A Trial of a Walter Reed Army Institute of Research (WRAIR) Live Attenuated Virus Tetravalent Dengue Vaccine in Healthy US Adults

NCT00239577 | Completed Phase 2 Results

• 1 other identifier: 103996
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

This descriptive study will evaluate the safety and immunogenicity of 5 different formulations of the WRAIR dengue vaccine compared to a placebo.

Conditions

Dengue

Keywords

Dengue infection

Outcome Measures

Primary Outcomes (5)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.

  During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  Assessed solicited general symptoms were abdominal pain, arthralgia, fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], headache, muscle aches, nausea, pain behind the eyes, photophobia, pruritus, rash and vomiting. Any = occurrence of the symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.0 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.

  During the 21-day (Days 0-20) follow-up after Dose 1 of the study vaccine

• Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4

  Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum.

  At 30 days (Month 7) after Dose 2 of the study vaccine

• Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status

  Titers for DEN-1, DEN-2, DEN-3 and DEN-4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.

  At 5 to 12 months post-Dose 2 of the study vaccine

• Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status

  Titers for DEN 1, DEN 2, DEN 3 and DEN 4 neutralizing antibodies, expressed as Geometric Mean Titers (GMTs), with cut-off values greater than or equal to (≥) 10 estimated dose giving 50% (ED50) signal reduction when compared to a control without serum. Not primed = Not primed by MN50; Primed = Primed by MN50. Primed subject is a subject with neutralizing antibody titer ≥ 10 ED50 at pre-vaccination for at least one DEN type. Not primed subject is a subject with neutralizing antibody titer \<10 ED50 for any DEN type at pre-vaccination.

  At Month 1 post-booster dose of the study vaccine

Secondary Outcomes (25)

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 21-day (Days 0-20) follow-up after Dose 2 of the study vaccine

• Number of Subjects With Any and Grade 3 Solicited Local Symptoms

  During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

• Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms

  During the 21-day (Days 0-20) follow-up after each dose of the study vaccine

• Number of Subjects With Unsolicited Adverse Events (AEs)

  During the 31-day (Days 0-30) follow-up after any study vaccine dose

Study Arms (4)

DENGUE FORMULATION 17A GROUP

EXPERIMENTAL

Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Dengue vaccine Formulation 17a, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.

Biological: Live attenuated tetravalent dengue vaccine

DENGUE FORMULATION 17B GROUP

EXPERIMENTAL

Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 17b, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6, and one booster dose approximately 5-12 months after the second dose.

Biological: Live attenuated tetravalent dengue vaccine

DENGUE FORMULATION 19 GROUP

EXPERIMENTAL

Healthy male or female subjects, between and including 18-45 years of age, who received two primary doses of Dengue vaccine Formulation 19, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6 and one booster dose approximately 5-12 months after the second dose.

Biological: Live attenuated tetravalent dengue vaccine

PLACEBO GROUP

PLACEBO COMPARATOR

Healthy male or female subjects, between and including 18-45 years of age, who received two doses of Placebo, administered subcutaneously into the upper-outer triceps/deltoid area of the non-dominant arm, at Months 0 and 6.

Biological: Placebo

Interventions

Live attenuated tetravalent dengue vaccine BIOLOGICAL

Live attenuated tetravalent dengue vaccine

DENGUE FORMULATION 17A GROUP; DENGUE FORMULATION 17B GROUP; DENGUE FORMULATION 19 GROUP

Placebo BIOLOGICAL

Placebo

PLACEBO GROUP

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female adult 18-45 years 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
• Females must be of non-childbearing potential, or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions as defined in the protocol 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:

• History of:
• recurrent migraine headache
• any neurological or behavioral disorder or seizures
• drug abuse or alcohol consumption (more than 2 drinks per day)
• allergic disease/reaction likely to be exacerbated by vaccine
• urticaria related to mosquito bites requiring medical attention
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect
• Any confirmed or suspected immunosuppressive or immunodeficient condition;
• Seropositive for HBsAg, anti-HCV or anti-HIV
• Acute disease at the time of enrollment
• Chronic hepatomegaly or splenomegaly
• Use of any investigational or non-registered drug or vaccine within 30 days preceding study or planned use
• Planned administration of a vaccine not foreseen by the study protocol 30 days ±each vaccine dose
• Planned move during study
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs or administration of immunoglobulins and/or blood products, within 90 days preceding the first dose or planned administration during the study period

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Silver Spring, Maryland, 20910, United States

Location

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: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2005
• First Posted: October 17, 2005
• Study Start: April 5, 2006
• Primary Completion: June 19, 2007
• Study Completion: June 19, 2007
• Last Updated: February 19, 2019
• Results First Posted: February 19, 2019

Record last verified: 2019-02

Locations

US (1)