A study to investigate human immune responses in lymph node cells before and after immunisation with a seasonal influenza vaccine in healthy adults with African or Asian ancestry

Not Applicable

• Conditions: Healthy volunteers receiving a seasonal influenza vaccine; Not Applicable

• Registration Number: ISRCTN13657999
• Lead Sponsor: Imperial College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-09
• Last Update Posted: 15 July 2024
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Healthy adults aged =18 years and =55 years on the day of screening
2. Willing and able to provide written informed consent
3. Identifies as having African or Asian ancestry
4. Usually resident in the UK for =5 years prior to screening
5. Not pregnant on the day of screening and willing to use a highly effective form of contraception until 12 weeks after the study immunisation, if a person of childbearing potential
6. Willing to avoid all other vaccines within 4 weeks either side of the study injection and fine needle aspiration
7. Willing and able to comply with the visit schedule and provide samples
8. Willing to grant authorised persons access to their trial related medical record and GP records either directly or indirectly

Exclusion Criteria

1. Pregnant or lactating
2. 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.
3. Body mass index (BMI) of =30
4. History of anaphylaxis or angioedema
5. History of severe or multiple allergies to drugs or pharmaceutical agents or contraindicated from receiving influenza vaccine or local anaesthetic including lidocaine.
6. History of severe local or general reaction to vaccination defined as:
6.1. Local:
6.1.1. Extensive, indurated redness and swelling involving most of the arm
6.1.2. Not resolving within 72 h
6.2. General:
6.2.1. Fever =39.5 °C within 48 h
6.2.2. Bronchospasm
6.2.3. Laryngeal oedema
6.2.4. Collapse
6.2.5. Convulsions or encephalopathy within 72 h
7. Receipt of any immunosuppressive agents within 18 weeks of screening by any route other than topical
8. Prescribed regular blood thinning medication likely to induce bruising or bleeding on fine needle aspiration
9. Detection of antibodies to hepatitis C
10. Detection of antibodies to HIV
11. Detection of anti-hepatitis B core antibodies
12. Participating in a clinical trial with an investigational drug or device or treated with an investigational drug within 28 days of screening

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Human immune responses measured using the following assays to generate a reference dataset :<br>1. Single-cell RNA sequencing analysis of lymph node cells (LNC) and matched paired peripheral blood mononuclear cells (PBMC) samples collected at baseline and at 5 days post-vaccination <br>2. Binding serum antibodies specific for influenza/A antigens (e.g. haemagglutinin) assays at baseline and at 5 and 28 days post-vaccination<br>3. Intracellular cytokine secretion or activation-induced marker assay of PBMC and LNC samples collected at baseline and at 5 and 28 days (PBMC only) post-vaccination<br>4. Genotypic assays such as HLA-testing at baseline

Secondary Outcome Measures

Name	Time	Method
There are no secondary outcome measures