Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children

Wendy Newcomer, Beth Rivin, Raymond Reid, Lawrence Hale Moulton, Mark Wolff, Janne Croll, Carol Johnson, Leora Brown, David Nalin, Mathuram Santosham

Research output: Contribution to journalArticle

Abstract

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 ± 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 (≥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.

Original languageEnglish (US)
Pages (from-to)640-642
Number of pages3
JournalPediatric Infectious Disease Journal
Volume13
Issue number7
StatePublished - 1994

Fingerprint

Hepatitis A Vaccines
Hepatitis A virus
Inactivated Vaccines
Safety
Viral Proteins
Vaccines
Hepatitis A
Viral Antigens
Virus Diseases
Formaldehyde
Antibodies
Research
Population
Proteins

Keywords

  • American indians
  • Hepatitis A
  • Inactivated vaccine

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)
  • Pediatrics, Perinatology, and Child Health

Cite this

Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children. / Newcomer, Wendy; Rivin, Beth; Reid, Raymond; Moulton, Lawrence Hale; Wolff, Mark; Croll, Janne; Johnson, Carol; Brown, Leora; Nalin, David; Santosham, Mathuram.

In: Pediatric Infectious Disease Journal, Vol. 13, No. 7, 1994, p. 640-642.

Research output: Contribution to journalArticle

Newcomer, Wendy ; Rivin, Beth ; Reid, Raymond ; Moulton, Lawrence Hale ; Wolff, Mark ; Croll, Janne ; Johnson, Carol ; Brown, Leora ; Nalin, David ; Santosham, Mathuram. / Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children. In: Pediatric Infectious Disease Journal. 1994 ; Vol. 13, No. 7. pp. 640-642.
@article{64f53e63aa7544c6b111d23355c39a21,
title = "Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children",
abstract = "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{\circledR}; 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 ± 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 (≥10 mIU/ml, modified HAVAB{\circledR}; 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.",
keywords = "American indians, Hepatitis A, Inactivated vaccine",
author = "Wendy Newcomer and Beth Rivin and Raymond Reid and Moulton, {Lawrence Hale} and Mark Wolff and Janne Croll and Carol Johnson and Leora Brown and David Nalin and Mathuram Santosham",
year = "1994",
language = "English (US)",
volume = "13",
pages = "640--642",
journal = "Pediatric Infectious Disease Journal",
issn = "0891-3668",
publisher = "Lippincott Williams and Wilkins",
number = "7",

}

TY - JOUR

T1 - Immunogenicity, safety and tolerability of varying doses and regimens of inactivated hepatitis A virus vaccine in Navajo children

AU - Newcomer, Wendy

AU - Rivin, Beth

AU - Reid, Raymond

AU - Moulton, Lawrence Hale

AU - Wolff, Mark

AU - Croll, Janne

AU - Johnson, Carol

AU - Brown, Leora

AU - Nalin, David

AU - Santosham, Mathuram

PY - 1994

Y1 - 1994

N2 - 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 ± 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 (≥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.

AB - 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 ± 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 (≥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.

KW - American indians

KW - Hepatitis A

KW - Inactivated vaccine

UR - http://www.scopus.com/inward/record.url?scp=0028303525&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0028303525&partnerID=8YFLogxK

M3 - Article

VL - 13

SP - 640

EP - 642

JO - Pediatric Infectious Disease Journal

JF - Pediatric Infectious Disease Journal

SN - 0891-3668

IS - 7

ER -