TABLE. Detection of recombinant vesicular stomatitis virus–vaccine virus in persons vaccinated with Ervebo.
Specimen type | Vaccine virus detected by rRT-PCR | Longest recorded positive rRT-PCR (dpv) | Culture of vaccine virus attempted | Vaccine virus detected by culture |
---|---|---|---|---|
Blood |
Yes |
14* |
Yes |
No |
Urine |
Yes |
7* |
No |
Not performed |
Saliva |
Yes |
14* |
No |
Not performed |
Synovial fluid |
Yes |
17† |
Yes§ |
No§ |
Skin vesicles | Yes | 20¶ | Yes | Yes** |
Abbreviation: dpv = days postvaccination; rRT-PCR = reverse transcriptase–polymerase chain reaction.
* One study also tested at 28 dpv and none of 38 were positive (Source: Heppner DG Jr, Kemp TL, Martin BK, et al; V920-004 Study Team. Safety and immunogenicity of the rVSV∆G-ZEBOV-GP Ebola virus vaccine candidate in healthy adults: a phase 1b randomised, multicentre, double-blind, placebo-controlled, dose-response study. Lancet Infect Dis 2017;17:854–66).
† Of three participants in one study, whose synovial fluid was tested by rRT-PCR, one tested positive 17 dpv and two tested negative 16 and 23 dpv (Source: Halperin SA, Arribas JR, Rupp R, et al; V920-012 Study Team. Six-month safety data of recombinant vesicular stomatitis virus–Zaire Ebola virus envelope glycoprotein vaccine in a phase 3 double-blind, placebo-controlled randomized study in healthy Adults. J Infect Dis 2017;215:1789–98).
§ One synovial fluid specimen tested positive by rRT-PCR 15 dpv and virus isolation was negative (Source: Agnandji ST, Huttner A, Zinser ME, et al. Phase 1 trials of rVSV Ebola vaccine in Africa and Europe. N Engl J Med 2016;374:1647–60).
¶ Source: Ervebo [Package Insert]. Whitehouse Station, NJ: Merck; 2009. https://www.fda.gov/media/133748/download
** Of three participants with rash in one study, all were positive by rRT-PCR up to 17 dpv, and virus isolation was positive in one specimen with the highest RNA level 9 dpv (Source: Agnandji ST, Huttner A, Zinser ME, et al. Phase 1 trials of rVSV Ebola vaccine in Africa and Europe. N Engl J Med 2016;374:1647–60).