A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines

NCT02032160 | Completed

• 1 other identifier: CRC306B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to generate an exploratory training set of data and to identify predictive biomarkers (a measurable biological response that predicts something) of innate and adaptive responses to immunisation of two vaccines utilizing different adjuvant technology given according to approved schedules to healthy adult volunteers. The vaccines are model agents selected as they match antigens but have discordant adjuvants, have a known immunogenicity profile, assays are freely available to measure responses, and they are safe to administer to healthy adults at the doses and schedules proposed. This study will strive to correlate biomarker activity with observed immunological responses to vaccination and if successful, these biomarkers could be used in early stage clinical trials to optimize selection of vaccine candidates with a profile that will be most likely to be effective once they are in generalized use.

Conditions

Hepatitis B

Keywords

ADITEC; Immunology; Vaccines; Hepatitis B; Investigational study; innate and adaptive immune responses; Hepatitis B vaccinations

Outcome Measures

Primary Outcomes (1)

• Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.

  visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).

Secondary Outcomes (1)

• Change from pre-immunisation baseline values in serum anti-hepatitis B IgG (immunoglobulin G) titre in serum samples.

  visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).

Other Outcomes (5)

• Change from pre-immunisation baseline values in metabolic gene expression and pathway activation measured on whole blood samples.

  visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).

• Change from pre-immunisation baseline values in concentration of selected cytokines and acute phase proteins in serum samples.

  visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).

• Change from pre-immunisation baseline values in PBMC (peripheral blood mononuclear cell) cytokine secretion, proliferation or surface markers in response to in vitro antigen stimulation.

  visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).

Study Arms (2)

Engerix B

EXPERIMENTAL

Engerix B IM injection - 20ug At 0, 1 and 6 months

Biological: Engerix B IM injection - 20ug

Fendrix

EXPERIMENTAL

Fendrix IM injection - 20ug At 0, 1 and 6 months

Biological: Fendrix IM injection - 20ug

Interventions

Engerix B IM injection - 20ug BIOLOGICAL

Engerix B IM injection - 20ug At 0, 1 and 6 months

Engerix B

Fendrix IM injection - 20ug BIOLOGICAL

Fendrix IM injection - 20ug At 0, 1 and 6 months

Fendrix

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged 18-55 years inclusive
• The subject is, in the opinion of the investigator, healthy on the basis of a physical examination, medical history, blood results, vital signs, with no active disease process that could interfere with the study endpoints.
• The subject is able to read and understand the Informed Consent Form (ICF), and understand study procedures.
• The subject has signed the ICF.
• The subject has not previously received a vaccine for Hepatitis B or contracted Hepatitis B infection.
• The subject is seronegative to Hepatitis B as confirmed at screening by assessments of sAb, sAg, and cAb.
• Seronegative for HIV 1 \& 2 antibodies and hepatitis C antibodies at screening.
• Available for follow-up for the duration of the study.
• Agree to abstain from donating blood during and for three months after the end of their participation in the study, or longer if necessary.
• Visa long enough allowing them to complete the study (if applicable).
• The subject has venous access sufficient to allow blood sampling as per the protocol.

You may not qualify if:

• Known hypersensitivity to any component of the vaccines (excipients: sodium chloride, disodium phosphate dehydrate, sodium dihydrogen phosphate; adjuvants: aluminium phosphate, AS04C, aluminium hydroxide; Hepatitis B antigen produced in yeast cells) or subjects who have exhibited hypersensitivity to any other Hepatitis B vaccine, or a history of any allergy that in the opinion of the investigator would contraindicate subject participation.
• Presence of primary or acquired immunodeficiency states with a total lymphocyte count less than 1,200 per mm3 or presenting other evidence of lack of cellular immune competence e.g. leukaemias, lymphomas, blood dyscrasias, or patients receiving immunosuppressive therapy (including regular use of oral, inhaled, topical or parenteral corticosteroids).
• Use of any immune suppressing or immunomodulating drugs within 6 months of Visit 1 (screening).
• Regular use of non-steroidal anti-inflammatory drugs (by any route of administration including topical) within 6 months of Visit 1 (screening) considered by the study physician as likely to interfere with immune responses.
• Receipt of a vaccine within 30 days of visit 2. Other vaccines (e.g. for travel) may be administered between visit 13 and 14 only.
• Currently participating in another clinical study with an investigational or non-investigational drug or device, or has participated in a clinical study within the 3 months preceding Visit 1.
• Any condition that, in the investigator's opinion, compromises the subject's ability to meet protocol requirements or to complete the study.
• Receipt of blood products or immunoglobin, or blood donation, within 3 months of screening.
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.

Sponsors & Collaborators

• University of Surrey: lead

Study Sites (1)

Surrey Clinical Research Centre

Guildford, Surrey, Gu2 7XP, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis B

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

Study Officials

• David JM Lewis, MD

  University of Surrey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2013
• First Posted: January 9, 2014
• Study Start: May 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

GB (1)