A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: An interim analysis in Indonesia

Fadlyana, Eddy; Rusmil, Kusnandi; Tarigan, Rodman; Rahmadi, Andri Reza; Prodjosoewojo, Susantina; Sofiatin, Yulia; Khrisna, Citra Vravita; Sari, Rini Mulia; Setyaningsih, Lilis; Surachman, Fikrianti; Bachtıar, Novilia Sjafri; Sukandar, Hadyana; Megantara, Imam; Murad, Chrysanti; Pangesti, Krisna Nur Andriana; Setiawaty, Vivi; Sudigdoadi, Sunarjati; Hu, Yaling; Gao, Qiang; Kartasasmita, Cissy B.

doi:10.1016/j.vaccine.2021.09.052

Cited by 117 publications

(110 citation statements)

References 15 publications

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“…Our study found that heterologous vaccination with CV-AZ induced higher SARS-CoV-2 RBD-specific antibody responses and neutralizing activities against wild type and variants of concern than that of the licensed CV-CV vaccine schedule with proven 65-83% efficacy against symptomatic COVID-19. [16][17] Furthermore, the CV-AZ schedule, which is administered with a 28-day interval, induced similar RBD-specific binding and neutralizing antibody responses to the licensed AZ-AZ vaccine, which is administered 10-12 weeks apart. Although the cutoff antibody titer that correlates with clinical protection has not yet been clearly defined, a study of nonhuman primate animals has shown that high levels of binding and neutralizing antibodies correlate with the reduction of viral replication in the upper and lower airways after SARS-CoV-2 challenge.…”

Section: Discussionmentioning

confidence: 91%

“…The reported AE in the homologous groups are in line with what has previously been published. 16,22 A previous report showed that heterologous schedules incorporating ChAdOx1-S and BNT162b2 vaccines are more reactogenic than the homologous schedule. 15 This could be explained by the different types of vaccines that induced different types of local inflammation and systemic reactions.…”

Section: Discussionmentioning

confidence: 99%

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Safety and immunogenicity of heterologous and homologous inactivated and adenoviral-vectored COVID-19 vaccines in healthy adults

Wanlapakorn

Suntronwong

Phowatthanasathian

et al. 2021

Preprint

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In light of intermittent supply shortages of individual vaccines and evidence of rare but serious adverse events after vaccination, heterologous regimens for COVID-19 vaccines have gained significant interest. This study aims to assess the reactogenicity and immunogenicity of the heterologous adenoviral vector vaccine regimen (ChAdOx1-S, AstraZeneca; hereafter referred to as AZ) and the inactivated vaccine regimen (CoronaVac; hereafter referred to as CV) regimen in healthy Thai adults immunized between June and September 2021. Our study showed that adverse events following homologous CV-CV and AZ-AZ, and heterologous CV-AZ and AZ-CV combinations, were mild and well tolerated overall. Receptor-binding domain (RBD)-specific antibody responses and neutralizing activities against wild-type and variants of concern after two-dose vaccination were higher in the heterologous CV-AZ and homologous AZ-AZ groups compared to the CV-CV and AZ-CV groups. Conversely, the spike-specific IgA response was detected only in the CV-AZ group after two doses of vaccination. The total interferon gamma response was detected in both the CV-AZ and AZ-CV groups after the two-dose vaccination. Given the shorter completion time of two doses, heterologous CoronaVac followed by ChAdOx1-S can be considered as an alternative regimen to homologous efficacy-proven ChAdOx1-S in countries with circulating variants. Additional studies on the efficacy and durability of immune responses induced by heterologous vaccine regimens are warranted.

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Section: Discussionmentioning

confidence: 91%

Section: Discussionmentioning

confidence: 99%

Safety and immunogenicity of heterologous and homologous inactivated and adenoviral-vectored COVID-19 vaccines in healthy adults

Wanlapakorn

Suntronwong

Phowatthanasathian

et al. 2021

Preprint

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“…Our study found that both the short and long-interval heterologous regimens with CoronaVac followed by BNT162b2 induced higher SARS-CoV-2 RBD-specific antibody responses and neutralizing activities against wild type and variants of concern than that of the licensed two-dose CoronaVac vaccine with proven 65–83% efficacy against symptomatic COVID-19 [2, 3]. In addition, the SARS-CoV-2 RBD-specific total Ig and IgG responses elicited by CoronaVac/BNT162b2 were comparable to those elicited by homologous two-dose BNT162b2 vaccine.…”

Section: Discussionmentioning

confidence: 99%

Immunogenicity of heterologous prime/boost inactivated and mRNA COVID-19 vaccine

Wanlapakorn

Yorsaeng

Phowatthanasathian

et al. 2021

Preprint

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IntroductionIn August 2021, Thailand imported the BNT162b2 mRNA COVID-19 vaccine. The prioritised group to receive the BNT162b2 vaccine were health professionals. The BNT162b2 vaccine scheduled for healthcare workers were two-dose regimen administered three weeks apart, the third dose booster in two-dose inactivated CoronaVac vaccine recipients or as a second dose in health professionals who had received the CoronaVac or adenoviral-vectored (ChAdOx1-S) vaccine as the first dose regardless of the interval between the first and second dose.MethodsThis study aims to evaluate the immunogenicity of the heterologous prime boost CoronaVac followed by BNT162b2 in health professionals.ResultsThe CoronaVac/BNT162b2 vaccine recipients elicited higher neutralizing activity against the original Wuhan and all variants of concern than in the recipients of the two-dose CoronaVac.ConclusionsThe heterologous CoronaVac/BNT162b2 could be used as an alternative regimen in countries experiencing the vaccine shortages and in individuals experiencing the adverse events following CoronaVac.

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“…The most common type of vaccine in these studies was viral vector, with the viral vectors used were adenovirus in 11 studies [17,22,23,26,29,33,34,36,39,40,54] and baculovirus in 2 studies [35,48]. Eighteen studies using vaccines with adjuvants: AlOH3/Algel-IMDG in 21 studies [18][19][20][27][28][29][30][31]35,45,48,51,52,[55][56][57]59,64,66,68,70], Matrix-M1 in three studies [21,63,74], AS03/CpG + Alum in one study [25], Af03/AS03 in one study [36], and MF59 in one study [42].…”

Section: Study Characteristicsmentioning

confidence: 99%

“…Most studies (62.5%) were multicenter studies. One study was conducted in Argentina, Brazil, Chile, Columbia, Mexico, Peru, South Africa, and United States [17], two studies were conducted in the United States, Argentina, Brazil, South Africa, Germany, and Turkey [24], one study was conducted in the United Kingdom, Brazil, and South Africa [34], one study was conducted in Belgium and United States [57], and one study was conducted in Germany and Belgium [47]. Most studies (n = 24) were double-blind studies.…”

Section: Study Characteristicsmentioning

confidence: 99%

Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review

et al. 2022

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Background: Assessing the quality of evidence from vaccine clinical trials is essential to ensure the safety and efficacy of the vaccine and further enhance public acceptance. This study aims to summarize and critically evaluate the quality of harm reporting on randomized controlled trials for the COVID-19 vaccine and determine the factors associated with reporting quality. Methods: We systematically searched the literature using PRISMA guidelines for randomized controlled trials (RCT) on COVID-19 Vaccine until 30 December 2021. Published articles were searched from electronic databases such as PubMed, Science Direct, Google Scholar, and Bibliovid. Bias analysis was performed using RoB-2 tools. The quality of reporting was assessed by the Consolidated Standards of Reporting Trials (CONSORT) harm extension modified into 21 items. Results: A total of 61 RCT studies (402,014 patients) were analyzed. Over half the studies demonstrated adequate reporting (59.02%), and 21 studies (34.4%) reported a low risk of bias. All studies reported death and serious adverse events (AEs), but only six studies mentioned how to handle the recurrent AEs. Reporting of AEs in subgroup analysis was also poor (25%). Conclusion: The RCTs on the COVID-19 vaccine were less biased with good quality on reporting harm based on the modified CONSORT harm extension. However, study quality must be considered, especially for a balance of information between effectivity and safety.

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A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18–59 years: An interim analysis in Indonesia

Cited by 117 publications

References 15 publications

Safety and immunogenicity of heterologous and homologous inactivated and adenoviral-vectored COVID-19 vaccines in healthy adults

Safety and immunogenicity of heterologous and homologous inactivated and adenoviral-vectored COVID-19 vaccines in healthy adults

Immunogenicity of heterologous prime/boost inactivated and mRNA COVID-19 vaccine

Adverse Events Reporting Quality of Randomized Controlled Trials of COVID-19 Vaccine Using the CONSORT Criteria for Reporting Harms: A Systematic Review

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