Drug intelligence / Profile preview

JNJ-65195208

Development stage
Unknown
Lead developer
Janssen Pharmaceutical
Modality
Prophylactic Vaccines → Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

**JNJ-65195208** is a prophylactic vaccine consisting of a modified vaccinia Ankara (MVA)-vectored construct expressing HPV16 and HPV18 antigens, developed by Janssen Vaccines & Prevention B.V. for intramuscular administration as the booster dose in a heterologous prime-boost regimen with Ad26-vectored HPV vaccines (JNJ-63682918 or JNJ-63682931). It aims to elicit robust humoral and cellular immune responses against high-risk human papillomavirus types 16 and 18 to prevent persistent infection and associated precancerous cervical lesions in women with normal cytology but at risk of HPV16/18 infection. The vaccine was evaluated at a dose of **2x10^8 infectious units (Inf.U)** in a Phase 1/2a trial (NCT03610581), demonstrating an acceptable safety profile with solicited local and systemic adverse events, alongside immunogenicity endpoints including neutralizing antibodies, T-cell responses via IFNγ ELISpot and ICS, and virological clearance of HPV16/18.[1][5][13]

Other names
MVA.HPV16/18MVA-BN HPV
02

Targets

HPV16 E6 oncoproteinHPV16 E7 (Human papillomavirus 16 E7 protein)HPV18 E7

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