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Publikasi Scopus 2024 per tanggal 30 April 2024 (334 artikel)
Publikasi Scopus 2024 per tanggal 30 April 2024 (334 artikel)
Nurdin, Asrawati (57222723390); Movieta Nency, Yetty (58978026100); Maddeppungeng, Martira (57215873957); Sekartini, Rini (50162572300); Mulia Sari, Rini (57191341371); Surachman, Fikrianti (57291637300); Fitry Yani, Finny (58978803500); Raveinal (57190950973); Anggrainy, Fenty (57482526800); Hafiz, Al (58978418200); Linosefa (57200363909); Machmud, Rizanda (23972739800); Awaliyah Deza, Putri (58978026200); Rujiana, Vovinda (58978803600); Bella Rahimi, Martga (58977892000); Farhanah, Nur (572080
Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults: A phase 3, randomized, active-controlled, multicenter trial
2024
Vaccine
42
12
3009
3017
8
0
https://www.scopus.com/inward/record.uri?eid=2-s2.0-85189903880&doi=10.1016%2fj.vaccine.2024.03.077&partnerID=40&md5=8b095a26b1de379c48e9591b7a3d8959
Faculty of Medicine, Universitas Andalas, Padang, Indonesia; Faculty of Medicine, Universitas Diponegoro, Semarang, Indonesia; Faculty of Medicine, Universitas Hasanuddin, Makassar, Indonesia; Faculty of Medicine, Universitas Indonesia, Jakarta, Indonesia; Faculty of Medicine, Universitas Muslim Indonesia, Makassar, Indonesia; PT Bio Farma, Bandung, Indonesia
Background: Bio Farma has developed a recombinant protein subunit vaccine (IndoVac) that is indicated for active immunization in population of all ages. This article reported the results of the phase 3 immunogenicity and safety study in Indonesian adults aged 18 years and above. Methods: We conducted a randomized, active-controlled, multicenter, prospective intervention study to evaluate the immunogenicity and safety of IndoVac in adults aged 18 years and above. Participants who were SARS-CoV-2 vaccine-naïve received two doses of either IndoVac or control (Covovax) with 28 days interval between doses and were followed up until 12 months after complete vaccination. Results: A total of 4050 participants were enrolled from June to August 2022 and received at least one dose of vaccine. The geometric mean ratio (GMR) of neutralizing antibody at 14 days after the second dose was 1.01 (95 % confidence interval (CI) 0.89–1.16), which met the WHO non-inferiority criteria for immunobridging (95 % CI lower bound > 0.67). The antibody levels were maintained through 12 months after the second dose. The incidence rate of adverse events (AEs) were 27.95 % in IndoVac group and 32.15 % in Covovax group with mostly mild intensity (27.70 %). The most reported solicited AEs were pain (14.69 %) followed by myalgia (7.48 %) and fatigue (6.77 %). Unsolicited AEs varied, with each of the incidence rate under 5 %. There were no serious AEs assessed as possibly, probably, or likely related to vaccine. Conclusions: IndoVac in adults showed favourable safety profile and elicited non-inferior immune response to Covovax. (ClinicalTrials.gov: NCT05433285, Indonesian Clinical Research Registry: INA-R5752S9). © 2024 The Authors
Adjuvants, Immunologic; Adult; Alum Compounds; Antibodies, Neutralizing; Antibodies, Viral; COVID-19; COVID-19 Vaccines; Double-Blind Method; Humans; Immunogenicity, Vaccine; Indonesia; Myalgia; Prospective Studies; Protein Subunit Vaccines; SARS-CoV-2; adjuvant; aluminum potassium sulfate; cpg 1018 adjuvant; indovac; neutralizing antibody; nvx-cov2373 vaccine; SARS-CoV-2 vaccine; subunit vaccine; unclassified drug; aluminum sulfate; immunological adjuvant; SARS-CoV-2 vaccine; virus antibody; adult; anion exchange chromatography; antibody titer; Article; chemiluminescence immunoassay; controlled study; coronavirus disease 2019; disease surveillance; drug efficacy; drug safety; fatigue; female; fever; human; immunization; immunogenicity; injection site pain; injection site swelling; major c
Bio Farma
This study was supported by PT Bio Farma .
Elsevier Ltd
0264410X
38575433
Article
Q1
1493
2151