Drug intelligence / Profile preview

GTU-MultiHIV B clade vaccine

Development stage
Phase 2
Lead developer
FIT Biotech
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics, DNA Vaccines → Plasmid DNA → DNA Therapeutics → Nucleic Acid Therapeutics
Administration
Intramuscular
01

Overview

GTU-MultiHIV B clade vaccine is a synthetic DNA-based therapeutic HIV-1 vaccine developed to induce cellular immune responses against HIV-1 subtype B. The vaccine encodes a MultiHIV antigen—a synthetic fusion protein constructed from full-length polypeptides of Rev, Nef, Tat, and Gag p17 and p24 proteins. It also includes more than 20 T-helper (Th) and cytotoxic T lymphocyte (CTL) epitopes derived from protease, reverse transcriptase, and gp160 regions of the HAN2 HIV-1 subtype B strain. The primary mechanism is to stimulate robust CD4+ and CD8+ T-cell responses targeting multiple conserved regions of the virus. The product does not contain live or killed whole virus but instead uses plasmid DNA encoding these antigens. The main indication has been as a therapeutic (not preventive) HIV-1 vaccine in people living with HIV on suppressive antiretroviral therapy (ART), aiming to enhance immune control over viral replication. Clinical trials have shown that it is safe and well-tolerated but has limited efficacy as monotherapy in improving pre-existing immune responses in ART-treated individuals; prime-boost strategies are being explored for greater effect[1][2][3][5][7].

Brand names
GTU-MultiHIV
Other names
GTU®MultiHIV DNA vaccineDNA-GTU-multiHIV B clade vaccine
02

Targets

Bovine papillomavirus type 1 regulatory protein E2Env (HIV-1 envelope glycoprotein)p17 (HIV-1 matrix protein p17)p24 (HIV-1 capsid protein p24)Nef (HIV-1 Nef)Pol (HIV-1 Pol polyprotein)Rev (HIV-1 Rev)Tat (HIV-1 Tat)

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