Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and low-seropositive healthy adults

Macaladad, N.; T, Marcano; Guzmán, Manuel; Moya, Jaynier; Cruz, Fermín Jurado-Santa; Thompson, Macy A; Meechan, C; Li, D.; Schlienger, Katia; Chan, Ivan S. F.; Sadoff, Jerald C.; Schödel, Florian; Silber, Jeffrey L.

doi:10.1016/j.vaccine.2006.11.011

Cited by 47 publications

(23 citation statements)

References 15 publications

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“…Zostavax is generally well tolerated in subjects 50 to 59 years of age and in subjects Ն60 years of age, consistent with data from previously reported Zostavax clinical trials (6,17,20,23,24,29,31). Although the proportions of subjects who reported nonserious clinical AEs were generally higher in the group comprised of subjects 50 to 59 years of age than in the group comprised of subjects Ն60 years of age, most were mild or moderate in intensity.…”

Section: Discussionsupporting

confidence: 87%

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

Sutradhar

Wang

Schlienger

et al. 2009

Clin Vaccine Immunol

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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.Herpes zoster (HZ), also known as shingles, is a manifestation of reactivation of varicella-zoster virus (VZV), which, as a primary infection, is responsible for chickenpox (varicella). The incidence and severity of HZ increase with age (14,26,28). In the United States, Canada, and Europe, the overall annual incidence of HZ is consistently estimated to be 3 to 4 per 1,000 population (1,7,8,11,15,18,22). The annual risk of developing HZ increases markedly around 50 years of age and rises sharply afterwards, up to 1% per year among those over 75 years of age. The lifetime risk of HZ is estimated to range from 10% to 30% in the general population, with estimates closer to 30% in recent studies (2,4,5,8,14,15), and is as high as 50% in individuals reaching 85 years of age (14,26,32).Zostavax (live zoster vaccine), a vaccine for the prevention of HZ (shingles) in individuals Ն60 years of age, has been recently licensed in the United States (3, 13, 30) and was subsequently licensed by the European Union for the prevention of HZ and HZ-related postherpetic neuralgia (PHN) in individuals Ն50 years of age (9). As demonstrated by the Shingles Prevention Study (SPS), Zostavax has been shown to reduce the incidence of HZ and PHN in adults Ն60 years of age and to lessen acute and chronic pain associated with HZ, presumably through boosting of VZV-specific immune responses (19,24). The SPS demonstrated that the VZV antibody (Ab) response correlated with vaccine effect in preventing HZ (19).Two recent studies of Zostavax enrolled su...

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Section: Discussionsupporting

confidence: 87%

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

Sutradhar

Wang

Schlienger

et al. 2009

Clin Vaccine Immunol

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“…[7][8][9][10][11][12][13][14][15][16][17] In these studies, the overall incidence of systemic clinical adverse experiences (AEs) following a dose of ZV is similar to that following a dose of placebo. The incidence of vaccine-related systemic clinical AEs is slightly higher after a dose of ZV than after a dose of placebo, but no particular systemic AE is consistently reported at a higher rate among ZV recipients across studies.…”

Section: Discussionmentioning

confidence: 99%

Safety and tolerability of zoster vaccine in adults ≥60 years old

et al. 2011

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“…17 In people who are seronegative, the vaccine is likely to be well tolerated and immunogenic, although the incidence of injection site reactions may be slightly higher. 31 It is not necessary to provide laboratory evidence of a history of chickenpox in adults over 50 years of age before administering zoster vaccine. However, serologic testing prior to zoster vaccination is recommended for people with asymptomatic HIV infection or those who anticipate significant immunocompromise in the future.…”

Section: Vaccination Of Other Groupsmentioning

confidence: 99%

Adverse events following vaccination of older people may be under‐reported

Clothier

Crawford

Russell

et al. 2017

Medical Journal of Australia

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 Herpes zoster or 'shingles' is a localised, painful, vesicular skin rash resulting from reactivation of the same virus (the varicella-zoster virus) that causes chickenpox earlier in life. Shingles can affect any part of the body but the rash classically takes the shape of a belt or band in the thoracic or lumbar region. Although usually self-limiting, shingles can lead to post-herpetic neuralgia (PHN), a chronic neuropathic pain syndrome, and other complications. About 20-30% of people will have shingles in their lifetime, most after the age of 50 years. Older people (particularly those aged over 70 years) are also more likely to have shingles complicated by PHN. Who should be vaccinated There is one zoster vaccine that is registered for use in people aged 50 years and over as a single dose. It is recommended for adults aged 60 years and over who are not immunocompromised. Zoster vaccine is funded under the National Immunisation Program for persons aged 70 years, with catch-up for those aged 71-79 years also funded until October 2021. Who should not be vaccinated People who are immunocompromised due to disease or medication, pregnant women, and those who have previously had anaphylaxis to any VZV-containing vaccine or its components should not receive the zoster vaccine. Vaccine The vaccine contains live attenuated varicella-zoster virus. The amount of virus in the zoster vaccine is approximately 14 times greater than in varicella (chickenpox) vaccines. Vaccination of people aged 70-79 years is estimated to prevent about 41% of the cases of shingles and two-thirds of post-herpetic neuralgia cases in that population. In vaccinated people in whom an episode of shingles occurs, the pain, severity and duration is reduced by 50%. Protection from vaccination tends to decline with older age at vaccination and the time since vaccination. However, a booster dose is not currently recommended. Medical therapy (such as analgesics and antivirals) should still be considered for treatment of shingles, regardless of the patient's immunisation status. The vaccine is safe and well tolerated among immunocompetent individuals aged 50 years and over in clinical trials and post-licensure studies. Mild reactions at the injection site, such as pain, swelling and redness, are likely to occur in approximately 50% of vaccine recipients.

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Safety and immunogenicity of a zoster vaccine in varicella-zoster virus seronegative and low-seropositive healthy adults

Cited by 47 publications

References 15 publications

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

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

Safety and tolerability of zoster vaccine in adults ≥60 years old

Adverse events following vaccination of older people may be under‐reported

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