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NOT YET RECRUITING
NCT07647107
PHASE1

A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations

Sponsor: PT Bio Farma

View on ClinicalTrials.gov

Summary

A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia

Official title: A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia

Key Details

Gender

All

Age Range

18 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2027-08

Last Updated

2026-06-15

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

LipovaxinS4-EAH (Middle Dose)

0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart

BIOLOGICAL

LipovaksinS4-EAH (High Dose)

0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart

BIOLOGICAL

Placebo

0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart

Locations (1)

Cipto Mangunkusumo Hospital, Jl. Pangeran Diponegoro No. 71, Kenari, Jakarta Pusat, DKI Jakarta.

Jakarta Pusat, DKI Jakarta, Indonesia