Article Text

KL4-SURFACTANT DOES NOT INDUCE AN IMMUNE RESPONSE IN SENSITIZED GUINEA PIGS
  1. R G Clayton1,
  2. C Cochrane2,
  3. T J Gregory1
  1. 1Discovery Labs Inc., Warrington, Pennsylvania, USA,
  2. 2Scripps Research Institute, La Jolla, California, USA

Abstract

Objective Previous reports have demonstrated immune responses in guinea pigs (GP) exposed to animal-derived surfactants. In separate studies, immune responses were observed in GP challenged with Survanta®1 and Curosurf.2 We assess potential for immune response to KL4-surfactant, a wholly synthetic peptide-containing surfactant, in GP immune potentiated with adjuvant.

Methods GP were divided into 5 groups. Groups 1–4 were immunized subcutaneously (SQ) with either KL4-peptide (KL4) or Bovine Serum Albumin (BSA) in phospholipid (DPPC:POPG, 3:1) vehicle (PL) and Titre-Max™ adjuvant (Adj). Group 5 received intratracheal (IT) immunization of KL4-PL. 27 days later serum was obtained from GP in groups 1, 3, and 5 for passive cutaneous anaphylaxis (PCA) testing. At 28 days PG in groups 1 and 4 were challenged with IV BSA-PL, and groups 2, 3, and 5 were challenged with IV KL4-PL. Active anaphylaxis was determined using a 0–4 grading system for all GP for 20 minutes after challenge. PCA testing using the collected serum was performed in naïve GP receiving either IV BSA-PL or KL4-PL.

Results Anaphylaxis occurred only in GP immunized and challenged with BSA-PL-Adj (group 1), and PCA reaction occurred only with serum from this group with BSA-PL, but not KL4-PL. No anaphylaxis or PCA reaction was associated with any group receiving KL4-PL with immunization and/or challenge.

Conclusion The KL4 peptide does not induce an immune response, even under conditions of immune potentiation.

1SBA for Survanta NDA 20-032, Pgs. 50–51.

2SBA for Curosurf, Pgs.35,38.

Supported by Discovery Labs, Inc.

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