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Tetravalent Chimeric Dengue Vaccine Trial

2014-08-27 03:14:11 | BioPortfolio

Summary

The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.

Description

This purpose of this study is to evaluate the safety and immunogenicity of a tetravalent chimeric dengue vaccine. The primary objective is to evaluate the safety and tolerability of a subcutaneous (SC) and intradermal (ID) administered chimeric tetravalent dengue vaccine to healthy normal adult volunteers. The secondary objective of this study is to obtain preliminary data in assessing the immunogenicity of the vaccine, at 2 different dose levels and 2 different modes of administration, against all 4 dengue serotypes in healthy adults. This study is a single-center, placebo-controlled, double blind, randomized, Phase I dose escalation study to evaluate the safety, tolerability and immunogenicity of DENVax dengue vaccine in flavivirus-negative normal male and female volunteers. The study will enroll 72 subjects, ages of 18-45. DENVax (modified live tetravalent chimeric dengue vaccine) is a vaccine under investigation for the prevention of dengue disease. It is comprised of 4 recombinant, live attenuated chimeric dengue virus strains: DENVax-1, DENVax-2, DENVax-3 and DENVax-4. The vaccine will be tested by SC and ID routes of administration using 2 dose levels. The low dose level will contain 8 x10^3, 5 x10^3, 1 x 10^4 and 2 x 10^5 plaque forming units (PFU) of DENVax-1, DENVax-2, DENVax-3 and DENVax-4, respectively. The high dose level will contain 2 x 10^4, 5 x 10^4, 1 x 10^5 and 3 x 10^5 PFU of the same 4 serotypes, respectively. Phosphate buffered saline will be used as the placebo control. Subjects will be vaccinated twice (Days 0 and 90). Groups 1 and 2 will receive the study low dose of DENVax vaccine or placebo by the SC or ID route, respectively, while Groups 3 and 4 will receive the study high dose of vaccine or placebo, by the SC or ID route, respectively. Two sentinel subjects in groups 1 and 2 will be dosed open label with vaccine via the SC or ID route and followed for safety for 14 days. If acceptable safety is seen in the 2 sentinel subjects, the remainder of the low dose cohort will be randomly assigned to Groups 1 or 2, and then randomized to treatment within each group in a ratio of 11 DENVax to 6 placebo. Two sentinel subjects in groups 3 and 4 will be dosed open label with vaccine via the SC or ID route and followed for safety for 14 days. If acceptable safety is seen in the 2 sentinel subjects, the remainder of the high dose cohort will be randomly assigned to Groups 3 and 4 and then randomized to treatment, as above. Study product will be administered by SC injection (groups 1 and 3) or by ID injection (groups 2 and 4) in the deltoid region. Screening and enrollment for prime-dosing for the first 2 sentinel subjects (low dose SC (group 1) and low dose ID (group 2) will commence after receipt of approvals for study conduct. The Safety Committee will review the safety data collected through day 14 from the sentinel subjects, including safety labs, memory aids, and any adverse events (AEs) and determine whether to allow enrollment of the remaining 34 subjects in groups 1 and 2. The Safety Committee will review the safety data collected through day 21 from the first 2 groups and determine whether to allow enrollment of the sentinel subjects for the high dose groups 3 and 4 and boosting of groups 1 and 2. The sentinel subjects for the high dose groups [high dose SC (group 3) and high dose ID (group 4)] will have safety data collected through day 14 and the Safety Committee will review data to determine whether to allow enrollment of the remaining 34 subjects in groups 3 and 4. The Safety Committee will review the safety data collected through day 21 from groups 3 and 4 to determine whether to allow boosting of groups 3 and 4. The duration for each subject is approximately 10 months including recruitment and collection of data for primary outcomes (through Day 120) as well as collection of additional samples for measurement of longer term antibody titers (Day 180 and 270).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Conditions

Dengue

Intervention

Modified Live Tetravalent Chimeric Dengue Vaccine (ID), Placebo (ID), Placebo (SC), Modified Live Tetravalent Chimeric Dengue Vaccine (SC)

Location

Saint Louis University Center for Vaccine Development
St. Louis
Missouri
United States
63104

Status

Recruiting

Source

National Institute of Allergy and Infectious Diseases (NIAID)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:11-0400

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