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study confirms vaccination of older adults for herpies works

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January 18, 2011 — A new community-based study confirms that vaccination of adults older than 60 years with the herpes zoster vaccine (Zostavax, Merck & Co Inc) reduced subsequent herpes zoster cases by about 50% compared with those not vaccinated.

The study, using real-world data on people enrolled in the Kaiser Permanente Southern California health plan, is published in the January 12 issue of the Journal of the American Medical Association.

Dr. Hung Fu Tseng

The vaccine was approved by the US Food and Drug Administration (FDA) in 2006 and recommended for use in adults 60 years and older without contraindications by the Advisory Committee on Immunization Practices, Centers for Disease Control and Prevention (CDC), in 2007 when the practice was taken up in the Kaiser system, said lead study author Hung Fu Tseng, PhD, MPH, research scientist and epidemiologist at Kaiser Permanente Department of Research and Evaluation in San Francisco, California.

"What we found was that the vaccine performed similar to what has been found in the clinical trial data, and in addition, we found that the vaccine also works among the oldest old...as well as among people with chronic conditions and those of various racial groups," he told Medscape Medical News.

In a separate publication, a new study from CDC shows that at least by 2008 less than 7% of US seniors had chosen to get the herpes zoster vaccine. Investigators, with lead study coauthor Gary Euler, an epidemiologist with the CDC’s National Center for Immunization and Respiratory Diseases, found low overall rates of vaccination that were particularly low among minority groups.

These findings are published online and will appear in the February issue of the American Journal of Preventive Medicine.

Shingles Prevention Study

The pain of herpes zoster is often disabling and can last for months or years, a complication called postherpetic neuralgia, the study authors write. About 1 million cases occur each year in the United States. Except for age and immunosuppression, risk factors are not really known, they note.

Results of the Shingles Prevention Study (SPS) showed that a vaccine prepared from the Oka/Merck strain of varicella zoster virus reduced the incidence of herpes zoster by about 51% (P < .001) and of postherpetic neuralgia by 67% (P < .001) among some 38,546 participants older than 60 years but without a history of herpes zoster, immunosuppression, or other conditions that would prevent participation (N Engl J Med. 2005;352:2271-2284).

In this study, Dr. Tseng and colleagues aimed to see whether these benefits in the "idealized" clinical trial setting would translate to the community when the vaccine was used in clinical practice. "This is particularly important for herpes zoster vaccine, given the medical and physiological diversity in the elderly population for whom the vaccine is indicated and since there are stringent storage and handling requirements for this live-attenuated vaccine," they write.

The researchers conducted a retrospective cohort study comparing the risk for herpes zoster among 75,761 plan members 60 years and older who were immunocompetent and received the vaccine with that of 227,283 unvaccinated age-matched members who did not receive the vaccine (matching of 3 unvaccinated members for each 1 vaccinated).

Compared with the unvaccinated cohort, vaccine recipients were more likely to be white, to be women, and to have had more outpatient visits and a lower prevalence of chronic diseases.

There were 5434 herpes zoster cases identified in the study, 6.4 cases per 1000 person-years among those vaccinated vs 13.0 cases per 1000 person-years among unvaccinated individuals. In the fully adjusted analysis, vaccination was associated with a 55% reduced risk for herpes zoster.

Table 1. Herpes Zoster Cases With Vaccine vs No Vaccine

Endpoint Vaccinated (95% CI) Unvaccinated (95% CI) Hazard Ratio (95% CI) Herpes zoster cases (per 1000 person-years)6.4 (5.9 – 6.8)13.0 (12.6 – 13.3)0.45 (0.42 – 0.48)

CI = confidence interval

The reduction in risk did not vary by age at vaccination, sex, race, or presence of chronic diseases, the study authors write. Of note was the effect in those older than 80 years where there was still significant benefit from the vaccine, a finding that was divergent from findings of the SPS, Dr. Tseng said.

Vaccine recipients also had reduced risks for ophthalmic herpes zoster and hospitalizations coded as herpes zoster.

Table 2. Risk for Ophthalmic Herpes Zoster and Herpes Zoster Hospitalizations With Vaccine vs No Vaccine

Outcome Hazard Ratio (95% CI) Ophthalmic herpes zoster0.37 (0.23 – 0.61)Hospitalizations coded herpes zoster0.35 (0.24 – 0.51)

CI = confidence interval

Because the vaccine was only licensed 4 years ago, the durability of its protection needs to be assessed in future studies, the study authors write. "Meanwhile, however, this vaccine has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally."

To date, uptake of the vaccine "has been poor due to weaknesses in the adult vaccine infrastructure and also due to serious barriers to the vaccine among clinicians and patients," they conclude. "Solutions to these challenges need to be found so that individuals seeking to receive herpes zoster vaccine will be able to reduce their risk of experiencing this serious condition.

"I think the implication is because the lifetime risk is about 30% and the risk of shingles increases with age, persons over the age of 60 should probably consider talking with their physician about the possibility of receiving the vaccine to reduce the risk, and the physician can evaluate if the person is eligible or in healthy condition to receive the vaccine," Dr. Tseng concluded.

People ineligible for vaccination include those taking immunosuppressant agents, those who have leukemia or lymphoma, those who are HIV positive, or those who have had allergic reactions to components of the vaccine, he added.

Merck & Co Inc has applied to the FDA for use of the vaccine in those aged 50 to 59 years on the strength of a study showing a 70% reduction in zoster cases among vaccinated subjects over placebo. That study was presented at the 48th Infectious Diseases Society of America meeting in Vancouver, British Columbia, Canada.

Results Mirror Trials

Asked for comment on the study, Karen Roos, MD, John and Nancy Nelson Professor of Neurology and professor of neurological surgery at Indiana University School of Medicine, Indianapolis, and a member of the American Academy of Neurology, said that as the study authors note, these new results mirror those from the original clinical trials of the herpes zoster vaccine.

"The vaccine is associated with a 51% to 55% reduction in the incidence of herpes zoster," Dr. Roos told Medscape Medical News. "We do not know an individual's risk of zoster," she noted, "or what causes the virus to reactivate."

However, she pointed to some limitations of the study, including the retrospective design and relatively short period of follow-up, so that it's not clear at this time whether protective immunity declines over time. "Is the individual protected for 1 year, 2 years, 3 years?" she said.

Finally, Dr. Roos said, the study authors do not report adverse events related to the vaccine. "In the original Shingles Prevention Study, there were more cardiac events in the vaccine recipients than in the placebo recipients."

The study did not receive external funding. Dr. Tseng reports having received research funding from Merck for other vaccine studies. Disclosures for the coauthors appear in the original paper. Dr. Roos has disclosed no relevant financial relationships.

JAMA. 2011;305:160-166. Abstract

Clinical Context

In the United States, the annual incidence of clinical herpes zoster infections is approximately 1 million, with age and immunosuppression being known risk factors. The pain of postherpetic neuralgia is often severe, disabling, and persistent for months or even years, and additional complications may include ophthalmic herpes zoster.

Herpes zoster vaccine is effective in a select study population under idealized circumstances, based on prelicensure data, but the vaccine needs to be assessed in field conditions, particularly in the elderly population. In addition, uptake of herpes zoster vaccine has been poor because of weaknesses in the adult vaccine infrastructure and because of barriers to uptake among clinicians as well as patients.

Study Highlights

  • The goal of this retrospective cohort study was to assess the risk for herpes zoster infection among individuals who had received herpes zoster vaccine in general practice settings.
  • From January 1, 2007, through December 31, 2009, a total of 75,761 immunocompetent, community-dwelling adults 60 years or older who were enrolled in the Kaiser Permanente Southern California health plan received herpes zoster vaccine.
  • These participants were age matched (1:3) to 227,283 unvaccinated members.
  • The primary study endpoint was the incidence of herpes zoster.
  • Compared with unvaccinated members, those who received herpes zoster vaccine were more likely to be white, to be women, to have more outpatient visits, and to have fewer chronic diseases.
  • Among vaccinated members, there were 828 herpes zoster cases in 130,415 person-years (6.4 per 1000 person-years; 95% confidence interval [CI], 5.9 - 6.8).
  • For unvaccinated members, there were 4606 herpes zoster cases in 355,659 person-years (13.0 per 1000 person-years; 95% CI, 12.6 - 13.3).
  • Vaccination was associated with an overall 55% reduced risk for herpes zoster (hazard ratio
    , 0.45; 95% CI, 0.42 - 0.48), based on an adjusted analysis.
  • These results would be consistent with an absolute reduction in herpes zoster risk for 1.4% at 30 months of follow-up, or 1 episode of herpes zoster prevented for every 71 persons vaccinated.
  • Reduction in risk did not vary by age at vaccination, sex, race, or presence of chronic diseases.
  • These findings did not appear to be the result of bias because the risk for herpes zoster differed by vaccination status to a greater extent than did the risk for unrelated acute medical conditions.
  • Vaccinated recipients were less likely than unvaccinated members to have ophthalmic herpes zoster (HR, 0.37; 95% CI, 0.23 - 0.61) and hospitalizations coded as herpes zoster (HR, 0.35; 95% CI, 0.24 - 0.51).
  • On the basis of these findings, the investigators concluded that among immunocompetent community-dwelling adults 60 years or older, vaccination against herpes zoster was associated with a lower incidence of herpes zoster among all age strata and among individuals with chronic diseases.
  • Therefore, these results support recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population.
  • For the oldest group, the reduction in their relative risk for herpes zoster could translate into a very large absolute reduction in disease, because they bear the greatest burden of herpes zoster and postherpetic neuralgia and are also especially vulnerable to these disabling conditions.
  • Limitations of this study include study cohort derived from a fully insured population in 1 region of the country, limiting generalizability; and inability to determine severity or duration of symptoms.
  • In addition, the efficacy of herpes zoster vaccine to prevent postherpetic neuralgia could not be determined, average length of follow-up was short, and misclassification was possible.
  • The investigators note that because herpes zoster vaccine was recently licensed, the durability of its protection needs to be determined in future studies, but it has the potential to annually prevent tens of thousands of cases of herpes zoster and postherpetic neuralgia nationally.

Clinical Implications

  • Among immunocompetent, community-dwelling adults 60 years or older, vaccination against herpes zoster was associated with a lower incidence of herpes zoster overall, based on a retrospective cohort study.
  • Reduction in the risk for herpes zoster seen with vaccination was observed among all age strata and among individuals with chronic diseases, supporting recommendations to offer herpes zoster vaccine to eligible patients of all ages, including the oldest population.

CME Test

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helpiamconfused2

What does this mean for people w/ hsv1 or 2?

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Herpes Awareness
What does this mean for people w/ hsv1 or 2?

nothing...

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Pattycake928

Lets' hope they can find something for us

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soul5821

the only way that we can find out about if this vaccine work for hsv1 or 2 its taking it, I'm willing to take the vaccine, it has very low side effects... I'm just waiting to talk with my doctor and see if he is available to do so.

For many years I was using a drug for herpes zoster to treat my hsv2 with excellents results... Everyone its different, herpes zoster hides on the nerves as well hsv1 and 2 so i will think that the vaccine could help in some way...

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package deal

I beleive it for both. This may not really help us as we already have herpies but this could keep others protected from getting it

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camomile

Withbaggage

Shingle vaccine is for elderly ppl in this country where I live but I might look into it.

Soul, I might follow suit...:)

Thanks. xxx

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helpiamconfused2

Does the chickenpox hide out in the ganglia, etc like herpes does? If so, then why the hell can't they apply the same technology for hsv...

I see the reason behind the logic - makes sense...

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hfighter

Yeah mee too, I dont undestand why there is a vaccine for herpes zoster but not for herpes simplex

I remember that when I asked with my doctor about why I didn't get the first horrible VHS outbreak as most people do when they are infected for the first time he told me that the reason why is beacause I have had "varicella" when I was a kid, so I already had herpes, that why I became infected but asyntomatic because I had antibodies since my childhood.

I think this could help us if we decide to try it. Good news

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Katiehope

I think I'm going to try it. I got permission from my doc to get the shot. I'm only 45 and I know it's a long shot but maybe it will have some cross-protection that will at least reduce my constant OB's. Once I get over the fear of having the shot and any negative side effects I'll keep you posted to see if it helps.

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soul5821

Why u should have negative effects?

Don't undertand why we are so negative?... Stay positive, don't lose hope... I don't see in which way the vaccine is going to have a neg effect on you?.

Any way, if in a remote case that happens we still have valtrex and all the other antivirus drugs... If you don't try it u will never get over it...

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