Heterologous prime-boost immunization with CoronaVac and Convidecia
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Abstract
Background
The safety and immunogenicity of heterologous prime-boost COVID-19 vaccine regimens with one shot of a recombinant adenovirus type-5-vectored COVID-19 vaccine Convidecia has not been reported.
Methods
We conducted a randomized, controlled, observer-blinded trial of heterologous prime-boost immunization with CoronaVac and Convidecia in healthy adults 18-59 years of age. Eligible participants who were primed with one or two doses of CoronaVac were randomly assigned at a 1:1 ratio to receive a booster dose of Convidecia or CoronaVac. Participants were masked to the vaccine received but not to the three-dose or two-dose regimen. The occurrences of adverse reactions within 28 days after the vaccination were documented. The geometric mean titers of neutralizing antibodies against live SARS-CoV-2 virus were measured at 14 and 28 days after the booster vaccination.
Results
Between May 25 and 26, 2021, a total of 300 participants were enrolled. Participants who received a booster shot with a heterologous dose of Convidecia reported increased frequencies of solicited injection-site reactions than did those received a homogeneous dose of CoronaVac, but frequencies of systemic reactions. The adverse reactions were generally mild to moderate. The heterologous immunization with Convidecia induced higher live viral neutralizing antibodies than did the homogeneous immunization with CoronaVac (197.4[167.7, 232.4] vs. 33.6[28.3, 39.8] and 54.4[37. 9, 78.0] vs. 12.8[9.3, 17.5]) at day 14 in the three- and two-dose regimen cohort, respectively.
Conclusions
The heterologous prime-boost regimen with Convidecia after the priming with CoronaVac was safe and significantly immunogenic than a homogeneous boost with CoronaVac ( ClinicalTrials.gov , number NCT04892459 ).
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SciScore for 10.1101/2021.09.03.21263062: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by the institutional review board of the Jiangsu Provincial Center of Disease Control and Prevention, and no protocol change was made after the initial of the study. Sex as a biological variable Healthy participants, male or female, aged between 18 and 59 years, who have received one dose of CoronaVac in the past 1∼3 months or two doses of CoronaVac in the past 3∼6 months were recruited for screening of eligibility. Randomization Objectives, Participants, and Oversight: We conducted a randomized, controlled, observer-blinded trial to access the safety and immunogenicity of heterologous prime-boost immunization with CoronaVac and Convidecia. Blind… SciScore for 10.1101/2021.09.03.21263062: (What is this?)
Please note, not all rigor criteria are appropriate for all manuscripts.
Table 1: Rigor
Ethics IRB: The trial protocol was reviewed and approved by the institutional review board of the Jiangsu Provincial Center of Disease Control and Prevention, and no protocol change was made after the initial of the study. Sex as a biological variable Healthy participants, male or female, aged between 18 and 59 years, who have received one dose of CoronaVac in the past 1∼3 months or two doses of CoronaVac in the past 3∼6 months were recruited for screening of eligibility. Randomization Objectives, Participants, and Oversight: We conducted a randomized, controlled, observer-blinded trial to access the safety and immunogenicity of heterologous prime-boost immunization with CoronaVac and Convidecia. Blinding not detected. Power Analysis Statistical Analysis: The sample size calculation was based on the hypothesis on a boost vaccination following the two-dose of inactivated vaccine regimen, and performed by using Power Analysis and Sample Size (PASS) software. Cell Line Authentication not detected. Table 2: Resources
Antibodies Sentences Resources Receptor binding domain (RBD)- and N-specific ELISA antibody responses were measured at the same time points, using an indirect ELISA assay. N-specific ELISAsuggested: NoneRBD-binding IgG isotype in serum was also determined by ELISA, and the type 1 helper T cells (Th1)-dependent IgG1 vs. type 2 helper T cells (Th2)-dependent IgG4 antibody subclasses were calculated to evaluate the Th1/Th2 profiling. RBD-binding IgGsuggested: NoneTh2)-dependent IgG4suggested: NoneThe antibodies against SARS-CoV-2 were presented as GMTs, geometric mean fold increases (GMFIs) and the proportion of participants with at least four-fold increase with 95% CIs. SARS-CoV-2suggested: NoneExperimental Models: Cell Lines Sentences Resources Live viral neutralizing antibody titer in serum was determined by using a cytopathic effect (CPE)-based microneutralization assay with a wild-type SARS-CoV-2 virus strain BetaCoV/Jiangsu/JS02/2020 (EPI_ISL_411952) in Vero-E6 cells. Vero-E6suggested: NoneSoftware and Algorithms Sentences Resources Statistical analyses were done by using SAS (version 9.4) or GraphPad Prism 8.0.1. GraphPad Prismsuggested: (GraphPad Prism, RRID:SCR_002798)Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).
Results from LimitationRecognizer: We detected the following sentences addressing limitations in the study:The first limitation of this study is that only adults aged between 18-59 years were involved in, but not older adults, particularly those over 75 years of age, who are often immunocompromised or with coexisting conditions, and poorly respond to vaccines. We are carrying out another study to evaluate the heterologous prime-boost vaccination with CoronaVac and Convidecia in the older population (NCT04952727). Second, studies on the mechanism of the enhanced immune responses and the detailed B- and T cell activation associated with the heterologous prime-boost were not performed, thus we can only have a speculation about the reasons why this regimen are more immunogenic. Third, we could not access the efficacy of the heterologous prime-boost vaccination regimen against COVID-19 diseases, and the protection of this regimen remain undetermined. But several previous studies found that binding and neutralizing antibodies correlated with COVID-19 risk and were most likely to be able to predict the vaccine efficacy.29 Besides, the neutralizing antibody titers against delta variant B.1.617.2 was not reported. As the delta variant has become predominant variants of concern in many countries, whether the heterologous prime-boost regimen could potentially offer an additional protection to the delta variant over currently licensed two-dose inactivated vaccine schedule needs to be answered. At last, the relatively small number of participants in this study was insufficient to identify pote...
Results from TrialIdentifier: We found the following clinical trial numbers in your paper:
Identifier Status Title NCT04892459 Active, not recruiting Study on Sequential Immunization of Inactivated SARS-CoV-2 V… NCT04952727 Not yet recruiting Study on Sequential Immunization of Inactivated COVID-19 Vac… Results from Barzooka: We did not find any issues relating to the usage of bar graphs.
Results from JetFighter: We did not find any issues relating to colormaps.
Results from rtransparent:- Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
- Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
- No protocol registration statement was detected.
Results from scite Reference Check: We found no unreliable references.
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