PMID- 20864814 OWN - NLM STAT- MEDLINE DCOM- 20110715 LR - 20211020 IS - 1554-8619 (Electronic) IS - 1554-8600 (Print) IS - 1554-8600 (Linking) VI - 6 IP - 11 DP - 2010 Nov TI - Concomitant or sequential administration of live attenuated Japanese encephalitis chimeric virus vaccine and yellow fever 17D vaccine: randomized double-blind phase II evaluation of safety and immunogenicity. PG - 906-14 LID - 10.4161/hv.6.11.12854 [doi] AB - A randomized, double-blind, study was conducted to evaluate the safety, tolerability and immunogenicity of a live attenuated Japanese encephalitis chimeric virus vaccine (JE-CV) co-administered with live attenuated yellow fever vaccine (YF-17D strain; Stamaril(R), Sanofi Pasteur) or administered successively. Participants (n = 108) were randomized to receive: YF followed by JE-CV 30 days later, JE followed by YF 30 days later, or the co-administration of JE and YF followed or preceded by placebo 30 days later or earlier. Placebo was used in a double-dummy fashion to ensure masking. Neutralizing antibody titers against JE-CV, YF-17D and selected wild-type JE strains was determined using a 50% serum-dilution plaque reduction neutralization test. Seroconversion was defined as the appearance of a neutralizing antibody titer above the assay cut-off post-immunization when not present pre-injection at day 0, or a least a four-fold rise in neutralizing antibody titer measured before the pre-injection day 0 and later post vaccination samples. There were no serious adverse events. Most adverse events (AEs) after JE vaccination were mild to moderate in intensity, and similar to those reported following YF vaccination. Seroconversion to JE-CV was 100% and 91% in the JE/YF and YF/JE sequential vaccination groups, respectively, compared with 96% in the co-administration group. All participants seroconverted to YF vaccine and retained neutralizing titers above the assay cut-off at month six. Neutralizing antibodies against JE vaccine were detected in 82-100% of participants at month six. These results suggest that both vaccines may be successfully co-administered simultaneously or 30 days apart. FAU - Nasveld, Peter E AU - Nasveld PE AD - Australian Army Malaria Institute, Queensland, Australia. FAU - Marjason, Joanne AU - Marjason J FAU - Bennett, Sonya AU - Bennett S FAU - Aaskov, John AU - Aaskov J FAU - Elliott, Suzanne AU - Elliott S FAU - McCarthy, Karen AU - McCarthy K FAU - Kanesa-Thasan, Niranjan AU - Kanesa-Thasan N FAU - Feroldi, Emmanuel AU - Feroldi E FAU - Reid, Mark AU - Reid M LA - eng PT - Comparative Study PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't DEP - 20101101 PL - United States TA - Hum Vaccin JT - Human vaccines JID - 101265291 RN - 0 (Antibodies, Neutralizing) RN - 0 (Antibodies, Viral) RN - 0 (Japanese Encephalitis Vaccines) RN - 0 (Placebos) RN - 0 (Vaccines, Attenuated) RN - 0 (Vaccines, Combined) RN - 0 (Yellow Fever Vaccine) SB - IM MH - Adolescent MH - Adult MH - Antibodies, Neutralizing MH - Antibodies, Viral/blood MH - Double-Blind Method MH - Encephalitis, Japanese/*prevention & control MH - Female MH - Humans MH - Japanese Encephalitis Vaccines/*administration & dosage/adverse effects/*immunology MH - Male MH - Middle Aged MH - Neutralization Tests MH - Placebos/administration & dosage MH - Vaccination/*methods MH - Vaccines, Attenuated/administration & dosage/adverse effects/immunology MH - Vaccines, Combined/administration & dosage/adverse effects/immunology MH - Viral Plaque Assay MH - Yellow Fever/*prevention & control MH - Yellow Fever Vaccine/*administration & dosage/adverse effects/*immunology MH - Young Adult PMC - PMC3060385 EDAT- 2010/09/25 06:00 MHDA- 2011/07/16 06:00 PMCR- 2010/11/30 CRDT- 2010/09/25 06:00 PHST- 2010/09/25 06:00 [entrez] PHST- 2010/09/25 06:00 [pubmed] PHST- 2011/07/16 06:00 [medline] PHST- 2010/11/30 00:00 [pmc-release] AID - 12854 [pii] AID - 1554-8600-6-11-10 [pii] AID - 10.4161/hv.6.11.12854 [doi] PST - ppublish SO - Hum Vaccin. 2010 Nov;6(11):906-14. doi: 10.4161/hv.6.11.12854. Epub 2010 Nov 1.