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

Asrawati Nurdin, Yetty Movieta Nency, Martira Maddeppungeng, 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, MulyonoEndang Mahati, Nani Maharani, Sidrah Darma, Andi Husni Esa Darussalam, Sharifah Shakinah, Muhammad Nasrum Massi, Soedjatmiko

Research output: Contribution to journalArticlepeer-review

Abstract

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).

Original languageEnglish
Pages (from-to)3009-3017
Number of pages9
JournalVaccine
Volume42
Issue number12
DOIs
Publication statusAccepted/In press - 2024

Keywords

  • COVID-19
  • Immunogenicity
  • IndoVac
  • Safety
  • SARS-CoV-2
  • Vaccine

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