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Study of HBV-001 D1 in Healthy Adults

Primary Purpose

Dengue Fever

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)

Placebo for DEN1-80E

About this trial

This is an interventional prevention trial for Dengue Fever focused on measuring Dengue fever, Dengue hemorrhagic fever, Dengue shock syndrome, Vaccine, Hawaii Biotech

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Saint Louis University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

10 µg DEN1-80E + 3.5 mg Alhydrogel

50 µg DEN1-80E + 3.5 mg Alhydrogel

Placebo

Arm Description

Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Administration of placebo vaccine at Weeks 0, 4, and 8.

Outcomes

Primary Outcome Measures

To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data

Secondary Outcome Measures

To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses

Full Information

NCT ID

NCT00936429

First Posted

July 8, 2009

Last Updated

February 3, 2011

Sponsor

Hawaii Biotech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00936429

Brief Title

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

2. Study Status

Record Verification Date

February 2011

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

July 2010 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Hawaii Biotech, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dengue Fever

Keywords

Dengue fever, Dengue hemorrhagic fever, Dengue shock syndrome, Vaccine, Hawaii Biotech

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

10 µg DEN1-80E + 3.5 mg Alhydrogel

Arm Type

Experimental

Arm Description

Administration of 10 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Arm Title

50 µg DEN1-80E + 3.5 mg Alhydrogel

Arm Type

Experimental

Arm Description

Administration of 50 µg DEN1-80E vaccine at Weeks 0, 4, and 8.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Administration of placebo vaccine at Weeks 0, 4, and 8.

Intervention Type

Biological

Intervention Name(s)

DEN1-80E (HBV-001 D1 + 3.5 mg Alhydrogel)

Other Intervention Name(s)

HBV-001 D1

Intervention Description

3 doses of DEN1-80E vaccine administered as 0.5 ml intramuscularly in deltoid.

Intervention Type

Biological

Intervention Name(s)

Placebo for DEN1-80E

Intervention Description

3 doses of placebo vaccine administered as 0.5 ml intramuscularly in deltoid.

Primary Outcome Measure Information:

Title

To determine the safety of the study vaccine formulations in healthy adult subjects by assessing adverse events and laboratory data

Time Frame

Assessed at each study visit

Secondary Outcome Measure Information:

Title

To assess the impact of vaccine dose level on immunogenicity determined by the levels of neutralizing antibodies and cell mediated immune responses

Time Frame

Every 2 weeks during treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Beth-Ann Coller, PhD

Organizational Affiliation

Hawaii Biotech, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Saint Louis University

City

St. Louis

State/Province

Missouri

ZIP/Postal Code

63104

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

32394880

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.

Results Reference

derived

PubMed Identifier

26458804

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.

Results Reference

derived

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Study of HBV-001 D1 in Healthy Adults

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