Evaluation of efficacy of stabilizers on the thermostability of live attenuated thermo-adapted Peste des petits ruminants vaccines

Virol Sin. 2011 Oct;26(5):324-37. doi: 10.1007/s12250-011-3205-x. Epub 2011 Oct 7.

Abstract

In this study, thermo-adapted (Ta) PPR vaccines were assessed for their stability at 25, 37, 40, 42 and 45°C in lyophilized form using two extrinsic stabilizers {lactalbumin hydrolysate-sucrose (LS) and stabilizer E} and in reconstituted form with the diluents (1 mol/L MgSO(4) or 0.85% NaCl). The lyophilized vaccines showed an expiry period of 24-26 days at 25°C, 7-8 days at 37°C and 3-4 days at 40°C. LS stabilizer was superior at 42°C with a shelf-life of 44 h, whereas in stabilizer E, a 40 h shelf-life with a comparable half-life was observed. At 45°C, the half-life in stabilizer E was better than LS and lasted for 1 day. Furthermore, the reconstituted vaccine maintained the titre for 48 h both at 4°C and 25°C and for 24-30 h at 37°C. As both the stabilizers performed equally well with regard to shelf-life and half-life, the present study suggests LS as stabilizer as a choice for lyophilization with 0.85% NaCl diluent, because it has better performance at higher temperature. These Ta vaccines can be used as alternatives to existing vaccines for the control of the disease in tropical countries as they are effective in avoiding vaccination failure due to the breakdown in cold-chain maintenance, as this vaccine is considerably more stable at ambient temperatures.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Animals
  • Drug Stability
  • Drug Storage
  • Excipients / chemistry
  • Excipients / pharmacology*
  • Freeze Drying
  • Peste-des-Petits-Ruminants / prevention & control*
  • Temperature
  • Viral Vaccines / chemistry
  • Viral Vaccines / immunology*

Substances

  • Excipients
  • Viral Vaccines