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Phase II Trial to Evaluate Safety and Immunogenicity of a Dengue 1,2,3,4 (Attenuated) Vaccine

NCT01696422 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2019-01-16

No results posted yet for this study

Summary

This is a phase II step-wise, randomized, multicenter, double-blind and controlled clinical trial to evaluate the safety and immunogenicity of a attenuated tetravalent lyophilized dengue vaccine manufactured by Butantan Institute. Three Clinical Sites at University of Sao Paulo - Brazil will participate in the study. A total of 300 volunteers will be recruited and divided into two steps: Step A (with no previous exposure to dengue) and Step B (with and without previous exposure to dengue). In step A the participants will be assigned to receive either the lyophilized vaccine, or the liquid vaccine(developed at NIH and produced and formulated at Butantan according to the NIH-Protocol), or the placebo. In Step B participants will be assigned to receive either the lyophilized vaccine, or the placebo. Both vaccine formulations (lyophilized and liquid) are composed of the same attenuated viruses: rDEN1∆30, rDEN2/4∆30(ME), rDEN3∆30/31, and rDEN4∆30. At the end of the study, 20 volunteers will have received the liquid formulation (NIH), 210 the lyophilized formulation (Butantan), and 70 will have received the placebo. All participants included in both steps will be followed by a period of five years after their inclusion in the study. The study hypothesis is that the investigational lyophilized dengue vaccine manufactured by Butantan Institute is safe and confers balanced immune response, after one dose of 1000PFU, to all for vaccine viruses.

Conditions

  • Dengue

Interventions

BIOLOGICAL

Dengue 1,2,3,4 (attenuated) vaccine

Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous

BIOLOGICAL

TetraVax-DV Vaccine - Admixture TV003

Dose 1000 PFU per virus (1,2,3,4) Route: subcutaneous

OTHER

Placebo

Route:subcutaneous

Sponsors & Collaborators

  • Banco Nacional de Desenvolvimento Economico e Social

    collaborator UNKNOWN

  • Fundação de Amparo à Pesquisa do Estado de São Paulo

    collaborator OTHER_GOV

  • Butantan Foundation

    collaborator UNKNOWN

  • Butantan Institute

    lead OTHER_GOV

Principal Investigators

  • Alexander R Precioso, MD, PhD · Instituto Butantan

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2016-04-30
Completion
2020-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01696422 on ClinicalTrials.gov