Study of HBV-001 D1 in Healthy Adults

Phase 1, Placebo-Controlled, Double-Blind, Safety Study of HBV-001 D1 in Healthy Adults

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.

Study Overview

• Status: Completed
• Conditions: Dengue Fever
• Intervention / Treatment: Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel); Biological: Placebo for DEN1-80E

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.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • St. Louis, Missouri, United States, 63104
      • Saint Louis University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 43 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 10 µg DEN1-80E + 3.5 mg Alhydrogel; Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.	Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel); 3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.; Other Names: HBV-001 D1
Experimental: 50 µg DEN1-80E + 3.5 mg Alhydrogel; Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.	Biological: DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel); 3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.; Other Names: HBV-001 D1
Placebo Comparator: Placebo; Administration of placebo vaccine at Weeks 0, 4, and 8.	Biological: Placebo for DEN1-80E; 3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data	Assessed at each study visit

Secondary Outcome Measures

Outcome Measure	Time Frame
To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses	Every 2 weeks during treatment

Collaborators and Investigators

• Sponsor: Hawaii Biotech, Inc.
• Investigators: Study Director: Beth-Ann Coller, PhD, Hawaii Biotech, Inc.

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): July 1, 2010
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 8, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Estimate): February 7, 2011
• Last Update Submitted That Met QC Criteria: February 3, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Vaccine; Dengue fever; Dengue hemorrhagic fever; Dengue shock syndrome; Hawaii Biotech
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Arbovirus Infections; Vector Borne Diseases; Flavivirus Infections; Flaviviridae Infections; Hemorrhagic Fevers, Viral; Dengue; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Immunologic Factors; Gastrointestinal Agents; Adjuvants, Immunologic; Antacids; Aluminum Hydroxide
• Other Study ID Numbers: HBV-001-C-101