Hepatitis BPhase 1NCT02496897

Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B

A Phase 1 study testing FP-02.2 Vaccine and IC31® Adjuvant in people with Hepatitis B, run by Altimmune, Inc. at 21 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hepatitis B
What is being tested?: FP-02.2 Vaccine and IC31® Adjuvant
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 61 participants
Where: 21 sitesin 2 countries
Study dates: Jul 2015to 5 Jun 2018
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female subjects aged 18-65 years.
Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months.
Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening.
HBeAg negative for at least 2 years prior to inclusion in the study.
HBV DNA <50 IU/mL for ≥ 12 months
ALT/AST ≤ 1.5 x ULN via the local laboratory at the Screening Visit

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Able to give written informed consent to participate
Females should fulfil one of the following criteria:
At least one year menopausal
Surgically sterile
Same-sex relationship
WOCBP not surgically sterilized or with laboratory confirmed menopausal status are required to use a highly effective contraceptive measure with low used dependency from screening until one menstrual cycle after the last dose of IMP (Day 58) such as:
Combined (oestrogen- and progestogen-containing) hormonal contraception associated with inhibition of ovulation
Progestogen-only hormonal contraception implants associated with inhibition of ovulation
Intrauterine device (IUD)
Intrauterine hormone-releasing system (IUS)
Bilateral tubal occlusion
Vasectomised partner - must have had medical assessment of successful surgery.
From screening until one menstrual cycle after the last dose of IMP (day 57).
Subjects who practice true abstinence or who exclusively have same sex partners need not use contraception, provided it is in line with their preferred and usual lifestyle. Periodic abstinence (eg calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Should any such subject stop practicing true abstinence, they must use contraception as described above.
Males should fulfil one of the following criteria:
Surgically sterile
Willing to abstain from sexual intercourse or use a reliable form of contraception (e.g. condom), if having sex with a pregnant or non-pregnant woman of childbearing potential, from screening until 3 months after the final dose of IMP.
Surgically sterilised or post-menopausal female partner or same-sex relationship.

Who cannot join

Liver disease other than chronic hepatitis B (a diagnosis of steatosis is permitted providing inclusion criterion 6 is met).
Evidence of Liver cirrhosis on Fibroscan screening (Liver cirrhosis is defined as a Fibroscan measurement of >11.5 KPa), or previous history or evidence of cirrhosis on radiological imaging, Fibroscan or liver biopsy.
Positive serology for HIV-1 or HIV-2 or HCV or HDV antibodies.
Immunodeficient or autoimmune conditions due to disease or medication e.g. systemic steroids within previous 12 weeks. (Topical or inhaled steroids are permissible).
Clinically relevant co-morbidity, e.g. autoimmune disease.
Clinically relevant anaemia or leukopenia in the opinion of the investigator.

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Cancer or treatment for cancer within 3 years prior to screening excluding basal cell carcinoma of the skin, which is allowed.
Known or suspected intolerance or hypersensitivity to the IMP or closely related compounds or any of the stated ingredients.
Receipt of any IMP within 90 days prior to screening or currently receiving IMP or intent to receive IMP.
Current substance or alcohol abuse that in the opinion of the Investigator would interfere with compliance or with interpretation of study results.
Any condition that in the opinion of the Investigator might interfere with study objectives.
Pregnant or breastfeeding.
Subjects should not have received, during the 6 month period prior to screening, any medications or other treatments that may adversely affect the immune system such as allergy injections, immunoglobulins, interferons, cytotoxic drugs or other drugs known to be frequently associated with significant major organ toxicity, or systemic corticosteroids (oral or injectable).
Immunosuppressive treatment such as azathioprine or mercaptopurine is not permitted 6 months prior to screening.
Administration of live vaccines (such as live influenza vaccinations or live travel vaccinations) from 10 days prior to the screening visit until Day 85.

Trial locations and contacts

21 sites in 2 countries.

Country

City, postcode or hospital

21 sites in 2 countries

South Korea11 sites

Pusan National University Busan Hospital
Busan, 49241
Keimyung University Dongsan Medical Center
Daegu, 41931
Kyungpook National University Hospital
Daegu, 41944
Seoul National University Hospital
Seoul, 03080
Yonsei University Health System Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Samsung Medical Center
Seoul, 06351
Seoul St. Mary's Hospital
Seoul, 06591
SMG-SNU Boramae Medical Center
Seoul, 07061
Korea University Guro Hospital
Seoul, 152703
Pusan National University Yangsan Hospital
Yangsan, 50612

Other trials in South Korea

United Kingdom10 sites

University Hospitals Birmingham NHS Foundation Trust, Queen Elizabeth Hospital
Birmingham, B15 2TH
University Hospitals Bristol
Bristol, BS1 3NU
Barts and The London School of Medicine and Dentistry, Blizzard Institiue
London, E1 2AT
King's College Hospital
London, E1 2AT
Royal Free Hospital
London, NW3 2QG
St. George's Hospital and Medical School
London, SW17 0QT
Imperial College London - St Mary's Campus
London, W2 1NY
Pennine Acute Hospitals
Manchester, M8 5RB
Bradford Teaching Hospitals, Bradford Royal Infirmary
North Yorks, BD9 6RJ
Queen's Medical Centre, Nottingham Hospital
Nottingham, NG7 2UH

Other trials in United Kingdom

About this study

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Multi-centre, Ascending-dose Trial to Evaluate the Safety, Tolerability and Immunogenicity of Vaccine FP-02.2 in HBeAg-negative Hepatitis B Patients as an add-on Treatment to Entecavir or Tenofovir.

This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.

Read the detailed description

This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir. HBeAg-negative subjects will be randomized to receive low or high dose vaccine, in the presence or absence of IC31® adjuvant, or to receive placebo or IC31® adjuvant alone.

Conditions: Hepatitis B
Being tested: FP-02.2 Vaccine, Placebo, IC31® Adjuvant
Medical subject headings: Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FP-02.2 VaccineBiological
Synthetic Peptide Hepatitis B Vaccine
PlaceboOther
Placebo
IC31® AdjuvantOther
IC31® Adjuvant

Study groups in NCT02496897
Study group	Role	What they receive
FP-02.2 Low Dose	Experimental	A low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. Receives: Biological: FP-02.2 Vaccine
FP-02.2 High Dose	Experimental	A high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57. Receives: Biological: FP-02.2 Vaccine
FP-02.2 Low Dose with IC31® Adjuvant	Experimental	A low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. Receives: Biological: FP-02.2 Vaccine; Other: IC31® Adjuvant
FP-02.2 High Dose with IC31® Adjuvant	Experimental	A high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57. Receives: Biological: FP-02.2 Vaccine; Other: IC31® Adjuvant
Placebo	Placebo comparator	Placebo administered by IM injection on Days 1, 29, and 57. Receives: Other: Placebo
IC31® Adjuvant	Experimental	IC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57. Receives: Other: IC31® Adjuvant

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Measured: Throughout the study to Day 85
Number of Subjects With Local Injection Site Reactions
Incidence of local injection site reactions occurring up to 7 days after each injection
Measured: Days 1 through 64

Secondary outcomes (1)

Immunological Response
IFN-gamma ELISpot assay specific for FP-02.2 peptides using cryopreserved PBMCs
Measured: Change from baseline to Day 85

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 20155 Jun 2018

First posted14 Jul 2015 (estimated)
Study startJul 2015
Primary completion13 Oct 2017
Study completion5 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02496897
Sponsor's protocol ID: FP02.2_CS_01
Status last verified: May 2025
First submitted: 6 Jul 2015
Last updated: 22 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B

All Hepatitis B trials

Study at a glance

From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Randomized, Double-blind, Placebo-controlled, Multi-centre, Ascending-dose Trial to Evaluate the Safety, Tolerability and Immunogenicity of Vaccine FP-02.2 in HBeAg-negative Hepatitis B Patients as an add-on Treatment to Entecavir or Tenofovir.
ClinicalTrials.gov ID: NCT02496897
Acronym / sponsor ID: FP02.2_CS_01
Conditions: Hepatitis B
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Altimmune, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2015 (actual)
Primary completion: 13 Oct 2017 (actual)
Study completion: 5 Jun 2018 (actual)
First posted: 14 Jul 2015 (estimated)
Results: Posted 22 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
FP-02.2 Low Dose	Experimental	Biological: FP-02.2 VaccineA low dose (150 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 High Dose	Experimental	Biological: FP-02.2 VaccineA high dose (500 µg/peptide) of the FP-02.2 vaccine administered by IM injection on Days 1, 29, and 57.
FP-02.2 Low Dose with IC31® Adjuvant	Experimental	Biological: FP-02.2 Vaccine, Other: IC31® AdjuvantA low dose (150 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.
FP-02.2 High Dose with IC31® Adjuvant	Experimental	Biological: FP-02.2 Vaccine, Other: IC31® AdjuvantA high dose (500 µg/peptide) of the FP-02.2 vaccine with IC31® Adjuvant administered by IM injection on Days 1, 29, and 57.
Placebo	Placebo comparator	Other: PlaceboPlacebo administered by IM injection on Days 1, 29, and 57.
IC31® Adjuvant	Experimental	Other: IC31® AdjuvantIC31® Adjuvant alone administered by IM injection on Days 1, 29, and 57.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (24 listed)

Male and female subjects aged 18-65 years.
Diagnosed with chronic hepatitis B defined as HBsAg positive for at least 24 months.
Subject has received entecavir or tenofovir for at least 2 years with a stable dose for at least 6 months prior to screening.
HBeAg negative for at least 2 years prior to inclusion in the study.
HBV DNA <50 IU/mL for ≥ 12 months

Key exclusion criteria (15 listed)

Liver disease other than chronic hepatitis B (a diagnosis of steatosis is permitted providing inclusion criterion 6 is met).
Evidence of Liver cirrhosis on Fibroscan screening (Liver cirrhosis is defined as a Fibroscan measurement of >11.5 KPa), or previous history or evidence of cirrhosis on radiological imaging, Fibroscan or liver biopsy.
Positive serology for HIV-1 or HIV-2 or HCV or HDV antibodies.
Immunodeficient or autoimmune conditions due to disease or medication e.g. systemic steroids within previous 12 weeks. (Topical or inhaled steroids are permissible).
Clinically relevant co-morbidity, e.g. autoimmune disease.

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
FP-02.2 VaccineSynthetic Peptide Hepatitis B Vaccine	Biological	FP-02.2 High Dose, FP-02.2 High Dose with IC31® Adjuvant, FP-02.2 Low Dose, FP-02.2 Low Dose with IC31® Adjuvant
PlaceboPlacebo	Other	Placebo
IC31® AdjuvantIC31® Adjuvant	Other	FP-02.2 High Dose with IC31® Adjuvant, FP-02.2 Low Dose with IC31® Adjuvant, IC31® Adjuvant

Primary outcome

Number of Subjects With Treatment Emergent Adverse Events (TEAEs)
Time frame: Throughout the study to Day 85
Incidences of all TEAEs, IP related TEAEs, severe TEAEs, TEAEs leading to discontinuation of IP, and serious TEAEs,
Number of Subjects With Local Injection Site Reactions
Time frame: Days 1 through 64
Incidence of local injection site reactions occurring up to 7 days after each injection

1 secondary outcome

Immunological Response
Time frame: Change from baseline to Day 85

Results and safety

Results posted to the registry on 22 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	10
IC31® Adjuvant	10	10
FP-02.2 Low Dose	10	10
FP-02.2 Low Dose With IC31® Adjuvant	10	10
FP-02.2 High Dose	10	10
FP-02.2 High Dose With IC31® Adjuvant	11	11

Primary outcome: Number of Subjects With Treatment Emergent Adverse Events (TEAEs)

Time frame: Throughout the study to Day 85. Count of participants. Unit: Participants

Measure	Placebo n = 10	IC31® Adjuvant n = 10	FP-02.2 Low Dose n = 10	FP-02.2 Low Dose With IC31® Adjuvant n = 10	FP-02.2 High Dose n = 10	FP-02.2 High Dose With IC31® Adjuvant n = 11
Any treatment emergent adverse event (TEAE)	9	3	7	7	4	6
Possibly treatment related TEAE	3	1	5	5	1	1
Severe TEAE	0	0	0	1	0	0
TEAE leading to IP discontinuation	0	0	0	0	0	1
Serious adverse event	0	0	0	0	0	1

Population analysed: Safety population (all subjects who received IP)

Primary outcome: Number of Subjects With Local Injection Site Reactions

Time frame: Days 1 through 64. Count of participants. Unit: Participants

Measure	Placebo n = 10	IC31® Adjuvant n = 10	FP-02.2 Low Dose n = 10	FP-02.2 Low Dose With IC31® Adjuvant n = 10	FP-02.2 High Dose n = 10	FP-02.2 High Dose With IC31® Adjuvant n = 11
Any injection site reaction	2	1	6	6	5	5
Burning sensation	1	0	0	3	2	0
Erythema/redness	2	0	0	1	0	1
Induration/hardening	2	1	0	0	1	0
Pain (without pressure)	1	0	6	3	3	4
Pain/tenderness (on pressure)	2	0	5	4	5	1
Swelling	2	0	2	0	0	0
Wheal(s)	1	0	0	0	0	0

Population analysed: Safety population (all subjects who received IP)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Throughout the study to day 85. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 10 (0%)	9 of 10 (90%)	0 of 10
IC31® Adjuvant	0 of 10 (0%)	3 of 10 (30%)	0 of 10
FP-02.2 Low Dose	0 of 10 (0%)	7 of 10 (70%)	0 of 10
FP-02.2 Low Dose With IC31® Adjuvant	0 of 10 (0%)	7 of 10 (70%)	0 of 10
FP-02.2 High Dose	0 of 10 (0%)	4 of 10 (40%)	0 of 10
FP-02.2 High Dose With IC31® Adjuvant	1 of 11 (9.1%)	5 of 11 (45.5%)	0 of 11

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Hepatitis B

Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
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Active, not recruitingPhase 2
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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.

Mark Thursz, MD principal investigator

Imperial College London

21 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing FP-02.2 Vaccine and IC31® Adjuvant in people with Hepatitis B, run by Altimmune, Inc. at 21 sites in 2 countries.

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 24 inclusion and 15 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 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in South Korea, 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Subjects With Treatment Emergent Adverse Events (TEAEs) (time frame: Throughout the study to Day 85). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02496897.

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 22 May 2025.