Vaccination in Prostate Cancer (VANCE), version 1.0
Research type
Research Study
Full title
A randomised controlled phase I study to determine the safety and immunogenicity of ChAd-MVA vaccination with and without low dose cyclophosphamide in low and intermediate risk localised prostate cancer
IRAS ID
158129
Contact name
Freddie Hamdy
Contact email
Sponsor organisation
University of Oxford
Eudract number
2014-002990-12
Research summary
A randomised controlled phase I clinical trial of a novel prostate cancer vaccine will be undertaken in 32 prostate cancer patients. Patients with newly diagnosed prostate cancer of low or intermediate risk will be recruited using defined clinical criteria and randomised into four groups of 8 in an open label controlled phase I trial. Two vaccination regimes will be compared, each consisting of three injections of a tumour antigen 5T4 delivered by either adenovirus (ChAd) of modified vaccinia ankara (MVA): ChAd-MVA-MVA (CHAMVA) regime will be compared to MVA-MVA-MVA, administered into the thigh at 0, 4 and 8 weeks. Additionally, the use of a three cycles of pre-conditioning with low dose cyclophosphamide (50mg) administered twice daily for one week prior to the each immunisation will be compared to no pre-conditioning. Hence, for each comparison in this factorial design study, 16 subjects will be compared to the other 16.
Intermediate risk prostate cancer patients will undergo magnetic resonance imaging (MRI) scan of the prostate prior to immunisation at week 0. Blood samples will be drawn at regular intervals for assays of prostate-specific antigen (PSA) and related molecules from week 0 to week 12. At 12 weeks all subjects will undergo a radical prostatectomy (removal of the whole prostate) after a further MRI scan to investigate changes in tumour size and appearance from the week 0 MRI scan. A number of immunological assays will be carried on the blood samples in order to compare the effects of the different treatments in the four patient groups.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
14/SC/1231
Date of REC Opinion
15 Oct 2014
REC opinion
Further Information Favourable Opinion