Study of Varying Injection Schedules of TDENV-PIV Vaccine With AS03B Adjuvant and Placebo in Healthy US Adults

NCT ID: NCT02421367

Last Updated: 2019-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-03-31

Brief Summary

This study is being conducted to evaluate the safety and immunogenicity and antibody persistence of the candidate dengue vaccine.

Conditions

Dengue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

TDENV-PIV (0-1)

The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

The placebo is sodium chloride.

TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

The intervention will be administered on Day 0 and Day 28. The placebo will be administered on Day 84 and Day 168.

Group Type: EXPERIMENTAL

TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.

Intervention Type: BIOLOGICAL

Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)

TDENV-PIV (0-1-6)

The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

The placebo is sodium chloride.

TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

The intervention will be administered on Day 0, Day 28, and Day 168. The placebo will be administered on Day 84.

Group Type: EXPERIMENTAL

TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.

Intervention Type: BIOLOGICAL

Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)

TDENV-PIV (0-3)

The intervention is a tetravalent dengue virus purified inactivated vaccine (1µg/DENV type) with adjuvant, AS03B.

The placebo is sodium chloride.

TDENV-PIV vaccine and placebo will be administered in a single 0.5 mL dose intramuscularly in the non-dominant (whenever possible) deltoid region of the upper arm.

The intervention will be administered on Day 84 and Day 168. The placebo will be administered on Day 0 and Day 28.

Group Type: EXPERIMENTAL

TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.

Intervention Type: BIOLOGICAL

Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)

Interventions

TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.

Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Subjects must be able to provide written informed consent.

2. Subjects must be healthy as established by medical history and clinical examination at study entry

3. Subjects who the investigator believes can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits, etc.)

4. Subjects at WRAIR CTC must be able to pass Department of Defense (DoD) base entry requirements, including the possession of a valid government issued ID card.

5. Male or non-pregnant, non-breastfeeding female between 20 and 49 years of age (inclusive) at the time of consent

6. Female subjects of non-childbearing potential (non-childbearing potential is defined as having had one of the following: a tubal ligation at least 3 months prior to enrollment, a hysterectomy, an ovariectomy, or is post-menopausal).

7. Female subjects of childbearing potential may be enrolled in the study, if all of the following apply:

• Practiced adequate contraception (see Definition of Terms, section 5) for 30 days prior to vaccination
• Has a negative urine pregnancy test on the day of vaccination
• Agrees to continue adequate contraception until two months after completion of the vaccination series.

Exclusion Criteria

1. Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines/placebo during the period starting 30 days preceding the first dose of study vaccine/placebo and/or planned use during the study period

2. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the first vaccine/placebo dose (for corticosteroids, this will mean prednisone >=5mg/day or equivalent; inhaled, intranasal and topical steroids are allowed)

3. Planned administration or administration of a vaccine/product not planned in the study protocol during the period starting 30 days prior to the first dose of vaccine/placebo until 30 days after the last dose of study vaccine/placebo (routine influenza vaccination will be allowed as long as it is not administered within 14 days of the vaccine/placebo, and will not lead to study exclusion although it should be reported to the PI)

4. History of dengue infection or dengue illness, or history of flavivirus vaccination (e.g., yellow fever, tick-borne-encephalitis virus [TBEV], Japanese encephalitis, and dengue)

5. Planned administration of any flavivirus vaccine for the entire study duration

6. Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device)

7. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required)

8. Family history of congenital or hereditary immunodeficiency

9. Autoimmune disease or history of autoimmune disease

10. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study vaccine/placebo or related to a study procedure

11. Major congenital defects or serious chronic illness

12. History of any neurological disorders or seizures

13. Diagnosed with excessive daytime sleepiness (unintended sleep episodes during the day present almost daily for at least 1 month) or narcolepsy; or history of narcolepsy in a subject's parent, sibling, or child

14. Acute disease and/or fever (≥37.5°C/99.5°F oral body temperature) at the time of enrollment: note that a subject with a minor illness such as mild diarrhea, mild upper respiratory infection, etc., without fever, may be enrolled at the discretion of the investigator

15. Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests

16. Administration of immunoglobulins and/or any blood products during the period starting 90 days preceding the first dose of study vaccine/placebo or planned administration during the study period

17. Recent history of chronic alcohol consumption (more than 2 drinks per day and/or drug abuse (based on subject reported history)

18. Pregnant or breastfeeding female or female currently planning to become pregnant or planning to discontinue adequate contraception

19. A planned move to a location that will prohibit participating in the trial until Study End for the participant

20. Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.

21. Subject seropositive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (anti-HCV), or human immunodeficiency virus antibodies (anti-HIV)

22. Safety laboratory test results at screening that are deemed clinically significant or more than Grade 1 deviation from normal

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Walter Reed Army Institute of Research (WRAIR)

FED

Sponsor Role: collaborator

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Leyi Lin, M.D.

Role: PRINCIPAL_INVESTIGATOR

USAMRMC/WRAIR

Locations

University of Maryland, Center for Vaccine Development,

Baltimore, Maryland, United States

WRAIR, Clinical Trials Center

Silver Spring, Maryland, United States

Countries

United States

References

Lin L, Lyke KE, Koren M, Jarman RG, Eckels KH, Lepine E, McArthur MA, Currier JR, Friberg H, Moris P, Keiser PB, De La Barrera R, Vaughn DW, Paris RM, Thomas SJ, Schmidt AC. Safety and Immunogenicity of an AS03B-Adjuvanted Inactivated Tetravalent Dengue Virus Vaccine Administered on Varying Schedules to Healthy U.S. Adults: A Phase 1/2 Randomized Study. Am J Trop Med Hyg. 2020 Jul;103(1):132-141. doi: 10.4269/ajtmh.19-0738. Epub 2020 Apr 23.

Reference Type: DERIVED

PMID: 32342848 (View on PubMed)

Other Identifiers

WRAIR # 2195

Identifier Type: OTHER

Identifier Source: secondary_id

201658

Identifier Type: OTHER

Identifier Source: secondary_id

S-14-13

Identifier Type: -

Identifier Source: org_study_id