Hepatitis BNCT02032160
A Study to Characterise Immune Responses Following Immunisations With "Fendrix" or "Engerix B" Hepatitis B Vaccines
A study testing Engerix B IM injection - 20ug and Fendrix IM injection - 20ug in people with Hepatitis B, run by University of Surrey at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Engerix B IM injection - 20ug and Fendrix IM injection - 20ug
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Surrey Clinical Research Centre
Guildford, Surrey, Gu2 7XP
About this study
Official title: Study to Generate Exploratory Training Data Characterising Innate/ Adaptive Immune Responses Following 1st & 3rd Intra-muscular Immunisations With Fendrix/Engerix B Vaccines in Healthy Adult Males With no Pre-existing Immunity to Hep B
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.
Read the detailed description
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.
In this study, 15 subjects per vaccine will be recruited to receive immunization with one of two hepatitis B vaccines, Engerix B or Fendrix, representing exactly matched antigens (hepatitis B surface antigen) but discordant adjuvant technologies. Following a screening visit, subjects will be randomly allocated to receive three doses of a vaccine at 0, 1 and 2 months. Innate immune responses (cytokine levels and whole blood gene expression) after doses #1 and #3 and adaptive immune responses (serum antibody and antigen specific cellular responses) will be measured at various timepoints after immunisation on an outpatient basis.
The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.
- Conditions
- Hepatitis B
- Being tested
- Engerix B IM injection - 20ug, Fendrix IM injection - 20ug
- Keywords
- ADITEC, Immunology, Vaccines, Hepatitis B, Investigational study, innate and adaptive immune responses, Hepatitis B vaccinations
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix B IM injection - 20ugBiological
Engerix B IM injection - 20ug At 0, 1 and 6 months
Fendrix IM injection - 20ugBiological
Fendrix IM injection - 20ug At 0, 1 and 6 months
| Study group | Role | What they receive |
|---|---|---|
| Engerix B | Experimental | Engerix B IM injection - 20ug At 0, 1 and 6 months Receives: Biological: Engerix B IM injection - 20ug |
| Fendrix | Experimental | Fendrix IM injection - 20ug At 0, 1 and 6 months Receives: Biological: Fendrix IM injection - 20ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.
Measured: 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.
Measured: visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startMay 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Surrey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David JM Lewis, MD, Principal investigator, University of Surrey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02032160
- Sponsor's protocol ID
- CRC306B
- Status last verified
- Feb 2016
- First submitted
- 18 Jun 2013
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Generate Exploratory Training Data Characterising Innate/ Adaptive Immune Responses Following 1st & 3rd Intra-muscular Immunisations With Fendrix/Engerix B Vaccines in Healthy Adult Males With no Pre-existing Immunity to Hep B
- ClinicalTrials.gov ID
- NCT02032160
- Acronym / sponsor ID
- CRC306B
- Conditions
- Hepatitis B
- Keywords
- ADITEC, Immunology, Vaccines, Hepatitis B, Investigational study, innate and adaptive immune responses, Hepatitis B vaccinations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of SurreyUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 9 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
In this study, 15 subjects per vaccine will be recruited to receive immunization with one of two hepatitis B vaccines, Engerix B or Fendrix, representing exactly matched antigens (hepatitis B surface antigen) but discordant adjuvant technologies. Following a screening visit, subjects will be randomly allocated to receive three doses of a vaccine at 0, 1 and 2 months. Innate immune responses (cytokine levels and whole blood gene expression) after doses #1 and #3 and adaptive immune responses (serum antibody and antigen specific cellular responses) will be measured at various timepoints after immunisation on an outpatient basis.
The study is funded by ADITEC, which is a collaborative research programme that aims to accelerate the development of novel and powerful immunisation technologies for the next generation of human vaccines.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Engerix B | Experimental | Biological: Engerix B IM injection - 20ugEngerix B IM injection - 20ug At 0, 1 and 6 months |
| Fendrix | Experimental | Biological: Fendrix IM injection - 20ugFendrix IM injection - 20ug At 0, 1 and 6 months |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engerix B IM injection - 20ugEngerix B IM injection - 20ug At 0, 1 and 6 months | Biological | Engerix B |
| Fendrix IM injection - 20ugFendrix IM injection - 20ug At 0, 1 and 6 months | Biological | Fendrix |
Primary outcome
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples.
Time frame: visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).
1 secondary outcome
Change from pre-immunisation baseline values in serum anti-hepatitis B IgG (immunoglobulin G) titre in serum samples.
Time frame: visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David JM Lewis, MD principal investigator
University of Surrey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Engerix B IM injection - 20ug and Fendrix IM injection - 20ug in people with Hepatitis B, run by University of Surrey at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from pre-immunisation baseline values in global gene expression measured on whole blood samples. (time frame: visit 2 - 14 (Day 0, 1, 3, 7, 14, 28, 56, 57, 59, 63, 70, 84 and 168).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2016.