Clinical trial NCT00936429: Study of HBV-001 D1 in Healthy Adults
Official title: Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dengue Fever
Keywords: Dengue fever
Dengue hemorrhagic fever
Dengue shock syndrome
Vaccine
Hawaii Biotech
Lead sponsor: Hawaii Biotech, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-10
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects.

Detailed description: This is a single-center, double-blind, randomized, Phase 1 study to assess the safety and tolerability of HBV-001 D1 in healthy adult subjects. This will be an upward titration of two dose levels of HBV-001 D1 (10 µg and 50 µg of DEN1-80E) in 16 subjects across two cohorts. Participants in each cohort will receive HBV-001 D1 vaccine or placebo on Visits 1, 3 and 5.

Eligibility criteria: Inclusion Criteria:

* Males or females age 18 to 45.
* Body weight ≥ 110 pounds (50 kg).
* Satisfactory medical condition established by medical history and physical examination.
* Females must be of non-child bearing potential (i.e., surgically sterile) or, if of child-bearing potential must be abstinent or willing to employ adequate means of contraception.

Exclusion Criteria:

* Positive serum test for HIV, Hepatitis B surface antigens (HBsAg) and/or Hepatitis C antibodies.
* Abuse of drugs or alcohol within 12 months prior to screening.
* Use of corticosteroids or immunosuppressive drugs within 30 days of screening (use of topical or nasal corticosteroids is allowed).
* Any confirmed or suspected immunosuppressive or immunodeficient condition.
* Receipt of any vaccination within 30 days prior to screening.
* Receipt of blood products within 6 months of screening.
* Previous flavivirus vaccination (e.g., Japanese encephalitis or yellow fever) or flavivirus vaccination planned during the study period.
* History of flavivirus infection.
* No easy access to a fixed or mobile telephone.
* History of residing in a country endemic for dengue, Japanese encephalitis virus, or Yellow Fever virus for a period of \> 1 year.
* Donation of ≥ 450 mL of blood within the previous 12 weeks.

Primary outcomes:
measure: To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data
timeFrame: Assessed at each study visit
Secondary outcomes:
measure: To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses
timeFrame: Every 2 weeks during treatment
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
Study officials:
affiliation: Hawaii Biotech, Inc.
name: Beth-Ann Coller, PhD
role: STUDY_DIRECTOR
References:
citation: Durbin AP, Pierce KK, Kirkpatrick BD, Grier P, Sabundayo BP, He H, Sausser M, Russell AF, Martin J, Hyatt D, Cook M, Sachs JR, Lee AW, Wang L, Coller BA, Whitehead SS. Immunogenicity and Safety of a Tetravalent Recombinant Subunit Dengue Vaccine in Adults Previously Vaccinated with a Live Attenuated Tetravalent Dengue Vaccine: Results of a Phase-I Randomized Clinical Trial. Am J Trop Med Hyg. 2020 Aug;103(2):855-863. doi: 10.4269/ajtmh.20-0042. Epub 2020 May 7.
citation: Manoff SB, George SL, Bett AJ, Yelmene ML, Dhanasekaran G, Eggemeyer L, Sausser ML, Dubey SA, Casimiro DR, Clements DE, Martyak T, Pai V, Parks DE, Coller BA. Preclinical and clinical development of a dengue recombinant subunit vaccine. Vaccine. 2015 Dec 10;33(50):7126-34. doi: 10.1016/j.vaccine.2015.09.101. Epub 2015 Oct 14.