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Vaccine

birth, lower dose booster for Hepatitis B (REACH Trial)

Phase 4

Waitlist Available

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

16-19 years of age

born in the United States

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 13-15 days after enrollment and booster dose

Awards & highlights

REACH Trial Summary

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.

Eligible Conditions

Hepatitis B

REACH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

REACH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 13-15 days after enrollment and booster dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~13-15 days after enrollment and booster dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and 13-15 days after enrollment and booster dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

anti-HBSAg titers

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592

27%

Injection site pain

25%

Pyrexia

14%

Decreased appetite

14%

Upper respiratory tract infection

14%

Diarrhea

10%

Injection site erythema

Nasopharyngitis

Irritability postvaccinal

Headache

Vomiting

Injection site induration

Myalgia

Hypersomnia

Injection site swelling

Fatigue

Crying

Injection site hemorrhage

Gastroenteritis

Pneumonia

Animal Bite

100%

80%

60%

40%

20%

Study treatment Arm

ATIV (6 to <72 Months)

TIV (6 to <72 Months)

Comparator TIV (6 to <72 Months)

REACH Trial Design

4Treatment groups

Experimental Treatment

Group I: birth, lower dose boosterExperimental Treatment1 Intervention

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

Group II: birth, higher dose boosterExperimental Treatment1 Intervention

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

Group III: 4 weeks, lower dose boosterExperimental Treatment1 Intervention

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

Group IV: 4 weeks, higher dose boosterExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hepatitis B Vaccine (Recombinant)

FDA approved

0 / 4Eligibility criteria met