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17DD YELLOW FEVER VACCINE A DOUBLE BLIND, RANDOMIZED CLINICAL TRIAL OF IMMUNOGENICITY AND SAFETY ON A DOSE-RESPONSE STUDY
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Abstract
Objective: To verify if the Bio-Manguinhos 17DD yellow fever vaccine (17DD-YFV) used in lower doses is as immunogenic
and safe as the current formulation.
Results: Doses from 27,476 IU to 587 IU induced similar seroconversion rates and neutralizing antibodies geometric
mean titers (GMTs). Immunity of those who seroconverted to YF was maintained for 10 mo. Reactogenicity was low for
all groups.
Methods: Young and healthy adult males (n = 900) were recruited and randomized into 6 groups, to receive deescalating
doses of 17DD-YFV, from 27,476 IU to 31 IU. Blood samples were collected before vaccination (for neutralization
tests to yellow fever, serology for dengue and clinical chemistry), 3 to 7 d after vaccination (for viremia and clinical
chemistry) and 30 d after vaccination (for new yellow fever serology and clinical chemistry). Adverse events diaries were
filled out by volunteers during 10 d after vaccination. Volunteers were retested for yellow fever and dengue antibodies
10 mo later. Seropositivity for dengue was found in 87.6% of volunteers before vaccination, but this had no significant
influence on conclusions.
Conclusion: In young healthy adults Bio-Manguinhos/Fiocruz yellow fever vaccine can be used in much lower doses
than usual.
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