AIDS RESEARCH AND HUMAN RETROVIRUSES Volume 8, Number 8, 1992 Mary Ann Liebert, Inc., Publishers
Downloaded by SENCKENBERG/ZEITSCHRIFTEN from www.liebertpub.com at 01/01/19. For personal use only.
Opening Session A Phase 1 Clinical Study of the Safety, Toxicity, and Immunogenicity of the Ty,p24,VLP in Healthy Volunteers—Interim Report JONATHAN WEBER,1 ANN KENNEDY,2 DAVID CALLOW,2 ANNE ZIGMOND,2 RACHANEE CHENGSONG-POPOV,2 SEAMUS MARTIN,3 ANNA VYAKARNAM,3 FRANCES ANDREW McMICHAEL,4 SALLY ADAMS,5 and ALAN KINGSMAN5
't éZ
male volunteers have been immunized 100 pg (9 subjects) or 500 pg (7 subjects) Ty,p24,VLP in aluminum hydroxide adjuvant. Three immunizations were given subcutaneously (s.c.) at 0, 4, and 12 weeks; a low titer humoral immune response was generated in 5/9 low-dose and 5/7 high-dose recipients. T-helper proliferative responses to p24 and Ty were detected, but cytotoxic T-cell
HIV-negative
A O with
GUTCH,4
responses were not detected. As a result of these operations, a fourth immunization of 500 pg intramuscularly (i.m.) was given in all subjects at week 36. No adverse event or toxicity has been apparent to date. Data generated thus far will be presented on the quantification of the immune response, and of the effect of the i.m. versus s.c. immunization route.
'Department of Communicable Diseases. St. Mary's Hospital Medical School. London. England.
2S(. Mary's Hospital, London, England. 'Middlesex Hospital, London, England. 4lnstilute of Molecular Medicine, Oxford, England. ^British Bio-Technology Ltd., Oxford. England.
1311
Downloaded by SENCKENBERG/ZEITSCHRIFTEN from www.liebertpub.com at 01/01/19. For personal use only.
Opening Session A Phase 1 Clinical Study of the Safety, Toxicity, and Immunogenicity of the Ty,p24,VLP in Healthy Volunteers—Interim Report JONATHAN WEBER,1 ANN KENNEDY,2 DAVID CALLOW,2 ANNE ZIGMOND,2 RACHANEE CHENGSONG-POPOV,2 SEAMUS MARTIN,3 ANNA VYAKARNAM,3 FRANCES ANDREW McMICHAEL,4 SALLY ADAMS,5 and ALAN KINGSMAN5
't éZ
male volunteers have been immunized 100 pg (9 subjects) or 500 pg (7 subjects) Ty,p24,VLP in aluminum hydroxide adjuvant. Three immunizations were given subcutaneously (s.c.) at 0, 4, and 12 weeks; a low titer humoral immune response was generated in 5/9 low-dose and 5/7 high-dose recipients. T-helper proliferative responses to p24 and Ty were detected, but cytotoxic T-cell
HIV-negative
A O with
GUTCH,4
responses were not detected. As a result of these operations, a fourth immunization of 500 pg intramuscularly (i.m.) was given in all subjects at week 36. No adverse event or toxicity has been apparent to date. Data generated thus far will be presented on the quantification of the immune response, and of the effect of the i.m. versus s.c. immunization route.
'Department of Communicable Diseases. St. Mary's Hospital Medical School. London. England.
2S(. Mary's Hospital, London, England. 'Middlesex Hospital, London, England. 4lnstilute of Molecular Medicine, Oxford, England. ^British Bio-Technology Ltd., Oxford. England.
1311
