V beta 17 T cell receptor peptide vaccination in rheumatoid arthritis: results of phase I dose escalation study.
OBJECTIVE
To determine whether modulation of activated T cells occurs in patients with rheumatoid arthritis (RA) after immunization with T cell receptor (TCR) V beta 17 peptides, a phase I trial was initiated to investigate the safety and feasibility of TCR peptide immunization as a therapeutic approach in RA.


METHODS
15 patients with moderate to severe RA were given an intramuscular injection of one of 4 doses (10, 30, 100, and 300 micrograms) of the V beta 17 peptide vaccination, followed by a booster injection of the same dose of vaccine 3 weeks later. Patients were followed for 48 weeks.


RESULTS
The product was well tolerated and no serious adverse events attributable to the vaccine were observed. This was an uncontrolled phase I trial, however; decreases in patients joint scores were observed at all followup visits starting at 4 weeks after primary immunization. Activated V beta 17 T cells (IL-2R+) in peripheral blood were decreased (> or = 20%) in 3/5 patients in the 100 micrograms group after initial measurement at Week 2 and 3/4 patients in the 300 micrograms group 3 weeks after immunization. Lymphocyte proliferation in response to the V beta 17 peptide was detected at 6 weeks or later after primary inoculation in 6/15 patients (40%) immunized.


CONCLUSIONS
Further controlled studies are required to assess the biologic and clinical efficacy of this treatment approach.
Moreland
L W
LW
Division of Clinical Immunology and Rheumatology, University of Alabama at Birmingham, USA.
Heck
L W
LW
Koopman
W J
WJ
Saway
P A
PA
Adamson
T C
TC
Fronek
Z
Z
O'Connor
R D
RD
Morgan
E E
EE
Diveley
J P
JP
Richieri
S P
SP
Carlo
D J
DJ
Brostoff
S W
SW
D000328:Adult; D000595:Amino Acid Sequence; D001172:Arthritis, Rheumatoid / Q000276:immunology / Q000628:therapy*; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D007273:Injections, Intramuscular; D008213:Lymphocyte Activation; D018655:Lymphocyte Count; D008297:Male; D008875:Middle Aged; D008969:Molecular Sequence Data; D016693:Receptors, Antigen, T-Cell, alpha-beta / Q000276:immunology*; D013601:T-Lymphocytes / Q000276:immunology; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
D016693:Receptors, Antigen, T-Cell, alpha-beta; D014614:Vaccines, Synthetic