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
The primary objectives of this trial is to assess the safety of Lipovaxin in adults aged 18-40 years while the secondary objectives are; (1) To assess the frequency of antigen-specific CD4 and CD8 T cell responses measured by expression of IFN-y, IL-2, or TNF-α between groups, and 2.) To assess serum changes in the levels of antigen-specific total IgG antibodies Participants will be given two dose of 0.5 ml of Lipovaxin or control IM deltoid region of upper arm. A total of 60 participants will be recruited and randomized to either receive Medium-dose/ High-dose Lipovaksin or Control. The recruitment will start with 6 sentinel participants, randomised to received mid dose or control vaccine. After evaluation of safety for mid dose of Lipovaksin TB, recruitment will be continued to recruit 24 participants to receive either mid dose or control vaccine. Additionally, 6 sentinel participants will also be recruited to receive either high dose or control vaccine. After evaluation of safety of high dose Lipovaksin TB, recruitment will be continued to recruit the 24 participants to receive either high dose or control vaccine. All subjects will be evaluated for the local and systemic reactions and safety assessments in 30 minutes, 7 days and 28 days after 1st and 2nd injection. Additionally, the participants will be evaluated on the cellular and humoral immunogenicity in D0 and 14 days after 2nd dose of vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
0,5 mL of Middle Dose LipovaxinS4-EAH. Administered twice, 28 days apart
0,5 mL of HIgh Dose LipovaxinS4-EAH. Administered twice, 28 days apart
0,5 mL of Placebo containing NaCl 0.9%. Administered twice, 28 days apart
Cipto Mangunkusumo Hospital, Jl. Pangeran Diponegoro No. 71, Kenari, Jakarta Pusat, DKI Jakarta.
Jakarta Pusat, DKI Jakarta, Indonesia
Local and systemic reactions
Local reactions and systemic events 30 minutes, 7 days and 28 days after 1st and 2nd dose of Vaccine/Placebo (additional 14 days after 1st dose for sentinel group)
Time frame: 30 minutes, 7 days and 28 days after 1st injection and 2nd injection for all group, and 30 minutes, 7 days and 28 days after 1st injection and 2nd injection and 14 days after 1st dose for sentinel group
Any AEs and SAEs
Any Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: until 6 months after 2nd injection
Laboratory changes
Laboratory changes in D0, 14 days after 1st dose (sentinel group) and 28 days after 2nd dose.
Time frame: D0, 14 days after 1st injection (sentinel), 28 days after 2nd injection
Cellular Immunogenicity
Intracellular cytokine staining of antigen specific T-cells (IFN-y, IL-2, or TNF-α) in D0 and 14 days after 2nd dose
Time frame: D0 and 14 days after 2nd dose.
Humoral Immunogenicity
Geometric mean time (GMT), seropositive, seroconversion of total serum IgG antigen specific in D0 and 28 days after 2nd dose
Time frame: D0 and 28 days after 2nd dose.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.