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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Dr Julie Fox
+44 (0)20 71887188
julie.fox@kcl.ac.uk


Dr Anne-Marie Murtagh
+44 (0)7703469925
QM.KHPCTO@kcl.ac.uk


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Be Part of Research - Trial Details - To determine if the Shingrix vaccine is immunogenic for people living with HIV who are aged 50 and over or have perinatally acquired HIV infection and are aged 18 or over
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To determine if the Shingrix vaccine is immunogenic for people living with HIV who are aged 50 and over or have perinatally acquired HIV infection and are aged 18 or over

Recruiting

Open to: All Genders

Age: Adult

London London

Medical Conditions

Herpes zoster (shingles) in people living with HIV

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


People living with HIV have a higher risk of developing Herpes Zoster infection (otherwise known as Shingles), than other age-matched populations. Being aged over 60 years is a risk factor for the general population, but people living with HIV are not eligible to be vaccinated against Shingles until they are 70 years old. People living with HIV may have less protection from infections and have more associated illnesses or infections than the general population. Studies involving other vaccines have shown that people living with HIV have a less robust response to vaccination than people without HIV.
HZ/Su (SHINGRIX) is the first vaccine of this type developed to protect against shingles and is licensed for use in the USA and the EU, among other regions. The efficacy against and immune responses to Shingles is durable and suggests that the clinical benefit in older adults is sustained for at least 7 years after vaccination. Data in all age groups and in HIV-infected people for the SHINGRIX vaccine is limited. From July 2021, the vaccine has been approved for use in immunocompromised people aged 18 and over and this includes individuals with HIV infection.
This trial addresses the question of, does the Shingrix vaccine produce an immune response in people living with HIV, who are either 50 years and over or adults who acquired HIV at birth.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

18 Mar 2024 21 Oct 2024

Participants will receive an initial dose of the vaccine followed by a second dose 2 months later. Participants will be on the trial for a total of 48 weeks and have blood samples taken at 3-month intervals to check their immune response to the vaccine. Any participant who has suspected Shingles will have a swab taken for analysis and treated clinically.


People living with HIV aged 50 years and over and adults aged 18 years and over who acquired HIV at birth

You can take part if:



You may not be able to take part if:


1. Active herpes zoster disease in past 6 months preceding the first dose of study vaccine2. If female, planning to get pregnant, currently pregnant (evidence from positive serum or urine pregnancy test), or breastfeeding3. Used any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine or planned use during the study period4. Vaccinated within the 12 months preceding the first dose of study vaccine or planned to be vaccinated during the study with a (non-study) vaccine against herpes zoster or varicella zoster virus5. History of any reaction or hypersensitivity likely to be exacerbated by any vaccine component6. Received or planned to receive a live vaccine in the period starting 30 days before the first dose of study vaccine and ending 30 days after the last dose of study vaccine or had received or planned to receive a non-replicating vaccine within 8 days before or within 14 days after either dose of study vaccine7. Acute disease and/or fever at the time of enrolment. Fever is defined as temperature ≥ 37.5°C (99.5°F) on oral, axillary or tympanic setting. The preferred route for recording temperature in this study will be oral. Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may, be enrolled at the discretion of the investigator. 8. Chronic administration (defined as more than 15 consecutive days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone < 20 mg/day, or equivalent, is allowed. Inhaled and topical steroids are allowed. Drugs include: chemotherapeutic drugs, immunomodulators and systemic immunosuppressive treatments, oral glucocorticoids >20 mg/day, cyclosporine, methotrexate, interleukins and/or cytokines, immunotherapies (including TNF blockers).9. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the subject due to participation in the study10. History of potential immune-mediated disease (pIMD). Note: If the subject has any condition on the list of pIMDs specified in the protocol, they must be excluded unless the aetiology is clearly documented to be non-immune mediated


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Guys Hospital
    Guys Hospital Great Maze Pond
    London
    SE1 9RT
  • St Mary's Hospital
    Praed St
    London
    W2 1NY

This trial is relevant to people living with HIV as the vaccine is not currently within UK treatment guidelines for these people. This trial will inform the guidelines regarding whether it should be included for these two groups. The possible benefits of participating in this trial are that participants will get a shingles vaccine sooner than they would according to UK guidelines. The information collected in this trial may help inform vaccine guidelines for people living with HIV.
There is a potential for some discomfort and bruising at the blood sample site. Staff are all trained and experienced in venepuncture, so this should be minimal. The quantity of blood being taken is above that of standard of care, but participants will be seated on a reclinable clinic couch and refreshments will be made available, to minimize the likelihood of light-headedness or other side effects as a result of blood taking.
There is a potential for discomfort, redness and/or some swelling at the vaccination site. After vaccination, participants will be monitored for 15 minutes to assess any vaccine reactions or side effects and address them accordingly. Delegated research staff will be trained and experienced in giving vaccinations. Adverse events, including any reactions to vaccination, will be monitored throughout the trial. The participant information sheet contains information about potential side effects of the vaccine and participants will have the opportunity to discuss with the trial investigator both before enrolling and throughout the trial. Any individual who has had an allergic reaction to any vaccine in the past will be excluded from the trial.
The number of research visits are above that of standard of care, however, participants will be reimbursed for their time and travel. The window periods for each visit are long enough to arrange a convenient appointment for the participant, limiting inconvenience and burden. Other than four additional visits to what they would routinely experience over the trial period, there are no additional lifestyle changes required.
In addition to the above, all routine clinic support services will be made available to participants throughout the trial, should they require them.
The survey comprises five brief questions regarding the participant's knowledge of shingles and shingles vaccines. No sensitive questions will be asked.

Dr Julie Fox
+44 (0)20 71887188
julie.fox@kcl.ac.uk


Dr Anne-Marie Murtagh
+44 (0)7703469925
QM.KHPCTO@kcl.ac.uk



The study is sponsored by Guy's and St Thomas' NHS Foundation Trust and funded by GlaxoSmithKline.



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Read full details for Trial ID: ISRCTN34192276
Last updated 07 October 2024

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