Drug intelligence / Profile preview

Ad26.ENVA.01

Development stage
Phase 1
Lead developer
Johnson & Johnson
Modality
Viral Vectors → Gene Addition/Replacement → Gene Therapies, Vaccines & Immunotherapeutics
Administration
Intramuscular
01

Overview

Ad26.ENVA.01 is an E1/E3-deleted recombinant adenovirus serotype 26 (Ad26) vector vaccine expressing a modified gp140 HIV-1 clade A Env glycoprotein (strain 92rw020)[3]. This vaccine was developed as part of HIV vaccine research efforts and has been evaluated in clinical trials for safety and immunogenicity. ## Development and Clinical Testing Ad26.ENVA.01 was manufactured by Crucell and has been studied in collaboration with the International AIDS Vaccine Initiative (IAVI) and Beth Israel Deaconess Medical Center[1]. The vaccine was tested in Phase 1 clinical trials, including the IPCAVD 001 study (NCT00618605), which ran from February 2008 to June 2011[7]. In clinical trials, Ad26.ENVA.01 was administered intramuscularly at various dosages (10^9, 10^10, and 10^11 viral particles) to evaluate safety and immunogenicity[6][7]. The vaccine was generally found to be safe and immunogenic at all doses tested, with minimal reactogenicity at doses of 5 × 10^10 viral particles or less[6]. The vaccine elicited multiclade HIV-1-specific immune responses, including the development of Ad26 neutralizing antibody titers, EnvA-specific enzyme-linked immunosorbent assays (ELISA) titers, and EnvA-specific enzyme-linked immunospot assays (ELISPOT) responses that persisted at week 52[6]. Ad26.ENVA.01 represents one of several Ad26-based vaccines that have been evaluated in clinical programs, alongside vaccines for other diseases such as Ebola virus, Malaria, RSV, Filovirus, Zika, and HPV[2].

Other names
Ad26-EnvAAd-26-EnvAAd 26-EnvA
02

Targets

gp41 (Human immunodeficiency virus type 1 glycoprotein 41)

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