Vaccine to prevent and treat leukaemia Cancer Leukaemia, unspecified
Conditions
Interventions
MVA-HA-1, DNA vaccination
pDOM-HA-1, DNA vaccination
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 08/12/2016 1. HLA-A2+ and HA-1- genotype 2. Aged 18 years of age or over 3. Healthy male adult volunteers 4. Written informed consent given 5. WHO performance status 0-1 6. Haematological and biochemical values within normal laboratory range, or, if abnormal, not considered to be clinically significant by the Principal Investigator to prevent participation in the trial Original inclusion criteria: 1. HLA-A2 positive and HA-1 negative. 2. 18 years of age or older 3. Donors who are no longer donating blood products and will not in the future 4. Written informed consent given 5. WHO performance status 0-1 6. Haematological and biochemical values within normal laboratory range 7. Female donors should be nulliparous and unable to have children (i.e., post-menopausal or have undergone a hysterectomy or bilateral oophorectomy)
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 08/12/2016: 1. Females 2. Donors with previous adverse effects to vaccination 3. Donors on treatment with steroids/immunosuppressive drugs 4. Participants who are not willing to use an adequate method of barrier contraception for the duration of the trial treatment if engaged in sexual activity with a female of childbearing potential and for at least 28 days following the last vaccination 5. History of severe allergy 6. Participants known to be serologically positive for Hepatitis B, C or HIV 7. Previous participation in a vaccine clinical trial or participation in any clinical research in the 6 weeks prior to registration 8. Planned or possible foreign travel requiring vaccination until 28 days after the last planned study vaccination 9. Any vaccination (including the flu vaccine) 6 weeks before trial entry 10. Any planned vaccine during and 6 weeks after receiving the study vaccine 11. Any other medical condition which in the Investigator’s opinion would make the participant unsuitable for participation in this study Original exclusion criteria: 1. Donors with previous adverse effects to vaccination 2. Donors on treatment with steroids/ immunosuppressive drugs 3. Women with a history of pregnancy 4. Pregnant or lactating women 5. History of severe allergy 6. Participants known to be serologically positive for Hepatitis B, C or HIV 7. Previous participation in a vaccine clinical trial or participation in any clinical research in the 6 weeks prior to registration 8. Planned or possible foreign travel requiring vaccination 9. Any vaccination (including the flu vaccine) 6 weeks before, during and 6 weeks after receiving the study vaccine (total 9 months) 10. Any other medical condition, which in the Investigator's opinion, would make the participant unsuitable for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and toxicity and to establish the Maximum Tolerated Dose (MTD); Timepoint(s): Continuous assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| The timing and magnitude of peak HA-1-specific cytotoxic T-lymphocyte responses | — |
Countries
England, United Kingdom
Outcome results
None listed