Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children - Full Text View

Sponsors and Collaborators:	Centers for Disease Control and Prevention Alaska Native Medical Center GlaxoSmithKline
Information provided by:	Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:	NCT00139113

Purpose

Infants born to immune mothers and therefore having passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules. We found that when vaccination is begun at or after 12 months of age, there was no difference in the immune response to the vaccine between infants born to immune vs. susceptible mothers.

Condition	Intervention	Phase
Hepatitis A	Biological: hepatitis A vaccine (HAVRIX)	Phase IV

MedlinePlus related topics: Hepatitis Hepatitis A

Drug Information available for: Hepatitis A Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study
Official Title:	Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children

Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:

concentration of antibody to hepatitis A virus

Secondary Outcome Measures:

reported side effects and adverse events
antibodies to routine childhood vaccinations

Estimated Enrollment:	180
Study Start Date:	September 1996
Estimated Study Completion Date:	December 2011

Detailed Description:

Background: Infants with passively-transferred maternal antibody (PMA) to hepatitis A virus (HAV) have a blunted immune response to hepatitis A vaccine. We compared the immunogenicity of hepatitis A vaccine among infants with and without PMA, vaccinated on different schedules.

Methods: Infants were randomized to one of three groups, each receiving two doses of 720 EL.U. of hepatitis A vaccine (HAVRIX, Glaxo SmithKline) according to the following schedules: Group 1 at ages 6 and 12 months; Group 2 at ages 12 and 18 months; Group 3 at ages 15 and 21 months. We determined antibody to HAV (anti-HAV) status of mothers at the time of delivery, and measured infants’ anti-HAV concentrations at the time of the first vaccine dose (baseline), and at 1, 7 and 12 months thereafter. Anti-HAV concentrations > 33 milli-International Units/milliliter (mIU/mL) were considered protective. We monitored adverse reactions using diary cards and chart reviews.

Results: A total of 239 infants were enrolled, including 134 born to anti-HAV negative mothers (Groups 1N, 2N, 3N) and 105 born to anti-HAV positive mothers (Groups 1P, 2P, 3P).

At month 12, 6 months after the second vaccine dose, the difference in GMC between Groups 1P and 1N was the only statistically significant difference within groups (p<0.05). There were no statistically significant differences in GMC among groups of infants born to anti-HAV negative mothers (“N” groups), but the difference between Group 1P and Group 3P infants was significant (p < 0.05). No serious adverse reactions related to vaccination were detected.

Conclusions: Hepatitis A vaccine is immunogenic among infants born to anti-HAV negative mothers, and among those born to anti-HAV positive mothers and vaccinated beginning as young as 12 months old. The persistence of PMA for at least six months among the majority of infants born to anti-HAV positive mothers results in lower seroconversion rates and GMC’s.

Eligibility

Ages Eligible for Study:	up to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:term infant with normal growth and development, considered to be healthy at age 6 months; written informed consent by parent/guardian -

Exclusion Criteria:received or expected to receive immune globulin or blood/blood products while enrolled; received or expected to receive immunosuppressive therapy within 30 days of vaccination or has immune deficiency; currently enrolled in another vaccine trial; progressive or unstable neurological disorder

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Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00139113

Locations

United States, Alaska
Alaska Native Medical Center
Anchorage, Alaska, United States, 99508
Anchorage Neighborhood Health Center
Anchorage, Alaska, United States, 99501

Sponsors and Collaborators

Centers for Disease Control and Prevention

Alaska Native Medical Center

GlaxoSmithKline

Investigators

Principal Investigator:

Brian McMahon

Alaska Native Medical Center

More Information

Study ID Numbers:	CDC-NCID-1358, U50/CCU022279
Study First Received:	August 29, 2005
Last Updated:	August 29, 2005
ClinicalTrials.gov Identifier:	NCT00139113
Health Authority:	United States: Food and Drug Administration

Keywords provided by Centers for Disease Control and Prevention:

hepatitis A
hepatitis A vaccine

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases

Picornaviridae Infections
Hepatitis, Viral, Human
Hepatitis A
Enterovirus Infections

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on January 16, 2009