PMID- 34128975 OWN - NLM STAT- MEDLINE DCOM- 20220418 LR - 20220418 IS - 1708-8305 (Electronic) IS - 1195-1982 (Linking) VI - 28 IP - 8 DP - 2021 Dec 29 TI - Feasibility and safety of rVSV-ZEBOV vaccination of humanitarian health workers against Ebola virus disease: an observational study. LID - taab086 [pii] LID - 10.1093/jtm/taab086 [doi] AB - BACKGROUND AND RATIONALE: Geneva University Hospitals were granted a temporary authorization to administer the recombinant live vesicular stomatitis virus rVSV-ZEBOV (Ervebo(R)) vaccine to expatriate humanitarian frontline workers (FLWs) prior to mission deployment. OBJECTIVES: Our aims were to assess the feasibility of FLW vaccination before deployment and to report adverse events (AEs). METHODS: FLWs received a single injection of rVSV-ZEBOV (>7.2E7 plaque forming unit) during their pre-deployment medical check-up at the Travel Medicine Clinic of the Geneva University Hospitals (Day 0). A safety questionnaire regarding potential AEs was emailed to FLWs on Days 3 and 21. Early and delayed AEs were those starting within 3 or 21 days of vaccination, respectively. RESULTS: Between 1 August 2019 and 30 June 2020, 124 FLWs received the rVSV-ZEBOV vaccine. Eighty-six volunteers (86/124; 69%) received a concomitant vaccine. The response rate to the follow-up questionnaire was 88 and 55% at Days 3 and 21, respectively. Most respondents (105/109; 96.3%), experienced at least one AE, with a mean of three (+/-SD 1.75) AEs per person. The most common AE was injection site pain, followed by fever (53/109; 48.6%), fatigue (51/109; 46.7%) and myalgia (49/109; 44.9%). Most early AEs (360/377; 95.4%) resolved within 3 days, reflecting vaccine reactogenicity. Delayed AEs were reported by 6/69 (7.2%) subjects, the median time to symptom onset was 11 days (range: 5-14); half of them were joint-related AEs (3/6). Four serious adverse events (SAE) were observed: two cases of high grade fever, one rash and one case of arthritis. Two suspected unexpected serious adverse reactions were observed: one case of continuing recurrent transient dizziness and fatigue considered related to the vaccine; and one case of presbyopia that was deemed unrelated. CONCLUSION: AEs to rVSV-ZEBOV were common but in general transient and were well tolerated, pre-deployment rVSV-ZEBOV vaccination in FLW is feasible and can be included with pre-mission check-up. CI - (c) The Author(s) 2021. Published by Oxford University Press on behalf of International Society of Travel Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Carnino, Luisa AU - Carnino L AD - Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. FAU - Vetter, Pauline AU - Vetter P AUID- ORCID: 0000-0002-9902-5069 AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. AD - Geneva Center for Emerging Viral Diseases, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, Geneva 1205, Switzerland. AD - Division of Infectious Diseases, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. FAU - Peyraud, Nicolas AU - Peyraud N AD - Medecins Sans Frontieres, Geneva 1205, Switzerland. FAU - Aebischer-Perone, Sigiriya AU - Aebischer-Perone S AD - Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. AD - Health Unit, International Committee of the Red Cross (ICRC), Geneva 1205, Switzerland. FAU - Chappuis, Francois AU - Chappuis F AD - Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. FAU - Huttner, Angela AU - Huttner A AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. AD - Division of Infectious Diseases, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. AD - Center for Vaccinology, University and University Hospitals of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. FAU - Kaiser, Laurent AU - Kaiser L AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. AD - Geneva Center for Emerging Viral Diseases, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 4, Geneva 1205, Switzerland. AD - Division of Infectious Diseases, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. FAU - Eperon, Gilles AU - Eperon G AUID- ORCID: 0000-0002-3371-4320 AD - Division of Tropical and Humanitarian Medicine, Geneva University Hospitals, Rue Gabrielle-Perret-Gentil 6, Geneva 1205, Switzerland. AD - University of Geneva, Rue Michel-Servet 1, Geneva 1205, Switzerland. LA - eng GR - Geneva Center for Emerging Viral Diseases and the Division of Humanitarian and Tropical Medicine/ PT - Journal Article PT - Observational Study PL - England TA - J Travel Med JT - Journal of travel medicine JID - 9434456 RN - 0 (Antibodies, Viral) RN - 0 (Ebola Vaccines) SB - IM MH - Antibodies, Viral MH - *Ebola Vaccines MH - *Ebolavirus MH - Fatigue/chemically induced/drug therapy MH - Feasibility Studies MH - *Hemorrhagic Fever, Ebola/prevention & control MH - Humans MH - Vaccination/adverse effects MH - Vesiculovirus OTO - NOTNLM OT - Ebola OT - Ervebo OT - humanitarian health care OT - live vaccine OT - rVSV-EBOV OT - rVSV-ZEBOV OT - vaccination OT - workers EDAT- 2021/06/16 06:00 MHDA- 2022/04/19 06:00 CRDT- 2021/06/15 13:33 PHST- 2021/01/25 00:00 [received] PHST- 2021/04/12 00:00 [revised] PHST- 2021/05/20 00:00 [accepted] PHST- 2021/06/16 06:00 [pubmed] PHST- 2022/04/19 06:00 [medline] PHST- 2021/06/15 13:33 [entrez] AID - 6299197 [pii] AID - 10.1093/jtm/taab086 [doi] PST - ppublish SO - J Travel Med. 2021 Dec 29;28(8):taab086. doi: 10.1093/jtm/taab086.