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A subclinical primary infection of the genital tract would be of little clinical or public health significance if a vaccine prevented both symptomatic genital herpes and the establishment of latent infection in sensory ganglia. A third possibility would be the development of a vaccine that provides partial protection against symptomatic genital herpes i. In this setting, immunization would be expected to completely prevent symptomatic genital herpes in some individuals and reduce the severity of the primary infection in others.
This situation might be analogous to the milder course of influenza seen in some people who receive the influenza virus vaccine but still become symptomatically infected [ ]. On the basis of animal studies [ 36 , 37 ], vaccines would also partially protect the ganglia, resulting in a reduction in the magnitude of the latent infection and a significant decrease in the frequency and severity of recurrent infections.
Vaccine recipients who become subclinically infected would be intermittently at some risk for transmitting the infection to susceptible partners. However, it is likely that subclinically infected vaccine recipients may shed smaller amounts of virus and shed less frequently than do nonimmunized infected persons, thus making them less contagious than those who become asymptomatically infected without the benefit of the vaccine.
Although subclinically infected immunized people might inadvertently spread infection to others with resultant disease, this problem might be effectively managed by universal immunization, so that immunized persons exposed to someone who is shedding virus in the absence of symptoms might become infected but would not have clinical disease.
If the vaccine altered the natural history of genital herpes so that those persons who became infected were less contagious and also made those who were uninfected less susceptible, the net effect would be to reduce the spread of genital HSV infection. When anticipating the effect of a vaccine on the spread of genital herpes, it must be considered whether a partially effective vaccine might facilitate the spread of infection by encouraging some people to engage in riskier sexual behaviors. Therefore, the issue of whether a partially protective vaccine would have a positive or negative impact on the epidemic of genital HSV infection is an important public health question that demands thorough examination.
A partially protective vaccine, however, would be expected to reduce the likelihood of developing symptomatic disease, thereby preventing the pain and discomfort associated with genital herpes. Two other important issues regarding the use of a vaccine that prevents genital HSV disease, but not infection, are whether the vaccine will impact the spread of virus from infected mother to fetus or infant and whether subclinical genital infection in immunized subjects places them at any increased risk of acquiring HIV infection through sexual exposure.
The HSV vaccines currently in development are intended for the prevention of genital herpes. The choice of genital herpes rather than another HSV disease to assess vaccine efficacy and safety is based on public health need, perceived market size, and the feasibility of conducting vaccine trials. On the basis of our understanding of the pathogenesis and immunobiology of the different HSV diseases, it is likely that a vaccine that does not prevent infection will be useful in controlling some illnesses but not others.
The possible effects of a genital herpes vaccine on nongenital HSV infections are summarized in table 3. Although it may be possible to directly assess vaccine efficacy for relatively common illnesses such as herpetic gingivostomatitis, for uncommon conditions direct assessment will be problematic. The potential for success and the special issues related to vaccine evaluation in nongenital herpetic illnesses are discussed next.
There is an obvious need for more effective strategies for protecting the newborn from HSV infection. Because of the natural history of neonatal herpes, immunization of the newborn with a safe vaccine would, at best, have limited effectiveness. An alternative strategy would be to immunize women before or possibly during pregnancy.
Epidemiological data suggest that immunization of women might afford some protection to the fetus or neonate, even if the vaccine does not completely prevent maternal genital HSV infection. Depending on the effectiveness of the passively acquired antibody, maternal immunization might also afford the infant some protection against infection acquired in the postpartum period. Because of the low incidence of neonatal herpes, it would be impractical to conduct clinical trials specifically designed to assess the effectiveness of maternal immunization in preventing neonatal infection.
Effectiveness might be assessed indirectly by population-based surveillance programs designed to determine the impact of immunization on the incidence of neonatal herpes. Oral-facial herpes. An effective vaccine for genital herpes could have a significant effect on oral-facial herpes and its complications. This effect might come about in 3 ways: 1 reduction in the severity of primary and recurrent oral-facial diseases; 2 reduction of virus excretion associated with primary and recurrent oral-facial diseases, with reduced transmission of the virus; and 3 increased resistance to acquisition of the infection.
Initial assessment of the efficacy of a vaccine for oral-facial infections might be conducted in seronegative college students. The impact of vaccination on controlling oral-facial infection would depend on the immunization plan universal immunization in childhood vs. A program of universal childhood immunization might over time gradually lower the prevalence of HSV-1 and HSV-2 infections with a concomitant reduction in associated morbidity. Given the widespread nature of oral-facial HSV infections, mass childhood immunization would appear to be the preferred strategy.
Herpetic keratitis. An HSV vaccine could impact the frequency of herpetic keratitis directly or indirectly. A vaccine may indirectly reduce the risk of ocular disease by lowering the frequency and severity of oral-facial disease and the likelihood of virus transmission. Stromal keratitis may be an immunopathologic disease determined by the immune characteristics of the host.
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Accordingly, alteration of the immune status of someone with ocular herpes with a vaccine should be approached with caution, and persons with preexisting ocular disease probably should be excluded from an immunization program. However, preliminary data indicate that an HSV glycoprotein vaccine injected subcutaneously did not exacerbate preexisting or postimmunization experimental ocular HSV infection in mice [ ].
Limited epidemiological data suggest that the incidence of ocular herpes is too low to permit direct evaluation of the efficacy of an HSV vaccine in controlling ocular disease. Effectiveness might be assessed indirectly by developing population-based surveillance programs to determine the impact of immunization on preventing ocular herpes after vaccine licensure. Herpetic encephalitis. The effects of a genital herpes vaccine on HSV encephalitis after the neonatal period are difficult to estimate, unless the vaccine is completely protective against HSV infection.
The effect of enhancing immunity to HSV without protection against infection is difficult to predict since HSV encephalitis is not increased in incidence or severity in immunocompromised patients e. Clinical trials of HSV vaccines to determine their effects on HSV encephalitis would be impractical because of the large number of subjects required for appropriate statistical power. The effect of a vaccine on herpetic encephalitis could be assessed only by population-based surveillance studies.
Dermatological complications. A prophylactic vaccine effective against genital herpes caused by HSV-1 or HSV-2 would probably prevent most cases of eczema herpeticum, if given universally at a population level in early childhood. Because of our incomplete understanding of the pathogenesis of erythema multiforme, the effect of an HSV vaccine is difficult to predict.
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It will not be possible to directly assess the effect of HSV vaccines on dermatological complications; rather, the impact will be determined after universal childhood or adolescent prophylactic vaccination through postmarketing surveillance programs. The need for a vaccine to control genital herpes has been acknowledged for decades. Recent recognition of the extent of asymptomatic and underrecognized genital herpes and the frequency of HSV shedding in the genital tract emphasize that a vaccine is the only practical measure to control disease and the spread of infection.
From earlier discussions, it is clear that the morbidity, mortality, and likely economic impact of nongenital HSV infections are also significant. Therefore, broadening the target population for an HSV vaccine beyond those persons at risk for genital herpes should be considered. It will also be important to reach a consensus regarding the goals for an HSV vaccine. Should we insist that a vaccine provide complete protection against infection or is this an unrealistic goal? The recent failure of a recombinant subunit vaccine to prevent infection suggests that it may be so.
Prevention or amelioration of disease with or without partial protection against infection may be achievable, but it is difficult to know whether a partially protective vaccine will favorably impact the ongoing epidemic of genital herpes. In considering the potential benefit of an HSV vaccine that prevents disease but not infection, it is worth noting that other vaccines including pertussis vaccine [ — ] and influenza virus vaccine [ — ] also prevent disease without preventing infection.
As discussed earlier, there are some theoretical benefits and potential problems that could be associated with use of an HSV vaccine that prevents disease but not infection. The extent of the benefits and the problems will be influenced by how widely and at what age the vaccine is used i.
Immunization of targeted groups may benefit the vaccine recipient but may have little impact on public health. Alternatively, universal immunization in infancy with administration of a booster dose in adolescence might protect the vaccine recipient against symptomatic oral-facial, ocular, and genital herpes and also reduce the risk of spread to people who are not immunized. Although the latter strategy is the most expensive, it could be incorporated into existing pediatric vaccine regimens, and prevention of all HSV diseases would have significant medical and economic benefits.
With promising new HSV vaccines in clinical trials, now is the time for public discussion regarding how these vaccines should be used and their potential cost-effectiveness, benefits, and limitations. Oxford University Press is a department of the University of Oxford. It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide.
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