Comparison of the Immune Response of Four Different Dosages of a Yeast-Recombinant Hepatitis B Vaccine in Singapore Children: A Four-Year Follow-Up Study

By Goh, K. T.; Tan, K. L. et al. | Bulletin of the World Health Organization, March-April 1992 | Go to article overview

Comparison of the Immune Response of Four Different Dosages of a Yeast-Recombinant Hepatitis B Vaccine in Singapore Children: A Four-Year Follow-Up Study


Goh, K. T., Tan, K. L., Kong, K. H., Oon, C. J., Chan, S. H., Bulletin of the World Health Organization


Introduction

The scarcity of suitable plasma for the manufacture of hepatitis B vaccine and the possible transmission of human immunodeficiency virus [1] led to the development of genetic-engineered vaccines. One of the recombinant DNA hepatitis B vaccines is produced in yeast (Saccharomyces cerevisiae) that has been inactivated by formalin, absorbed in aluminium hydroxide and purified by hydrophobic chromatography [2]. The safety and immunogenicity of the yeast-derived vaccines in children and adults have been demonstrated [3-5]. The vaccine is well tolerated, with side-effects similar to those of plasma-based vaccine [4]. There was no increase in antibody titre to Candida albicans [3] or elevations of IgE-specific antibodies to S. cerevisiae [6] among the vaccinees. The vaccine is a efficacious as the plasma-based vaccine in the prevention of perinatal transmission of hepatitis B virus (HBV) infection [7].

Owing to the high cost of the DNA-recombinant yeast-derived vaccine (as high as the plasma-based vaccine when it was first marketed), clinical trials were conducted in Singapore to evaluate the immunogenicity and efficacy of reduced dosages of the recombinant vaccine in infants, children, teenagers [8] and adults [9]. If a lower dosage is compatible with both immunogenicity and efficacy, the cost of the vaccination programme could be reduced considerably. This is of particular importance in developing countries where HBV infections is endemic. We report the findings of our study on the immune response of healthy children to four different dosages of the vaccine, with follow-up for 4 years.

Materials and methods

The study population were 1-12-year-olds who were on regular follow-up in a postnatal clinic at Kandang Kerbau Hospital. The purpose of the trial was carefully explained to the parent or guardian and informed consent was obtained before venous blood (5 ml) was collected from each child using disposable needles and syringes. At the time of blood collection, relevant demographic data such as date of birth, weight, height, sex and ethnic group of each child were recorded.

At the end of each collection, the samples were immediately dispatched to the Ransome Research Laboratory, Department of Clinical Research, Singapore General Hospital, where the sera were separated and stored at -70 [degrees] C before analysis in batches. Hepatitis B surface antigen (HBsAg) and antibody to hepatitis B surface antigen (anti-HBs) were tested by radio-immunoassay (AUSRIA II and AUSAB, respectively, Abbott Laboratories, Chicago) and antibody to hepatitis B core antigen (anti-HBc) by enzyme immunoassay (CORZYME, Abbott Laboratories, Chicago). Serum alanine aminotransferase (ALT) was determined by the Greiner Analyser G-400 (Greiner Electronics Diagnostica, Switzerland).

Children found to be negative for HBsAg, anti-HBs and anti-HBc, with normal ALT levels (9-36 IU/ml) and with no previous history of hepatitis B vaccination were randomized into 4 groups (about 30 in each group) to receive 3 doses of 0.6 [Mu] g, 1.25 [Mu] g, 2.5 [Mu] g or 5.0 [Mu] g of Merck, Sharp and Dohme yeast-derived hepatitis B vaccine. The vaccine was mixed well and the given intramuscularly into the upper deltoid muscle using a 0.5 ml insulin syringe type U100 at 0, 1 month and 6 months (0-1-6 schedule). Prior to the administration of the vaccine, the parent or guardian was questioned regarding allergies and children with known allergies to yeast were excluded. The parent or guardian was asked to record any local or systemic complaints which occurred after each vaccination. Blood samples were obtained at 3 months, 6 months (before the last dose was given), 9 months, 12 months, 24 months and 48 months after the first dose, and tested for HBsAg, anti-HBs, anti-HBc and ALT levels. The reciprocal anti-HBs titres were expressed in milli-international units (mIU/ml, based on a WHO Reference Standard supplied by the International Laboratory for Biological Standards, Central Laboratory of the Netherlands Red Cross Blood Transfusion Service). …

The rest of this article is only available to active members of Questia

Already a member? Log in now.

Notes for this article

Add a new note
If you are trying to select text to create highlights or citations, remember that you must now click or tap on the first word, and then click or tap on the last word.
One moment ...
Default project is now your active project.
Project items

Items saved from this article

This article has been saved
Highlights (0)
Some of your highlights are legacy items.

Highlights saved before July 30, 2012 will not be displayed on their respective source pages.

You can easily re-create the highlights by opening the book page or article, selecting the text, and clicking “Highlight.”

Citations (0)
Some of your citations are legacy items.

Any citation created before July 30, 2012 will labeled as a “Cited page.” New citations will be saved as cited passages, pages or articles.

We also added the ability to view new citations from your projects or the book or article where you created them.

Notes (0)
Bookmarks (0)

You have no saved items from this article

Project items include:
  • Saved book/article
  • Highlights
  • Quotes/citations
  • Notes
  • Bookmarks
Notes
Cite this article

Cited article

Style
Citations are available only to our active members.
Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

(Einhorn, 1992, p. 25)

(Einhorn 25)

1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

Cited article

Comparison of the Immune Response of Four Different Dosages of a Yeast-Recombinant Hepatitis B Vaccine in Singapore Children: A Four-Year Follow-Up Study
Settings

Settings

Typeface
Text size Smaller Larger Reset View mode
Search within

Search within this article

Look up

Look up a word

  • Dictionary
  • Thesaurus
Please submit a word or phrase above.
Print this page

Print this page

Why can't I print more than one page at a time?

Help
Full screen

matching results for page

    Questia reader help

    How to highlight and cite specific passages

    1. Click or tap the first word you want to select.
    2. Click or tap the last word you want to select, and you’ll see everything in between get selected.
    3. You’ll then get a menu of options like creating a highlight or a citation from that passage of text.

    OK, got it!

    Cited passage

    Style
    Citations are available only to our active members.
    Buy instant access to cite pages or passages in MLA, APA and Chicago citation styles.

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn, 1992, p. 25).

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences." (Einhorn 25)

    "Portraying himself as an honest, ordinary person helped Lincoln identify with his audiences."1

    1. Lois J. Einhorn, Abraham Lincoln, the Orator: Penetrating the Lincoln Legend (Westport, CT: Greenwood Press, 1992), 25, http://www.questia.com/read/27419298.

    Cited passage

    Thanks for trying Questia!

    Please continue trying out our research tools, but please note, full functionality is available only to our active members.

    Your work will be lost once you leave this Web page.

    Buy instant access to save your work.

    Already a member? Log in now.

    Author Advanced search

    Oops!

    An unknown error has occurred. Please click the button below to reload the page. If the problem persists, please try again in a little while.