Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
7
pubmed:dateCreated
1994-12-7
pubmed:abstractText
The Navajo are known to be at high risk for hepatitis A virus (HAV) infection. This study investigated the safety and immunogenicity of an investigational, alum-adjuvanted, formalin-inactivated HAV vaccine (VAQTA) developed by Merck Research Laboratories in Navajo children. One hundred two of 212 children, ages 4 to 12 years, were HAV-seronegative (< 10 mIU/ml by an enhanced sensitivity modification of the HAVAB; Abbott). Ninety of these children received the HAV vaccine. Study participants were given vaccines containing various viral protein concentrations: Group A (n = 18), 6 units; Group B (n = 36), 13 units; and Group C (n = 36), 25 units HAV protein (1 unit approximately 1 ng viral protein antigen). Three-dose (0, 8, 24 weeks) and two-dose (0, 24 weeks) regimens were compared in subgroups within B and C. The vaccine was well-tolerated and there were no serious adverse reactions; no vaccinee developed hepatitis A. After 1 dose 82 to 100% of children seroconverted (> or = 10 mIU/ml, modified HAVAB; Abbott) and 100% seroconverted after 2 doses. After 1 dose the geometric mean titer for antibody was: Group A, 22 mIU/ml; Group B, 18 mIU/ml; and Group C, 38 mIU/ml. After 3 doses geometric mean titers increased to 10,106 mIU/ml in Group A, 7258 mIU/ml in Group B and 11,856 mIU/ml in Group C. Further field studies are indicated to evaluate its use in high risk populations, such as the Navajo.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:month
Jul
pubmed:issn
0891-3668
pubmed:author
pubmed:issnType
Print
pubmed:volume
13
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
640-2
pubmed:dateRevised
2006-11-15
pubmed:meshHeading
pubmed-meshheading:7970954-Age Factors, pubmed-meshheading:7970954-Child, pubmed-meshheading:7970954-Child, Preschool, pubmed-meshheading:7970954-Dose-Response Relationship, Immunologic, pubmed-meshheading:7970954-Female, pubmed-meshheading:7970954-Hepatitis A, pubmed-meshheading:7970954-Hepatitis A Vaccines, pubmed-meshheading:7970954-Hepatitis A Virus, Human, pubmed-meshheading:7970954-Hepatitis Antibodies, pubmed-meshheading:7970954-Humans, pubmed-meshheading:7970954-Immunization Schedule, pubmed-meshheading:7970954-Immunogenetics, pubmed-meshheading:7970954-Indians, North American, pubmed-meshheading:7970954-Male, pubmed-meshheading:7970954-Regression Analysis, pubmed-meshheading:7970954-Seroepidemiologic Studies, pubmed-meshheading:7970954-Vaccination, pubmed-meshheading:7970954-Vaccines, Inactivated, pubmed-meshheading:7970954-Viral Hepatitis Vaccines
pubmed:year
1994
pubmed:articleTitle
Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children.
pubmed:affiliation
Johns Hopkins University School of Hygiene and Public Health, Baltimore, MD 21205.
pubmed:publicationType
Journal Article, Clinical Trial, Comparative Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't