Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study

Hsieh, Shu‐Ching; Liu, Wang-Da; Huang, Yu‐Shan; Lin, Yi‐Jiun; Hsieh, Erh-Fang; Lian, Wei-Cheng; Chen, Charles; Janssen, Robert S.; Shih, Shin‐Ru; Huang, Chung‐Guei; Tai, I-Chen; Chang, Shan‐Chwen

doi:10.1016/j.eclinm.2021.100989

Cited by 66 publications

(71 citation statements)

References 17 publications

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“… 3 The combination of CpG 1018 and aluminium hydroxide with this S-2P pre-fusion spike protein shows promising enhancements of both T-cell and B-cell immunity, as shown in our phase 1 trial. 6 The interim analysis of MVC-COV1901 shows that two doses of vaccination is safe, well tolerated, and elicits favourable neutralising antibody responses in participants aged 20 years and older. One of the most distinct findings in our safety profile is the extremely low incidence of fever (23 [0·7%] of 3295 participants in the MVC-COV1901 group and two [0·4%] of 549 in the placebo group).…”

Section: Discussionmentioning

confidence: 99%

“…Compared with other vaccines that have received emergency use authorisation, 11 , 12 , 13 MVC-COV1901 leads to substantially fewer febrile reactions and has a good reactogenicity profile, as observed in this study and our phase 1 trial. 6 …”

Section: Discussionmentioning

confidence: 99%

“…For the conversion of GMTs to BAUs/mL, total serum anti-spike IgG titres were measured by use of an ELISA with customised 96-well plates coated with S-2P antigen, as previously reported. 6 The WHO NIBSC 20/136 reference standard was tested with the same ELISA assay that was used for our study samples. The GMT of the anti-spike IgG titre for NIBSC 20/136 was 10 960·9, which was calculated from seven repeated tests.…”

Section: Methodsmentioning

confidence: 99%

“… 5 The result of our phase 1 trial showed that MVC-COV1901 (containing 5 μg, 15 μg, or 25 μg of S-2P) was well tolerated and elicits robust T-cell and B-cell immune responses. 6 In this interim analysis of the phase 2 trial, we assessed the safety, tolerability, and immunogenicity of the MVC-COV1901 vaccine (containing 15 μg of S-2P protein) versus placebo in healthy adults and adults with stable pre-existing medical conditions.…”

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

Hsieh

Liu

Chen

et al. 2021

The Lancet Respiratory Medicine

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Background MVC-COV1901, a recombinant protein vaccine containing pre-fusion-stabilised spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide, has been shown to be well tolerated with a good safety profile in healthy adults aged 20–49 years in a phase 1 trial, and provided a good cellular and humoral immune responses. We present the interim safety, tolerability, and immunogenicity results of a phase 2 clinical trial of the MVC-COV1901 vaccine in Taiwan. Methods This is a large-scale, double-blind, randomised, placebo-controlled phase 2 trial done at ten medical centres and one regional hospital in Taiwan. Individuals aged 20 years or older who were generally healthy or had stable pre-existing medical conditions were eligible for enrolment. Exclusion criteria included (but were not limited to) travel overseas within 14 days of screening, intention to travel overseas within 6 months of the screening visit, and the absence of prespecified medical conditions, including immunosuppressive illness, a history of autoimmune disease, malignancy with risk to recur, a bleeding disorder, uncontrolled HIV infection, uncontrolled hepatitis B and C virus infections, SARS-CoV-1 or SARS-CoV-2 infections, an allergy to any vaccine, or a serious medical condition that could interfere with the study. Study participants were randomly assigned (6:1) to receive two doses of either MVC-COV1901 or placebo, administered via intramuscular injection on day 1 and day 29. MVC-COV1901 contained 15 μg of S-2P protein adjuvanted with 750 μg CpG 1018 and 375 μg aluminium hydroxide in a 0·5 mL aqueous solution, and the placebo contained the same volume of saline. Randomisation was done centrally by use of an interactive web response system, stratified by age (≥20 to <65 years and ≥65 years). Participants and investigators were masked to group assignment. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from day 1 (the day of the first dose) to day 57 (28 days after the second dose). Safety was assessed in all participants who received at least one dose. Immunogenicity was assessed by measuring geometric mean titres (GMTs) and seroconversion rates of neutralising antibody and antigen-specific IgG in the per-protocol population. This study is registered with ClinicalTrials.gov , NCT04695652 . Findings Of 4173 individuals screened between Dec 30, 2020, and April 2, 2021, 3854 were enrolled and randomly assigned: 3304 to the MVC-COV1901 group and 550 to the placebo group. A total of 3844 participants (3295 in the MVC-COV1901 group and 549 in the placebo group) were included in the safety analysis set, and 1053 participants (903 and 150) had received both doses and were included in the per-protocol immunogenicity analysis set. From the start of this phase 2 trial to the time of interim analysis, no vaccine-related serious adverse events were recorded. The most com...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

Hsieh

Liu

Chen

et al. 2021

The Lancet Respiratory Medicine

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120

140

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“…The vaccine has obtained emergency use approval in Taiwan [53]. MVC-COV1901 is given intramuscularly at day 0 and 28 has shown tolerability and immunogenicity in phase1 and phase 2 studies with seroconversion rate of 99.8% after 28 days of second dose [54,55].…”

Section: Mvc-cov1901 (Medigen)mentioning

confidence: 99%

Vaccines against COVID-19 – Catching the Rays of Hope

Srinivasamurthy

Bairy

2021

JPRI

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COVID-19 pandemic has affected the world in all its dimensions. With herd immunity being a distant and non-practical possibility, vaccination remains most tractable approach to reduce morbidity and mortality. Several early phase clinical trials have proved the immunogenicity of vaccines. The efficacy trials have shown reduction in chance of acquiring COVID-19 disease after vaccination. The vaccines approved for emergency use have reported efficacy above 50% thus making them important public health tool in controlling the pandemic. Nevertheless, several questions remain elusive such as whether these approved vaccines are effective against newer variants of the virus; whether vaccination prevents transmission of the virus in the community; clinical impact of vaccination on morbidity and mortality. This review aims to elucidate the status of vaccine candidates in advanced trials along with the vaccines, which have been granted emergency approvals. Further, we collate the data on vaccines efficacy phase 3 trials and their probability of efficacy against newer variants.

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Efficacy and safety of COVID-19 vaccines

Graña

Ghosn

Evrenoglou

et al. 2022

Cochrane Database of Systematic Reviews

187

135

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Background Different forms of vaccines have been developed to prevent the SARS‐CoV‐2 virus and subsequent COVID‐19 disease. Several are in widespread use globally. Objectives To assess the efficacy and safety of COVID‐19 vaccines (as a full primary vaccination series or a booster dose) against SARS‐CoV‐2. Search methods We searched the Cochrane COVID‐19 Study Register and the COVID‐19 L·OVE platform (last search date 5 November 2021). We also searched the WHO International Clinical Trials Registry Platform, regulatory agency websites, and Retraction Watch. Selection criteria We included randomized controlled trials (RCTs) comparing COVID‐19 vaccines to placebo, no vaccine, other active vaccines, or other vaccine schedules. Data collection and analysis We used standard Cochrane methods. We used GRADE to assess the certainty of evidence for all except immunogenicity outcomes. We synthesized data for each vaccine separately and presented summary effect estimates with 95% confidence intervals (CIs). Main results We included and analyzed 41 RCTs assessing 12 different vaccines, including homologous and heterologous vaccine schedules and the effect of booster doses. Thirty‐two RCTs were multicentre and five were multinational. The sample sizes of RCTs were 60 to 44,325 participants. Participants were aged: 18 years or older in 36 RCTs; 12 years or older in one RCT; 12 to 17 years in two RCTs; and three to 17 years in two RCTs. Twenty‐nine RCTs provided results for individuals aged over 60 years, and three RCTs included immunocompromized patients. No trials included pregnant women. Sixteen RCTs had two‐month follow‐up or less, 20 RCTs had two to six months, and five RCTs had greater than six to 12 months or less. Eighteen reports were based on preplanned interim analyses. Overall risk of bias was low for all outcomes in eight RCTs, while 33 had concerns for at least one outcome. We identified 343 registered RCTs with results not yet available. This abstract reports results for the critical outcomes of confirmed symptomatic COVID‐19, severe and critical COVID‐19, and serious adverse events only for the 10 WHO‐approved vaccines. For remaining outcomes and vaccines, see main text. The evidence for mortality was generally sparse and of low or very low certainty for all WHO‐approved vaccines, except AD26.COV2.S (Janssen), which probably reduces the risk of all‐cause mortality (risk ratio (RR) 0.25, 95% CI 0.09 to 0.67; 1 RCT, 43,783 participants; high‐certainty evidence). Confirmed symptomatic COVID‐19 High‐certainty evidence found that BNT162b2 (BioNtech/Fosun Pharma/Pfizer), mRNA‐1273 (ModernaTx), ChAdOx1 (Oxford/AstraZeneca), Ad26.COV2.S, BBIBP‐CorV (Sinopharm‐Beijing), and BBV152 (Bharat Biotect) reduce the incidence of symptomatic COVI...

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Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study

Cited by 66 publications

References 17 publications

Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan

Vaccines against COVID-19 – Catching the Rays of Hope

Efficacy and safety of COVID-19 vaccines

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