scholarly journals Comparison of the Levels of Immunogenicity and Safety of Zostavax in Adults 50 to 59 Years Old and in Adults 60 Years Old or Older

2009 ◽  
Vol 16 (5) ◽  
pp. 646-652 ◽  
Author(s):  
Santosh C. Sutradhar ◽  
William W. B. Wang ◽  
Katia Schlienger ◽  
Jon E. Stek ◽  
Jin Xu ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Herpes Zoster ◽  
Lower Bound ◽  
Confidence Interval ◽  
Geometric Mean ◽  
Age Groups ◽  
Safety Data ◽  
Enzyme Linked Immunosorbent Assay ◽  
Varicella Zoster ◽  
Adverse Experiences

ABSTRACT Zostavax has been shown to be efficacious in the prevention of herpes zoster and generally well tolerated in clinical trials among subjects 60 years old or older. This prespecified combined analysis from two studies compares the levels of immunogenicity and safety of Zostavax in subjects 50 to 59 years old versus those in subjects ≥60 years old. Varicella-zoster virus (VZV) antibody (Ab) titers were measured by glycoprotein enzyme-linked immunosorbent assay at baseline and 4 weeks postvaccination. Noninferiority was evaluated by estimated geometric mean severalfold rise (GMFR) ratio (50 to 59 years old/≥60 years old) and two-sided 95% confidence interval (CI). Success was defined by a lower bound (LB) of the 95% CI of the GMFR ratio of >0.67. Acceptability of postvaccination VZV Ab was defined by an LB of the 95% CI of the GMFR of >1.4. Safety data were recorded for 28 days postvaccination by standardized vaccination report card. The estimated GMFRs from baseline to 4 weeks postvaccination were 2.6 (95% CI, 2.4, 2.9) in subjects 50 to 59 years old and 2.3 (95% CI, 2.1, 2.4) in subjects ≥60 years old. The estimated GMFR ratio (50 to 59 years old/≥60 years old) was 1.13 (95% CI, 1.02, 1.25). No serious Zostavax-related adverse experiences were reported. After a dose of Zostavax, the GMFR of the VZV Ab response in subjects 50 to 59 years old was noninferior to that in subjects ≥60 years old. The VZV Ab response was acceptable in both age groups. Zostavax was generally well tolerated in both age groups.

scholarly journals A Double-Blind, Randomized, Controlled, Multicenter Safety and Immunogenicity Study of a Refrigerator-Stable Formulation of Zostavax

2007 ◽  
Vol 15 (2) ◽  
pp. 314-319 ◽  
Author(s):  
Larry I. Gilderman ◽  
James F. Lawless ◽  
Thomas M. Nolen ◽  
Tina Sterling ◽  
Ruth Z. Rutledge ◽  
...  
Keyword(s):  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Clinical Settings ◽  
Double Blind ◽  
Varicella Zoster ◽  
Adverse Experiences ◽  
Primary Endpoints ◽  
Current Formulation ◽  
To Receive

ABSTRACT The vaccine Zostavax has been shown to prevent herpes zoster (HZ) and postherpetic neuralgia and is recommended for individuals ≥60 years of age. This study compared the safety and the immunogenicity of a refrigerator-stable formulation (Zostavax refrigerated) with those of the current formulation (Zostavax frozen) in subjects ≥50 years of age. Subjects with a negative history for HZ were randomized 1:1 to receive one dose of either formulation. Enrollment was stratified 1:2 by age (50 to 59 years and ≥60 years). Safety was evaluated for 28 days postvaccination. Varicella-zoster virus (VZV) antibody responses were measured by a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The primary endpoints were the VZV antibody geometric mean titer (GMT; day 28), the VZV antibody geometric mean rise (GMR; days 1 to 28), and the incidence of vaccine-related serious adverse experiences (AEs) over 28 days. The refrigerated (n = 182) and frozen (n = 185) formulations induced similar GMTs (727.4 and 834.4 gpELISA units/ml, respectively); the estimated GMT ratio (refrigerated formulation/frozen formulation) was 0.87 (95% confidence interval, 0.71 to 1.07). The GMRs were 2.6- and 2.9-fold, respectively. No vaccine-related serious AEs were reported in either group, and the safety profiles of the formulations were generally similar. The frequencies of injection-site AEs during follow-up were 35.6% and 46.4% in the refrigerated and the frozen formulation groups, respectively, and were generally mild. The frequencies of systemic AEs were similar in the two groups, and those of vaccine-related AEs were ∼6% in both groups. The refrigerator-stable formulation of Zostavax has an acceptable safety profile and is as immunogenic as the frozen formulation; thus, the vaccine may be used in clinical settings where freezer availability is limited.

scholarly journals Humoral and Cellular Immunogenicity of Zoster Vaccine within One Year after Herpes Zoster

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S414-S414
Author(s):  
Eunyoung Lee ◽  
June Young Chun ◽  
Kyoung-Ho Song ◽  
Pyeong Gyun Choe ◽  
Ji Whan Bang ◽  
...  
Keyword(s):  
Herpes Zoster ◽  
Geometric Mean ◽  
Enzyme Linked Immunosorbent Assay ◽  
Prior History ◽  
Zoster Vaccine ◽  
Varicella Zoster ◽  
Humoral Immune ◽  
History Of ◽  
Specific Igg ◽  
One Year

Abstract Background Herpes zoster vaccination is recommended to patients with a prior history of herpes zoster to prevent reactivation. However, the appropriate timing of vaccination is controversial. We compared immunogenicity of vaccine according to timing of vaccination after zoster illness. Methods In this prospective observational study, subjects were stratified into two groups by the vaccination timing since their zoster illness: 6–12 months (within-1 year group) vs. 1–5 years (after-1 year group). Blood samples were collected before and 6 weeks after vaccination of zoster vaccine live. Varicella-zoster virus (VZV)-specific IgG concentrations were measured by enzyme-linked immunosorbent assay. Interferon-gamma enzyme-linked immunosorbent spot (ELISPOT) assays were performed to assess VZV specific T-cell responses. Results A total of 59 patients (18 in the within-1 year group and 41 in the after-1 year group) were enrolled. Ages were not significantly different between groups. The baseline geometric mean titer (GMT) of VZV IgG was higher in the within-1 year group than in the after-1 year group (245.8 IU/mL vs. 124.9 IU/mL; P = 0.040). The geometric mean fold-rise (GMFR) of VZV IgG was lower in the within-1 year group than in the after-1 year group (1.42 vs. 2.46; P = 0.002). The GMT of spot forming cell (SFC) counts by ELISPOT at baseline and 6 weeks after vaccination were not significantly different between groups. The GMFRs of SFCs were also comparable. Conclusion Zoster vaccination within 1 year after zoster illness may have disadvantage in the aspect of humoral immune response (ClinicalTrials.gov number, NCT02704572). Disclosures All authors: No reported disclosures.

scholarly journals Varicella-Zoster Virus-Specific Enzyme-Linked Immunospot Assay Responses and Zoster-Associated Pain in Herpes Zoster Subjects

2012 ◽  
Vol 19 (9) ◽  
pp. 1411-1415 ◽  
Author(s):  
Stephen K. Tyring ◽  
Jon E. Stek ◽  
Jeffrey G. Smith ◽  
Jin Xu ◽  
Marco Pagnoni ◽  
...  
Keyword(s):  
Herpes Zoster ◽  
Varicella Zoster Virus ◽  
Pain Score ◽  
Geometric Mean ◽  
Age Groups ◽  
Brief Pain Inventory ◽  
Cell Mediated Immunity ◽  
Specific Cell ◽  
Varicella Zoster ◽  
Ifn Γ

ABSTRACTVaricella-zoster virus (VZV)-specific cell-mediated immunity (CMI) responses were compared over time following an episode of herpes zoster (HZ) with those of age-, race-, and gender-matched healthy controls (HC) without HZ, using a validated gamma interferon (IFN-γ) enzyme-linked immunospot (ELISPOT) assay. The zoster brief-pain inventory (ZBPI) was used to assess zoster-associated pain. HZ patients (n= 140) had significantly higher IFN-γ ELISPOT responses to VZV antigen than did HC (n= 140). ELISPOT geometric mean count (GMC) responses (with 95% confidence intervals [CI]) for subjects who presented within 72 h were as follows: for HZ patients ≥ 60 years of age, at day 0 the GMC was 110 and at week 2 the GMC was 235; for HZ patients 21 to 59 years of age, at day 0 the GMC was 111 and at week 2 the GMC was 198; for HC ≥ 60 years of age, at day 0 the GMC was 19 and at week 2 the GMC was 18; and for HC 21 to 59 years of age, at day 0 the GMC was 59 and at week 2 the GMC was 56. The mean pain score (95% CI) across age groups at 1 week postrash (n= 106) was 6.0 (5.5, 6.5) and at 2 weeks postrash (n= 119) was 3.5 (2.9, 4.0). The percentage of HZ patients with substantial pain (score ≥ 3) at 6 weeks postrash increased with age from 8% for patients 21 to 49 years of age to 16% for patients 50 to 59 years of age to 22% for patients ≥ 60 years of age. The VZV-specific CMI response was substantially boosted by an episode of HZ, as measured by ELISPOT results. Older adults had lower VZV-specific cellular immunity than younger subjects at baseline, but the boosting effect of HZ was substantial for all age groups. HZ patients experienced considerable zoster-associated acute (1 to 2 weeks after rash) pain across age groups, while chronic pain increased with age.

scholarly journals Effectiveness of Live Zoster Vaccine in Preventing Herpes Zoster Ophthalmicus (HZO)

2017 ◽  
Vol 4 (suppl_1) ◽  
pp. S413-S413 ◽  
Author(s):  
Laurie Aukes ◽  
Joan Bartlett ◽  
Bruce Fireman ◽  
John Hansen ◽  
Edwin Lewis ◽  
...  
Keyword(s):  
Herpes Zoster ◽  
Cox Regression ◽  
Age Groups ◽  
Weighted Average ◽  
Care Seeking ◽  
Zoster Vaccine ◽  
Herpes Zoster Ophthalmicus ◽  
Varicella Zoster ◽  
Grant Recipient ◽  
Restricted Stock

Abstract Background Herpes zoster ophthalmicus (HZO), caused by reactivation of varicella-zoster virus in or around the eye, can be severe and often results in care-seeking that may be less discretionary than for uncomplicated herpes zoster (HZ). We compared the vaccine effectiveness (VE) of live zoster vaccine against HZO with the VE against HZ overall. Methods Kaiser Permanente Northern California (KPNC) members enter the ongoing cohort study when age-eligible for zoster vaccine starting in 2007. Incident HZ was defined as a new diagnosis of HZ with an antiviral prescription or a positive varicella viral test. Among those, an HZO case was defined as having an HZO diagnosis during an ophthalmology visit within 30 days of the initial HZ diagnosis. VE by age at vaccination and time since vaccination was estimated using Cox regression adjusted for age, race, sex and time-varying measures of healthcare use, comorbidities and immunocompromise status. Average VE over the first 5 years following vaccination was calculated as a weighted average of annual VE estimates. Results During 2007–2014, ~1.3 million individuals ≥50 years of age entered the study population and 29% were vaccinated. Among 48,889 incident HZ cases, 2,858 (6%) had HZO, 87% of whom were unvaccinated. For all ages combined, VE against HZO was 72% (95% CI, 64%-79%) in year 1, similar to 68% (95% CI, 65%-70%) against HZ. VE fell in years 2, 3, 4, and 5 to 47%, 45%, 42% and 27% for HZO and to 47%, 39%, 41% and 37% for HZ. For age groups 60 – 69 and 70 – 79, where we have the most data, initial VE and waning were similar for HZO and HZ. Numbers of HZO cases for 50–59 year olds were too small to evaluate at this time. Average VE against HZO over the first 5 years following vaccination was 52% (95% CI, 42%–60%) for ages 60–69, 51% (95% CI, 39%–61%) for ages 70-79, and 39% (95% CI, 14%-57%) for ages 80+; similarly, 5-year average VE against HZ was 49%, 46%, and 44% for these 3 age groups. Conclusion VE against HZO was similar to VE against HZ regardless of age at vaccination or time since vaccination. Effectiveness of live zoster vaccine in preventing HZO was highest in year one with subsequent waning. Disclosures E. Earley, Merck & Co.: Research Contractor, Salary; M. Marks, Merck and Co. Inc.: Employee, Restricted Stock and Salary; P. Saddier, Merck & Co., Inc.: Employee, Salary; N. P. Klein, GSK: Investigator, Grant recipient; sanofi pasteur: Investigator, Grant recipient; Merck & Co.: Investigator, Grant recipient; MedImmune: Investigator, Grant recipient; Protein Science: Investigator, Grant recipient Pfizer: Investigator, Grant recipient

scholarly journals Clinical Study on Outcome of Treatment for Herpes Zoster

2021 ◽  
Author(s):  
Kishan Rasubhai Ninama ◽  
Rashmi Samir Mahajan ◽  
Atmakalyani Rashmi Shah ◽  
Apexa Prakash Jain
Keyword(s):  
Herpes Zoster ◽  
Lupus Erythematosus ◽  
De Novo ◽  
Clinical Manifestations ◽  
Pemphigus Vulgaris ◽  
Clinical History ◽  
Skin Lesions ◽  
Enzyme Linked Immunosorbent Assay ◽  
Oral Acyclovir ◽  
Varicella Zoster

Introduction: Herpes Zoster (HZ) is caused by reactivation of Varicella Zoster Virus (VZV). It is characterised by occurrence of grouped vesicles on erythematous base which involves the entire dermatome innervated by a single spinal or cranial sensory ganglion and is associated with radicular pain. Antivirals (Acyclovir, Famciclovir and Valacyclovir) started within 72 hours of onset of lesions are the agents of choice. Aim: To study the clinical manifestations, comorbidities, efficacy and safety of Acyclovir, complications and sequelae associated with HZ. Materials and Methods: A 3-year longitudinal cohort study was conducted in 212 adult patients (>18 years of age) suffering with HZ in the Department of Dermatology, Dhiraj General Hospital, Pipariya, Gujarat, India. In this study 212 patients with HZ were prescribed oral Acyclovir in a dose of 800 mg 5 times a day for 7 days. All patients were analysed in terms of clinical manifestations, pre-existing co-morbidities and incidence of complications. The clinical history and findings were recorded in a prestructured proforma. All patients were subjected to cytological examination (Tzanck smear) and Human immunodeficiency viruses (HIV) testing Enzyme-Linked Immunosorbent Assay (ELISA). Diagnosis was made primarily on the basis of clinical findings and presence of multinucleated giant cells in Tzanck smear. All the patients were treated with Oral Acyclovir. Cases were followed-up fortnightly for six weeks and evaluated for relief of symptoms, treatment outcome and complications/sequelae. Results: Two hundred and twelve cases were studied. One hundred and forty-two cases were in the 4th and 5th decades of life. Sixty-three cases had comorbidities like diabetes mellitus in 31, autoimmune diseases like pemphigus vulgaris, systemic lupus erythematosus, rheumatoid arthritis and inflammatory bowel disease in 19 and AIDS in 8 cases. Five cases had malignancy/lymphomas and were receiving chemotherapy for the same. In the majority, HZ occurred de novo without any comorbidities. The most common dermatomes involved were cervical and thoracic. Out of 212 cases Oral Acyclovir 800 mg was well tolerated by 74. Most common complication was Postherpetic Neuralgia (PHN), seen in 80 cases. Conclusion: The treatment of HZ with Oral Acyclovir 800 mg 5 times a day for 7 days is efficacious for healing of skin lesions and also reduces the chances of PHN if instituted within 72 hours.

scholarly journals A study on clinical characteristics of herpes zoster in a tertiary care center

2017 ◽  
Vol 3 (1) ◽  
pp. 79
Author(s):  
Rachana R. ◽  
Shivaswamy K. N. ◽  
Anuradha H. V.
Keyword(s):  
Herpes Zoster ◽  
Clinical Characteristics ◽  
Care Center ◽  
Tertiary Care ◽  
Age Groups ◽  
Age Group ◽  
Female Ratio ◽  
Varicella Zoster ◽  
Medical College ◽  
Male To Female

<p class="abstract"><strong>Background:</strong> <span lang="EN-IN">Herpes zoster (HZ), also known as shingles, derived from the Latin word Cingulum, for “girdle”. This is because a common presentation of HZ involves a unilateral rash that can wrap around the waist or torso like a girdle. HZ results due to reactivation of an earlier latent infection with the varicella zoster virus (VZV) in dorsal root ganglia. It occurs at all age groups, common over 60 years of age. It is estimated that in non-immune populations, approximately 15 cases per 1000 people occur per year. The objective of the study was to study the clinical characteristics in patients with uncomplicated herpes zoster.</span></p><p class="abstract"><strong>Methods:</strong> A total of 72 patients attending dermatology OPD at Ramaiah medical college between June 2013 to September 2014 were recruited after obtaining informed consent. A detailed history regarding onset of rash, pain, progression, duration and distribution of the lesions were recorded. Demographic information including age, sex, and any other co morbidities noted. Tzanck smear and serology for HIV was done where-ever necessary.<strong></strong></p><p class="abstract"><strong>Results:</strong> <span lang="EN-IN">Of the 72 patients, females outnumbered males [M=35(48.61%), F=37 (51.39%)] with male to female ratio of 0.9 to 1. The mean age of presentation was 58±18 years. Majority of the patients (54%) were in the age group of 51 to 70 years followed by 31-50 years (25%). Least number of cases (9%) was in the age group of 21 to 30 years. Of the 72 subjects, thoracic involvement was noted in 30.6%, followed by lumbar (22%), and trigeminal (16%). Cervical (4%) and sacral (2%) involvement was the least. </span></p><p class="abstract"><strong>Conclusions:</strong> <span lang="EN-IN">Herpes zoster commonly occurs in old age and the presenting symptom being pain and burning sensation. Thoracic dermatome is the commonest site. Immunocompromised states like diabetes, malignancy and HIV can increase the risk of developing herpes zoster.</span></p>

scholarly journals Prevalence of human herpesvirus 8 antibodies in the population of Belém, Pará, Brazil

2002 ◽  
Vol 44 (6) ◽  
pp. 309-313 ◽  
Author(s):  
Ronaldo B. FREITAS ◽  
Maria Rute FREITAS ◽  
Alexandre C. LINHARES
Keyword(s):  
Geometric Mean ◽  
Age Groups ◽  
Human Herpesvirus ◽  
Human Herpesvirus 8 ◽  
Enzyme Linked Immunosorbent Assay ◽  
Serum Samples ◽  
Herpesvirus 8 ◽  
North Brazil ◽  
Significant Difference ◽  
Male Subjects

Serum samples from 497 children and adults inhabiting two neighbourhoods (Guamá and Terra Firme) in Belém, Pará, North Brazil were screened for the presence of human herpesvirus 8 (HHV-8) antibody using an enzyme-linked immunosorbent assay. An overall 16.3% prevalence was found for these urban communities. Taken both genders together, prevalence rates of HHV-8 antibody increase gradually, across age-groups, ranging from 12.0% to 33.3%. When seroprevalence is analysed by gender, similar rates are found for female (18.4%) and male (14.0%) individuals. In the former gender group, seroprevalence rates increased from 10.3%, in children <FONT FACE=Symbol>£</FONT> 10 years of age, to 30.0% in adults 41-50 years of age. Conversely, among male subjects, the prevalence of HHV-8 antibodies decreased from 13.3% in children/young adults aged <FONT FACE=Symbol>£</FONT> 10 to 20 years of age to 6.1% in adults aged 21-30 years. From the 31-40 year-old group male onwards, seropositivity rates increased gradually, ranging from 8.3% to 66.7%. A significant difference in seropositivity rates was noted when comparing 21-30 age groups for female and male subjects: 23.3% and 6.1%, respectively (P = 0.03). Geometric mean optical densities were found to increase slightly from the lower to the higher age-groups. Our data suggest that transmission of HHV-8 occurs frequently in the general urban population of Belém, and that prevalence of antibody seems to increase with age.

scholarly journals Herpes Zoster Radiculomyelitis With Aquaporin-4 Antibodies: A Case Report and Literature Review

2020 ◽  
Vol 11 ◽  
Author(s):  
Hiroto Eguchi ◽  
Haruka Takeshige ◽  
Sho Nakajima ◽  
Masayoshi Kanou ◽  
Asuka Nakajima ◽  
...  
Keyword(s):  
Case Report ◽  
Herpes Zoster ◽  
Healthy Woman ◽  
Aquaporin 4 ◽  
Enzyme Linked Immunosorbent Assay ◽  
Varicella Zoster ◽  
Initial Symptoms ◽  
A Cell ◽  
Specific Igg ◽  
Upper Thoracic

Background: The relationship between varicella-zoster virus (VZV)-associated myelitis and aquaporin-4 immunoglobulin-G (AQP4-IgG) remains unknown.Case Report: We report a case of acute radiculomyelitis with longitudinal extensive hyperintensity signals traversing the brainstem until the upper thoracic cord in a 55-year-old healthy woman following herpes zoster infection in the left C4-T3 dermatome. VZV-specific IgG in the cerebrospinal fluid (CSF) and AQP4-IgG positivity on enzyme-linked immunosorbent assay (ELISA) were undetectable. Thus, she was diagnosed with immune-competent VZV radiculomyelitis. Forty-two months later, she experienced a relapse, and AQP4-IgG positivity was detected on ELISA. A cell-based assay (CBA) showed AQP4-IgG positivity not only at the time of recurrence but also retrospectively at 1 month after the initial symptoms. We concluded that AQP4-IgG-positive neuromyelitis optica spectrum disorder (NMOSD) was concurrent with VZV myelitis. After the second attack, she was treated with azathioprine and has had no relapse since then.Conclusion: We reported a case of VZV radiculomyelitis with confirmed concurrent AQP4-IgG positivity. NMOSD induced by herpes zoster has been recently identified, but distinguishing it from VZV myelitis can be difficult and whether these two diseases aggravate each other is unknown. Awareness of the potentially varied presentation of VZV myelitis can enable earlier recognition and proper treatment.

scholarly journals Varicella Zoster Antibodies after Herpes Zoster, Varicella and Multiple Sclerosis

1997 ◽  
Vol 24 (2) ◽  
pp. 137-139 ◽  
Author(s):  
R.T. Ross ◽  
L.E. Nicolle ◽  
M.R. Dawood ◽  
Mary Cheang ◽  
C. Feschuk
Keyword(s):  
Herpes Zoster ◽  
Virus Infection ◽  
Varicella Zoster Virus ◽  
Population Group ◽  
Population Based ◽  
Postal Code ◽  
Enzyme Linked Immunosorbent Assay ◽  
Varicella Zoster Virus Infection ◽  
Varicella Zoster ◽  
Physician Care

ABSTRACT:Background:We previously showed that Manitoba Hutterites seek physician care for varicella zoster virus infection significantly less than non-Hutterites. The current study was undertaken to measure varicella zoster virus seroprevalence for Hutterite and non-Hutterite controls.Methods:Blood was obtained from 315 Hutterites and 259 similar age and sex controls at the time of blood donations to The Canadian Red Cross Society. The controls were from the same or a contiguous postal code area and were collected at the same time as the Hutterite samples. The immune status of the specimens was determined by the ELISA method (enzyme linked immunosorbent assay).Results:Twenty-eight per cent of 315 Hutterites had no immunity and an additional 25% had only marginal immunity. Among the 259 controls, 10% had no immunity and an additional 10% had only marginal immunity (p < .0001).Conclusions:Manitoba Hutterites have significantly decreased seroprevalence to varicella zoster virus infection. This study of serum varicella zoster virus antibodies verifies a previous population based study that demonstrated the relative rarity of varicella and herpes zoster among a particular population group.

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