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

NCT07647107 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-15

No results posted yet for this study

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

Conditions

Interventions

BIOLOGICAL

Placebo

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

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

Sponsors & Collaborators

  • Fakultas Kedokteran Universitas Indonesia

    collaborator OTHER

  • Dr Cipto Mangunkusumo General Hospital

    collaborator OTHER

  • PT Bio Farma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-07-31
Completion
2027-08-31

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07647107 on ClinicalTrials.gov