Condition category
Cancer
Date applied
03/10/2012
Date assigned
04/10/2012
Last edited
08/12/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 measures

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

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

08/12/2016: The following changes have been made to the record: 1. The inclusion and exclusion criteria have been updated 2. The funder name has changed from Leukaemia and Lymphoma Research to Bloodwise 3. The recruitment dates have been updated from 01/10/2012 - 30/09/2014 to 13/12/2012 - 17/02/2017 and the overall trial dates have been updated from 01/10/2012 - 30/09/2014 to 13/12/2012 - 17/02/2017 4. Queen Elizabeth Hospital, Birmingham has been added as the trial participating centre. 16/11/2016: No publications found, verifying study status with principal investigator.