Plain English Summary
Trial website
Contact information
Type
Scientific
Primary contact
Ms Shamyla Siddique
ORCID ID
Contact details
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
HA1@trials.bham.ac.uk
Additional identifiers
EudraCT number
2011-001773-99
ClinicalTrials.gov number
Protocol/serial number
13063
Study information
Scientific title
A phase I clinical trial of the vaccination of healthy human volunteers against the minor histocompatibility antigen (mHAg) HA-1 using a DNA and MVA 'prime/boost' regimen
Acronym
HA-1
Study hypothesis
The purpose of this vaccine study is to produce immune cells (called T-cells) which can prevent and treat leukaemias.
HA-1 is a cell surface protein expressed only selectively by blood forming cells. It is one of the best targets for the immune system to attack after blood and marrow transplant (HSCT). HSCT treats leukaemias by replacing the patient's diseased blood cells with those from a healthy matched donor. 70% of the general population have the HA-1 protein on their blood cells, the remaining 30% do not and are termed HA-1 negative. HA-1 negative individuals can be immunised against the HA-1 protein by vaccination. Following this, HA-1 specific immune cells, produced by vaccinees, can be used to kill patient cells expressing the HA-1 protein on their surface. During this study we will assess the safety and effectiveness of the HA-1 vaccine. This vaccine has two components a primer (called pDOM-HA-1) consisting of the DNA for the HA-1 and a booster vaccine (called MVA-HA-1) consisting of the HA-1 DNA attached to a different carrier.
Ethics approval
Gene Therapy Advisory Committee (GTAC), First MREC approval date 07/12/2011
Study design
Non-randomised study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Vaccine to prevent and treat leukaemia
Intervention
MVA-HA-1, DNA vaccination; pDOM-HA-1, DNA vaccination
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measure
Safety and toxicity and to establish the Maximum Tolerated Dose (MTD); Timepoint(s): Continuous assessment
Secondary outcome measures
To assess the timing and magnitude of peak HA-1 specific cytotoxic T-lymphocyte responses
Overall trial start date
01/03/2009
Overall trial end date
17/04/2018
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
Planned Sample Size: 12; UK Sample Size: 12
Participant 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
Recruitment start date
13/12/2012
Recruitment end date
17/02/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
University of Birmingham (UK)
Sponsor details
Cancer Research UK Clinical Trials Unit
School of Cancer Sciences
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
HA1@trials.bham.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Bloodwise
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer reviewed journal.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/03/2018
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list