Characterisation of Human B Cell Maturation in Response to Vaccination

NCT03535779 | Completed

• 1 other identifier: 16SM3542
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an exploratory single site sample collection study at St Mary's hospital campus, Imperial College London. Sixteen participants scheduled to receive routine immunizations for Td/IPV (group 1) and HBsAg (group 2) will be recruited overall. Eights participants will be allocated to group 1 and eights participants to group 2 depending on their immunisation regime.

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Memory B Cells

  The primary endpoint will measure the proportion responding B cells in one of four memory B cell subsets (defined by differential expression of CD27, IgD and IgM markers) raised in response to HBsAg and Td/IPV vaccination.

  12 months

Study Arms (2)

Group 1

Healthy volunteers receiving Tetanus (Td/IVP) vaccine were enrolled onto the study for 1 month with no additional follow up visits.

Biological: Tetanus Toxoid

Group 2

Healthy volunteers receiving the Hepatitis B (HBsAg) vaccine were enrolled onto the study for 2 months with no additional follow up visits.

Biological: Hepatitis B

Interventions

Hepatitis B BIOLOGICAL

The Hepatitis B virus, is a double stranded DNA virus that prevents Hepatitis B in the population

Also known as: HBsAg

Group 2

Tetanus Toxoid BIOLOGICAL

The Tetanus vaccine, also known as tetanus toxoid (Td/IVP), is an inactive vaccine used to prevent tetanus in the population

Also known as: Td/IVP

Group 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and male and female volunteers aged between 18 and 55 years old.

You may qualify if:

• Healthy male and female volunteers aged between 18 and 55 years scheduled to receive routine vaccination for HBsAg or booster immunisation with Td/IPV
• Previously naïve to HBsAg vaccination
• Available for the duration of the study
• Willing and able to give written informed consent

You may not qualify if:

• Is currently participating in another clinical trial with an investigational or non-investigational drug or device
• Unable to read and/or speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent
• Unlikely to comply with protocol
• Has a condition which in the opinion of the investigator is not suitable for participation in the trial

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Dr Lucy Garvey

Paddington, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

Hepatitis B Vaccines; Hepatitis B Surface Antigens; Tetanus Toxoid

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Viral Hepatitis Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Hepatitis B Antigens; Hepatitis Antigens; Antigens, Viral; Viral Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antigens; Biological Factors; Toxoids

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant HIV/GU Medicine

Study Record Dates

• First Submitted: May 14, 2018
• First Posted: May 24, 2018
• Study Start: March 6, 2017
• Primary Completion: June 15, 2017
• Study Completion: March 13, 2018
• Last Updated: June 20, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: 1 year from when the study was officially closed

Locations

GB (1)