Long-term Safety and Immunogenicity of a Tetravalent Dengue Vaccine Candidate in Children and Adults: A Randomized, Placebo-Controlled, Phase 2 Study.
J Infect Dis
; 225(9): 1513-1520, 2022 05 04.
Article
in En
| MEDLINE
| ID: mdl-32658250
ABSTRACT
BACKGROUND:
We report long-term safety and immunogenicity of Takeda's tetravalent dengue vaccine candidate (TAK-003) in healthy children and adults living in dengue-endemic areas in Puerto Rico, Columbia, Singapore, and Thailand.METHODS:
In part 1 of this phase 2, randomized, placebo-controlled trial we sequentially enrolled 1.5-45 year olds (nâ =â 148) into 4 age-descending groups, randomized 21 to receive 2 doses of TAK-003 or placebo 90 days apart. In part 2, 1-11 year olds (nâ =â 212) were enrolled and randomized 31 to TAK-003 or placebo groups. We assessed neutralizing antibody titers for the 4 dengue serotypes (DENV) up to month 36 in part 1, and symptomatic dengue and serious adverse events (SAEs) up to month 36 in both parts.RESULTS:
At month 36, seropositivity rates were 97.3%, 98.7%, 88.0% and 56.0% for DENV-1, -2, -3 and -4, respectively. Seropositivity rates varied significantly for DENV-4 according to serostatus at baseline (89.5% in seropositives versus 21.6% in seronegatives). No vaccine-related SAEs were reported.CONCLUSIONS:
The trial demonstrated persistence of neutralizing antibody titers against TAK-003 over 3 years in children and adults living in dengue-endemic countries, with limited contribution from natural infection. TAK-003 was well tolerated. CLINICAL TRIALS REGISTRATION NCT01511250.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Dengue
/
Dengue Virus
/
Dengue Vaccines
Type of study:
Clinical_trials
Limits:
Adult
/
Child
/
Humans
Language:
En
Journal:
J Infect Dis
Year:
2022
Document type:
Article
Affiliation country:
Thailand