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

• DOI: 10.1016/j.vaccine.2024.03.077
• Publication Date: 2024-04-04T08:39:13Z
• Authors: Asrawati Nurdin; Yetty Movieta Nency; Martira Maddeppun...; Rini Sekartini; Rini Mulia Sari; Fikrianti Surachman; Finny Fitry Yani; Raveinal; Fenty Anggrainy; Al Hafiz; Linosefa; Rizanda Machmud; Putri Awaliyah Deza; Vovinda Rujiana; Martga Bella Rahimi; Nur Farhanah; Setyo Gundi Pramudo; Rebriarina Hapsari; Dimas Tri Anantyo; Mulyono; Endang Mahati; Nani Maharani; Sidrah Darma; Andi Husni Esa Da...; Sharifah Shakinah; Muhammad Nasrum M...; Soedjatmiko
• Keywords: Alum

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 phase 3 immunogenicity and safety study Indonesian adults aged 18 years above. We conducted randomized, active-controlled, multicenter, prospective intervention to evaluate IndoVac Participants who were SARS-CoV-2 vaccine-naïve received two doses either or control (Covovax) with 28 days interval between followed up until 12 months after complete vaccination. A total 4050 participants enrolled from June August 2022 at least one dose vaccine. The geometric mean ratio (GMR) neutralizing antibody 14 second was 1.01 (95 % confidence (CI) 0.89–1.16), which met WHO non-inferiority criteria immunobridging CI lower bound > 0.67). levels maintained through dose. incidence rate adverse events (AEs) 27.95 group 32.15 Covovax mostly mild intensity (27.70 %). most solicited AEs pain (14.69 %) by myalgia (7.48 fatigue (6.77 Unsolicited varied, each under 5 %. There no serious assessed as possibly, probably, likely related showed favourable profile elicited non-inferior immune response Covovax. (ClinicalTrials.gov: NCT05433285, Clinical Research Registry: INA-R5752S9).