Background And Aims: ROTAVIN-M1® (licensed, frozen vaccine) and ROTAVIN (second-generation, liquid candidate vaccine) are two rotavirus vaccine formulations developed from a live attenuated G1P8 (KH0118) strain by Center for Research and Production of Vaccines and Biologicals (POLYVAC), Vietnam. This study compared the safety and immunogenicity of these two formulations.
Methods: A Phase 3, randomized, partially double-blinded, active-controlled study was conducted in healthy infants aged 60-91 days in Vietnam. Infants received two doses of ROTAVIN or ROTAVIN-M1 in a ratio of 2:1 with an interval of 8 weeks. Solicited reactions were collected for 7 days after each vaccination. Blood samples were collected pre-vaccination and 4 weeks after the second vaccination in a subset of infants. Non-inferiority criteria required that the lower bound of 95% confidence intervals (CIs) of the post-vaccination anti-rotavirus IgA GMC (Geometric Mean Concentration) ratio of ROTAVIN/ROTAVIN-M1 should be >0.5. A co-primary objective was to compare the safety of the two vaccines in terms of solicited reactions.
Results: A total of 825 infants were enrolled. The post-vaccination GMC was 48.25 (95% CI: 40.59, 57.37) in the ROTAVIN group and 35.04 (95% CI: 27.34, 44.91) in the ROTAVIN-M1 group with an IgA GMC ratio of 1.38 (95% CI: 1.02, 1.86) thus meeting the pre-set criteria for non-inferiority. A total of 605 solicited reactions were reported in 297 (36.0%) participants with 35.4% in the ROTAVIN group and 37.2% in the ROTAVIN-M1 group. There were no cases of intussusception or death reported in the study.
Conclusions: Based on the data generated, it can be concluded that ROTAVIN is immunologically non-inferior and has similar safety profile to ROTAVIN-M1 when administered to infants in a two-dose schedule. Therefore, it can be considered as a more suitable option for programmatic use to prevent rotavirus diarrhoea in Vietnam and the Mekong region.
Trial Registration Number: ClinicalTrials.gov identifier: NCT03703336, October 11, 2018.
Download full-text PDF |
Source |
|---|---|
| http://dx.doi.org/10.1016/j.vaccine.2021.06.056 | DOI Listing |
Publication Analysis
Top Keywords
Similar Publications
Ultrasound-activated erythrocyte membrane-camouflaged Pt (II) layered double hydroxide enhances PD-1 inhibitor efficacy in triple-negative breast cancer through cGAS-STING pathway-mediated immunogenic cell death.
Theranostics
January 2025
Cancer Research Center, School of Medicine, Xiamen University, Xiamen, 361102, China.
Immunogenic cell death (ICD) offers a promising avenue for the treatment of triple-negative breast cancer (TNBC). However, optimizing immune responses remains a formidable challenge. This study presents the design of RBCm@Pt-CoNi layered double hydroxide (RmPLH), an innovative sonosensitizer for sonodynamic therapy (SDT), aimed at enhancing the efficacy of programmed cell death protein 1 (PD-1) inhibitors by inducing robust ICD responses.
View Article and Find Full Text PDFEfficacy of angiotensin receptor neprilysin inhibitor in hypertension management: A systematic review and meta-analysis of clinical trials.
Narra J
December 2024
Department of Internal Medicine, Faculty of Medicine, Universitas Airlangga, Surabaya, Indonesia.
Dysregulation of renin-angiotensin-aldosterone system (RAAS) often leads to hypertension and severe cardiorenal complications. Although RAAS-targeted therapies have proven effective, it remains yet optimal in reducing cardiovascular events. The aim of this study was to evaluate the efficacy and safety of angiotensin receptor neprilysin inhibitor (ARNI) compared to control in patients with hypertension.
View Article and Find Full Text PDFFirst-in-human study on tolerability, pharmacokinetics and pharmacodynamics of single and multiple escalating doses of XKH001, a recombinant humanized monoclonal antibody against IL-25 in healthy Chinese volunteers.
Expert Opin Investig Drugs
January 2025
Department of Pediatric Respiratory, Children's Medical Center，The First Hospital of Jilin University, Jilin, China.
Background: XKH001 is a recombinant humanized IgG1 monoclonal antibody against IL-25 for the treatment of type 2 inflammatory diseases. This study aimed to evaluate the tolerability, pharmacokinetics, and pharmacodynamics of XKH001 in humans for the first time.
Research Design And Methods: This clinical investigation adopted a randomized, double-blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) design.
Proteolysis-targeting influenza vaccine strains induce broad-spectrum immunity and in vivo protection.
Nat Microbiol
January 2025
State key Laboratory of Quantitative Synthetic Biology, Shenzhen Institute of Synthetic Biology, Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences, Shenzhen, China.
Generating effective live vaccines from intact viruses remains challenging owing to considerations of safety and immunogenicity. Approaches that can be applied in a systematic manner are needed. Here we created a library of live attenuated influenza vaccines by using diverse cellular E3 ubiquitin ligases to generate proteolysis-targeting (PROTAR) influenza A viruses.
View Article and Find Full Text PDFBiomimetic co-immobilization of β-glucosidase, glucose oxidase, and horseradish peroxidase to construct a multi-enzyme biosensor for determination of amygdalin.
Int J Biol Macromol
January 2025
School of Light Industry and Chemical Engineering, Dalian Polytechnic University, Dalian 116034, China. Electronic address:
Accurate, specific, and cost-effective detection of toxic cyanogenic glycosides is crucial for ensuring biological health and food safety. In this study, a novel biosensor based on co-immobilized multi-enzyme system was constructed by artificial antibody-antigen-directed immobilization for the colorimetric detection of amygdalin through a cascade reaction catalyzed by β-glucosidase, glucose oxidase, and horseradish peroxidase. Artificial antibodies and antigens were prepared using catechol and 3,4-dihydroxybenzaldehyde, respectively, to generate mutual affinity recognition ability for enzyme immobilization.
View Article and Find Full Text PDFWant AI Summaries of new PubMed Abstracts delivered to your In-box?
Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!