Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Clinical Trial
. 2023 Aug;19(2):2263228.
doi: 10.1080/21645515.2023.2263228. Epub 2023 Oct 16.

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

Zhi-Wei Wu  1 , Fei Jin  1 , Qing-Liang Li  2 , Jia-Mei Gao  3 , Hai-Song Zhou  4 , Kai Duan  2 , Zhao Gao  1 , Yan Liu  3 , Zhi-Yong Hao  4 , Wei Chen  2 , Yue-Yue Liu  3 , Ge-Lin Xu  2 , Biao Yang  2 , Ben Dong  2 , Jiu-Wei Zhang  2 , Yu-Liang Zhao  1 , Xiao-Ming Yang  2
Affiliations
Clinical Trial

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

Zhi-Wei Wu et al. Hum Vaccin Immunother. 2023 Aug.

Abstract

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 105.5 focus-forming unit (FFU) or 106.5FFU 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.

Keywords: Rotavirus; immunogenicity; safety; vaccine.

PubMed Disclaimer

Conflict of interest statement

Qing-Liang Li, Kai Duan, Wei Chen, Ge-Lin Xu, Biao Yang, Ben Dong, and Jiu-Wei Zhang are currently employees of the Wuhan Institute of Biological Products Co., Ltd. Xiao-Ming Yang is currently an employee of China National Biotec Group Co., Ltd., Beijing, China. The other authors declare that they have no conflicts of interest.

Figures

Figure 1.
Figure 1.
Trial profile.
Figure 2.
Figure 2.
Seroconversion rates of serum 28d after last vaccination in vaccine and placebo groups.
See this image and copyright information in PMC

References

    1. Kuri PR, Goswami P.. Current update on rotavirus in-silico multiepitope vaccine design. ACS Omega. 2023;8(1):190–7. doi: 10.1021/acsomega.2c07213. - DOI - PMC - PubMed
    1. Britoh Mlan A, Burke RM, Koné H, Boni-Cisse C, N’Guessan R, Zaba F, Aka LN, N’Zue K, Adom SK, Kouadio SK, et al. Impact of rotavirus vaccine introduction in Abidjan, Côte d’Ivoire. Hum Vaccin Immunother. 2023;19(1):2156231. doi: 10.1080/21645515.2022.2156231. - DOI - PMC - PubMed
    1. Gundogdu Z, Yendur Sezer O. Changing parental attitudes towards rotavirus vaccine. Cureus. 2023;15:e35348. doi: 10.7759/cureus.35348. - DOI - PMC - PubMed
    1. Ndwandwe D, Runeyi S, Mathebula L, Wiysonge C. Rotavirus vaccine clinical trials: a cross-sectional analysis of clinical trials registries. Trials. 2022;23(1):945. doi: 10.1186/s13063-022-06878-6. - DOI - PMC - PubMed
    1. Tate JE, Burton AH, Boschi-Pinto C, Steele AD, Duque J, Parashar UD. 2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis. Lancet Infect Dis. 2012;12:136–41. doi: 10.1016/S1473-3099(11)70253-5. - DOI - PubMed

Publication types