Safety and Immunogenicity of Different Formulations of a Tetravalent Dengue Purified Inactivated Vaccine in Healthy Adults from Puerto Rico: Final Results after 3 Years of Follow-Up from a Randomized, Placebo-Controlled Phase I Study
| Autor: | Robert Paris, Maribel Campos, Kenneth H. Eckels, Alexander C. Schmidt, Luis J. Martinez, Richard G. Jarman, Irma Febo, Clemente Diaz, David W. Vaughn, Edith Lepine, Michael Koren, Rafael De La Barrera, Stephen J. Thomas, Todd M. Wilson, Leyi Lin |
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| Rok vydání: | 2020 |
| Předmět: |
Adult
Male Serotype 030231 tropical medicine Dengue Vaccines Dengue virus Antibodies Viral Placebo medicine.disease_cause Dengue fever Dengue 03 medical and health sciences 0302 clinical medicine Virology Humans Medicine Neutralizing antibody biology business.industry Immunogenicity Puerto Rico Articles Dengue Virus medicine.disease Antibodies Neutralizing Vaccination Infectious Diseases Inactivated vaccine biology.protein Female Parasitology business Follow-Up Studies |
| Zdroj: | The American Journal of Tropical Medicine and Hygiene |
| ISSN: | 1476-1645 0002-9637 |
| DOI: | 10.4269/ajtmh.19-0461 |
| Popis: | Four formulations of an investigational tetravalent dengue purified inactivated vaccine, administered as two doses one month (M) apart, were previously shown to be immunogenic and well-tolerated up to M13 of the phase I study NCT01702857. Here, we report results of the follow-up from M14 to year (Y) 3. One hundred healthy Puerto Rican adults, predominantly dengue virus (DENV)–primed, were randomized 1:1:1:1:1 to receive placebo or vaccine formulations: 1 μg/serotype/dose adjuvanted with aluminum, AS01E or AS03B, or aluminum-adjuvanted 4 μg/serotype/dose. No serious adverse events occurred. Two medically-attended potential immune-mediated disease cases, vaccination unrelated, were reported (groups 1 µg+Alum and 1 µg+AS03B). Of 14 instances of suspected dengue, none were laboratory confirmed. Geometric mean neutralizing antibody titers against DENV 1-4 waned from M14, but remained above pre-vaccination levels for DENV 1-3, with the highest values for group 1 µg+AS03B: 1220.1, 920.5, 819.4, and 940.5 (Y2), and 1329.3, 1169.2, 1219.8, and 718.9 (Y3). All formulations appeared to be safe and immunogenic during the 3-year follow-up. |
| Databáze: | OpenAIRE |
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