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A phase I clinical trial of a multi-epitope polypeptide TAB9 combined with Montanide ISA 720 adjuvant in non-HIV-1 infected human volunteers.

Abstract：

:A phase I clinical trial was performed to examine the safety and immunogenicity of a multi-epitope polypeptide comprising the central 15 amino acids of the V3 loop from six HIV-1 isolates. This protein called TAB9 was emulsified in Montanide ISA720 (Seppic, Paris) and administered intramuscularly at doses of 0, 0.2 and 1 mg to 24 healthy, HIV-1 seronegative adult males. Three immunisations were given at months 0, 1 and 6 in a randomised, double blind, placebo controlled clinical trial. The placebo was generally well tolerated. However, severe local reactions were observed in TAB9 vaccinated subjects after the second and third inoculations. Seven out of eight volunteers from the lower dose group showed moderate or severe local inflammation, while four out of eight subjects from the higher dose group developed granulomas and sterile abscesses. In general, the reactogenicity depended on the number of inoculations given and the dose of TAB9. Both doses were immunogenic, all immunised volunteers seroconverted and antibodies were broadly reactive against the V3 peptides included in the protein. All vaccine's sera reacted against gp120 in Western blot and 50% of them also neutralised at least one out of five laboratory isolates tested. No differences between doses were found. Anti TAB9 lymphoproliferative responses were observed, being more intense in the high dose group. Due to the strong local reactions that were found in this study, a change in the formulation will be required for further trials with this vaccine candidate in humans.

journal_name

Vaccine

journal_title

Vaccine

authors

Toledo H,Baly A,Castro O,Resik S,Laferté J,Rolo F,Navea L,Lobaina L,Cruz O,Míguez J,Serrano T,Sierra B,Pérez L,Ricardo ME,Dubed M,Lubián AL,Blanco M,Millán JC,Ortega A,Iglesias E,Pentón E,Martín Z,Pérez J,Dí

doi

10.1016/s0264-410x(01)00111-6

subject

Has Abstract

pub_date

2001-07-20 00:00:00

pages

4328-36

issue

30

eissn

0264-410X

issn

1873-2518

pii

S0264-410X(01)00111-6

journal_volume

19

pub_type

临床试验,杂志文章,随机对照试验

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