TY - JOUR
T1 - Immunogenicity and safety of SARS-CoV-2 recombinant protein subunit vaccine (IndoVac) adjuvanted with alum and CpG 1018 in Indonesian adults
T2 - A phase 3, randomized, active-controlled, multicenter trial
AU - Nurdin, Asrawati
AU - Movieta Nency, Yetty
AU - Maddeppungeng, Martira
AU - Sekartini, Rini
AU - Mulia Sari, Rini
AU - Surachman, Fikrianti
AU - Fitry Yani, Finny
AU - Raveinal,
AU - Anggrainy, Fenty
AU - Hafiz, Al
AU - Linosefa,
AU - Machmud, Rizanda
AU - Awaliyah Deza, Putri
AU - Rujiana, Vovinda
AU - Bella Rahimi, Martga
AU - Farhanah, Nur
AU - Gundi Pramudo, Setyo
AU - Hapsari, Rebriarina
AU - Tri Anantyo, Dimas
AU - Mulyono,
AU - Mahati, Endang
AU - Maharani, Nani
AU - Darma, Sidrah
AU - Husni Esa Darussalam, Andi
AU - Shakinah, Sharifah
AU - Nasrum Massi, Muhammad
AU - Soedjatmiko, null
N1 - Publisher Copyright:
© 2024 The Authors
PY - 2024
Y1 - 2024
N2 - 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).
AB - 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).
KW - COVID-19
KW - Immunogenicity
KW - IndoVac
KW - Safety
KW - SARS-CoV-2
KW - Vaccine
UR - http://www.scopus.com/inward/record.url?scp=85189903880&partnerID=8YFLogxK
U2 - 10.1016/j.vaccine.2024.03.077
DO - 10.1016/j.vaccine.2024.03.077
M3 - Article
AN - SCOPUS:85189903880
SN - 0264-410X
VL - 42
SP - 3009
EP - 3017
JO - Vaccine
JF - Vaccine
IS - 12
ER -