Unknown

Dataset Information

0

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.


ABSTRACT: 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 ?g/serotype/dose adjuvanted with aluminum, AS01E or AS03B, or aluminum-adjuvanted 4 ?g/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.

SUBMITTER: Diaz C 

PROVIDER: S-EPMC7204593 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

altmetric image

Publications

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.

Diaz Clemente C   Koren Michael M   Lin Leyi L   Martinez Luis J LJ   Eckels Kenneth H KH   Campos Maribel M   Jarman Richard G RG   De La Barrera Rafael R   Lepine Edith E   Febo Irma I   Vaughn David W DW   Wilson Todd M TM   Paris Robert M RM   Schmidt Alexander C AC   Thomas Stephen J SJ  

The American journal of tropical medicine and hygiene 20200501 5


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  ...[more]

Similar Datasets

| S-EPMC5953365 | biostudies-literature
| S-EPMC5462566 | biostudies-literature
| S-EPMC9622737 | biostudies-literature
| S-EPMC8341694 | biostudies-literature
| S-EPMC4385761 | biostudies-literature
| S-EPMC3328431 | biostudies-literature
| S-EPMC6095627 | biostudies-literature
| S-EPMC6649339 | biostudies-literature
| S-EPMC7644226 | biostudies-literature
| S-EPMC4559679 | biostudies-literature