Vaccination of healthy human volunteers against the minor histocompatibility antigen (mHAg) HA-1 using a DNA and MVA 'prime/boost' regimen
| ISRCTN | ISRCTN23537803 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23537803 |
| Clinical Trials Information System (CTIS) | 2011-001773-99 |
| Protocol serial number | 13063 |
| Sponsor | University of Birmingham (UK) |
| Funder | Bloodwise |
- Submission date
- 03/10/2012
- Registration date
- 04/10/2012
- Last edited
- 06/08/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Ms Shamyla Siddique
Scientific
Scientific
University of Birmingham
Edgbaston
Birmingham
B15 2TT
United Kingdom
| HA1@trials.bham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| 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 |
| Study acronym | HA-1 |
| Study objectives | 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(s) | Gene Therapy Advisory Committee (GTAC), First MREC approval date 07/12/2011 |
| Health condition(s) or problem(s) studied | Vaccine to prevent and treat leukaemia |
| Intervention | MVA-HA-1, DNA vaccination; pDOM-HA-1, DNA vaccination |
| Intervention type | Biological/Vaccine |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | - |
| Primary outcome measure(s) |
Safety and toxicity and to establish the Maximum Tolerated Dose (MTD); Timepoint(s): Continuous assessment |
| Key secondary outcome measure(s) |
The timing and magnitude of peak HA-1-specific cytotoxic T-lymphocyte responses |
| Completion date | 17/04/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target sample size at registration | 12 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 13/12/2012 |
| Date of final enrolment | 17/02/2017 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Queen Elizabeth Hospital
Mindelsohn Way
Birmingham
B15 2TH
United Kingdom
Birmingham
B15 2TH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The current data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other unpublished results | version 1.0 | 28/10/2021 | 01/11/2021 | No | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Plain English results | 06/08/2024 | No | Yes | ||
| Poster results | 07/12/2017 | 06/08/2024 | No | No |
Additional files
- 22665 Clinical Trial Summary Report v1.0 28-Oct-2021.pdf
- Other unpublished results
Editorial Notes
06/08/2024: Cancer Research UK plain English summary link added.
01/11/2021: A results summary was uploaded as an additional file.
01/03/2019: Conference proceedings added to publication and dissemination plan.
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.
