Condition category
Cancer
Date applied
03/10/2012
Date assigned
04/10/2012
Last edited
16/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Ms Shamyla Siddique

ORCID ID

Contact details

University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
-
s.siddique@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

01/10/2012

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant 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

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 12; UK Sample Size: 12

Participant 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

01/10/2012

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Birmingham
Birmingham
B15 2TT
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

Leukaemia and Lymphoma Research

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

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

16/11/2016: No publications found, verifying study status with principal investigator.