TY - JOUR
T1 - Safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 in healthy Indonesian adults
T2 - A multicenter, randomized, comparative, observer-blind, placebo-controlled phase 2 study
AU - Maddeppungeng, Martira
AU - Nurdin, Asrawati
AU - Nency, Yetty Movieta
AU - Sekartini, Rini
AU - Medise, Bernie Endyarni
AU - Soedjatmiko, Soedjatmiko
AU - Massi, Muh Nasrum
AU - Darma, Sidrah
AU - Darussalam, Andi Husni Esa
AU - Ramadhani, Nur
AU - Hidayah, Najdah
AU - Chalid, Maisuri Tadjuddin
AU - Ramadany, Sri
AU - Wahyuni, Sitti
AU - Djaharuddin, Irawaty
AU - Santoso, Arif
AU - Fikri, Bahrul
AU - Alimuddin, Suriani
AU - Pelupessy, Ninny Meutia
AU - Masadah, Rina
AU - Putri, Azka Zhafira
AU - Setyaningsih, Lilis
AU - Yani, Finny Fitry
AU - Anggrainy, Fenty
AU - Deza, Putri Awaliyah
AU - Maharani, Nani
AU - Mahati, Endang
AU - Hapsari, Rebriarina
AU - Farhanah, Nur
AU - Pramudo, Setyo Gundi
AU - Tri Anantyo, Dimas
N1 - Publisher Copyright:
© 2024 The Author(s). Published with license by Taylor & Francis Group, LLC.
PY - 2024
Y1 - 2024
N2 - Globally, dozens of COVID-19 vaccines are licensed under emergency or conditional authorization, but especially in low and middle-income countries, their availability varies. Indonesia decided to become independent and produce its own vaccines locally. This study investigated the safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018. This study involved 360 adults aged 18 years and above. It compared two vaccine dosages, a-12.5 µg and a 25-µg dose of receptor binding domain protein, to a placebo (1:1:1). A total of 40.6% of participants in this study experienced at least one adverse event (AE), with most being mild. There was no statistically significant difference in AEs between the groups. The microneutralization test showed the highest neutralizing antibody titer (IU/mL) in the 25 µg dose vaccine group at day 28 after the second dose (3,300 95%CI 2,215-4,914), although it was not statistically different from the 12.5 µg dose group (3,157 95%CI 2,135-4,669). Similarly, IgG antibody concentrations in the 25 µg dose vaccine group at day 28 were the highest compared to the 12.5 µg dose and placebo. According to protocol, only the formulation with the better antibody profile and comparable reactogenicity was further evaluated at months three and six. Thus, follow-up was only performed for the 25 µg dose vaccine, demonstrating antibody persistence at month six and had a favorable safety profile. These results position this SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 as a promising candidate to fight against COVID-19.
AB - Globally, dozens of COVID-19 vaccines are licensed under emergency or conditional authorization, but especially in low and middle-income countries, their availability varies. Indonesia decided to become independent and produce its own vaccines locally. This study investigated the safety and immunogenicity of a SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018. This study involved 360 adults aged 18 years and above. It compared two vaccine dosages, a-12.5 µg and a 25-µg dose of receptor binding domain protein, to a placebo (1:1:1). A total of 40.6% of participants in this study experienced at least one adverse event (AE), with most being mild. There was no statistically significant difference in AEs between the groups. The microneutralization test showed the highest neutralizing antibody titer (IU/mL) in the 25 µg dose vaccine group at day 28 after the second dose (3,300 95%CI 2,215-4,914), although it was not statistically different from the 12.5 µg dose group (3,157 95%CI 2,135-4,669). Similarly, IgG antibody concentrations in the 25 µg dose vaccine group at day 28 were the highest compared to the 12.5 µg dose and placebo. According to protocol, only the formulation with the better antibody profile and comparable reactogenicity was further evaluated at months three and six. Thus, follow-up was only performed for the 25 µg dose vaccine, demonstrating antibody persistence at month six and had a favorable safety profile. These results position this SARS-CoV-2 recombinant protein subunit vaccine adjuvanted with Alum + CpG 1018 as a promising candidate to fight against COVID-19.
KW - Covid-19
KW - immunogenicity
KW - recombinant protein subunit vaccine
KW - safety
KW - SARS-CoV-2
UR - http://www.scopus.com/inward/record.url?scp=85211688407&partnerID=8YFLogxK
U2 - 10.1080/21645515.2024.2429231
DO - 10.1080/21645515.2024.2429231
M3 - Article
C2 - 39632708
AN - SCOPUS:85211688407
SN - 2164-5515
VL - 20
JO - Human Vaccines and Immunotherapeutics
JF - Human Vaccines and Immunotherapeutics
IS - 1
M1 - 2429231
ER -