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NOT YET RECRUITING
NCT07831226
PHASE1

Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-59 Years

Sponsor: Guangzhou Patronus Biotech Co., Ltd.

View on ClinicalTrials.gov

Summary

This is a clinical trial in which healthy volunteers will receive one of three investigational malaria vaccines (LYB014, LYB017, and LYB027) administered in combination with the A02B adjuvant, or the A02B adjuvant alone as the control.

Official title: A Phase I, Randomized, Double-Blinded, Controlled, Dose Escalation Study to Evaluate the Safety and Immunogenicity of Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years Old

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

72

Start Date

2026-10

Completion Date

2028-04

Last Updated

2026-09-21

Healthy Volunteers

Yes

Conditions

Interventions

BIOLOGICAL

LYB014 low dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

LYB014 high dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

LYB017 low dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

LYB017 high dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

LYB027 low dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

LYB027 high dose

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

BIOLOGICAL

Control A02B adjuvant

Dosage forms and strengths: Solution for injection. Each dose is 0.5 mL and is administered by intramuscular injection. Participants will receive a total of three doses.

Locations (1)

Nucleus Network Pty Ltd.

Melbourne, Australia