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WHO's new rabies recommendations

implications for high incidence countries

Pattanaik, Amrita; Mani, Reeta S.

Current Opinion in Infectious Diseases: October 2019 - Volume 32 - Issue 5 - p 401–406
doi: 10.1097/QCO.0000000000000578
TROPICAL AND TRAVEL-ASSOCIATED DISEASES: Edited by Christina Coyle
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Purpose of review Rabies is virtually always fatal; however, it is nearly 100% preventable with timely and appropriate prophylactic immunization. This review summarizes the recently revised WHO guidelines for rabies prophylaxis published in 2018, following a scientific review by a strategic advisory group of experts on immunization. The scientific basis for the major changes and its implications for countries with high disease burden are also discussed.

Recent findings The key changes in the updated WHO 2018 guidelines for rabies prophylaxis include abbreviated vaccination regimens for pre and postexposure prophylaxis. These cost and dose-sparing regimens allow equitable sharing of vaccines, necessitate fewer clinic visits and thus can enhance patient compliance. The recommendations on rabies immunoglobulin administration permit prioritization and optimal use of this life-saving biologic, especially in areas with scarcity. However, there is a need for additional evidence to support the abridgment of some regimens and need for data on the safety and immunogenicity of these regimens in special groups such as infants and the immunocompromised.

Summary National health authorities in high incidence countries need to develop consensus for effective implementation of simplified, cost-effective, and logistically feasible regimens for rabies prophylaxis, on the basis of the revised WHO guidelines.

Department of Neurovirology, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore, India

Correspondence to Reeta S. Mani, Department of Neurovirology, National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore 560029, India. Tel: +91 8026995495; e-mail: drreeta@gmail.com

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INTRODUCTION

Rabies, one of the most dreaded neglected tropical diseases is caused by the rabies virus, the archetypal virus of the Rhabdoviridae family in the genus Lyssavirus. About 59 000 cases are being reported worldwide every year, most of which are from Asia and Africa, acquired frequently through exposure to rabid dogs. Human rabies is almost always fatal; however, it can be prevented by avoiding exposure and by prophylactic immunization. Preexposure prophylaxis (PrEP) is highly effective for those at risk of exposure like laboratory workers, veterinarians, and travelers visiting rabies endemic areas. After an exposure, prompt and correct administration of postexposure prophylaxis (PEP) that consists of wound care, infiltration of rabies immune globulin (RIG) as indicated, and administration of rabies vaccine virtually ensure survival [1▪▪,2▪▪]. Owing to competing public health priorities, rabies continues to be a neglected disease and most high incidence countries have weak rabies control programs and poor surveillance systems in place [3▪▪]. The WHO has been reviewing, updating, and putting forth recommendations for rabies PrEP and PEP regimens periodically, keeping in mind the availability and affordability of the vaccines without compromising on the quality and efficacy. These are based on clinical data that have been critically analyzed and reviewed by a group of experts in the field [4▪,5]. The updated recent WHO guidelines are published and are accessible online [1▪▪,2▪▪]. This review provides a brief outline of the recent WHO guidelines, scientific rationale for the changes and the implications for countries with high burden of human rabies.

Box 1

Box 1

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RABIES PROPHYLAXIS

The aim of PrEP is to prime the immune system by inducing the formation of rabies-neutralizing antibodies. If an exposure occurs later, a short booster course of vaccine is sufficient to elicit a rapid and high anamnestic response, obviating the use of RIG and extended PEP vaccination regimens. PEP, comprising wound cleaning, active, and passive immunization, is given as soon as possible after suspected exposure. The objective is to kill or neutralize the virus around the bite site before it gains access to the nervous system [2▪▪].

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PREEXPOSURE PROPHYLAXIS

PrEP has been considered for certain groups of individuals (occupationally exposed, children and exposed subpopulations in remote areas that are endemic for rabies). Modeling estimates indicate that PrEP, as a large-scale public health intervention, is not cost-effective and would be cost-neutral in remote settings with limited access to PEP, and if the annual dog bite incidence is more than 5% [1▪▪].

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PREEXPOSURE PROPHYLAXIS (INTRADERMAL REGIMENS)

The intradermal PrEP regimen recommended by WHO previously [6] included one-site intradermal vaccination on 3 days over a 1-month period (days 0, 7, 21/28). In the recent guidelines [1▪▪,2▪▪], WHO recommends two-site intradermal vaccination on 2 days (days 0, 7) completing the schedule in a week's time (Table 1).

Table 1

Table 1

The rationale for this change was based on a noninferiority trial in 500 healthy adults by Soentjens et al.[7▪] which compared the safety and immunogenicity of a two-visit double-dose intradermal primary vaccination [two doses of 0.1 ml intradermal of the human diploid cell culture rabies vaccine (HDCV) on days 0 and 7] and a standard three-visit schedule (single dose of 0.1 ml intradermal on days 0, 7, and 28). One to 3 years after primary vaccination, a single booster dose (0.1 ml intradermal of HDCV) was given to evaluate the anamnestic rabies antibody response. All patients in both study groups demonstrated a rabies antibody titer more than 0.5 IU/ml on day 7 following the booster dose, confirming the safety and noninferiority of the two-visit, double-dose intradermal PrEP regimen to the single-dose, three-visit schedule, in healthy adults [7▪].

An observational study in travelers by Mills et al.[8] provided evidence to suggest that a double-dose, two-visit (days 0, 7) intradermal regimen produced antibody responses consistent with the 2010 WHO-recommended intradermal PrEP regimen. Wieten et al.[9] reviewed nine studies using abbreviated intradermal PrEP regimens and concluded that dose and cost-sparing intradermal PrEP regimens are comparable alternatives to current schedules.

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PREEXPOSURE PROPHYLAXIS (INTRAMUSCULAR REGIMENS)

Current WHO guidelines [1▪▪,2▪▪] include a shortened intramuscular PrEP regimen (single-site vaccination on 2 days, day 0 and 7), compared with the earlier recommendation (single-site vaccination on 3 days, day 0, 7, 21/28) [6] (Table 1).

The rationale for change was based on indirect evidence from intradermal studies [8,9,10▪]. A prospective study by Khawplod et al.[11] in 109 volunteers indicated that one-time immunization with one full intramuscular dose or two-site intradermal injections of 0.1 ml each on a single day are adequate to prime immune memory and obtain an accelerated immune response, following booster injections (0.l ml intradermal at four sites or single-site intramuscular on days 0 and 3) a year later. Jonker and Visser [12] too demonstrated that priming with a single dose (intramuscular or intradermal) of rabies vaccine could elicit adequate anamnestic antibody response following simulated PEP a year later, even in those patients who did not achieve titers of 0.5 IU/ml after priming.

The abbreviated 1-week PrEP regimen is relevant for travelers to high-incidence regions as many leaving at short notice can complete PrEP predeparture and the costs are reduced by 30% [13▪]. In emergencies, a one-visit PrEP (Table 1) will likely confer some protection, though it is considered an incomplete course. Those who have received PrEP only on day 0 should receive another dose as soon as possible, within 1 year. In the event of a potential rabies exposure prior to the second dose, a full course of PEP (including RIG, if indicated) should be advised [1▪▪].

Currently, there is no evidence to support a two-visit PrEP regimen in immunocompromised individuals. Where serologic testing is available, clinical experience suggests that healthcare providers could administer a two-visit PrEP (days 0 and 7) regimen, followed by serology, and administer a third dose of vaccine if the patient has not adequately seroconverted [2▪▪].

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POSTEXPOSURE PROPHYLAXIS

Timely access to affordable and effective PEP is primarily hindered by high cost to the national governments and patients, the lengthy and complicated PEP regimens, low availability in remote areas, inability to forecast rabies biologics needs, and the knowledge and skills of healthcare staff [5].

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POSTEXPOSURE PROPHYLAXIS (INTRADERMAL REGIMENS)

The previous WHO-recommended regimen for intradermal PEP was the two-site updated Thai Red Cross (TRC) regimen administered on 4 days over a 1-month period (days 0, 3, 7, 28) [6]. The current guidelines primarily recommend two-site intradermal vaccination on 3 days (days 0, 3, 7) which is completed in a week's time [1▪▪,2▪▪]. The regimens for previously vaccinated individuals remain the same, that is, one-site intradermal on 2 days (days 0, 3) or four-site intradermal on 1 day is recommended (Table 2).

Table 2

Table 2

The evidence for the newly recommended three-visit 1-week intradermal schedule was based on a study by Tarantola et al.[14▪▪] on a broad range of patients exposed to sick looking or confirmed rabid dogs from the rabies clinic of the ‘Institut Pasteur du Cambodge’ (IPC). This clinical effectiveness, active follow-up study after at least 6 months found no significant difference in survival (>99%) among patients exposed to confirmed rabid dogs who received three (n = 129) versus four or more sessions (n = 1591) of two intradermal doses of purified Vero cell rabies vaccine (PVRV) with or without equine RIG. All rabies deaths (three in number) were attributed to direct nerve inoculation and/or protocol deviations [14▪▪]. In persons similarly managed after exposure to rabid-suspect, but untested dogs, no deaths were reported among 155 patients who received only three sessions versus 904 patients who received four or more sessions of vaccination (100% survival in both groups) [14▪▪].

The alternative regimens suggested in the current WHO guidelines (Table 2) are based on evidence generated from previous studies for the 1-week four-site intradermal regimen [15–17] and the 1-month, modified four-site intradermal schedule [18–20].

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POSTEXPOSURE PROPHYLAXIS (INTRAMUSCULAR REGIMENS)

The previous WHO PEP guidelines recommend three intramuscular regimens: The five-dose Essen regimen, the four-dose Zagreb Regimen, and the four-dose shortened Essen regimen [6]. In the current 2018 WHO guidelines, the abbreviation of the four-dose Essen intramuscular regimen to three doses (days 0, 3, and 7) was considered. However, because of the lack of adequate good-quality studies providing direct evidence on the three-dose regimen and for want of comparative data on the immunosuppressive effects of RIG, the shortened Essen regimen (wherein the fourth dose can be given at any time between days 14 and 28) is retained along with the three-visit Zagreb intramuscular regimen. There is no change in guidelines for the previously vaccinated individuals, which is one-site intramuscular on 2 days (days 0, 3) [1▪▪,2▪▪,5] (Table 2).

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ADMINISTRATION OF RABIES IMMUNOGLOBULINS

The WHO 2010 guidelines stated that RIG should be administered only once as soon as possible, in all people with category III exposure and in immunodeficient people with category II exposure, within 7 days of the first vaccine dose. The calculated dose of RIG (20 IU/kg and 40 IU/kg body weight of human and equine RIG, respectively) should be administered in and around the wound site(s), with as much volume as anatomically feasible (avoiding possible compartment syndrome). The remainder should be injected intramuscularly at a distance from the site of vaccine administration. RIG can be diluted to a volume enough for all wounds to be effectively and safely infiltrated [6].

The recent WHO guidelines do not mandate the intramuscular injection of the remainder of the calculated RIG dose. Instead, the remainder can be fractionated in smaller, individual syringes and can be used for several patients, maintaining aseptic conditions. Unused fractionated doses and open vials of RIG should be discarded by the end of the day [1▪▪,2▪▪]. However, if there is a high likelihood of additional small wounds, the exposure was to a bat or in case of nonbite exposures (e.g., aerosols), injection of the remaining RIG volume intramuscularly is indicated, as close as possible to the presumed exposure site [1▪▪,2▪▪,5].

The change has been prompted by studies conducted by Bharti et al.[21▪▪,22▪▪], which indicated that passive immunization can be restricted to local infiltration of RIG, as the intramuscular dose of RIG does not result in a circulating antibody level sufficient to neutralize or kill the virus. In their study in 2016, 269 patients with suspected category III rabies exposure were administered vaccines (updated TRC regimen) and RIG volumes just enough to infiltrate wounds irrespective of body weight. The doses of RIG ranged from 0.25 to 8 ml, with an average volume of 1.26 ml, with 60–80% reduction in volume compared with the volumes calculated according to the body weight of individuals. No interference was observed between RIG and vaccine-induced neutralizing antibody titers. Within the 82% follow-up rate for a time period of over 9 months, there was a 100% survival rate [21▪▪]. Another study by Bharti et al.[22▪▪] using the same methodology, investigated 26 WHO category III rabies exposed patients who had been bitten by laboratory-confirmed rabid dogs. The patients were followed for over one year and all survived.

The recent WHO guidelines state that wherever the supply of RIG is limited, it may be used sparingly and its allocation be prioritized for patients with the highest risk such as those with multiple bites, deep wounds, bites to highly innervated parts of the body (such as head, neck, and hands), severe immunodeficiency, bites from animal with confirmed or probable rabies, and bites, and scratches or exposures of mucous membranes from a bat [1▪▪,2▪▪].

The chronic global shortage of RIG has led to the development of alternative products. WHO has promoted the use of rabies monoclonal antibodies (mAbs) which are being investigated as alternatives to RIG [23▪]. These antibodies, produced by recombinant DNA technology are suitable for large-scale production, eliminate the problems of availability and safety (compared with equine or human RIG), and appear promising in their effectiveness in preventing rabies in the high incidence countries. The first recently licensed mAb product (SII RMAb) for rabies PEP by Serum Institute of India is available for use and postmarketing surveillance is ongoing [24,25▪]. Future improvements should be considered for a ‘cocktail product’ with more than one monoclonal antibody [5].

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IMPLICATIONS OF THE NEW WHO GUIDELINES

WHO-recommended vaccine schedules of 2010 required up to five clinic visits over approximately one month. Direct (vaccine) and indirect (vaccine transport, visits to clinics, and loss of income) costs of vaccination are major deterrents to patient compliance. The significant change in the 2018 WHO recommendations for rabies prophylaxis is the shortening of all regimens. They have several practical and economic advantages. The recent guidelines on RIG usage will allow optimal use of this life-saving biologics, especially in areas with scarcity. The abbreviated regimens, particularly, the intradermal regimens, actively promoted by WHO, are cost and dose-sparing, allowing vaccine doses to be shared equitably by reducing the use [4▪,5]. However, limitations of the intradermal regimens include the availability of two vial types with different volumes of diluent (0.5 and 1 ml) which may cause confusion among health workers about the vaccine potency and intradermal dose (although WHO recommends a single intradermal dose of 0.1 ml irrespective of the diluent volume). The vaccine must be kept in cold storage and opened vials must be discarded at the end of the day. As these vaccines do not contain preservatives, they cannot be registered as multidose vials. Vaccine wastage can be a problem in clinics with lesser number of patients. Also, there is some resistance to implementing intradermal vaccination in few countries because of the ‘off-label’ recommendations [26,27▪].

Another limitation includes the lack of a good quantity of data and evidence that support the abridgment of regimens. Many studies providing evidence for the changes have small sample sizes and limited representation of various geographic regions and vaccine types/brands. Most trials were conducted in Asia and vaccine trials in African countries are underrepresented in the current literature [28▪]. For example, the IPC regimen for intradermal PEP introduced in the new guidelines is economical and requires just three clinic visits. However, it is based on the clinical evidence from a single study from Cambodia, in a small population, using one vaccine (0.5 ml, PVRV). The intradermal dose would be half as much, using a purified chick embryo cell vaccine (1 ml); however, the antibody response with this type of vaccine has not been studied using the shortened regimen [23▪,29▪]. Hence, it is important that additional local evidence is generated to strengthen available data before effecting any shortening of life-saving PEP regimens in high-burden countries. This will also meet the regulatory requirements of respective national drug regulatory authorities for change of label/package inserts of the rabies vaccines and avoid the liability of ‘off-label use’ for physicians [27▪,29▪].

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CONCLUSION

The recent WHO-recommended regimens for rabies prophylaxis offer several economic and logistic advantages. National public health authorities in high incidence countries need to develop consensus to incorporate these guidelines into national strategies directed toward the elimination of human rabies.

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Acknowledgements

None.

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Financial support and sponsorship

None.

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Conflicts of interest

There are no conflicts of interest.

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REFERENCES AND RECOMMENDED READING

Papers of particular interest, published within the annual period of review, have been highlighted as:

  • ▪ of special interest
  • ▪▪ of outstanding interest
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REFERENCES

1▪▪. WHO. World Health Organization expert consultation on rabies: third report. WHO technical report series 1012 2018.

The information in this WHO report is the most current data on rabies prevention and control and supersedes that of the report of the second WHO Expert Consultation on Rabies, published in 2013. This information is extensively used to establish public health priorities, allocate resources for disease control, and measure the impact and cost-effectiveness of interventions.

2▪▪. Vaccines Rabies. WHO position paper: April. Wkly Epidemiol Rec 2018; 16:201–220.

This position article replaces the 2010 WHO position on rabies vaccines. It presents new evidence in the field of rabies and the use of rabies vaccines with a focus on programmatic feasibility, and simplification and enhanced cost-effectiveness of vaccine regimens. Recommendations have been put forth for PEP and PrEP, including revised guidelines for the use of rabies immunoglobulins.

3▪▪. World Health Organization. World Organisation for animal health food and agriculture organization. Global alliance for rabies control zero by 30: the global strategic plan to end human deaths from dog-mediated rabies by 2030 2018.

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This study demonstrated the safety and noninferiority of the two-visit, double-dose intradermal vaccination regimen for preexposure prophylaxis compared with the single-dose, three-visit schedule in healthy adults. It provided evidence for the abridged preexposure regimens recommended in the current revised WHO guidelines.

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The recent revised WHO recommendations on usage of rabies immunoglobulins, promoting local infiltration of wounds only (without the need for systemic injection) and allocation on the basis of prioritization, especially in areas with scarcity, were based on these studies carried out in remote areas of northern India with limited access to rabies biologics.

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The recent revised WHO recommendations on usage of rabies immunoglobulins, promoting local infiltration of wounds only (without the need for systemic injection) and allocation on the basis of prioritization, especially in areas with scarcity, were based on these studies carried out in remote areas of northern India with limited access to rabies biologics.

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This clinical trial demonstrated that a rabies postexposure prophylaxis regimen containing a novel recombinant human monoclonal antibody (SII RMAb) was well-tolerated and noninferior to standard methods. This is the first rabies monoclonal antibody to be licensed for use.

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This extensive review describes new evidence for abridged vaccination schedules with a focus on the immunogenicity and effectiveness of postexposure regimens, efficacy studies in special populations and the effect of altering routes of vaccine administration.

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This article summarizes the recent changes in the WHO guidelines regarding rabies prophylaxis and its implications in India, a country with the highest burden of human rabies.

Keywords:

rabies; rabies postexposure prophylaxis; rabies preexposure prophylaxis; updated WHO position

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