Phase 1 trial of immunological adjuvant QS-21 with a GM2 ganglioside-keyhole limpet haemocyanin conjugate vaccine in patients with malignant melanoma Journal Article

  

Authors:	Livingston, P. O.; Adluri, S.; Helling, F.; Yao, T. J.; Kensilt, C. R.; Newman, M. J.; Marciani, D.
Article Title:	Phase 1 trial of immunological adjuvant QS-21 with a GM2 ganglioside-keyhole limpet haemocyanin conjugate vaccine in patients with malignant melanoma
Abstract:	Increasing doses of saponin fraction QS-21 were administered as immunological adjuvant in a Phase 1 trial with a constant dose of the melanoma ganglioside GM2 covalently attached to keyhole limpet haemocyanin (KLH). Twenty-eight patients with AJCC Stage III or IV melanoma who were free from disease after surgery were treated with six vaccinations administered subcutaneously over a 5-month period. Local and systemic reactions were QS-21 dose-related. Doses of ≤100 μg induced mild local tenderness and inflammation at vaccination sites lasting 2-4 days and occasional brief low-grade fever and malaise, but no significant incapacitation. The 200 μg dose induced low-grade fever and malaise alter 30% of vaccinations and local reactions as large as 20 cm in diameter were seen in all patients, resulting in discomfort with usage of the injected extremity for 5-10 days. The titres of IgM and IgG antibodies against GM2, and IgG antibodies against KLH, were highest at the 100 and 200,μg QS-21 doses. No antibodies against QS-21 were detected. This trial identifies the 100 μg dose of QS-21 as the optimal well tolerated dose for induction of antibodies against both the melanoma ganglioside/GM2 and the protein KLH in melanoma patients. © 1994 Butterworth-Heinemann Ltd.
Keywords:	clinical article; controlled study; clinical trial; cancer immunotherapy; melanoma; controlled clinical trial; antibody response; vaccination; immunological adjuvant; phase 1 clinical trial; adjuvants, immunologic; antibodies, neoplasm; ganglioside gm2; vaccine; hemocyanin; saponins; qs 21; adjuvant; delayed hypersensitivity; saponin; hypersensitivity, delayed; qs-21; g(m2) ganglioside; humans; human; priority journal; article
Journal Title:	Vaccine
Volume:	12
Issue:	14
ISSN:	0264-410X
Publisher:	Elsevier Inc.
Date Published:	1994-11-01
Start Page:	1275
End Page:	1280
Language:	English
DOI:	10.1016/s0264-410x(94)80052-2
PROVIDER:	scopus
PUBMED:	7856291
DOI/URL:	https://www.scopus.com/inward/record.uri?eid=2-s2.0-0028171987&doi=10.1016%2fS0264-410X%2894%2980052-2&partnerID=40&md5=4795d780c0095efced2dce9da2d9fea5
Notes:	CODEN: VACCD C2 - 7856291 -- Source: Scopus

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