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Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults.
BMC Infect Dis. 2018 Sep 21; 18(1):475.BI

Abstract

BACKGROUND

The live attenuated tetravalent dengue vaccine (CYD-TDV) is licensed using a 0-, 6- and 12-month schedule in dengue-endemic areas. An effective shorter schedule may provide more rapid, optimal protection of targeted populations during vaccine campaigns in dengue-endemic countries. We compared immune responses to two schedules of CYD-TDV in a non-endemic population. We also evaluated the impact of yellow fever (YF) co-administration.

METHODS

This phase II, open-label, multicentre study enrolled 390 healthy 18-45-year-olds in the USA with no prior exposure to dengue. Participants were randomised (4:4:4:1) to four treatment groups stratified by prior YF vaccine status: Group 1, CYD-TDV standard 0-6-12 months schedule; Group 2, CYD-TDV accelerated 0-2-6 months schedule; Group 3, CYD-TDV accelerated schedule with YF co-administered (dose 1); Group 4, YF vaccination only. Neutralising antibody geometric mean titres (GMTs) and percentages of seropositive participants (antibody titres ≥10 [1/dil]) were measured against each dengue serotype using a 50% plaque reduction neutralisation test.

RESULTS

On D28 post-CYD-TDV dose 3, there were no marked differences in seropositivity rates and GMTs between Groups 1 and 2. In Groups 1 and 2 respectively, 73.4 and 82.4% were dengue seropositive for ≥3 serotypes, with 50.0 and 42.6% seropositive against all four serotypes. Flavivirus status (FV+ or FV-) at baseline did not markedly affect GMTs and seropositivity rates with either schedule. In Groups 1 and 2, GMTs measured 6 months after the third dose decreased against all serotypes, except for a small increase in GMT for serotype 4 in Group 1. In addition, dengue seropositivity remained above 70% for serotypes 2, 3 and 4 in Groups 1 and 2. Co-administration with YF did not affect antibody responses against dengue and YF or impact vaccine safety following completion of the compressed schedule, compared to dengue or YF vaccination alone.

CONCLUSIONS

The live attenuated CYD-TDV vaccine given in a compressed schedule in a non-endemic setting can elicit similar antibody responses to the licensed CYD-TDV schedule.

TRIAL REGISTRATION

This trial was registered on cinicaltrials.gov, NCT01488890 (December 8, 2011).

Authors+Show Affiliations

Advanced Clinical Research, West Jordan, UT, USA.Benchmark Research, Sacramento, CA, USA.Sanofi Pasteur, Global Clinical Immunology, Discovery Drive, Swiftwater, PA, 18370, USA.Sanofi Pasteur, Global Clinical Immunology, Discovery Drive, Swiftwater, PA, 18370, USA.Sanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France.Sanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France.Sanofi Pasteur, Siège Social, 14 Espace Henry Vallée, 69007, Lyon, France. Eric.Plennevaux@sanofipasteur.com.

Pub Type(s)

Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

30241510

Citation

Kirstein, Judith, et al. "Immunogenicity of the CYD Tetravalent Dengue Vaccine Using an Accelerated Schedule: Randomised Phase II Study in US Adults." BMC Infectious Diseases, vol. 18, no. 1, 2018, p. 475.
Kirstein J, Douglas W, Thakur M, et al. Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infect Dis. 2018;18(1):475.
Kirstein, J., Douglas, W., Thakur, M., Boaz, M., Papa, T., Skipetrova, A., & Plennevaux, E. (2018). Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. BMC Infectious Diseases, 18(1), 475. https://doi.org/10.1186/s12879-018-3389-x
Kirstein J, et al. Immunogenicity of the CYD Tetravalent Dengue Vaccine Using an Accelerated Schedule: Randomised Phase II Study in US Adults. BMC Infect Dis. 2018 Sep 21;18(1):475. PubMed PMID: 30241510.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults. AU - Kirstein,Judith, AU - Douglas,William, AU - Thakur,Manoj, AU - Boaz,Mark, AU - Papa,Thomas, AU - Skipetrova,Anna, AU - Plennevaux,Eric, Y1 - 2018/09/21/ PY - 2017/11/22/received PY - 2018/09/17/accepted PY - 2018/9/23/entrez PY - 2018/9/23/pubmed PY - 2018/11/1/medline KW - Dengue KW - Live attenuated tetravalent dengue vaccine KW - Vaccination schedule KW - Yellow fever SP - 475 EP - 475 JF - BMC infectious diseases JO - BMC Infect Dis VL - 18 IS - 1 N2 - BACKGROUND: The live attenuated tetravalent dengue vaccine (CYD-TDV) is licensed using a 0-, 6- and 12-month schedule in dengue-endemic areas. An effective shorter schedule may provide more rapid, optimal protection of targeted populations during vaccine campaigns in dengue-endemic countries. We compared immune responses to two schedules of CYD-TDV in a non-endemic population. We also evaluated the impact of yellow fever (YF) co-administration. METHODS: This phase II, open-label, multicentre study enrolled 390 healthy 18-45-year-olds in the USA with no prior exposure to dengue. Participants were randomised (4:4:4:1) to four treatment groups stratified by prior YF vaccine status: Group 1, CYD-TDV standard 0-6-12 months schedule; Group 2, CYD-TDV accelerated 0-2-6 months schedule; Group 3, CYD-TDV accelerated schedule with YF co-administered (dose 1); Group 4, YF vaccination only. Neutralising antibody geometric mean titres (GMTs) and percentages of seropositive participants (antibody titres ≥10 [1/dil]) were measured against each dengue serotype using a 50% plaque reduction neutralisation test. RESULTS: On D28 post-CYD-TDV dose 3, there were no marked differences in seropositivity rates and GMTs between Groups 1 and 2. In Groups 1 and 2 respectively, 73.4 and 82.4% were dengue seropositive for ≥3 serotypes, with 50.0 and 42.6% seropositive against all four serotypes. Flavivirus status (FV+ or FV-) at baseline did not markedly affect GMTs and seropositivity rates with either schedule. In Groups 1 and 2, GMTs measured 6 months after the third dose decreased against all serotypes, except for a small increase in GMT for serotype 4 in Group 1. In addition, dengue seropositivity remained above 70% for serotypes 2, 3 and 4 in Groups 1 and 2. Co-administration with YF did not affect antibody responses against dengue and YF or impact vaccine safety following completion of the compressed schedule, compared to dengue or YF vaccination alone. CONCLUSIONS: The live attenuated CYD-TDV vaccine given in a compressed schedule in a non-endemic setting can elicit similar antibody responses to the licensed CYD-TDV schedule. TRIAL REGISTRATION: This trial was registered on cinicaltrials.gov, NCT01488890 (December 8, 2011). SN - 1471-2334 UR - https://www.unboundmedicine.com/medline/citation/30241510/Immunogenicity_of_the_CYD_tetravalent_dengue_vaccine_using_an_accelerated_schedule:_randomised_phase_II_study_in_US_adults_ DB - PRIME DP - Unbound Medicine ER -