Immunogenicity and Safety of TDV Co-administered with an Hepatitis A V
Research type
Research Study
Full title
A Randomized, Observer Blind, Phase 3 Trial to Investigate the Immunogenicity and Safety of the Co-administration of a Subcutaneous Tetravalent Dengue Vaccine Candidate (TDV) and an Intramuscular Hepatitis A Virus (Inactivated) Vaccine in Healthy Subjects Aged 18 to 60 Years in a Non-endemic Country(ies) for Dengue
IRAS ID
231939
Contact name
Susannah Eyre
Contact email
Sponsor organisation
Takeda Vaccines, Inc.
Eudract number
2017-001071-23
Duration of Study in the UK
years, 9 months, days
Research summary
Dengue fever is a disease caused by infection with a dengue virus which is transmitted by infected mosquitos. Symptoms include a sudden onset of fever, headache, pain behind the eyes, joint and muscle pain, rash, profuse bleeding and a low white blood cell count.
Dengue haemorrhagic fever and dengue shock syndrome are severe forms of dengue fever that can result in death. There is currently no specific medicine to treat dengue.Hepatitis A is a vaccine-preventable, communicable disease of the liver caused by the hepatitis A virus (HAV). It is usually transmitted via the faecal-oral route or by consuming contaminated food or water. HAV is a self-limited disease that does not result in chronic infection. HAV antibodies last for life and protect against reinfection.
This is a Phase 3 randomized study to investigate the immunogenicity and safety of 2 doses of tetravalent dengue vaccine candidate (TDV) when administered with an HAV vaccine, 3 months apart, in healthy adults.
TDV is a live attenuated vaccine that induces a dengue-specific immune response. It is comprised of four dengue virus strains. Approximately 15900 people have received different formulations of TDV in clinical trials to date; it is considered to have an overall acceptable safety profile.
The purpose of this study is to find out whether the study vaccine is safe and prevents dengue fever when given with a licensed hepatitis A vaccine or placebo.
All participants will be followed-up for 6 months after the last vaccination, given at Month 3, meaning the total trial duration is 9 months.
There will be 5 study visits. Study procedures include a physical examination, blood pressure and pulse monitoring, blood tests and diary card completion. The study will enrol approximately 900 participants aged 18- 60 years from non-endemic countries and is sponsored by Takeda Vaccine Inc.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
18/NW/0008
Date of REC Opinion
26 Mar 2018
REC opinion
Further Information Favourable Opinion