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Fulltext Immunogenicity of a plasma-derived hepatitis B vaccine in children and adults

Sinniah M, Halimah M, Krishnamurthy T, Lye MS, Choo CH, Shamsiah I

Med J Malaysia, 1994 Dec;49(4):336-40.
PMID: 7674968

Immunisation of health care workers and staff working in laboratory and hospital settings has been implemented since 1988. However due to the high cost of currently available HBV vaccine, many health personnel outside the Ministry of Health are not being immunised. This study sought to determine the immunogenicity of three doses of a low cost plasma-derived Korean HBV vaccine on employees of an institute for mentally handicapped and their spouses and children. We found that the Hepatitis B Vaccine-KGCC to be safe and immunogenic. The response to 10 mcg and 20 mcg Hepatitis B Vaccine-KGCC after third dose was good with 100% seroconversion.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Fulltext Immune Persistence After Infant Hepatitis-B Vaccination: A Systematic Review and Meta-Analysis

Mahmood S, Shah KU, Khan TM

Sci Rep, 2018 08 22;8(1):12550.
PMID: 30135554 DOI: 10.1038/s41598-018-30512-8

A systematic review was performed to estimate the duration of protection of Hepatitis-B vaccine after primary vaccination during infancy. The number of seropositive participants with anti-HBs antibody titer ≥ 10 mIU/ml and seronegative participants who had anti-HBs antibody titer ≤ 10 mIU/ml after booster dose was the main outcome criteria to find out the protection time of Hepatitis-B vaccine. Twelve studies were selected for systematic review. Overall, results from the meta-analysis have revealed that the risk of Anti-HBs Titer ≤ 10 mIU/ml reduced by 50%. Upon performing the sub-group analysis it was revealed that the overall risk of having Anti-HBs Titre ≤ 10 mIU/ml was reduced up to 62% among the subjects age 21-30 years (0.38 [0.34, 0.44]; I2 = 0.0%, p = 0.938). Furthermore, it was observed that the risk of having titre level less than 10 mIU/ml for plasma derived vaccines were to be 56% [0.44, CI 0.33-0.57, I2 90.9%, p = <0.001]. Vaccination in early infancy does not ensure protection against Hepatitis-B infection. There is a strong correlation between the duration of protection and time elapsed after primary immunization during infancy.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
A new adjuvant improves the immune response to hepatitis B vaccine in hemodialysis patients

Kong NC, Beran J, Kee SA, Miguel JL, Sánchez C, Bayas JM, et al.

Kidney Int, 2008 Apr;73(7):856-62.
PMID: 18160963

Prehemodialysis and hemodialysis patients are at an increased risk of hepatitis B infection and have an impaired immune response to hepatitis B vaccines. We evaluated the immune response to the new adjuvant of hepatitis B vaccine AS04 (HBV-AS04) in this population. We measured antibody persistence for up to 42 months, and the anamnestic response and safety of booster doses in patients who were no longer seroprotected. The primary vaccination study showed that HBV-AS04 elicited an earlier antibody response and higher antibody titers than four double doses of standard hepatitis B vaccine. Seroprotection rates were significantly higher in HBV-AS04 recipients throughout the study. The decline in seroprotection over time was significantly less in the HBV-AS04 group with significantly fewer primed patients requiring a booster dose over the follow-up period. Solicited/unsolicited adverse events were rare following booster administration. Fifty-seven patients experienced a serious adverse event during the follow-up; none of which was vaccine related. When HBV-AS04 was used as the priming immunogen, the need for a booster dose occurred at a longer time compared to double doses of standard hepatitis B vaccine. Hence, in this population, the HBV-AS04 was immunogenic, safe, and well-tolerated both as a booster dose after HBV-AS04 or standard hepatitis B vaccine priming.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Immunogenicity and safety of an adjuvanted hepatitis B vaccine in pre-hemodialysis and hemodialysis patients

Tong NK, Beran J, Kee SA, Miguel JL, Sánchez C, Bayas JM, et al.

Kidney Int, 2005 Nov;68(5):2298-303.
PMID: 16221232

Due to their impaired immune system, patients with renal insufficiency have a suboptimal response to hepatitis B (HB) vaccination and frequent boosters are needed to maintain protection. GlaxoSmithKline Biologicals has developed a HB vaccine containing a new adjuvant system AS04 for use in this immunocompromised patient population.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Fulltext Immune response in infants after universal hepatitis B vaccination: a community-based study in Malaysia

Cheang HK, Wong HT, Ho SC, Chew KS, Lee WS

Singapore Med J, 2013 Apr;54(4):224-6.
PMID: 23624451

INTRODUCTION: This study aimed to assess the immune response in infants who received the three-shot hepatitis B vaccine in Malaysia.

METHODS: Consecutive infants born between March 2002 and April 2010 who received three doses of hepatitis B vaccine at a community clinic in Malaysia were enrolled in the study. Screening for hepatitis B surface antigen (HBsAg) and antibody against HBsAg (anti-HBs) was performed after the completion of primary immunisation, at approximately one year of age.

RESULTS: A total of 572 infants (median age 9.3 ± 2.7 months; range 6.3-48 months) were screened for immune response to hepatitis B vaccination - 553 (96.7%) infants had adequate levels of anti-HBs (≥ 10 IU/L). Of the 440 mothers whose HBsAg status was known, 14 (3.2%) were positive for HBsAg. None of the 14 infants who were born to HBsAg-positive mothers were positive for HBsAg, and all but one infant had anti-HBs level ≥ 10 IU/L. Gender, gestational age and maternal HBsAg status were not found to significantly affect the subsequent immune response in infants following vaccination.

CONCLUSION: The proportion of Malaysian mothers who are positive for HBsAg remains high. The three-shot hepatitis B vaccine, given as part of universal vaccination against hepatitis B, provides adequate anti-HBs in the vast majority of infants in a community setting in Malaysia.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Hepatitis B: review of development from the discovery of the "Australia Antigen" to end of the twentieth Century

Yap SF

Malays J Pathol, 2004 Jun;26(1):1-12.
PMID: 16190102

"Parenteral" or "serum" hepatitis is known to have afflicted man for centuries. However, it was not until the mid-1960s that the causative agent of this infection, the hepatitis B virus, was discovered. Since then, the biology and the replication strategy of the virus, and the clinical features and the epidemiology of the hepatitis B infection have been determined. Knowledge about the virus and the infection it causes led to the development of firstly, a plasma-derived vaccine and later a recombinant vaccine for the prevention of the infection. Integration of the hepatitis B vaccine into newborn vaccination programmes on a worldwide basis represents a major step in the effort to eliminate this infectious disease and its complications. Laboratory tests are available for the diagnosis and monitoring of the disease. Therapies have been developed to halt the progress of the chronic infection in affected individuals. While these developments have resulted in a decrease of the frequency of infection in many countries, particularly those that have implemented universal immunization of newborns, the chronic infection remains a significant global problem. Worldwide, over 300 million individuals are infected and each year, an estimated 1 million persons die from chronic complications of the disease including hepatocellular carcinoma and hepatic failure. The therapies currently available result in elimination of the virus in only a relatively small proportion of subjects and carry with it serious side effects. Geopolitical, economic and other factors hinder the vision of elimination of the infection through immunization programmes. Nevertheless, work continues to clarify further the underlying pathological mechanism of the infection, the host and viral factors that promote elimination or persistence of the virus in the human host. It is hoped that such investigations will reveal viral targets for the design of newer and potentially more effective drugs to treat the infection.

Matched MeSH terms: Hepatitis B Vaccines/immunology
Fulltext Naturally occurring hepatitis B virus surface antigen mutant variants in Malaysian blood donors and vaccinees

Hudu SA, Harmal NS, Saeed MI, Alshrari AS, Malik YA, Niazlin MT, et al.

Eur J Clin Microbiol Infect Dis, 2015 Jul;34(7):1349-59.
PMID: 25792010 DOI: 10.1007/s10096-015-2358-1

Hepatitis B virus surface mutants are of enormous importance because they are capable of escaping detection by serology and can infect both vaccinated and unvaccinated populations, thus putting the whole population at risk. This study aimed to detect and characterise hepatitis B-escaped mutants among blood donors and vaccinees. One thousand serum samples were collected for this study from blood donors and vaccinees. Hepatitis B surface antigen, antibodies and core antibodies were tested using a commercial enzyme-linked immunosorbent assay (ELISA) kit. DNA detection was performed via nested polymerase chain reaction (PCR), and the S gene was sequenced and analysed using bioinformatics. Of the 1,000 samples that were screened, 5.5% (55/1,000) were found to be HBsAg-negative and anti-HBc- and HBV DNA-positive. All 55 isolates were found to belong to genotype B. Several mutations were found across all the sequences from synonymous and non-synonymous mutations, with the most nucleotide mutations occurring at position 342, where adenine was replaced by guanine, and cytosine at position 46 was replaced by adenine in 96.4% and 98% of the isolates, respectively. Mutation at position 16 of the amino acid sequence was found to be common to all the Malaysian isolates, with 85.7% of the mutations occurring outside the major hydrophilic region. This study revealed a prevalence of 5.5% for hepatitis B-escaped mutations among blood donors and vaccinated undergraduates, with the most common mutation being found at position 16, where glutamine was substituted with lysine.

Matched MeSH terms: Hepatitis B Vaccines/immunology
Fulltext Chimeric Virus-Like Particles of Prawn Nodavirus Displaying Hepatitis B Virus Immunodominant Region: Biophysical Properties and Cytokine Response

Ninyio NN, Ho KL, Yong CY, Chee HY, Hamid M, Ong HK, et al.

Int J Mol Sci, 2021 Feb 15;22(4).
PMID: 33672018 DOI: 10.3390/ijms22041922

Hepatitis B is a major global health challenge. In the absence of an effective treatment for the disease, hepatitis B vaccines provide protection against the viral infection. However, some individuals do not have positive immune responses after being vaccinated with the hepatitis B vaccines available in the market. Thus, it is important to develop a more protective vaccine. Previously, we showed that hepatitis B virus (HBV) 'a' determinant (aD) displayed on the prawn nodavirus capsid (Nc) and expressed in Spodoptera frugiperda (Sf9) cells (namely, Nc-aD-Sf9) self-assembled into virus-like particles (VLPs). Immunisation of BALB/c mice with the Nc-aD-Sf9 VLPs showed significant induction of humoral, cellular and memory B-cell immunity. In the present study, the biophysical properties of the Nc-aD-Sf9 VLPs were studied using dynamic light scattering (DLS) and circular dichroism (CD) spectroscopy. Enzyme-linked immunosorbent assay (ELISA) was used to determine the antigenicity of the Nc-aD-Sf9 VLPs, and multiplex ELISA was employed to quantify the cytokine response induced by the VLPs administered intramuscularly into BALB/c mice (n = 8). CD spectroscopy of Nc-aD-Sf9 VLPs showed that the secondary structure of the VLPs predominantly consisted of beta (β)-sheets (44.8%), and they were thermally stable up to ~52 °C. ELISA revealed that the aD epitope of the VLPs was significantly antigenic to anti-HBV surface antigen (HBsAg) antibodies. In addition, multiplex ELISA of serum samples from the vaccinated mice showed a significant induction (p < 0.001) of IFN-γ, IL-4, IL-5, IL-6, IL-10, and IL-12p70. This cytokine profile is indicative of natural killer cell, macrophage, dendritic cell and cytotoxic T-lymphocyte activities, which suggests a prophylactic innate and adaptive cellular immune response mediated by Nc-aD-Sf9 VLPs. Interestingly, Nc-aD-Sf9 induced a more robust release of the aforementioned cytokines than that of Nc-aD VLPs produced in Escherichia coli and a commercially used hepatitis B vaccine. Overall, Nc-aD-Sf9 VLPs are thermally stable and significantly antigenic, demonstrating their potential as an HBV vaccine candidate.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Fulltext Isolated hepatitis B core antibody positive among vaccinated cohort in Malaysia

Hudu SA, Malik YA, Niazlin MT, Harmal NS, Alshrari AS, Sekawi Z

Ann Saudi Med, 2013;33(6):591-4.
PMID: 24413864 DOI: 10.5144/0256-4947.2013.591

BACKGROUND AND OBJECTIVES: Hepatitis B core antibodies (anti-HBc) are detected in almost every patient with previous exposure to hepatitis B virus (HBV). However, with this marker alone, one cannot understand the activity of the disease; therefore, this study aimed to identify the implication of isolated hepatitis B core antibody and evaluate the effect of hepatitis B vaccine booster in isolated anti-HBc among adults who received the HBV vaccine as infants.
DESIGN AND SETTINGS: A prospective cohort study of vaccinated undergraduate students of University Putra Malaysia.
PATIENTS AND METHODS: A total of 408 undergraduate students who received infant hepatitis B vaccination volunteered for this study; 5 mL of venous blood was taken from the volunteers. Hepatitis B surface antigen (HBsAg) and core antibodies were tested using a commercially available enzyme-linked immunosorbent assay kit according to the manufacturer's instructions (DRG international Inc., USA). Molecular detection of hepatitis B viral DNA was performed using nested polymerase chain reaction.
RESULTS: The prevalence of isolated anti-HBc among the vaccinated cohort was found to be 5.0%, out of which 80% had a hepatitis B surface antibodies (anti-HBs) titer higher than 10 IU/L, while 20% had less than 10 IU/L anti-HBs titer. All the anti-HBc positivesubjects had detectable hepatitis B viral DNA in their serum. Anamnestic response was found to be 100% among isolated anti-HBc with negative antibody.
CONCLUSION: Isolated anti-HBc developed protective levels of anti-HBs after a single dose of recombinant hepatitis B vaccination. HBV DNA was detected in all isolated anti-HBc indicating occult chronic HBV infection with undetectable HBsAg.

Matched MeSH terms: Hepatitis B Vaccines/immunology
Fulltext Induction of humoral and cell-mediated immune responses by hepatitis B virus epitope displayed on the virus-like particles of prawn nodavirus

Yong CY, Yeap SK, Goh ZH, Ho KL, Omar AR, Tan WS

Appl Environ Microbiol, 2015 Feb;81(3):882-9.
PMID: 25416760 DOI: 10.1128/AEM.03695-14

Hepatitis B virus (HBV) is a deadly pathogen that has killed countless people worldwide. Saccharomyces cerevisiae-derived HBV vaccines based upon hepatitis B surface antigen (HBsAg) is highly effective. However, the emergence of vaccine escape mutants due to mutations on the HBsAg and polymerase genes has produced a continuous need for the development of new HBV vaccines. In this study, the "a" determinant within HBsAg was displayed on the recombinant capsid protein of Macrobrachium rosenbergii nodavirus (MrNV), which can be purified easily in a single step through immobilized metal affinity chromatography (IMAC). The purified protein self-assembled into virus-like particles (VLPs) when observed under a transmission electron microscope (TEM). Immunization of BALB/c mice with this chimeric protein induced specific antibodies against the "a" determinant. In addition, it induced significantly more natural killer and cytotoxic T cells, as well as an increase in interferon gamma (IFN-γ) secretion, which are vital for virus clearance. Collectively, these findings demonstrated that the MrNV capsid protein is a potential carrier for the HBV "a" determinant, which can be further extended to display other foreign epitopes. This paper is the first to report the application of MrNV VLPs as a novel platform to display foreign epitopes.

Matched MeSH terms: Hepatitis B Vaccines/immunology*
Four is better than nine. a combined diphtheria-tetanus-pertussis-hepatitis B-Haemophilus influenzae type b vaccine for routine immunization in Malaysia

Wong SL, Soosai P, Teoh YL, Han HH, Lefevre I, Bock HL

Southeast Asian J Trop Med Public Health, 2008 May;39(3):474-83.
PMID: 18564687

Malaysian infants would have to receive nine injections during the first few months of life in order to be protected against disease caused by hepatitis B (HBV), diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib) if single HBV and Hib vaccines were used. We evaluated a combined DTPw-HBV/Hib vaccine administered at 1.5, 3 and 5 months after a birth dose of hepatitis B vaccine (HBV). One month after completion of the primary vaccination, 99% of subjects had seroprotective anti-HBV antibody levels, and at least 98% had seroprotective antibodies against diphtheria, tetanus, and Hib, and were seropositive for pertussis antibodies. The immune response to the combined vaccine was comparable to that induced by separate injections with DTPw, HBV and Hib vaccines. Overall, the DTPw-HBV/Hib vaccine was as well tolerated as separate administration of DTPw, HBV and Hib vaccines. The combined DTPw-HBV/Hib vaccine induces protection against five diseases as recommended in the Malaysian routine vaccination schedule. Use of the combined DTPw-HBV/Hib vaccine can reduce the required number of injections from nine to four in the first few months of life.

Matched MeSH terms: Hepatitis B Vaccines/immunology

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