Phase 2 N=86 Randomized Prevention

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

Dengue

Bottom Line

View on ClinicalTrials.gov: NCT00239577 ↗

Enrolled (actual)

Serious AEs

3.5%

Results posted

Feb 2019

Primary outcome: Primary: Number of Subjects With Any and Grade 3 Solicited Local Symptoms — 7; 2; 4; 5 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Live attenuated tetravalent dengue vaccine (Biological); Placebo (Biological)
Age: Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Jun 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms	0; 0; 0; 0; 1; 2	—
PRIMARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	0; 1; 0; 0; 0; 0	—
PRIMARY Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4	10; 10; 13; 7; 51; 20	—
PRIMARY Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status	39; 73; 672; 2430; 104; 194	—
PRIMARY Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4 Based on Priming Status	39; 73; 672; 2430; 104; 194	—
SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms	0; 0; 0; 0; 1; 2	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	0; 1; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms	0; 0; 0; 0; 1; 2	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	0; 1; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs)	15; 10; 15; 12	—
SECONDARY Number of Subjects With Serious Adverse Events (SAEs)	0; 0; 1; 1	—
SECONDARY Number of Subjects With Alert Values for Safety Laboratory Determinations	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Abnormal Findings at Dengue Physical Examination	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Suspected and Confirmed Dengue	0; 0; 0; 0	—
SECONDARY Number of Subjects With Measurable Dengue Viremia	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Safety Laboratory Determinations Outside the Normal Ranges	0; 0; 0; 0; 1; 1	—
SECONDARY Titers for DEN Neutralizing Antibodies Types 1, 2, 3 and 4	10; 10; 13; 7; 51; 20	—
SECONDARY Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype	4; 5; 5; 7; 2; 2	—
SECONDARY Number of Subjects With Antibody Titers Above the Assay Cut-off Value (Tetravalent Response) for All Dengue Serotypes	6; 6; 6; 0; 10; 9	—
SECONDARY Number of Subjects With Sero-response to Each DEN Type	10; 6; 10; 0; 14; 11	—
SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms	0; 0; 0; 0; 1; 2	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms	0; 1; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Any, Grade 3 and Related Unsolicited AEs	6; 3; 2; 0; 0; 1	—
SECONDARY Number of Subjects With SAEs	2; 0	—
SECONDARY Number of Subjects With Hematological and Biochemical Determinations Within and Outside the Normal Ranges	9; 12; 9; 12; 9; 12	—
SECONDARY Number of Subjects With Alert Values for Safety Laboratory Determinations	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Abnormal Findings at Dengue Physical Examination	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Suspected and Confirmed Dengue	0; 0; 0; 0	—
SECONDARY Number of Subjects With Measurable Dengue Viremia	0; 0; 0; 0; 0; 0	—
SECONDARY Number of Subjects With Antibody Titers Above the Assay Cut-off Value for Each DEN Serotype	4; 5; 5; 7; 2; 2	—

Summary

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

Eligibility Criteria

Inclusion:

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

Exclusion:

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
Any chronic systemic drug therapy to be continued during the study period

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00239577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.