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Assessment of bivalent and tetravalent dengue vaccine formulations in flavivirus-naïve adults in Mexico.

AbstractUNLABELLED:
Several ChimeriVax-Dengue (CYD)-based vaccination strategies were investigated as potential alternatives to vaccination with tetravalent CYD vaccine (CYD-TDV) in this phase IIa trial conducted in 2008-9 in 150 healthy adults. Participants were randomized and vaccinated on D0 and D105 (± 15 days). One group received bivalent CYD vaccine against serotypes 1 and 3 (CYD-1;3) on day 0 and CYD-2;4 on day 105 (± 15 days). Two groups received an injection at each timepoint of a tetravalent blend of CYD-1;3;4 and a VERO cell derived, live attenuated vaccine against serotype 2 (VDV-2), or the reference CYD-TDV. A fourth group received Japanese encephalitis (JE) vaccine on days -14, -7 and 0, followed by CYD-TDV on day 105. Viraemia was infrequent in all groups. CYD-4 viraemia was most frequent after tetravalent vaccination, while CYD-3 viraemia was most frequent after the first bivalent vaccination. Immunogenicity as assessed by 50% plaque reduction neutralisation test on D28 was comparable after the first injection of either tetravalent vaccine, and increased after the second injection, particularly with the blended CYD-1;3;4/ VDV-2 vaccine. In the bivalent vaccine group, immune response against serotype 3 was highest and the second injection elicited a low immune response against CYD 2 and 4. Immune responses after the first injection of CYD-TDV in the JE-primed group were in general higher than after the first injection in the other groups. All tested regimens were well tolerated without marked differences between groups. Bivalent vaccination showed no advantage in terms of immunogenicity.
CLINICAL TRIAL REGISTRATION NUMBER:
NCT00740155.
AuthorsGustavo H Dayan, Juan-Francisco Galán-Herrera, Remi Forrat, Betzana Zambrano, Alain Bouckenooghe, Anke Harenberg, Bruno Guy, Jean Lang
JournalHuman vaccines & immunotherapeutics (Hum Vaccin Immunother) Vol. 10 Issue 10 Pg. 2853-63 ( 2014) ISSN: 2164-554X [Electronic] United States
PMID25483647 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References
  • Antibodies, Neutralizing
  • Antibodies, Viral
  • ChimeriVax
  • Dengue Vaccines
  • Japanese Encephalitis Vaccines
  • Vaccines, Attenuated
  • West Nile Virus Vaccines
Topics
  • Adolescent
  • Adult
  • Antibodies, Neutralizing (blood, immunology)
  • Antibodies, Viral (blood, immunology)
  • Dengue (immunology, prevention & control)
  • Dengue Vaccines (adverse effects, immunology, therapeutic use)
  • Dengue Virus (immunology)
  • Female
  • Humans
  • Immunity, Cellular (immunology)
  • Immunity, Humoral (immunology)
  • Japanese Encephalitis Vaccines (adverse effects, immunology, therapeutic use)
  • Male
  • Mexico
  • Neutralization Tests
  • Vaccination
  • Vaccines, Attenuated (adverse effects, immunology, therapeutic use)
  • Viremia (blood, immunology)
  • West Nile Virus Vaccines (adverse effects, immunology, therapeutic use)
  • Young Adult

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