Publikasi Scopus 2024 per tanggal 31 Mei 2024 (409 artikel)

Authors

Shakinah S.; Aini M.H.; Sekartini R.; Soedjatmiko; Medise B.E.; Gunardi H.; Yuniar I.; Indawati W.; Koesnoe S.; Harimurti K.; Maria S.; Wirahmadi A.; Sari R.M.; Setyaningsih L.; Surachman F.

Author_Full_Names

Shakinah, Sharifah (57428569400); Aini, Muhammad Hafiz (57734523100); Sekartini, Rini (50162572300); Soedjatmiko (56510278500); Medise, Bernie Endyarni (57226215370); Gunardi, Hartono (56510252700); Yuniar, Irene (57222295046); Indawati, Wahyuni (57190171077); Koesnoe, Sukamto (26028015000); Harimurti, Kuntjoro (23473513200); Maria, Suzy (57213345044); Wirahmadi, Angga (57215184865); Sari, Rini Mulia (57191341371); Setyaningsih, Lilis (57292321700); Surachman, Fikrianti (57291637300)

Author S Id

57428569400; 57734523100; 50162572300; 56510278500; 57226215370; 56510252700; 57222295046; 57190171077; 26028015000; 23473513200; 57213345044; 57215184865; 57191341371; 57292321700; 57291637300

Title

Immunogenicity Assessment of the SARS-CoV-2 Protein Subunit Recombinant Vaccine (CoV2-IB 0322) in a Substudy of a Phase 3 Trial in Indonesia

Year

2024

Source Title

Vaccines

Volume

Issue

Art No

371

Page Start

Page End

Page Count

Cited By

Link

https://www.scopus.com/inward/record.uri?eid=2-s2.0-85191734372&doi=10.3390%2fvaccines12040371&partnerID=40&md5=6cf5bb6b1e959356a86e16f114b8ef6b

Affiliations

Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Department of Internal Medicine, Universitas Indonesia Hospital, Jl. Prof. DR. Bahder Djohan, Depok, 16424, Indonesia; Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; PT Bio Farma, Jalan Pasteur No. 28, Bandung, 40161, Indonesia

Authors With Affiliations

Shakinah S., Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Aini M.H., Department of Internal Medicine, Universitas Indonesia Hospital, Jl. Prof. DR. Bahder Djohan, Depok, 16424, Indonesia; Sekartini R., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Soedjatmiko, Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Medise B.E., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Gunardi H., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Yuniar I., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Indawati W., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Koesnoe S., Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Harimurti K., Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Maria S., Department of Internal Medicine, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Wirahmadi A., Department of Child Health, Faculty of Medicine, Universitas Indonesia, Dr. Cipto Mangunkusumo General National Hospital, Jalan Diponegoro No 71, Jakarta, 10340, Indonesia; Sari R.M., PT Bio Farma, Jalan Pasteur No. 28, Bandung, 40161, Indonesia; Setyaningsih L., PT Bio Farma, Jalan Pasteur No. 28, Bandung, 40161, Indonesia; Surachman F., PT Bio Farma, Jalan Pasteur No. 28, Bandung, 40161, Indonesia

Abstract

Background: COVID-19 is one of the most devastating pandemics of the 21st century. Vaccination is one of the most effective prevention methods in combating COVID-19, and one type of vaccine being developed was the protein subunit recombinant vaccine. We evaluated the efficacy of the CoV2-IB 0322 vaccine in Depok, Indonesia. Methods: This study aimed to assess the humoral and cellular immune response of the CoV2-IB 0322 vaccine compared to an active control vaccine (COVOVAX™ Vaccine). A total of 120 subjects were enrolled and randomized into two groups, with 60 subjects in each group. Participants received either two doses of the CoV2-IB 0322 vaccine or two doses of the control vaccine with a 28-day interval between doses. Safety assessments were conducted through onsite monitoring and participant-reported adverse events. Immunogenicity was evaluated by measuring IgG anti-RBD SARS-CoV-2 and IgG-neutralizing antibodies. Cellular immunity was assessed by specific T-cell responses. Whole blood samples were collected at baseline, 14 days, 6 months, and 12 months after the second dose for cellular immunity evaluation. Results: Both vaccines showed high seropositive rates, with neutralizing antibody and IgG titers peaking 14 days after the second dose and declining by 12 months. The seroconversion rate of anti-S IgG was 100% in both groups, but the rate of neutralizing antibody seroconversion was lower in the CoV2-IB 0322 vaccine group at 14 days after the second dose (p = 0.004). The CoV2-IB 0322 vaccine showed higher IgG GMT levels 6 and 12 months after the second dose (p < 0.001 and p = 0.01). T-cell responses, evaluated by IFN-γ, IL-2, and IL-4 production by CD4+ and CD8+ T-cells, showed similar results without significant differences between both groups, except for %IL-2/CD4+ cells 6 months after the second dose (p = 0.038). Conclusion: Both vaccines showed comparable B- and T-cell immunological response that diminish over time. © 2024 by the authors.

Author Keywords

B-cell response; CoV2-IB 0322 vaccine; T-cell response

Index Keywords

cov 2 ib 0322; gamma interferon; interleukin 2; interleukin 4; neutralizing antibody; nvx-cov2373 vaccine; SARS-CoV-2 vaccine; unclassified drug; adult; Article; CD4+ T lymphocyte; CD8+ T lymphocyte; cellular immunity; controlled study; coronavirus disease 2019; drug safety; enzyme linked immunosorbent assay; female; human; human cell; humoral immunity; immunogenicity; major clinical study; male; peripheral blood mononuclear cell; phase 3 clinical trial; protein subunit; randomized controlled trial; risk assessment; seroconversion; virus neutralization test

Funding Details

Bio Farma, (006.21/DIR/VI/2023); Bio Farma

Funding Text

This study was funded by PT Bio Farma, Indonesia. Funding number: 006.21/DIR/VI/2023.

Publisher

Multidisciplinary Digital Publishing Institute (MDPI)

Issn

2076393X

Isbn

Pubmed Id

Document Type

Article

Sjr Best Quartile

Sjr

1655

Sjr Rank

1799