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Title: Replication and Excretion of the Live Attenuated Tetravalent Dengue Vaccine CYD-TDV in a Flavivirus-Naive Adult Population: Assessment of Vaccine Viremia and Virus Shedding
Austin Authors: Torresi, Joseph ;Richmond, Peter C;Heron, Leon G;Qiao, Ming;Marjason, Joanne;Starr-Spires, Linda;van der Vliet, Diane;Jin, Jing;Wartel, T Anh;Bouckenooghe, Alain
Affiliation: Department of Microbiology and Immunology, Peter Doherty Institute for Infection and Immunity, University of Melbourne, Melbourne, Victoria, Australia
Department of Infectious Diseases, Austin Health, Heidelberg, Victoria, Australia
University of Western Australia School of Paediatrics and Child Health, Western Australia, Australia
Vaccine Trials Group, Telethon Kids Institute, Subiaco, Western Australia, Australia
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases, Children's Hospital at Westmead, Westmead, NSW, Australia
Royal Adelaide Hospital, Adelaide, South Australia, Australia
SA Pathology, Adelaide, South Australia, Australia
Q-Pharm, Herston, Queensland, Australia
Global Clinical Immunology, Sanofi Pasteur, Swiftwater, Pennsylvania, USA
Clinical Development, Sanofi Pasteur, Marcy l'Etoile, France
Clinical Sciences and Operations, Sanofi, Beijing, China
Clinical Sciences, Sanofi Pasteur, Singapore
Issue Date: Oct-2017
Publication information: Journal of Infectious Diseases 2017; 216(7): 834-841
Abstract: BACKGROUND: We assessed replication and excretion of the live attenuated tetravalent dengue vaccine (CYD-TDV) into biological fluids following vaccination in dengue-naive adults in Australia. METHODS: Vaccinal viremia/shedding was assessed in a subset of participants enrolled in a lot-to-lot consistency study; 95 participants received 3 subcutaneous doses of CYD-TDV from phase 2/3 lots of the vaccine, and 8 received placebo; doses were administered 6 months apart. Quantitative reverse-transcription polymerase chain reaction (qR-PCR) analysis was used to initially detect the yellow fever virus (YFV) core protein gene in the backbone of CYD-TDV in serum, saliva and urine, followed by serotype-specific qRT-PCR analysis of samples positive for YFV by qRT-PCR (lower limit of detection, 5.16 GEq/mL). RESULTS: YFV viremia was detected by qRT-PCR in 69.5% of participants (66 of 95) who received CYD-TDV, mainly 6-14 days after injection 1. The serotypes detected were serotype 4 (in 68.2% of participants [45 of 95]), serotype 3 (in 19.7% [13 of 95]), and serotype 1 (in 12.1% [8 of 95]); serotype 2 was not detected. None of the placebo recipients had vaccinal viremia/shedding. No participants had detectable viral shedding into saliva at levels above the lower limit of quantitation. Two participants had low-level viral shedding (serotype 3) in urine (5.47 and 5.77 GEq/mL). None of the participants with viremia or shedding experienced concomitant fever. CONCLUSIONS: Low-level vaccinal viremia may occur following vaccination with CYD-TDV, but this is not associated with any symptom or adverse event. CLINICAL TRIALS REGISTRATION: NCT01134263.
DOI: 10.1093/infdis/jix314
ORCID: 0000-0002-8212-0887
Journal: Journal of Infectious Diseases
PubMed URL:
Type: Journal Article
Subjects: Flavivirus
Appears in Collections:Journal articles

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