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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.
- Authors
Torresi, Joseph; Richmond, Peter C.; Heron, Leon G.; Ming Qiao; Marjason, Joanne; Starr-Spires, Linda; van der Vliet, Diane; Jing Jin; Wartel, T. Anh; Bouckenooghe, Alain; Qiao, Ming; Jin, Jing
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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).<bold>Results: </bold>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.<bold>Conclusions: </bold>Low-level vaccinal viremia may occur following vaccination with CYD-TDV, but this is not associated with any symptom or adverse event.<bold>Clinical Trials Registration: </bold>NCT01134263.
- Subjects
AUSTRALIA; FLAVIVIRUSES; DENGUE; VIREMIA; PROTEIN genetics; POLYMERASE chain reaction; PUBLIC health; VACCINATION; THERAPEUTICS; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; RESEARCH; VIRAL vaccines; VIRAL physiology; EVALUATION research; RANDOMIZED controlled trials; SEROTYPES; REVERSE transcriptase polymerase chain reaction
- Publication
Journal of Infectious Diseases, 2017, Vol 216, Issue 7, p834
- ISSN
0022-1899
- Publication type
journal article
- DOI
10.1093/infdis/jix314