Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02678455
• Date of registration: 05/02/2016
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Safety and Immunogenicity of the Dengue Virus Vaccine TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
• Scientific title: Phase II, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Immunogenicity of the Recombinant Live Attenuated Tetravalent Dengue Virus Vaccine Admixture TV005 (TetraVax-DV TV005) in Healthy Adults, Adolescents, and Children in Dhaka, Bangladesh
• Date of first enrolment: March 2016
• Target sample size: 192
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02678455
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Bangladesh

Contacts

• Name: Beth D. Kirkpatrick, MD
• Affiliation: Vaccine Testing Center, University of Vermont College of Medicine

• Name: Rashidul Haque, MD
• Affiliation: Centre for Vaccine Sciences, International Centre for Diarrhoeal Disease Research, Bangladesh

Key inclusion & exclusion criteria

Inclusion Criteria:

- Healthy males or females (non-pregnant or lactating) between the ages of 12 months and
50 years at the time of enrollment into the study.

- Reside in Mirpur Wards 2, 3, or 5 (or other Wards within Mirpur as designated by the
PI if needed to reach enrollment targets) at the time of screening.

- Study participants and/or their parents/guardians/legally acceptable or authorized
representatives (LARs) who the Investigator believes can and will comply with the
requirements of the protocol (e.g., return for follow-up visits).

- Good general health as determined by physical examination, laboratory screening, and
review of medical history.

- If the participant is greater than or equal to 18 years of age, an informed consent
form signed and dated by the study participant (and by an independent witness if
required by local regulations). If the study participant is a minor, an assent form
(for participants age 11-17 years) and informed consent form signed and dated by the
participant's properly identified parent(s) or legally acceptable representative. If a
participant is less than 11 years of age, the participant's parent(s) or legally
acceptable representative will consent by signing the consent form for minor
participants.

- If the participant is female, she must not be pregnant or planning to become pregnant
up to 28 days post vaccination. Female participants under the age of 18 will be
enrolled, if they have not yet reached menarche. Females 18 years of age or older,
must be properly using a method of pregnancy prevention that is known to be highly
effective per the PI. Reliable methods of contraception include: hormonal birth
control, condoms with spermicide, diaphragm with spermicide, surgical sterilization,
intrauterine device, and abstinence (greater than or equal to 6 months since last
sexual encounter). For female study participants who are 18 years of age or older
pregnancy testing will occur at screening and again before vaccination and they must
have a negative pregnancy test prior to vaccination. Additionally, they will receive
counselling on the importance of effective contraception during the 30 days prior to
vaccination and continuing up to Day 28. Counselling will occur at their screening
visit, on all clinic visit days up to Day 28. Female participants 18 years of age and
older will be subject to pregnancy testing on the Study Day 28 and 56 visits. If
female participants under the age of 18 that have not yet reached menarche prior to
enrollment, reach menarche during the study, they will continue to be enrolled and
followed-up through the entire three year follow-up period.

Exclusion Criteria:

- Pregnant or lactating female or female planning to become pregnant within 28 days of
receiving an investigational product or planning to discontinue abstinence or
contraceptive precautions within 28 days of receiving an investigational product.
Menstruating females under the age of 18 will be excluded from being enrolled.

- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal,
autoimmune, hematologic, or endocrine disease or functional defect, as determined by
history, physical examination, or screening tests.

- History of any neurological, psychiatric, or behavioural disorder or seizures, with
the exception of a single febrile seizure in childhood.

- Self-reported or suspected congenital or acquired immunodeficiency; or receipt of
immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within
the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or
equivalent, greater than or equal to 0.5 mg/kg/day or 20 mg/day, for more than 2
consecutive weeks within the past 3 months). Inhaled and topical steroids are allowed.

- Having a height-for-age z-score (HAZ) or weight-for-age z-score (WAZ) of less than or
equal to 3 for children under the age of two. Severe malnutrition as observed by the
study physician for all study participants ages 2 years old and older.

- Hepatitis C virus (HCV) infection by screening and confirmatory assays (screening in
adults and adolescents only), or hepatitis B virus (HBV) infection, by hepatitis B
surface antigen (HBsAg) screening (all participants) or, unwilling to allow HCV
(adults and adolescents only) and HBV testing.

- Screening laboratory values of Grade 1 or above for absolute neutrophil count (ANC),
alanine transaminase (ALT), or platelet count, as defined in this protocol.

- For children under 5 years of age, screening laboratory values of Grade 1 or above for
Haemoglobin.

- History of allergic reaction likely to be exacerbated by any component of the vaccine;
any history of a severe allergic reaction or anaphylaxis.

- Current alcohol abuse or drug addiction that might interfere with the ability to
comply with trial procedures.

- Any other condition that in the opinion of the Investigator would jeopardize the
safety or rights of a participant participating in the trial or would render the
participant unable to comply with the protocol.

- Planned administration of any vaccine from 30 days prior to receipt of the study
vaccine and ending 30 days after; with the exceptions of standard infant and child
Expanded Program on Immunization (EPI) inactivated vaccines and the inactivated
influenza vaccine or the inactivated rabies vaccine (without administration of
immunoglobulin) administered to adults or children.

- Use of any investigational or non-registered drug or vaccine other than the study
vaccine within 30 days preceding receipt of study vaccine/placebo or planned use at
any time during the study period or history of having received any investigational
dengue vaccine at any previous time.

- Current participation in any clinical or investigational study.

- Administration of immunoglobulins and/or blood products within 90 days preceding the
dose or planned administration at any time during the study period, which might
interfere with assessment of the immune response.

- A planned or anticipated move to a location that will prohibit full participation in
the trial for the three year duration.

- Potential adult volunteers or parents of potential child volunteers, who do not have
easy access to a fixed or mobile telephone.

- Any participant that resides in a household with an individual previously enrolled in
an older age cohort in this study. Only one participant from each household will be



Age minimum: 12 Months
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Dengue

Intervention(s)

Biological: TV005 vaccine

Biological: Placebo

Primary Outcome(s)

Proportion of study participants who are seropositive or seroconvert following vaccination [Time Frame: Measured through Day 180]

Proportion of study participants with vaccine virus recovered following vaccination [Time Frame: Measured through Day 14]

Proportion of study participants with recoverable vaccine virus or wild-type virus after vaccination [Time Frame: Measured through Day 180]

Proportion of study participants with solicited or unsolicited adverse events [Time Frame: Measured through Day 28]

Secondary ID(s)

Dengue TV005 in Dhaka

PR-15097

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Johns Hopkins Bloomberg School of Public Health

University of Vermont