Baseline Asymptomatic Malaria Infection and Immunogenicity of Recombinant Vesicular Stomatitis Virus-Zaire Ebola Virus Envelope Glycoprotein Vaccine: The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE)

Background. The effect of malaria infection on the immunogenicity of the recombinant vesicular stomatitis virus-Zaire Ebola virus envelope glycoprotein (GP) vaccine (rVSV Delta G-ZEBOV-GP) (ERVEBO) is unknown. Methods. The Sierra Leone Trial to Introduce a Vaccine Against Ebola (STRIVE) vaccinated 7998 asymptomatic adults with rVSV Delta G-ZEBOV-GP during the 2014-2016 Ebola epidemic. In STRIVE's immunogenicity substudy, participants provided blood samples at baseline and at 1, 6, and 9-12 months. Anti-GP binding and neutralizing antibodies were measured using validated assays. Baseline samples were tested for malaria parasites by polymerase chain reaction. Results. Overall, 506 participants enrolled in the immunogenicity substudy and had >= 1 postvaccination antibody titer. Of 499 participants with a result, baseline malaria parasitemia was detected in 73 (14.6%). All GP enzyme-linked immunosorbent assay (ELISA) and plaque reduction neutralization test (PRNT) geometric mean titers (GMTs) at 1, 6, and 9-12 months were above baseline, and 94.1% of participants showed seroresponse by GP-ELISA (>= 2-fold rise and >= 200 ELISA units/mL), while 81.5% showed seroresponse by PRNT (>= 4-fold rise) at >= 1 postvaccination assessment. In participants with baseline malaria parasitemia, the PRNT seroresponse proportion was lower, while PRNT GMTs and GP-ELISA seroresponse and GMTs showed a trend toward lower responses at 6 and 9-12 months. Conclusion. Asymptomatic adults with or without malaria parasitemia had robust immune responses to rVSV Delta G-ZEBOV-GP, persisting for 9-12 months. Responses in those with malaria parasitemia were somewhat lower.