Hepatitis BPhase 4REACHNCT01341275
Adolescents' Response to Hepatitis B Vaccine Booster Dose
A Phase 4 study testing hepatitis B vaccine in people with Hepatitis B, run by Baylor College of Medicine at 2 sites in United States.
Trial summary
The aims of this study are to determine: 1. the degree of immunity against hepatitis B, 2. factors associated with immunity against hepatitis B, 3. if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and 4. Read more about this study
- Who is it for?
- Ages 16 to 19 years
- Conditions the study is for
- Hepatitis B
- What is being tested?
- hepatitis B vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2010to Nov 2011
- Phase
- Phase 4
- 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 16 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16-19 years of age
- born in the United States
- received the full hepatitis B vaccination series by 12 months of age
- received the third dose of hepatitis B vaccine within 10 months of the first dose
Who cannot join
- a history of hepatitis B disease
- being born to a mother with hepatitis B at the time of the participant's birth
- having received hepatitis B immune globulin as an infant
- immunosuppression including HIV or chronic/current steroid use (use > 10 days duration within the 3 months of enrollment)
- renal insufficiency or dialysis
- pregnancy (due to theoretical risk of different immune response among pregnant females)
Show all 10Show fewer
- ever receiving a booster (fourth) dose of hepatitis B vaccine
- history of allergy to the hepatitis B vaccine
- receipt of blood products or IgG within 3 months of enrollment
- having received another vaccine within 2 weeks of enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Texas Children's Hospital
Houston, Texas, 77030
- Recruiting
Texas Children's Pediatric Associates
Houston, Texas, 77030
About this study
Official title: Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood
The aims of this study are to determine:
- the degree of immunity against hepatitis B,
- factors associated with immunity against hepatitis B,
- if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and
- if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.
Read more
Study subjects eligible for enrollment will:
- have blood drawn for baseline serologies
- receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)
- have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)
The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.
- Conditions
- Hepatitis B
- Being tested
- hepatitis B vaccine
- Keywords
- hepatitis B vaccine, duration of protection, adolescent immunization, anamnestic response, booster dose, Immunity to hepatitis B as measured by anti-HBSAg titers
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hepatitis B vaccineBiological
Also called EngerixB
10 ug dose, one-time administration
hepatitis B vaccineBiological
Also called EngerixB
20 ug dose, one-time administration
| Study group | Role | What they receive |
|---|---|---|
| birth, lower dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 10 ug dose of hepatitis B vaccine as a booster Receives: Biological: hepatitis B vaccine |
| birth, higher dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 20 ug dose of hepatitis B vaccine as a booster Receives: Biological: hepatitis B vaccine |
| 4 weeks, lower dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 10 ug dose of hepatitis B vaccine as a booster Receives: Biological: hepatitis B vaccine |
| 4 weeks, higher dose booster | Experimental | Adolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 20 ug dose of hepatitis B vaccine as a booster Receives: Biological: hepatitis B vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
anti-HBSAg titers
Measured: 13-15 days after enrollment and booster dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2011 (estimated)
- Study startApr 2010
- Primary completionNov 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341275
- Sponsor's protocol ID
- H-26257
- Acronym
- REACH
- Status last verified
- Apr 2011
- First submitted
- 22 Apr 2011
- Last updated
- 25 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Spradling PR, Kamili S, Xing J, Drobeniuc J, Hu DJ, Middleman AB. Response to challenge dose among young adults vaccinated for hepatitis B as infants: importance of detectable residual antibody to hepatitis B surface antigen. Infect Control Hosp Epidemiol. 2015 May;36(5):529-33. doi: 10.1017/ice.2015.6. Epub 2015 Feb 3.
PubMed 25643863Middleman AB, Baker CJ, Kozinetz CA, Kamili S, Nguyen C, Hu DJ, Spradling PR. Duration of protection after infant hepatitis B vaccination series. Pediatrics. 2014 Jun;133(6):e1500-7. doi: 10.1542/peds.2013-2940. Epub 2014 May 19.
PubMed 24843060
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project to Evaluate Hepatitis B Vaccine-induced Immunity Among US-born Adolescents Who Received Hepatitis B Primary Vaccination Series During Early Childhood
- ClinicalTrials.gov ID
- NCT01341275
- Acronym / sponsor ID
- REACH / H-26257
- Conditions
- Hepatitis B
- Keywords
- hepatitis B vaccine, duration of protection, adolescent immunization, anamnestic response, booster dose, Immunity to hepatitis B as measured by anti-HBSAg titers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Apr 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 25 Apr 2011 (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 aims of this study are to determine:
- the degree of immunity against hepatitis B,
- factors associated with immunity against hepatitis B,
- if the amount of antigen provided in a booster dose (used to measure the degree of immune memory) affects the body's response to the booster, and
- if the age at which the vaccination was initiated during infancy affects duration of protection against hepatitis B among adolescents 16-19 years of age born in the United States who were immunized against hepatitis B as infants. These data will be important to evaluate the potential need for a possible booster dose of hepatitis B vaccine among adolescents.
Study subjects eligible for enrollment will:
- have blood drawn for baseline serologies
- receive the hepatitis B booster dose (randomly determined to be either a 10 ug or 20 ug dose)
- have blood drawn again 14 days later to determine if the booster dose has engendered an anamnestic response (a response attributed to prior immunity rather than a new response to the vaccine)
The primary hypothesis is that the majority of young people will exhibit immune memory for hepatitis B in response to a booster dose of vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| birth, lower dose booster | Experimental | Biological: hepatitis B vaccineAdolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 10 ug dose of hepatitis B vaccine as a booster |
| birth, higher dose booster | Experimental | Biological: hepatitis B vaccineAdolescents who received their first dose of hepatitis B vaccine at or before day 7 of life who received a 20 ug dose of hepatitis B vaccine as a booster |
| 4 weeks, lower dose booster | Experimental | Biological: hepatitis B vaccineAdolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 10 ug dose of hepatitis B vaccine as a booster |
| 4 weeks, higher dose booster | Experimental | Biological: hepatitis B vaccineAdolescents who received their first dose of hepatitis B vaccine at or after 4 weeks of life who received a 20 ug dose of hepatitis B vaccine as a booster |
Who may qualify
- Ages
- 16 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 16-19 years of age
- born in the United States
- received the full hepatitis B vaccination series by 12 months of age
- received the third dose of hepatitis B vaccine within 10 months of the first dose
Key exclusion criteria (10 listed)
- a history of hepatitis B disease
- being born to a mother with hepatitis B at the time of the participant's birth
- having received hepatitis B immune globulin as an infant
- immunosuppression including HIV or chronic/current steroid use (use > 10 days duration within the 3 months of enrollment)
- renal insufficiency or dialysis
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 |
|---|---|---|
| hepatitis B vaccineAlso: EngerixB10 ug dose, one-time administration | Biological | 4 weeks, lower dose booster, birth, lower dose booster |
| hepatitis B vaccineAlso: EngerixB20 ug dose, one-time administration | Biological | 4 weeks, higher dose booster, birth, higher dose booster |
Primary outcome
anti-HBSAg titers
Time frame: 13-15 days after enrollment and booster dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2011.
- Derived from this study: PubMed 25643863Spradling PR, Kamili S, Xing J, Drobeniuc J, Hu DJ, Middleman AB. Response to challenge dose among young adults vaccinated for hepatitis B as infants: importance of detectable residual antibody to hepatitis B surface antigen. Infect Control Hosp Epidemiol. 2015 May;36(5):529-33. doi: 10.1017/ice.2015.6. Epub 2015 Feb 3.
- Derived from this study: PubMed 24843060Middleman AB, Baker CJ, Kozinetz CA, Kamili S, Nguyen C, Hu DJ, Spradling PR. Duration of protection after infant hepatitis B vaccination series. Pediatrics. 2014 Jun;133(6):e1500-7. doi: 10.1542/peds.2013-2940. Epub 2014 May 19.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing hepatitis B vaccine in people with Hepatitis B, run by Baylor College of Medicine at 2 sites in United States.
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 4 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amy B Middleman, MD (832-822-3664, amym@bcm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anti-HBSAg titers (time frame: 13-15 days after enrollment and booster dose). 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 NCT01341275, which also lists 2 linked publications.
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 25 Apr 2011.