A Phase II Trial of a Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy Adults in Thailand

NCT00370682 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: WRAIR 1281Study no: 103854 (T-DEN-002)HSRRB A-13699
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This descriptive study will evaluate the safety and immunogenicity of different formulations of the WRAIR dengue vaccine compared to a placebo.

Conditions

Dengue

Outcome Measures

Primary Outcomes (2)

• Incidence of Any Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1

  Percentage of subjects with any grade 3 adverse events (AEs) within 21 days follow-up after dose 1 (0 month)

  0-21 days after dose 1

• Neutralizing Antibody Geometric Mean Titer (GMT) to DEN Types 1, 2, 3 and 4; 30 and 90 Days After Dose 2

  Neutralizing antibody geometric mean titer (GMT) to DEN types 1, 2, 3 and 4 will be measured 30 and 90 days following the administration of the 2nd dose (6 month)

  30 and 90 days after dose 2

Secondary Outcomes (9)

• Subjects With Any Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine

  0-21 days after dose 2 of study vaccine

• Incidence of Unsolicited AEs Within 31 Days (Days 0-30) After Any Study Vaccine Dose

  0-30 days after each study vaccine dose

• Incidence of Serious Adverse Events (SAEs) Throughout the Entire Study Period

  9 months

• Laboratory Values Above the Alert Values Within 31 Days (Days 0-30) After Each Vaccine Dose

  within 31 days after each vaccine dose

• Incidence of Abnormal Findings at DEN Physical Examination After Each Vaccine Dose

  31 days post-vaccination per dose

Study Arms (3)

T-DEN F17

EXPERIMENTAL

Full Dose (0.5 mL) 0 and 6 months

Biological: T-DEN F17

T-DEN F19

EXPERIMENTAL

Full Dose (0.5 mL) at 0 and 6 months

Biological: T-DEN F-19

Placebo Comparator

PLACEBO COMPARATOR

0.5 mL sterile buffer at 0 and 6, subcutaneous injection

Other: Placebo Comparator

Interventions

T-DEN F17 BIOLOGICAL

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Also known as: T-DEN vaccine

T-DEN F17

T-DEN F-19 BIOLOGICAL

A single dose of 0.5 mL of the dengue vaccine was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

T-DEN F19

Placebo Comparator OTHER

A single dose of 0.5 mL of the placebo sterile solution of buffer identical in appearance to vaccine)was injected subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm at Day 0 and at 6 months.

Placebo Comparator

Eligibility Criteria

• Age: 20 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• A healthy male or female adult 20-25 years of age (≥20 years of age and ≤25 years of age) at the time of vaccination;
• Free of obvious health problems as established by medical history and physical examination before entering into the study;
• Written informed consent obtained from the subject;
• Able to read the Subject Information Sheet and Consent Form;
• Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) should be enrolled in the study;
• females must be of non-childbearing potential, i.e. surgically sterilized or, if of childbearing potential, she must be abstinent or on adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series

You may not qualify if:

• Pregnant or lactating female, planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
• History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
• History of drug abuse or alcohol consumption (more than 2 drinks per day);
• History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
• Acute or chronic, pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
• Any confirmed or suspected immunosuppressive or immunodeficient condition or seropositive for HBsAg, anti-HCV or anti-HIV;
• Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever);
• Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
• Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
• Hypertension; chest pain, palpitations, dizziness, shortness of breath, arrhythmias or friction rubs;
• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period;
• Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before the first dose of the study vaccine/placebo and ending 30 days after the second dose;
• A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination;
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
• Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration during the study period;

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

Phramongkutklao Hospital

Bangkok, Thailand

Location

Related Publications (1)

• Watanaveeradej V, Gibbons RV, Simasathien S, Nisalak A, Jarman RG, Kerdpanich A, Tournay E, De La Barrerra R, Dessy F, Toussaint JF, Eckels KH, Thomas SJ, Innis BL. Safety and immunogenicity of a rederived, live-attenuated dengue virus vaccine in healthy adults living in Thailand: a randomized trial. Am J Trop Med Hyg. 2014 Jul;91(1):119-28. doi: 10.4269/ajtmh.13-0452. Epub 2014 May 27.

  PMID: 24865677 DERIVED

MeSH Terms

Conditions

Dengue

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Hemorrhagic Fevers, Viral

Results Point of Contact

• Title: Verrachai Watanaveeradej, MD
• Organization: Phramongkutklao Hospital, Bangkok, Thailand

veerachaiw@yahoo.com

662-644-8971

Study Officials

• Robert Gibbons, MD, MPH

  Department of Virology, Armed Forces Research Institute of Medical Sciences (AFRIMS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2006
• First Posted: September 1, 2006
• Study Start: April 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: May 30, 2017
• Results First Posted: May 30, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will share

Locations

TH (1)