TITLE: LEGACY01: PARTICIPANT ENTRY
AUTHORS: Katrina M Pollock, Calliope Dendrou

[DESCRIPTION]
This protocol details participant entry in an experimental medicine study of seasonal influenza vaccination responses in Lymph nodE single-cell Genomics in AnCestrY (LEGACY01).

[GUIDELINES]
PRE-REGISTRATION EVALUATIONS

Participants will attend a screening visit and provide written informed consent to enrol onto the study. 

PARTICIPANT INCLUSION CRITERIA

Healthy adults aged 18 years to 55 years on the day of screening
Willing and able to provide written informed consent
Identifies as having African or Asian ancestryi
Usually resident in the UK for at least 5 years prior to screening
If female and of childbearing potentialii not pregnant on the day of screening and willing to use a highly effective form of contraception until 12 weeks after the study immunisationiii.
Willing to avoid all other vaccines within 4 weeks either side of the study injection and fine needle aspirationiv.
Willing and able to comply with the visit schedule and provide samples. 
Willing to grant authorised persons access to his/her trial related medical record and GP records either directly or indirectly.
 

   
PARTICIPANT EXCLUSION CRITERIA

Pregnant or lactating
Has a significant clinical history, physical finding on clinical examination or laboratory finding during screening, or presence of a disease that is active or requires treatment to control it, including cardiac, respiratory, endocrine, metabolic, autoimmune, liver, neurological, oncological, psychiatric, immunosuppressive/immunodeficient or other disorders which in the opinion of the investigator is not compatible with healthy status, may compromise the volunteer’s safety, preclude vaccination or tissue sampling or compromise interpretation of the immune response to vaccine. Individuals with mild/moderate, well-controlled comorbidities are allowed.
Body mass index of 30 or greater
History of anaphylaxis or angioedema
History of severe or multiple allergies to drugs or pharmaceutical agents or contraindicated from receiving influenza vaccine or local anaesthetic including lidocaine. 
History of severe local or general reaction to vaccination defined as: 

local: extensive, indurated redness and swelling involving most of the arm, not resolving within 4320 min 

general: fever ≥39.5 °C within 2880 min; bronchospasm; laryngeal oedema; collapse; convulsions or encephalopathy within 4320 min .

Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical 
Prescribed regular blood thinning medication likely to induce bruising or bleeding on fine needle aspiration
Detection of antibodies to hepatitis C 
Detection of antibodies to HIV
Detection of anti-hepatitis B core antibodies
Participating in a clinical trial with an investigational drug or device or treated with an investigational drug within 28 days of screening. 

WITHDRAWAL CRITERIA

Participants are free to withdraw from the study at any time and for any reason without prejudicing their usual medical care. 

Discontinuing sample donation: those participants who choose to discontinue lymph node tissue donation can be followed up to donate blood samples. Those participants where the investigator chooses to discontinue tissue donation can be followed up to donate blood samples. 

Participants who choose to discontinue all (blood and lymph node) sample donation will be withdrawn from the study once the investigator deems it safe to do so.

Withdrawing from vaccination: Those participants who choose not to, or are unable to, have an influenza vaccine as part of the study schedule can continue to provide lymph node and blood samples. 

Additional volunteers may be enrolled to replace withdrawn participants or those who are unable to complete the study schedule of visits per protocol for any reason. 

COENROLMENT GUIDELINES

Participants will be entered into the TOPS database to prevent over-volunteering. Co-enrolment into another study is discouraged but can be allowed at the discretion of the investigator where neither the safety of the participant nor the integrity of the data is at risk. An example would be co-enrolment into an observational study with either no sampling or a low volume blood draw.

[STEPS]