New GMP manufacturing processes to obtain thermostable HIV-1 gp41 virosomes under solid forms for various mucosal vaccination routes - CNRS - Centre national de la recherche scientifique Accéder directement au contenu
Article Dans Une Revue NPJ vaccines Année : 2020

New GMP manufacturing processes to obtain thermostable HIV-1 gp41 virosomes under solid forms for various mucosal vaccination routes

Mario Amacker
Charli Smardon
Laura Mason
Jack Sorrell
  • Fonction : Auteur
Kirk Jeffery
  • Fonction : Auteur
Michael Adler
  • Fonction : Auteur
Farien Bhoelan
  • Fonction : Auteur
Olga Belova
  • Fonction : Auteur
Mark Spengler
  • Fonction : Auteur
Beena Punnamoottil
  • Fonction : Auteur
Markus Schwaller
  • Fonction : Auteur
Toon Stegmann
  • Fonction : Auteur
Andrew Naylor
  • Fonction : Auteur
Richard Johnson
  • Fonction : Auteur
Desmond Wong
  • Fonction : Auteur
Sylvain Fleury

Résumé

Abstract The main objective of the MACIVIVA European consortium was to develop new Good Manufacturing Practice pilot lines for manufacturing thermostable vaccines with stabilized antigens on influenza virosomes as enveloped virus-like particles. The HIV-1 gp41-derived antigens anchored in the virosome membrane, along with the adjuvant 3M-052 (TLR7/8 agonist) on the same particle, served as a candidate vaccine for the proof of concept for establishing manufacturing processes, which can be directly applied or adapted to other virosomal vaccines or lipid-based particles. Heat spray-dried powders suitable for nasal or oral delivery, and freeze-dried sublingual tablets were successfully developed as solid dosage forms for mucosal vaccination. The antigenic properties of vaccinal antigens with key gp41 epitopes were maintained, preserving the original immunogenicity of the starting liquid form, and also when solid forms were exposed to high temperature (40 °C) for up to 3 months, with minimal antigen and adjuvant content variation. Virosomes reconstituted from the powder forms remained as free particles with similar size, virosome uptake by antigen-presenting cells in vitro was comparable to virosomes from the liquid form, and the presence of excipients specific to each solid form did not prevent virosome transport to the draining lymph nodes of immunized mice. Virosome integrity was also preserved during exposure to <−15 °C, mimicking accidental freezing conditions. These “ready to use and all-in-one” thermostable needle-free virosomal HIV-1 mucosal vaccines offer the advantage of simplified logistics with a lower dependence on the cold chain during shipments and distribution.

Domaines

Immunologie

Dates et versions

hal-03994454 , version 1 (17-02-2023)

Identifiants

Citer

Mario Amacker, Charli Smardon, Laura Mason, Jack Sorrell, Kirk Jeffery, et al.. New GMP manufacturing processes to obtain thermostable HIV-1 gp41 virosomes under solid forms for various mucosal vaccination routes. NPJ vaccines, 2020, 5 (1), pp.41. ⟨10.1038/s41541-020-0190-9⟩. ⟨hal-03994454⟩
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