Efficacy of one-dose intramuscular rabies vaccine as pre-exposure prophylaxis in travellers

Abstract Background Current guidelines for rabies pre-exposure prophylaxis (PrEP) recommend multiple vaccine doses. Travellers sometimes present for pre-travel consultation with insufficient time to complete standard PrEP schedules. We investigated the efficacy of one-dose intramuscular (IM) vaccine in priming the immune system (as PrEP) by measuring antibody response to simulated post-exposure prophylaxis (PEP). Methods A quasi-experimental pre–post intervention clinical trial was conducted at a specialist travel clinic in Australia. Adults (≥18 years) without a history of rabies vaccination were included. At Visit 1, seronegative status was confirmed and one dose of 0.5 ml IM rabies vaccine (Verorab®) administered. At Visit 2 (≥60 days after Visit 1), serology was repeated and a simulated PEP dose (0.5 ml IM) given on this day and again 3 days later (Visit 3). Serology was repeated at Visit 4 (7 days after Visit 2). Results A total of 94 antibody-negative participants were included (<50 years [n = 50]; ≥50 years [n = 44]). At Visit 2, 38.0 and 31.8% of participants aged <50 and ≥50 years were antibody-positive (≥0.5 EU/ml). At Visit 4, all participants were antibody-positive; 82.0 and 47.7% of participants aged <50 and ≥50 years had antibody levels >4 EU/ml, respectively. Conclusions One-dose IM vaccine was effective as PrEP for priming the immune system in both age groups, resulting in rapid development of antibodies 7 days after commencing simulated PEP. If there is insufficient time to complete a standard PrEP schedule, one-dose IM could be considered as an alternative schedule for short trips, rather than not offering travellers any doses at all. Clinical trials registration: ACTRN12619000946112.

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Adverse reactions associated with a Fuenzalida-Palacios rabies vaccine: a quasi-experimental study

Revista da Sociedade Brasileira de Medicina Tropical ◽

10.1590/s0037-86822004000100002 ◽

2004 ◽

Vol 37 (1) ◽

pp. 7-9 ◽

Cited By ~ 7

Author(s):

Rosuita Fratari Bonito ◽

Neide Mattar de Oliveira ◽

Sérgio de Andrade Nishioka

Keyword(s):

Experimental Study ◽

Adverse Reactions ◽

Signs And Symptoms ◽

Rabies Vaccine ◽

Control Group ◽

Post Exposure Prophylaxis ◽

Post Exposure ◽

Quasi Experimental ◽

Group A ◽

Exposure Prophylaxis

The Fuenzalida-Palacios rabies vaccine has been used in South America for rabies post-exposure prophylaxis. To determine the frequency of adverse reactions associated with this vaccine compared to a control group a quasi-experimental study was carried out in Uberlândia, Brazil, from May 1997 to April 1998. Victims of bites or other injuries by dogs or other mammals and who received or not post-exposure prophylaxis with Fuenzalida-Palacios rabies vaccine were compared as to the occurrence of a list of signs and symptoms. Out of 2,440 victims of bites and other injuries from dogs and other mammals 2,114 participated in the study; 1,004 of them provided follow-up information within 10 to 15 days. Headache and pain at the injection sites were the most commonly found symptoms (125/1,000). No neuroparalytic event was detected. Patients who were given Fuenzalida-Palacios rabies vaccine and those who were not had similar incidences of symptoms (risk ratios close to 1). Regarding the occurrence of adverse reactions, Fuenzalida-Palacios rabies vaccine is a valid alternative for rabies post-exposure prophylaxis.

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State of Alaska epidemiology bulletin: Rabies vaccine: Alaska post-exposure prophylaxis summary and pre-exposure restrictions

PsycEXTRA Dataset ◽

10.1037/e471122008-001 ◽

2008 ◽

Keyword(s):

Rabies Vaccine ◽

Post Exposure Prophylaxis ◽

Post Exposure ◽

Exposure Prophylaxis

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986. Improvement in Administration of HIV Post-Exposure Prophylaxis in the Emergency Department Following Sexual Assault

Open Forum Infectious Diseases ◽

10.1093/ofid/ofaa439.1172 ◽

2020 ◽

Vol 7 (Supplement_1) ◽

pp. S521-S522

Author(s):

Jennifer R Silva-Nash ◽

Stacie Bordelon ◽

Ryan K Dare ◽

Sherrie Searcy

Keyword(s):

Emergency Department ◽

Sexual Assault ◽

Hiv Transmission ◽

Post Exposure Prophylaxis ◽

Intervention Period ◽

Post Intervention ◽

Post Exposure ◽

Assault Victims ◽

Exposure Prophylaxis

Abstract Background Nonoccupational post exposure prophylaxis (nPEP) following sexual assault can prevent HIV transmission. A standardized Emergency Department (ED) protocol for evaluation, treatment, and follow up for post assault victims was implemented to improve compliance with CDC nPEP guidelines. Methods A single-center observational study of post sexual assault patients before/after implementation of an ED nPEP protocol was conducted by comparing the appropriateness of prescriptions, labs, and necessary follow up. A standardized order-set based on CDC nPEP guidelines, with involvement of an HIV pharmacist and ID clinic, was implemented during the 2018-2019 academic year. Clinical data from pre-intervention period (07/2016-06/2017) was compared to post-intervention period (07/2018-08/2019) following a 1-year washout period. Results During the study, 147 post-sexual assault patients (59 Pre, 88 Post) were included. One hundred thirty-three (90.4%) were female, 68 (46.6%) were African American and 133 (90.4%) were candidates for nPEP. Median time to presentation following assault was 12.6 hours. nPEP was offered to 40 (67.8%) and 84 (95.5%) patients (P< 0.001) and ultimately prescribed to 29 (49.2%) and 71 (80.7%) patients (P< 0.001) in pre and post periods respectively. Renal function (37.3% vs 88.6%; P< 0.001), pregnancy (39.0% vs 79.6%; P< 0.001), syphilis (3.4% vs 89.8%; P< 0.001), hepatitis B (15.3% vs 95.5%; P< 0.001) and hepatitis C (27.1% vs 94.3%) screening occurred more frequently during the post period. Labratory, nPEP Prescription and Follow up Details for Patients Prescribed nPEP Conclusion The standardization of an nPEP ED protocol for sexual assault victims resulted in increased nPEP administration, appropriateness of prescription, screening for other sexually transmitted infectious and scheduling follow up care. While guideline compliance dramatically improved, further interventions are likely warranted in this vulnerable population. Disclosures Ryan K. Dare, MD, MS, Accelerate Diagnostics, Inc (Research Grant or Support)

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‘Stat’ workflow modifications to expedite care after needlestick injuries

Occupational Medicine ◽

10.1093/occmed/kqaa209 ◽

2021 ◽

Author(s):

J L Smith ◽

R Banerjee ◽

D R Linkin ◽

E P Schwab ◽

P Saberi ◽

...

Keyword(s):

Psychological Health ◽

Healthcare Workers ◽

Post Exposure Prophylaxis ◽

Psychological Consequences ◽

Intervention Period ◽

Needlestick Injuries ◽

Post Intervention ◽

Immunodeficiency Virus ◽

Physical And Psychological Health ◽

Exposure Prophylaxis

Abstract Background Post-exposure prophylaxis (PEP) for human immunodeficiency virus (HIV) is recommended to start within hours of needlestick injuries (NSIs) among healthcare workers (HCWs). Delays associated with awaiting the results of testing from the source patient (whose blood was involved in the NSI) can lead to psychological consequences for the exposed HCW as well as symptomatic toxicities from empiric PEP. Aims After developing a ‘stat’ (immediate) workflow that prioritized phlebotomy and resulting of source patient bloodwork for immediate handling and processing, we retrospectively investigated whether our new workflow had (i) decreased HIV order-result interval times for source patient HIV bloodwork and (ii) decreased the frequency of HIV PEP prescriptions being dispensed to exposed HCWs. Methods We retrospectively analysed NSI records to identify source patient HIV order-result intervals and PEP dispensing frequencies across a 6-year period (encompassing a 54-month pre-intervention period and 16-month post-intervention period). Results We identified 251 NSIs, which occurred at similar frequencies before versus after our intervention (means 3.54 NSIs and 3.75 NSIs per month, respectively). Median HIV order-result intervals decreased significantly (P < 0.05) from 195 to 156 min after our intervention, while the proportion of HCWs who received one or more doses of PEP decreased significantly (P < 0.001) from 50% (96/191) to 23% (14/60). Conclusion Using a ‘stat’ workflow to prioritize source patient testing after NSIs, we achieved a modest decrease in order-result intervals and a dramatic decrease in HIV PEP dispensing rates. This simple intervention may improve HCWs’ physical and psychological health during a traumatic time.

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Antibody persistence, 32 years after post-exposure prophylaxis with human diploid cell rabies vaccine (HDCV)

Vaccine ◽

10.1016/j.vaccine.2011.03.048 ◽

2011 ◽

Vol 29 (21) ◽

pp. 3742-3745 ◽

Cited By ~ 10

Author(s):

Ahmad Fayaz ◽

Susan Simani ◽

Alireza Janani ◽

Firouzeh Farahtaj ◽

Peyvand Biglari ◽

...

Keyword(s):

Diploid Cell ◽

Rabies Vaccine ◽

Post Exposure Prophylaxis ◽

Human Diploid Cell ◽

Post Exposure ◽

Antibody Persistence ◽

Exposure Prophylaxis

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Chemoprophylaxis trial designs in epidemics: insights from a systematic review of COVID-19 study registrations

Trials ◽

10.1186/s13063-021-05323-4 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Lakshmi Manoharan ◽

Piero Olliaro ◽

Peter W. Horby ◽

Conall H. Watson

Keyword(s):

Older Adults ◽

Effect Size ◽

Adaptive Design ◽

Rapid Development ◽

Control Group ◽

Post Exposure Prophylaxis ◽

Design Features ◽

Included Trial ◽

Term Care ◽

Exposure Prophylaxis

Abstract Background Chemoprophylactics against emerging epidemic and pandemic infectious diseases offer potential for prevention but require efficacy and safety analysis before widespread use can be recommended. Chemoprophylaxis with repurposed drugs enables deployment ahead of development of novel vaccines. It may have particular utility as a stopgap ahead of vaccine deployment or when vaccines become less effective on virus variants, in countries where there may be structural inaccessibility to vaccines or in specific risk-groups. Rapid implementation of robust trial designs is a persistent challenge in epidemics. We systematically reviewed SARS-CoV-2 and COVID-19 chemoprophylaxis trial registrations from the first 21 weeks of the pandemic to critically appraise significant design features and alignment of study populations to clinical and public health uses, and describe candidate chemoprophylactic agents. Methods We searched online international trial databases from 31 Dec 2019 to 26 May 2020 using keywords “proph*” or “prevention”. Trial protocols assessing efficacy of chemoprophylactic agents for COVID-19 were included. Trial components were screened for eligibility and relevant studies extracted. Key trial design features were assessed. Results We found 76 chemoprophylaxis study registrations, proposing enrolment of 208,367 people with median size of 490 (IQR 262–1710). A randomised design was specified for 63 trials, 61 included a control group and total proposed enrolment size was 197,010, median 600 (IQR 236–1834). Four protocols provided information on effect size sought. We estimate that for a control group attack rate of 10%, 66% of trials would be underpowered to detect a 50% effect size, and 97% of trials would be underpowered to detect a 30% effect size (at the 80% level). We found evidence of adaptive design in one trial registration only. Laboratory-confirmed infection with or without symptoms was the most common primary outcome. Polymerase chain reaction testing alone was used in 46% of trials, serological testing in 6.6% and 14.5% used both testing methods. Healthcare workers were the target population in 52/79 (65.8%) trials: 49 pre-exposure prophylaxis (PrEP) and 3 post-exposure prophylaxis (PEP). Sixteen trials (20.3%) planned PEP in close contacts. Five studies (6.3%) considered chemoprophylaxis in clinical-risk patients. Older adults were the focus of recruitment in only 3 (3.8%) studies (all long-term care facilities). Two (2.5%) studies of PrEP in the general population included older adults. Hydroxychloroquine was the most common candidate agent in 55/79 trials (69.6%), followed by chloroquine (4/79, 5.0%) and lopinavir/ritonavir (3/79, 3.8%). Conclusion Many registered COVID-19 chemoprophylaxis efficacy trials were underpowered to detect clinically meaningful protection at epidemiologically informed attack rates. This, compounded with the time that has taken to organise these trials as compared to the rapid development of COVID-19 vaccines, has rendered these trials of marginal importance. International coordination mechanisms and collaboration is required. Supporting the design of feasible chemoprophylaxis trials, large enough to generate strong evidence, early on in an epidemic using adaptive platform trial designs will allow structured entry and exit of candidate agents and rapid stand-up of trial infrastructure. Review protocol registration Our protocol is registered at https://www.osf.io/vp56f on May 20, 2020.

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A randomized non-inferiority clinical study to assess post-exposure prophylaxis by a new purified vero cell rabies vaccine (Rabivax-S) administered by intramuscular and intradermal routes

Vaccine ◽

10.1016/j.vaccine.2016.08.005 ◽

2016 ◽

Vol 34 (40) ◽

pp. 4820-4826 ◽

Cited By ~ 3

Author(s):

Anuradha Bose ◽

Renuka Munshi ◽

Radha Madhab Tripathy ◽

Shampur N. Madhusudana ◽

B.R. Harish ◽

...

Keyword(s):

Clinical Study ◽

Vero Cell ◽

Rabies Vaccine ◽

Post Exposure Prophylaxis ◽

Post Exposure ◽

Exposure Prophylaxis

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Human rabies post-exposure prophylaxis relative to the disease epidemiological status

Ciência & Saúde Coletiva ◽

10.1590/1413-81232018241.32832016 ◽

2019 ◽

Vol 24 (1) ◽

pp. 315-322 ◽

Cited By ~ 1

Author(s):

Bruno Fonseca Martins da Costa Andrade ◽

Taísa Santos de Melo Andrade ◽

Luzia Helena Queiroz

Keyword(s):

Rabies Vaccine ◽

Human Rabies ◽

Post Exposure Prophylaxis ◽

Post Exposure ◽

Paulo State ◽

Technical Manual ◽

Prophylactic Measures ◽

Exposure Prophylaxis ◽

Main City ◽

Technical Recommendations

Abstract This study evaluated the prophylactic measures adopted after attacks by dogs and cats in the main city of Northwester São Paulo State, based on the technical manual for post-exposure treatment, considering the not controlled (1990-1996) and controlled (1997-2010) rabies status. A retrospective analysis was done using the data from the SINAN records (W64-CID10) between 1990 and 2010. In most cases, the accidents were mild (76.9%), and biting animals were healthy (75.4%); therefore, no treatment was needed in 53.3% of the cases. In 64.6% of cases, the prescribed PEP treatment was inappropriate. The most indicated PEP treatments consisted of vaccine and RIG (43.4%), and either three doses of mouse brain vaccine or two doses of cell culture vaccine (76.5%), during the not controlled and controlled rabies periods, respectively. The treatment was more appropriate and followed the technical recommendations during controlled rabies periods compared to not controlled (p < 0.0001) periods. However, excessive application of RIG and rabies vaccine was observed in both periods.

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Current Rabies Vaccines Do Not Confer Protective Immunity against Divergent Lyssaviruses Circulating in Europe

Viruses ◽

10.3390/v11100892 ◽

2019 ◽

Vol 11 (10) ◽

pp. 892 ◽

Cited By ~ 1

Author(s):

Juan E. Echevarría ◽

Ashley C. Banyard ◽

Lorraine M. McElhinney ◽

Anthony R. Fooks

Keyword(s):

Protective Immunity ◽

Rabies Vaccine ◽

Human Rabies ◽

Post Exposure Prophylaxis ◽

Efficient Tool ◽

Imported Case ◽

Health Authorities ◽

European Health ◽

Preventive Vaccination ◽

Exposure Prophylaxis

The use of the rabies vaccine for post-exposure prophylaxis started as early as 1885, revealing a safe and efficient tool to prevent human rabies cases. Preventive vaccination is the basis for the control of canine-mediated rabies, which has already been eliminated from extensive parts of the world, including Europe. Plans to eliminate canine-mediated human rabies by 2030 have been agreed upon by international organisations. However, rabies vaccines are not efficacious against some divergent lyssaviruses. The presence in European indigenous bats of recently described lyssaviruses, which are not neutralised by antibody responses to existing vaccines, as well as the declaration of an imported case of an African lyssavirus, which also escapes vaccine-derived protection, leaves the European health authorities unable to provide efficacious protective vaccines to some potential situations of human exposure. All these circumstances highlight the need for a universal pan-lyssavirus rabies vaccine, able to prevent human rabies in all circumstances.

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