Safety and Immune Response to an Investigational Dengue Type 2 Vaccine

NCT01073306 | Completed Phase 1 DMC

• 2 other identifiers: CIR 254#20081980
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Dengue viruses can cause dengue fever and other serious health conditions, primarily affecting people living in tropical regions of the world. This study will test whether a vaccine developed to prevent infection with dengue virus type 2 causes a response in people's immune system and is safe.

Conditions

Dengue Virus

Keywords

Vaccine; Dengue Hemorrhagic Fever

Outcome Measures

Primary Outcomes (3)

• Immunogenicity of vaccine, as assessed by neutralizing antibody titers

  Measured at 4 and 6 weeks after vaccination

• Safety of vaccine, as assessed by the frequency of vaccine-related adverse events (AEs), graded by severity

  Measured throughout study

• Number of vaccinees infected with this dengue virus subtype 2 (DEN2) candidate vaccine, as defined by either recovery of vaccine virus from the blood of vaccinated participants and/or by seroconversion to DEN2

  Measured at Days 28 and 42

Secondary Outcomes (2)

• Frequency, quantity, and duration of viremia

  Measured after vaccination

• Comparison of infectivity rates, safety, and immunogenicity of a single dose of DEN2 vaccine from this trial to those variables on previous trials

  Measured at study completion

Study Arms (2)

Dengue Virus Subtype 2 Vaccine

EXPERIMENTAL

Participants will receive a single dose of investigational vaccine for dengue virus subtype 2.

Biological: Investigational Vaccine for Dengue Virus Subtype 2

Placebo

PLACEBO COMPARATOR

Participants will receive a single dose of placebo vaccine.

Other: Placebo

Interventions

Investigational Vaccine for Dengue Virus Subtype 2 BIOLOGICAL

Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)

Also known as: rDEN2/4Δ30

Dengue Virus Subtype 2 Vaccine

Placebo OTHER

Subcutaneous injection of placebo

Placebo

Eligibility Criteria

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

You may qualify if:

• Good general health as determined by physical examination, laboratory screening, and review of medical history
• Available for the duration of the study, approximately 6 weeks post-vaccination
• Female participants of childbearing potential must be willing to use effective contraception for the duration of the trial

You may not qualify if:

• Currently breastfeeding or pregnant
• Exhibits evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, rheumatologic, autoimmune, or renal disease by history, physical examination, and/or laboratory studies
• Presence of a behavioral, cognitive, or psychiatric disease that affects the ability of the participant to understand and cooperate with the requirements of the study protocol
• Has screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), and serum creatinine, as defined in protocol
• Presence of any condition that would jeopardize the safety or rights of the participant or would render the participant unable to comply with the protocol
• Significant alcohol or drug abuse in the past 12 months that has caused medical, occupational, or family problems, as indicated by participant history
• History of a severe allergic reaction or anaphylaxis
• Presence of severe asthma, defined as requiring emergency room visit or hospitalization within the last 6 months
• Presence of HIV infection, determined by screening and confirmatory assays
• Presence of hepatitis C virus (HCV) infection, determined by screening and confirmatory assays
• Presence of hepatitis B virus (HBV) infection, determined by hepatitis B surface antigen (HBsAg) screening
• Presence of any known immunodeficiency syndrome
• Uses anticoagulant medications
• Has used corticosteroids (excluding topical or nasal) or immunosuppressive drugs within 42 days prior to or following vaccination. An immunosuppressive dose of corticosteroids is defined as greater than or equal to 10 mg prednisone or equivalent per day for greater than or equal to 14 days.
• Has received a live vaccine within 28 days or a killed vaccine within 14 days prior to vaccination or anticipates receipt of any vaccine during the 42 days following vaccination

Sponsors & Collaborators

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

Study Sites (1)

Johns Hopkins Project SAVE, Center for Immunization Research

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (2)

• Blaney JE Jr, Durbin AP, Murphy BR, Whitehead SS. Development of a live attenuated dengue virus vaccine using reverse genetics. Viral Immunol. 2006 Spring;19(1):10-32. doi: 10.1089/vim.2006.19.10.

  PMID: 16553547 BACKGROUND

• Durbin AP, McArthur JH, Marron JA, Blaney JE, Thumar B, Wanionek K, Murphy BR, Whitehead SS. rDEN2/4Delta30(ME), a live attenuated chimeric dengue serotype 2 vaccine is safe and highly immunogenic in healthy dengue-naive adults. Hum Vaccin. 2006 Nov-Dec;2(6):255-60. doi: 10.4161/hv.2.6.3494. Epub 2006 Nov 5.

  PMID: 17106267 BACKGROUND

MeSH Terms

Conditions

Severe Dengue

Condition Hierarchy (Ancestors)

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

Study Officials

• Kawsar Talaat, MD

  Johns Hopkins Bloomberg 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: February 19, 2010
• First Posted: February 23, 2010
• Study Start: February 1, 2010
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: January 3, 2013

Record last verified: 2012-12

Locations

US (1)