Safety and immunogenicity of a novel oral hexavalent rotavirus vaccine：a phase I clinical trial

Wu, Zhiwei; Li, Qingliang; Zhou, Hai-Song; Duan, Kai; Gao, Zhili; Zhang, Xinjiang; Zhao, Jiang; Hao, Zhi-Yong; Jin, Fei; Bai, Xuan; Li, Qi; Gao-jian, XU; Zhao, Yuliang; Yang, Xiaoming

doi:10.1080/21645515.2020.1861874

Cited by 6 publications

(11 citation statements)

References 30 publications

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“…A comprehensive description of the investigational products using indigenous manufacturing technology at the Wuhan National Biological Institute of China is described elsewhere. 14 Two vaccine dose levels were assessed (low dose: 1 × 10 5.5 FFU, high dose: 1 × 10 6.5 FFU), according to the results of a phase 1 clinical trial. Each dose of the vaccine consisted of 2 ml.…”

Section: Methodsmentioning

confidence: 99%

“…The rotavirus IgA antibody GMC was measured by the National Institute of Food and Drug Control (NIFDC) with an in-house-developed enzyme-linked immunosorbent assay kit; the method has been described elsewhere. 14 The GMC was tested in the reference laboratory of the NIFDC, Beijing, China.…”

Section: Methodsmentioning

confidence: 99%

“…Seroconversion rates were defined as anti-rotavirus IgA antibody concentrations ≥20 U/ml in initially seronegative infants, and a fourfold increase in the concentration from baseline to postdose 3 (PD3). 14 An anti-rotavirus IgA antibody concentration <20 U/ml was calculated as 10 U/ml to be included in the GMC calculations.…”

Section: Methodsmentioning

confidence: 99%

“… 13 Based on the bovine rotavirus UK Compton strain, we developed a human-bovine reassortant hexavalent rotavirus vaccine (HRV) containing G1, G2, G3, G4, G8, and G9 serotypes, which was shown to be safe and highly immunogenic in animals and was well tolerated in a phase 1 clinical trial. 14 The present study is a double-blinded, randomized controlled phase 2 clinical trial to assess the safety and immunogenicity of the hexavalent rotavirus vaccine.…”

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and safety of a new hexavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled phase 2 clinical trial

Wu,

Jin,

et al. 2023

Human Vaccines & Immunotherapeutics

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Rotavirus remains a major cause of diarrhea among 5-y-old children, and vaccination is currently the most effective and economical measure. We conducted a randomized, double-blind, placebo-controlled phase II clinical trial designed to determine the dosage, immunogenicity, and safety profile of a novel hexavalent rotavirus vaccine. In total, 480 eligible healthy infants, who were 6–12 weeks of age at the time of randomization were randomly allocated (1:1:1) to receive 10 5.5 focus-forming unit (FFU) or 10 6.5 FFU of vaccine or placebo on a 0, 28 and 56-d schedule. Blood samples were collected 28 d after the third dose to assess rotavirus immunoglobulin A (IgA) antibody levels. Adverse events (AEs) up to 28 d after each dose and serious adverse events (SAEs) up to 6 months after the third dose were recorded as safety measurements. The anti-rotavirus IgA seroconversion rate of the vaccine groups reached more than 70.00%, ranging from 74.63% to 76.87%. The postdose 3 (PD3) geometric mean concentrations (GMCs) of anti-rotavirus IgA among vaccine recipients ranged from 76.97 U/ml to 84.46 U/ml. At least one solicited AE was recorded in 114 infants (71.25%) in the high-dose vaccine group, 106 infants (66.25%) in the low-dose vaccine group and 104 infants (65.00%) in the placebo group. The most frequently solicited AE was fever. The novel oral hexavalent rotavirus vaccine was safe and immunogenic in infants support the conclusion to advance the candidate vaccine for phase 3 efficacy trials.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immunogenicity and safety of a new hexavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled phase 2 clinical trial

Wu,

Jin,

et al. 2023

Human Vaccines & Immunotherapeutics

Self Cite

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show abstract

“…Based on the bovine rotavirus UK Compton strain, we developed a human-bovine reassortant hexavalent rotavirus vaccine (HRV) containing G1, G2, G3, G4, G8 and G9 serotypes to cover most serotypes of rotavirus in the world. The phase I and phase II clinical studies showed that this oral hexavalent rotavirus vaccine was well-tolerated in all adults, toddlers and infants, and was highly immunogenic in infants ( Wu et al., 2021 ).…”

Section: Introductionmentioning

confidence: 99%

Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants

Li²,

Liu³

et al. 2022

Virologica Sinica

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Human rotavirus strains circulating among children in the capital of China (2018–2022)_ predominance of G9P[8] and emergence ofG8P[8]

Yang¹,

Han²,

Ma³

et al. 2023

Heliyon

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Safety and immunogenicity of a novel oral hexavalent rotavirus vaccine：a phase I clinical trial

Cited by 6 publications

References 30 publications

Immunogenicity and safety of a new hexavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled phase 2 clinical trial

Immunogenicity and safety of a new hexavalent rotavirus vaccine in Chinese infants: A randomized, double-blind, placebo-controlled phase 2 clinical trial

Efficacy, safety and immunogenicity of hexavalent rotavirus vaccine in Chinese infants

Human rotavirus strains circulating among children in the capital of China (2018–2022)_ predominance of G9P[8] and emergence ofG8P[8]

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