudrajat, Dedy G Desi Salwani, Desi Dewi Gathmyr Dharmeizar Dharmeizar Dharmeizar Dharmeizar Djafar, Fitria Djumhana Atmakusuma Djumhana Atmakusuma, Djumhana Dono Antono E. Mudjaddid A. Siswanto Deddy N.W.Achadiono Hamzah Shatri Edy Rizal Wahyudi Eka Ginanjar Elza Febria Sari Elza Febria Sari Em Yunir Em Yunir, Em Ening Krisnuhoni Eric Daniel Tenda Erni Juwita Nelwan, Erni Juwita Esthika Dewiasty Esthika Dewiasty, Esthika Evy Yunihastuti Fiastuti Witjaksono Fifi Dwijayanti Ginova Nainggolan Gunawan Gunawan Gunawan Gunawan Gurmeet Singh Gurmeet Singh Hakim, Manfaluthy Harini Oktadiana Harini Oktadiana, Harini Harningtyas Jasmin Harryanto, A. Hasan Maulahela, Hasan Hikari Ambara Sjakti, Hikari Ambara HILMAN TADJOEDIN, HILMAN Idrus Alwi Idrus Alwi Idrus Alwi Ika P Wijaya, Ika P Ikhwan Rinaldi Imam Subekti Indra G Mansur, Indra G Irene Yuniar, Irene Iris Rengganis Iris Rengganis Jeo, Wifanto Saditya Juferdy Kurniawan Koesno, Soekamto M Sadikin Martini, Rose D Maruhum B.H. Marbun Megantara, Marcelino A. Mira Yulianti Mira Yulianti, Mira Muhadi Muhadi, Muhadi Muhammad Aini Murdani Abdullah Murdani Abdullah Murti Andriastuti, Murti Mururul Aisyi Nasrun, Martina W. Ni Made Hustrini, Ni Made Noto Dwimartutie Parlindungan Siregar Pringgodigdo Nugroho, Pringgodigdo Rachmat Hamonangan, Rachmat Rika Bur Rini Sekartini Rino Alvani Gani Rino Alvani Gani Roza Mulyana Rudi Putranto Sabrina Munggarani Yusuf Sally A Nasution, Sally A Saputra, Fahreza Setiati, Slti Shufrie Effendy Shufrie Effendy Siti Setiati Siti Setiati Siti Taqwa Fitria Lubis, Siti Taqwa Fitria Sudrajat, Dedy G. Suhardjono Suhardjono Suhardjono Suhardjono Suhendro Suwarto Suhendro Suwarto Suhendro Suwarto, Suhendro Sukamto Koesnoe Sukamto Koesnoe Sulistianingsih, Dyah Purnamasari Susilo Chandra Suzanna Immanuel Tagor, Alvin TB Djumhana TB Djumhana, TB Teguh Harjono Karjadi, Teguh Harjono Teny Tjitra Sari, Teny Tjitra Tri Juli Edi Tarigan Triyani Kresnawan Triyani Kresnawan, Triyani Ujainah Zaini Nasir Utomo, Ahmad Rusdan Handoyo Wahyuni Indawati Wawan Kurniawan Wawan Kurniawan Widayat Djoko Santoso, Widayat Djoko Wifanto Saditya Jeo Winnugroho Wiratman, Manfaluthy Hakim, Tiara Aninditha, Aru W. Sudoyo, Joedo Prihartono Wirahmadi, Angga Wulyo Rajabto Zulkifli Amin