Evaluating the Clinical and Immune Response to Two Dengue Virus Vaccines in Healthy Adults

NCT02392325 | Completed Phase 1 DMC

• 1 other identifier: CIR 302
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Dengue viruses infect millions of people throughout the tropics and subtropics each year. The development of a dengue vaccine is an important health priority. This study will evaluate the immunologic and clinical response to two dengue vaccines, given 9 months apart, in healthy adults with no history of previous flavivirus infection.

Conditions

Dengue

Outcome Measures

Primary Outcomes (3)

• Measurement of PRNT50 (plaque reduction neutralization titer) to DENV-1, DENV-2, DENV-3, and DENV-4

  Measured through Day 90 post-vaccination

• Incidence of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270

  Measured through Day 450

• Intensity of solicited adverse events (AEs) following administration of rDEN2Δ30-7169 at Day 270

  Measured through Day 450

Study Arms (2)

rDEN1Δ30 and rDEN2Δ30-7169

EXPERIMENTAL

Participants will receive the rDEN1Δ30 vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270.

Biological: rDEN1Δ30; Biological: rDEN2Δ30-7169

Placebo and rDEN2Δ30-7169

EXPERIMENTAL

Participants will receive placebo vaccine at Day 0. They will receive the rDEN2Δ30-7169 vaccine at Day 270.

Biological: Placebo; Biological: rDEN2Δ30-7169

Interventions

rDEN1Δ30 BIOLOGICAL

Administered subcutaneously in 0.5 mL containing 10\^3.0 plaque-forming units (PFU)

rDEN1Δ30 and rDEN2Δ30-7169

Placebo BIOLOGICAL

Administered subcutaneously in 0.5 mL

Placebo and rDEN2Δ30-7169

rDEN2Δ30-7169 BIOLOGICAL

Administered subcutaneously in 0.5 mL containing 10\^3.0 PFU

Placebo and rDEN2Δ30-7169; rDEN1Δ30 and rDEN2Δ30-7169

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult male or female between 18 and 50 years of age, inclusive
• Good general health as determined by physical examination, laboratory screening, and review of medical history
• Available for the duration of the study, approximately 26 weeks post-second inoculation
• Willingness to reside in the inpatient unit for 10 days following receipt of rDEN2Δ30-7169
• Willingness to participate in the study as evidenced by signing the informed consent document
• Females Only: Female participants of childbearing potential willing to use effective contraception. Reliable methods of contraception include: hormonal birth control, condoms with spermicide, diaphragm with spermicide, surgical sterilization, intrauterine device, and abstinence (greater than or equal to 6 months since last sexual encounter). All female participants will be considered having child-bearing potential except for those with hysterectomy, tubal ligation, tubal coil (at least 3 months prior to vaccination), or post-menopausal status documented as at least 1 year since last menstrual period.

You may not qualify if:

• Females Only: Currently pregnant, as determined by positive beta-human choriogonadotropin (HCG) test, breastfeeding
• Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and cooperate with the requirements of the study protocol
• Evidence of recent opiate use based on urine toxicology screen
• Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in this protocol
• Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
• Any significant alcohol or drug abuse in the past 12 months which has caused medical, occupational, or family problems, as indicated by participant history
• History of a severe allergic reaction or anaphylaxis
• Severe asthma (emergency room visit or hospitalization within the last 6 months)
• HIV infection, by screening and confirmatory assays
• Hepatitis C virus (HCV) infection, by screening and confirmatory assays
• Hepatitis B virus (HBV) infection, by Hepatitis B surface antigen (HBsAg) screening
• Any known immunodeficiency syndrome
• Use of anticoagulant medications (use of antiplatelet medication such as aspirin or non-steroidal anti-inflammatory medication is permitted and will not exclude a participant from enrollment)
• Use of corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 28 days prior to or following vaccination. Immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone equivalent per day for greater than or equal to 14 days

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

Center for Immunization Research, Johns Hopkins School of Public Health

Baltimore, Maryland, 21205, 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

Study Officials

• Anna Durbin, MD

  Center for Immunization Research (CIR), Johns Hopkins School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2015
• First Posted: March 18, 2015
• Study Start: March 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: February 1, 2017
• Last Updated: February 8, 2018

Record last verified: 2018-02

Locations

US (1)