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

Nurdin, Asrawati; Movieta Nency, Yetty; Maddeppungeng, Martira; Sekartini, Rini; Mulia Sari, Rini; Surachman, Fikrianti; Fitry Yani, Finny; Raveinal,; Anggrainy, Fenty; Hafiz, Al; Linosefa,; Machmud, Rizanda; Awaliyah Deza, Putri; Rujiana, Vovinda; Bella Rahimi, Martga; Farhanah, Nur; Gundi Pramudo, Setyo; Hapsari, Rebriarina; Tri Anantyo, Dimas; Mulyono,; Mahati, Endang; Maharani, Nani; Darma, Sidrah; Husni Esa Darussalam, Andi; Shakinah, Sharifah; Nasrum Massi, Muhammad; Soedjatmiko,

doi:10.1016/j.vaccine.2024.03.077

Cited by 2 publications

(7 citation statements)

References 25 publications

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“…The Ministry of Health in Indonesia was involved in the development and implementation of the COVID-19 vaccination programme, including the IndoVac ® vaccine [11]. IndoVac ® is a domestically produced COVID-19 vaccine developed by PT Bio Farma, a state-owned enterprise in Indonesia [11,12]. PT Bio Farma developed a candidate vaccine using a subunit protein recombinant platform to help overcome the issue.…”

Section: Introductionmentioning

confidence: 99%

“…PT Bio Farma developed a candidate vaccine using a subunit protein recombinant platform to help overcome the issue. IndoVac ® has recently been authorised for use in Indonesia following clinical trials [11][12][13]. In a phase 3 clinical trial comparing the primary doses of IndoVac ® with Covovax, 2070 participants were included in the immunogenicity group [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

“…IndoVac ® has recently been authorised for use in Indonesia following clinical trials [11][12][13]. In a phase 3 clinical trial comparing the primary doses of IndoVac ® with Covovax, 2070 participants were included in the immunogenicity group [11][12][13]. IndoVac ® demonstrated non-inferior immunogenicity to Covovax when assessed for neutralising antibody titres against the delta variant.…”

Section: Introductionmentioning

confidence: 99%

“…IndoVac ® demonstrated non-inferior immunogenicity to Covovax when assessed for neutralising antibody titres against the delta variant. The results of the clinical trial of IndoVac ® as a booster are now available [11][12][13]. As a locally produced vaccine, IndoVac ® has clear benefits for use in Indonesia [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

“…The results of the clinical trial of IndoVac ® as a booster are now available [11][12][13]. As a locally produced vaccine, IndoVac ® has clear benefits for use in Indonesia [11][12][13].…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

Rusmil,

Fadlyana,

Girsang

et al. 2024

Vaccines

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According to the WHO target product profile for COVID-19 vaccines, the vaccine in development should be indicated for active immunisation in all populations. Therefore, PT Bio Farma developed a candidate vaccine in a subunit protein recombinant platform to help overcome the issue. This trial was an observer-blind, randomised, prospective intervention study. This study targeted individuals who had received complete primary doses of the authorised/approved COVID-19 vaccine. The groups were divided into the primary inactivated vaccine (CoronaVac®) group, the primary viral vector vaccine (ChAdOx1) group, and the primary mRNA vaccine (BNT162b2) group that received the recombinant protein (IndoVac®). The groups were compared with the control and primary mRNA vaccine (BNT162b2). The participants enrolled in the study were from two primary care centres in Bandung City and three primary care centres in Denpasar City. A total of 696 participants were enrolled from 1 September to 31 October 2022. The demographic characteristics of the all-vaccine group showed a uniform distribution. The results showed that, compared with the control, the investigational product had inferior effectiveness 14 days after the booster dose was administered. However, 28 days after the booster dose, the investigational product exhibited non-inferior effectiveness compared with the primary groups that received CoronaVac® (GMR 0.76 (0.57–0.99)) and ChAdOx1 (GMR 0.72 (0.56–59.93)), but the BNT162b2 group (GMR 0.61 (0.39–0.94)) was inferior to the control. At 12 months follow-up after the booster dose, three serious adverse events (SAEs) were reported in three participants, with causality not correlated with the investigated products. Neither AEs of special interest nor severe COVID-19 cases were reported throughout the follow-up period; thus, the IndoVac® vaccine as a booster was immunogenic and safe. Until the 6-month follow-up after the booster dose, the IndoVac® vaccine was well tolerated and all reported AEs resolved. This vaccine is registered and can be included in the immunisation programme.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

Rusmil,

Fadlyana,

Girsang

et al. 2024

Vaccines

View full text Add to dashboard Cite

show abstract

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Heterologous Booster Dose against COVID-19 in Indonesian Adolescents

Fadlyana,

Rusmil,

Dwi Putra

et al. 2024

Vaccines

View full text Add to dashboard Cite

Adolescents are vulnerable to Coronavirus disease 2019 (COVID-19) infections; thus, their antibodies should be maintained above the protective value. This study aimed to evaluate the immune response and safety to the SARS-CoV-2 protein subunit recombinant vaccine (IndoVac®) as a heterologous booster dose against COVID-19 in Indonesian adolescents. This open-label prospective intervention study enrolled 150 clinically healthy adolescents aged 12–17 years who had received complete primary doses of the CoronaVac® vaccine from Garuda Primary Care Centres in Bandung City. The result of immunogenicity was presented with a 95% confidence interval (CI) and analyzed with t-tests from 14 days and 3, 6, and 12 months. The neutralizing antibody geometric mean titers (GMTs) (IU/mL) at baseline and 14 days after booster dose were 303.26 and 2661.2, respectively. The geometric mean fold rises (GMFR) at 3, 6, and 12 months after booster dose were 6.67 (5.217–8.536), 3.87 (3.068–4.886), and 2.87 (2.232–3.685), respectively. Both the neutralizing antibody and IgG antibody were markedly higher in the adolescents than in the adults at every timepoint. The incidence rate of adverse effects (AEs) until 28 days after booster dose was 82.7%, with a higher number of local events reported. Most reported solicited AEs were local pain followed by myalgia with mild intensity. Unsolicited AEs varied with each of the incidence rates < 10%, mostly with mild intensity. Adverse events of special interest (AESI) were not observed. At the 12-month follow-up after the booster dose, four serious adverse events (SAEs) not related to investigational products and research procedures were noted. This study showed that IndoVac® has a favorable immunogenicity and safety profile as a booster in adolescents and that the antibody titer decreases over time.

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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

Cited by 2 publications

References 25 publications

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Booster Dose against COVID-19 in Indonesian Adults

Immunogenicity and Safety of SARS-CoV-2 Protein Subunit Recombinant Vaccine (IndoVac®) as a Heterologous Booster Dose against COVID-19 in Indonesian Adolescents

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