Evaluation of hepatitis B vaccine immunogenicity among older adults during an outbreak response in assisted living facilities

doi:10.1016/j.vaccine.2011.10.011

Vaccine

Volume 29, Issue 50, 21 November 2011, Pages 9316-9320

https://doi.org/10.1016/j.vaccine.2011.10.011 Get rights and content

Abstract

Background

During the past decade, in the United States, an increasing number of hepatitis B outbreaks have been reported in assisted living facilities (ALFs) as a result of breaches in infection control practices. We evaluated the seroprotection rates conferred by hepatitis B vaccine among older adults during a response to an outbreak that occurred in multiple ALFs and assessed the influence of demographic and clinical factors on vaccine response.

Methods

Residents were screened for hepatitis B and C infection prior to vaccination and susceptible residents were vaccinated against hepatitis B with one dose of 20 μg Engerix-B™ (GSK) given at 0, 1, and 4 months. Blood samples were collected 80–90 days after the third vaccine dose to test for anti-HBs levels.

Results

Of the 48 residents who had post-vaccination blood specimens collected after the third vaccine dose, 16 (33.3%) achieved anti-HBs concentration ≥10 mIU/mL. Age was a significant determinant of seroprotection with rates decreasing from 88% among persons aged ≤60 years to 12% among persons aged ≥90 years (p = 0.001). Geometric mean concentrations were higher among non-diabetic than diabetic residents, however, the difference was not statistically significant (5.1 vs. 3.8 mIU/mL, p = 0.7).

Conclusions

These findings highlight that hepatitis B vaccination is of limited effectiveness when administered to older adults. Improvements in infection control and vaccination at earlier ages might be necessary to prevent spread of infection in ALFs.

Highlights

► The immunogenicity of monovalent hepatitis B vaccine was evaluated among older adults during an outbreak response. ► The overall vaccine response rate was 33%. ► Age was only significant predictor of seroprotection. ► Populations at risk of hepatitis B are more likely to benefit from vaccination at earlier ages. ► Use of double dose or extra-doses of hepatitis B vaccine might be alternative considerations among older adults.

Introduction

Hepatitis B virus (HBV) infection is a bloodborne and sexually transmitted infection that affects almost 730,000 persons in the United States with highest prevalence rates reported among persons aged 50 years or older compared to younger age groups [1]. The main consequences of HBV infection include cirrhosis, liver cancer, and death. Hepatitis B vaccination is the most effective measure to prevent HBV infection and its consequences. The Centers for Disease Control and Prevention (CDC) and the Advisory Committee for Immunization Practices (ACIP) recommend universal vaccination for all children and adolescents, as well as adults who are at high risk for HBV infection [2].

While the achievement of seroprotection (anti-HBs ≥ 10 mIU/mL) after receipt of hepatitis B vaccine has been established among persons aged less than 40 years, limited data are available regarding anti-HBs response among those aged 60 years or older. Outbreaks of HBV infection, with many acute infections resulting in death, are increasingly being recognized in long-term care (LTC) facilities as a result of improper cleaning and sharing of blood glucose monitoring devices [3], [4], [5], [6]. Projections indicate that the number of persons in the United States 65 years of age or older is expected to double to more than 70 million by 2030 with a concomitant increase in the number of residents in LTC facilities [7]. To prevent HBV infections among residents of LTC facilities, assiduous adherence to infection control guidelines is essential; however, adherence has proven challenging in such settings in the absence of federal oversight and variable state regulations regarding infection control practices [7].

The extent to which hepatitis B vaccination might be useful for susceptible persons living in LTC facilities is not clear, particularly in the acute context of prevention of HBV transmission during an outbreak. We evaluated the immunogenicity of monovalent hepatitis B vaccine administered to older adults during an outbreak that occurred in multiple assisted living facilities (ALFs) in one city and assessed the influence of demographic and clinical factors on vaccine response.

Section snippets

Study population

In June 2010, an outbreak of acute hepatitis B was identified in four ALFs housing a total of 289 older adults in the city of Houston, TX. Investigation of the outbreak suggested transmission through sharing of improperly cleaned blood glucose monitoring devices. In August 2010, the Houston Department of Health and Human Services with assistance from CDC implemented hepatitis B screening and vaccination of residents in the four facilities to prevent further transmission of hepatitis B.

Data collection and vaccine administration

Informed

Results

Of the 289 ALF residents, 136 (47.1%) consented to be screened for hepatitis B and C infection; of these, 120 (88.2%) were found to be susceptible to HBV infection, 2 had anti-HBs ≥10 mIU/mL and were negative for HBsAg and anti-HBc, and 14 (10.3%) were infected with hepatitis B of which 8 were acute infections (Fig. 1). Of the 69 residents who consented to receive 3 doses of hepatitis B vaccine, 48 (69.6%) residents had post-vaccination blood specimens collected 80–90 days after the third vaccine

Discussion

This paper describes the use of hepatitis B vaccine among older adults in several ALFs during an outbreak of hepatitis B. Seroprotection (anti-HBs concentration ≥ 10 mIU/mL) was achieved by one third of vaccinated respondents with available anti-HBs levels after receipt of the third vaccine dose. Very few studies have assessed the response to hepatitis B vaccine among older adults (aged 60 years or older); available data suggest variable seroprotection rates, ranging between 30% and 80%, depending

Acknowledgments

We would like to thank the following persons for their generous assistance with this project: William Bryant, Decrecia Robinson, MaryJane Lowery, and Howard Tuner from the Houston Department of Health and Human Services; Yenlik Zheteyeva, MD, MPH, Pritish Tosh, MD, Saleem Kamili, PhD, Yury Khudyakov, PhD, Ngoc-Thao Le, BS, and Natasha Khudyakov, MS, from the Centers for Disease Control and Prevention.

Conflict of interest statement: None declared. Funding: None.

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Participants’ socio-demographic data were obtained from medical records. Anti-HBs testing was performed. Descriptive and bivariate analyses were performed.
Among 431 participants, 62.2 % (n = 268) were males. In all, 43.2 % (n = 186) had normal weight, 24.8 % (n = 107) were overweight, and 17.6 % (n = 76) had obesity. Seroconversion after 3-dose HBV vaccination was 74.7 %. Participants with normal weight had higher seroprevalence (n = 156/186, 83.9 %), compared with those with overweight (n = 72/107, 67.3 %) or obesity (n = 48/76, 63.2 %) (Normal weight vs overweight: aOR = 2.44, 95 % CI: 1.38–4.32 and normal weight vs obesity: aOR = 2.97, 95 % CI:1.61–5.47).
BMI is an independent factor impairing the vaccine response. These findings urge for more tailored vaccination strategies with focus on higher risk populations.
Vaccination in Chronic Liver Disease: An Update
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Patients with chronic liver disease (CLD) with or without cirrhosis remain at risk of developing hepatic decompensation when infected with viral or bacterial pathogens. The Advisory Committee on Immunization Practices (ACIP) currently recommends vaccination in CLD against hepatitis A virus (HAV), hepatitis B virus (HBV), influenza, pneumococcus, herpes zoster, tetanus, diphtheria, pertussis, and SARS-CoV-2. Inactivated vaccines are preferred over live attenuated ones, especially in transplant recipients where live vaccines are contraindicated. As the severity of the liver disease progresses, vaccine efficacy declines, and therefore, vaccines should be ideally administered early in the disease course for optimal immune response. Despite the strong recommendations, overall vaccination coverage in CLD remains poor; however, it is encouraging to note that in recent years coverage against influenza and pneumococcus has shown some improvement. Inadequate access to healthcare, lack of information on vaccine safety, poor financial reimbursement for healthcare providers, and vaccine misinformation are often responsible for low immunization rates. This review summarizes the impact of vaccine-preventable illness in those with CLD, updated vaccine guidelines, seroconversion rates in the vaccinated, and barriers faced by healthcare professionals in immunizing those with liver disease.
Safety, tolerability, and immunogenicity of a SARS-CoV-2 recombinant spike RBD protein vaccine: A randomised, double-blind, placebo-controlled, phase 1-2 clinical trial (ABDALA Study)
2022, eClinicalMedicine
Multiple vaccine candidates against COVID-19 are currently being evaluated. We evaluate the safety and immunogenicity protein of a novel SARS-CoV-2 virus receptor-binding domain (RBD) vaccine.
A phase 1-2, randomised, double-blind, placebo-controlled trial was carried out in “Saturnino Lora” Hospital, Santiago de Cuba, Cuba. Subjects (healthy or those with controlled chronic diseases) aged between 19 and 80 years, who gave written informed consent were eligible. Subjects were randomly assigned (1:1:1, in blocks) to three groups: placebo, 25 µg and 50 µg RBD vaccine (Abdala). The product was administered intramuscularly, 0·5 mL in the deltoid region. During the first phase, two immunization schedules were studied: 0-14-28 days (short) and 0-28-56 days (long). In phase 2, only the short schedule was evaluated. The organoleptic characteristics and presentations of vaccine and placebo were identical. All participants (subjects, clinical researchers, statisticians, laboratory technicians, and monitors) remained masked during the study period. The main endpoints were safety and the proportion of subjects with seroconversion of anti-RBD IgG antibodies, analysed by intention to treat and per protocol, respectively. The trial is registered with the Cuban Public Registry of Clinical Trials, RPCEC00000346.
Between Dec 7, 2020, and Feb 9, 2021, 792 subjects were included; 132 (66 in each vaccination schedule, divided into 22 for each group) in phase 1, and 660 (220 in each group plus 66 from the short scheme of phase 1) in phase 2. The product was well tolerated. No severe adverse events were reported. During phase 1, the incidence of adverse events in the 25 µg, 50 µg, and placebo arms for the short schedule were 6/22 (27·3%), 6/22 (27·3%), 3/22 (13·6%), respectively, and for the long schedule were 8/22 (36·4%), 9/22 (40·9%), 4/22 (18·2%), respectively. In phase 2, adverse reactions were reported by 53/242 (21·9%), 75/242 (31·0%) and 41/242 (16·9%) participants in the 25 µg, 50 µg, and placebo group, respectively. Adverse reactions were minimal, mostly mild, and from the injection site, which resolved in the first 24-48 hours. In phase 1, seroconversion at day 56 was seen in 95·2% of the participants (20/21) in the 50 μg group, 81% (17/21) in the 25 μg group, and none in the placebo group (0/22). For the long schedule, seroconversion at day 70 was seen in 100% of the participants (21/21) in the 50 μg group, 94·7% (18/19) in the 25 μg group, and none in the placebo group (0/22). In phase 2, seroconversion of anti-RBD IgG antibodies at day 56 was seen in 89·2% of the participants in the 50 μg group (214/240; 95% CI 84·5-92·82), 77·7% in the 25 μg group (185/238; 72·0-82·9) and 4·6% in the placebo group (11/239; 2·3-8·1). Compared with the placebo arm, the differences in the proportion of participants with seroconversion were 73·1% (95% CI 66·8-79·5) and 84·6% (79·4-89·7) in the 25 μg and 50 μg groups, respectively. The seroconversion rate in the 50 μg group was significantly higher than in the 25 μg group (p=0·0012).
The Abdala vaccine was safe, well tolerated, and induced humoral immune responses against SARS-CoV-2. These results, in the context of the emergency COVID-19 pandemic, support the 50 μg dose, applied in a 0-14-28 days schedule, for further clinical trials to confirm vaccine efficacy.
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2021, Vaccine
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^☆: The findings and conclusions in this report are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. This paper was presented in part as a poster during the 5th Vaccine and ISV Annual Global Congress, October 2–4, 2011, Seattle, USA.

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Evaluation of hepatitis B vaccine immunogenicity among older adults during an outbreak response in assisted living facilities☆

Abstract

Background

Methods

Results

Conclusions

Highlights

Introduction

Section snippets

Study population

Data collection and vaccine administration

Results

Discussion

Acknowledgments

Vaccine

Vaccine

Vaccine

Am J Prev Med

Vaccine

Vaccine

The prevalence of hepatitis B virus infection in the United States in the era of vaccination

J Infect Dis

A comprehensive immunization strategy to eliminate transmission of hepatitis B virus infection in the United States: recommendations of the advisory committee on immunization practices (ACIP). Part II: immunization of adults

MMWR