NCT04563533

Clinical Trial of Quadrivalent Recombinant Norovirus Vaccine (Pichia Pastoris)

Completed Phase 1, PHASE2 Last updated 1 October 2024

What this trial tests

Phase 1, PHASE2 trial testing Low-dose vaccine in Acute Gastroenteritis in 580 participants. Completed in 29 September 2024.

Timeline

5 August 2020

Primary endpoint
29 September 2024

29 September 2024

Quick facts

Lead sponsor	Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Phase	Phase 1, PHASE2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	580
Start date	5 August 2020
Primary completion	29 September 2024
Estimated completion	29 September 2024
Sites	1 location across China

Drugs / interventions tested

• Low-dose vaccine
• High-dose vaccine
• Placebo (containing aluminum) — full drug profile →
• Placebo (without aluminum) — full drug profile →

Conditions studied

• Acute Gastroenteritis — all drugs for Acute Gastroenteritis →

Sponsor

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. — full company profile →

Who can join

6 Weeks and older, any sex, with Acute Gastroenteritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the research is to evaluate the safety and tolerability of the tetravalent recombinant Norovirus vaccine at different doses, to initially explore the immunogenicity of the vaccine, and to determine the appropriate dose of the product for later clinical trials.This trial adopts the seamless design of phase I/IIa, which is carried out in two phases, phase I and phase IIa, phase I is the age/dose climbing phase, and phase IIa is the dose expansion phase.It is planned to enroll 580 subjects, divided into 5 age groups, including: young adults (18-59 years old, 60 people), adolescents (6 -17 years old, 60 people), and elderly (≥60 years old, 160 people) , Toddlers (2-5 years old, 140), infants (6 weeks to 23 months old, 160).The test vaccine contains recombinant HuNoV GI.1-VP1 protein, HuNoV GII.3-VP1 protein, HuNoV GII.4-VP1 protein, HuNoV GII.17-VP1 protein, and each dose contains 12.5μg/type/0.5ml/bottle (Low dose), 25μg/type/0.5ml/piece (high dose).

Publications & conference data

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

1. Norovirus Vaccines: Current Clinical Development and Challenges.
   Tan M. · · 2021 · cited 58× · PMID 34959596 · DOI 10.3390/pathogens10121641
2. 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
3. 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
4. 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
5. 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
6. Vaccinia Virus Vector Bivalent Norovirus Vaccine.
   Bai Y, Wu X, Shen Y, Wang L, et al · · 2025 · cited 1× · PMID 40006992 · DOI 10.3390/v17020237
7. The Impact of Norovirus on Children and Adolescents: Implications for Ongoing Vaccine Development.
   Tan M. · · 2024 · PMID 40823381 · DOI 10.1007/s40124-025-00355-9