NCT04188691

A Clinical Trial to Evaluate the Safety and Immunogenicity of Norovirus Bivalent Vaccine

Completed Phase 1 Last updated 22 April 2021

What this trial tests

Phase 1 trial testing Norovirus Bivalent (GI.1 / GII.4) Vaccine（low） in Norwalk Gastroenteritis in 510 participants. Completed in 13 December 2020.

Timeline

28 November 2019

Primary endpoint
13 December 2020

13 December 2020

Quick facts

Lead sponsor	National Vaccine and Serum Institute, China
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	510
Start date	28 November 2019
Primary completion	13 December 2020
Estimated completion	13 December 2020
Sites	1 location across China

Drugs / interventions tested

• Norovirus Bivalent (GI.1 / GII.4) Vaccine（low） — full drug profile →
• Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle） — full drug profile →
• Norovirus Bivalent (GI.1 / GII.4) Vaccine（high） — full drug profile →
• Normal saline
• Aluminum adjuvant — full drug profile →

Conditions studied

• Norwalk Gastroenteritis — all drugs for Norwalk Gastroenteritis →
• Norovirus Infections — all drugs for Norovirus Infections →

Sponsor

National Vaccine and Serum Institute, China

Who can join

Adults 6 Months to 59, any sex, with Norwalk Gastroenteritis or Norovirus Infections. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A total of 450 subjects were enrolled, divided into four age groups, including 18-59 years, 6-17 years, 3-5 years, and 6-35 months. There are three types of the test vaccine component in each age group. A total of 30 people in each dose group were vaccinated with the test vaccine or placebo 1 or placebo 2, respectively, in a ratio of 3: 1: 1.

The 18-59-year-old, 6-17-year-old, and 3-5-year-old age groups were vaccinated 2 times at a time interval of 28 days. The 6-35 month age group is divided into two groups, Group 1 is inoculated with 2 doses interval of 28 days each, and Group 2 is inoculated with 3 doses interval of 28 days.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Recent advances in human norovirus research and implications for candidate vaccines.
   Cates JE, Vinjé J, Parashar U, Hall AJ. · · 2020 · cited 60× · PMID 32500763 · DOI 10.1080/14760584.2020.1777860
2. Norovirus Vaccines: Current Clinical Development and Challenges.
   Tan M. · · 2021 · cited 58× · PMID 34959596 · DOI 10.3390/pathogens10121641
3. Norovirus replication, host interactions and vaccine advances.
   Prasad BVV, Atmar RL, Ramani S, Palzkill T, et al · · 2025 · cited 33× · PMID 39824927 · DOI 10.1038/s41579-024-01144-9
4. Epidemiology and evolution of Norovirus in China.
   Wei N, Ge J, Tan C, Song Y, et al · · 2021 · cited 20× · PMID 34495811 · DOI 10.1080/21645515.2021.1961465
5. Lipid nanoparticles as adjuvant of norovirus VLP vaccine augment cellular and humoral immune responses in a TLR9- and type I IFN-dependent pathway.
   Dai W, Xing M, Sun L, Lv L, et al · · 2024 · cited 7× · PMID 39494905 · DOI 10.1128/jvi.01699-24
6. Unraveling the interplay between norovirus infection, gut microbiota, and novel antiviral approaches: a comprehensive review.
   Bai GH, Tsai MC, Lin SC, Hsu YH, et al · · 2023 · cited 7× · PMID 37485533 · DOI 10.3389/fmicb.2023.1212582
7. Chimeric virus-like particles of human norovirus constructed by structure-guided epitope grafting elicit cross-reactive immunity against both GI.1 and GII.4 genotypes.
   Hou YN, Jin YQ, Zhang XF, Tang F, et al · · 2023 · cited 2× · PMID 37792003 · DOI 10.1128/jvi.00938-23