Dengue FeverPhase 1NCT01224639

Safety and Immunogenicity Study to Assess TDV, a Live Attenuated Tetravalent Vaccine for Prevention of Dengue Fever

A Phase 1 study testing TDV - Low Dose and TDV - High Dose in people with Dengue Fever, run by Inviragen Inc. at 1 site in Colombia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dengue Fever
What is being tested?: TDV - Low Dose and TDV - High Dose
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 siteColombia
Study dates: 11 Oct 2010to 9 Nov 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Is male or female aged 18 to 45 years, inclusive, at time of screening.
Is in good health as determined by medical history, physical examination, and clinical safety laboratory examinations.
Has body mass index (BMI) in the range 18-27 kilogram per square meter (kg/m^2).
Has negative serology for Human Immunodeficiency Virus (HIV), Hepatitis C antibody, and Hepatitis B surface antigen.
Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at Day 270).
Is willing and able to give written informed consent to participate.
Is willing and able to communicate with the Investigator and understand the requirements of the study.

Who cannot join

Has any condition which would limit the participant's ability to complete the study.
Clinically significant hematological, renal, hepatic, pulmonary, central nervous system, cardiovascular or gastrointestinal disorders.
Has abnormal electrocardiogram (ECG).
Has febrile illness (temperature greater than or equal to (>=) 38 degree Celsius (°C) or 100.4 degree Fahrenheit (°F) or moderate or severe acute illness or infection within three days of vaccination.
Diabetes mellitus.
Has allergy to penicillin, neomycin, streptomycin or gentamicin.

Show all 22Show fewer

Hypersensitivity to any vaccine.
Seropositivity to any of the four dengue serotypes (TDV-1, TDV-2, TDV-3 or TDV-4), yellow fever (YF) virus or West Nile (WN) virus.
Has previous vaccination (in a clinical trial or with an approved product) against flaviviruses including dengue, YF or WN.
Has planned vaccination against YF throughout the duration of this study.
Has receipt of any vaccine in the 4 weeks preceding the first trial vaccination.
Planned receipt of any vaccine in the 4 weeks following each of the vaccinations in this study.
Travel to dengue-endemic areas in the two months prior to study start or planned travel to dengue-endemic areas during the study period, including low altitude regions of Colombia where dengue is endemic.
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months prior to the first vaccination, or long- term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 milligram per kilogram per day [mg/kg/day]) prior to the first vaccination.
Has a history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.
Use of any non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen or antihistamines for the 3 days immediately prior to each vaccination.
Use of prescription or over the counter medications 7 days before the first vaccination (Day 0), excluding contraceptives and painkillers containing NSAIDs or acetaminophen, cold remedies, hormone replacement and antihistamines.
Positive urine screen for cocaine, amphetamines, opiates, or cannabinoids.
Receipt of any other investigational product or participation in any other clinical trial in the month before the first vaccination (Day 0) or during the conduct of this study.
Receipt of blood products or immunoglobulins 8 weeks before the first vaccination (Day 0) or planned use during the study period.
Donation of blood 6 weeks before the first vaccination (Day 0) or at any time during the study.
Females who are pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Colombia1 site

Program For The Study and Control of Tropical Diseases
Medellín

Other trials in Colombia

About this study

Official title: Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety and Immunogenicity of DENVax Vaccine in Healthy Adults

The purpose of this study is to assess the safety of Takeda's Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) in healthy adults when given as either a subcutaneous (SC) or intradermal (ID) injection at two dose levels (low and high). The vaccine will be given as two doses 90 days apart. Safety assessments include injection site evaluation and adverse events. The immune response generated after vaccination will be assessed up to 9 months after the first vaccination.

Read the detailed description

This is a single center, placebo-controlled, randomized study assessing the safety and tolerability of two dose levels (low and high) of TDV administered subcutaneously or intradermally in two doses separated by an interval of 90 days. Initial dosing of low dose cohort will be performed and Day 21 safety assessed prior to administration of second dose to low dose cohort on Day 90 and initial dosing of high dose cohort. Day 21 safety for the high dose cohort will be assessed prior to administration of second dose for this cohort. Safety (local injection site reactions and solicited and unsolicited adverse events) will be assessed through Day 120 post-first (1 month after the second dose). Immunogenicity will be assessed at specified time points up to Day 120 post-prime (1 month after the second dose) and again on Days 180 and 270 (6 and 9 months post-first).

Conditions: Dengue Fever
Being tested: TDV - Low Dose, TDV - High Dose, Placebo
Keywords: dengue fever, live attenuated tetravalent dengue vaccine, TDV, Drug therapy
Medical subject headings: Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TDV - Low DoseBiological
Also called Live attenuated tetravalent dengue vaccine
TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, and TDV-4: 2 x 10^5 PFU, total virus per dose 2.2 x 10^5 PFU
TDV - High DoseBiological
Also called Live attenuated tetravalent dengue vaccine
TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, and TDV-4: 3 x 10^5 PFU, total virus per dose : 4.7 x 10^5 PFU. TDV administered intradermally.
PlaceboBiological
Also called PBS
Phosphate Buffered Saline (PBS)

Study groups in NCT01224639
Study group	Role	What they receive
Group 1: Low Dose; SC	Experimental	TDV-1: 8 x 10^3 Plaque Forming Units (PFU), TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, TDV-4: 2 x 10^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL. Receives: Biological: TDV - Low Dose
Group 2: Low Dose; ID	Experimental	TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, TDV-4: 2 x 10^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL. Receives: Biological: TDV - Low Dose
Group 3: High Dose; SC	Experimental	TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, TDV-4: 3 x 10^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL. Receives: Biological: TDV - High Dose
Group 4: High Dose; ID	Experimental	TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, TDV-4: 3 x 10^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL. Receives: Biological: TDV - High Dose
Placebo (SC)	Placebo comparator	Phosphate buffered saline administered subcutaneously in a volume of 0.5 mL. Receives: Biological: Placebo
Placebo (ID)	Placebo comparator	Phosphate buffered saline administered intradermally in a dose volume of 0.1 mL. Receives: Biological: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Local Injection Site Reaction by Severity
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Measured: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Systemic Adverse Events (AEs) by Severity
Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
Measured: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Solicited Local and Systemic AEs
Measured: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Unsolicited Local and Systemic AEs
Measured: Baseline up to 30 days after second vaccination (Day 120)

Secondary outcomes (8)

Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
GMT was assessed for the four dengue serotypes: Dengue TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95 percent (%) confidence interval (CIs) were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Measured: Days 14, 30, 60 and 90 after first vaccination
GMTs of All Four Dengue Serotypes After Second Vaccination
GMT was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. GMTs and 95% CIs were calculated by taking the anti-logs of the means and 95% CI of the log transformed titers.
Measured: Days 14 and 30 after second vaccination (Day 104 and 120 respectively)
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Seroconversion was defined as a Plaque Reduction Neutralization Test (PRNT) titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit.
Measured: Days 14, 30, 60 and 90 after first vaccination
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Seroconversion was defined as a PRNT titer resulting in 50% reduction in plaques (PRNT[50]) >=10 (if the pre-vaccination PRNT[50] value was <10, indicated as a value of 5 in the immunogenicity data collection sheet) OR a PRNT(50) value that was >=4-fold the pre-vaccination titer value (if the pre-vaccination PRNT[50] value was >=10). Seroconversion was assessed for the four dengue serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution. Percentages are based on the number of participants in the FAS with non-missing MN assay samples at each visit (n).
Measured: Days 14 and 30 after second vaccination (Days 104 and 120 respectively)
Percentage of Participants With Durability of Immune Response
Immune response was considered durable if the participant had detectable neutralizing antibodies (seroconversion) to all 4 dengue serotypes at 90 and 180 days after the second dose (i.e. Days 180 and 270, respectively). Seroconversion is defined as post-vaccination PRNT(50) titer >=10 where pre-vaccination PRNT 50 titer <10, or post-vaccination PRNT(50) Titer >=4-fold the pre-vaccination PRNT(50) titer value where pre-vaccination PRNT(50) titer >=10. Percentage of participants with seroconversion on Days 180 and 270 are based on the number of participants in the FAS with non-missing MN assay samples at each visit. The 95% CIs for percentages are the exact CIs (%) based upon the binomial distribution.
Measured: Days 180 and 270
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Serotype-specific vaccine viremia was assessed for the four vaccine strain serotypes: TDV-1, TDV-2, TDV-3 and TDV-4. Only those serotypes and time-points where at least 1 participant had serotype-specific vaccine viremia detection were reported.
Measured: Baseline and at multiple time points up to Day 14 after each vaccination
Duration of Vaccine Viremia
Measured: 14 Days after each vaccination
Titers of Vaccine Viremia
Measured: 14 Days after each vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Oct 20109 Nov 2011

First posted20 Oct 2010 (estimated)
Study start11 Oct 2010
Primary completion9 Jun 2011
Study completion9 Nov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dengue FeverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01224639
Sponsor's protocol ID: INV-DEN-102
Other IDs: U1111-1181-8290
Status last verified: Jun 2018
First submitted: 9 Oct 2010
Last updated: 19 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Osorio JE, Velez ID, Thomson C, Lopez L, Jimenez A, Haller AA, Silengo S, Scott J, Boroughs KL, Stovall JL, Luy BE, Arguello J, Beatty ME, Santangelo J, Gordon GS, Huang CY, Stinchcomb DT. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. Lancet Infect Dis. 2014 Sep;14(9):830-8. doi: 10.1016/S1473-3099(14)70811-4. Epub 2014 Jul 23.
PubMed 25087476

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
Dengue Fever
RecruitingPhase 2
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
Dengue Fever
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingObservational study
Bridging Economics and Public Trust: A Study of Dengue Vaccine Cost-effectiveness and Acceptance in Thais Visiting Hospital
Dengue Fever
RecruitingObservational study
Gut Leakage' in Dengue
Dengue, Dengue Hemorrhagic Fever

All Dengue Fever trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I, Randomized, Double-blind, Placebo-controlled, Dose-escalation Study to Assess the Safety and Immunogenicity of DENVax Vaccine in Healthy Adults
ClinicalTrials.gov ID: NCT01224639
Acronym / sponsor ID: INV-DEN-102
Conditions: Dengue Fever
Keywords: dengue fever, live attenuated tetravalent dengue vaccine, TDV, Drug therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Inviragen Inc.Industry (pharma, biotech, devices)
Study start: 11 Oct 2010 (actual)
Primary completion: 9 Jun 2011 (actual)
Study completion: 9 Nov 2011 (actual)
First posted: 20 Oct 2010 (estimated)
Results: Posted 27 Feb 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Group 1: Low Dose; SC	Experimental	Biological: TDV - Low DoseTDV-1: 8 x 10^3 Plaque Forming Units (PFU), TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, TDV-4: 2 x 10^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL.
Group 2: Low Dose; ID	Experimental	Biological: TDV - Low DoseTDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, TDV-4: 2 x 10^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL.
Group 3: High Dose; SC	Experimental	Biological: TDV - High DoseTDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, TDV-4: 3 x 10^5 PFU or placebo administered subcutaneously on Days 0 and 90. Dose volume is 0.5 mL.
Group 4: High Dose; ID	Experimental	Biological: TDV - High DoseTDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, TDV-4: 3 x 10^5 PFU or placebo administered intradermally on Days 0 and 90. Dose volume is 0.1 mL.
Placebo (SC)	Placebo comparator	Biological: PlaceboPhosphate buffered saline administered subcutaneously in a volume of 0.5 mL.
Placebo (ID)	Placebo comparator	Biological: PlaceboPhosphate buffered saline administered intradermally in a dose volume of 0.1 mL.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

Is male or female aged 18 to 45 years, inclusive, at time of screening.
Is in good health as determined by medical history, physical examination, and clinical safety laboratory examinations.
Has body mass index (BMI) in the range 18-27 kilogram per square meter (kg/m^2).
Has negative serology for Human Immunodeficiency Virus (HIV), Hepatitis C antibody, and Hepatitis B surface antigen.
Females of child bearing potential must have a negative urine pregnancy test result during screening and a negative urine pregnancy test immediately prior to vaccination and be willing to use oral, implantable, transdermal or injectable contraceptives or another reliable means of contraception approved by the Investigator (intrauterine device, female condom, diaphragm with spermicidal, cervical cap, use of condom by the sexual partner or a sterile sexual partner, or abstinence) from screening until after the last blood sample (at Day 270).

Key exclusion criteria (22 listed)

Has any condition which would limit the participant's ability to complete the study.
Clinically significant hematological, renal, hepatic, pulmonary, central nervous system, cardiovascular or gastrointestinal disorders.
Has abnormal electrocardiogram (ECG).
Has febrile illness (temperature greater than or equal to (>=) 38 degree Celsius (°C) or 100.4 degree Fahrenheit (°F) or moderate or severe acute illness or infection within three days of vaccination.
Diabetes mellitus.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TDV - Low DoseAlso: Live attenuated tetravalent dengue vaccineTDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, and TDV-4: 2 x 10^5 PFU, total virus per dose 2.2 x 10^5 PFU	Biological	Group 1: Low Dose; SC, Group 2: Low Dose; ID
TDV - High DoseAlso: Live attenuated tetravalent dengue vaccineTDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, and TDV-4: 3 x 10^5 PFU, total virus per dose : 4.7 x 10^5 PFU. TDV administered intradermally.	Biological	Group 3: High Dose; SC, Group 4: High Dose; ID
PlaceboAlso: PBSPhosphate Buffered Saline (PBS)	Biological	Placebo (ID), Placebo (SC)

Primary outcome

Number of Participants With Local Injection Site Reaction by Severity
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Solicited local reactions were reported using a participant diary. Pain was categorized as Mild (aware of pain but it does not interfere with daily activity and no pain medication is taken); Moderate (aware of pain; there is interference with daily activity or it requires use of pain medication); Severe (aware of pain and it prevents daily activity), redness was categorized as Mild (greater than [>] 15 millimeter [mm]); Moderate as (15-30 mm); Severe (>30 mm), swelling was categorized as Mild (<15 mm); Moderate (15-30 mm); Severe (>30 mm), and itching was categorized as Mild (slight itching at injection site); Moderate (moderate itching at injection extremity); Severe (itching over entire body).
Number of Participants With Systemic Adverse Events (AEs) by Severity
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Solicited systemic AEs were reported using a participant diary. Solicited systemic AEs included fever (>= 37.8°C), headache, muscle pain, joint pain, eye pain, photophobia, fatigue, body rash, nausea, vomiting and other (any other symptom not listed in the diary) and were categorized as Mild: transient symptoms, discomfort noticed but easily tolerated, no interference to normal daily activities; Moderate: marked symptoms, moderate interference with daily activities; Severe: considerable interference with daily activities.
Number of Participants With Solicited Local and Systemic AEs
Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)
Number of Participants With Unsolicited Local and Systemic AEs
Time frame: Baseline up to 30 days after second vaccination (Day 120)

8 secondary outcomes

Geometric Mean Neutralizing Antibody Titers (GMTs) of All Four Dengue Serotypes After First Vaccination
Time frame: Days 14, 30, 60 and 90 after first vaccination
GMTs of All Four Dengue Serotypes After Second Vaccination
Time frame: Days 14 and 30 after second vaccination (Day 104 and 120 respectively)
Rate of Seroconversion to Each of Four Dengue Serotypes After the First Vaccination
Time frame: Days 14, 30, 60 and 90 after first vaccination
Rate of Seroconversion to Each of Four Dengue Serotypes After the Second Vaccination
Time frame: Days 14 and 30 after second vaccination (Days 104 and 120 respectively)
Percentage of Participants With Durability of Immune Response
Time frame: Days 180 and 270
Number of Participants Positive for Vaccine Viremia for Each of the Four Vaccine Strain Serotypes After the First and Second Vaccination
Time frame: Baseline and at multiple time points up to Day 14 after each vaccination
Duration of Vaccine Viremia
Time frame: 14 Days after each vaccination
Titers of Vaccine Viremia
Time frame: 14 Days after each vaccination

Results and safety

Results posted to the registry on 27 Feb 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Low Dose Subcutaneous: TDV	19	19
Low Dose Subcutaneous: Placebo	5	5
Low Dose Intradermal: TDV	21	21
Low Dose Intradermal: Placebo	3	3
High Dose Subcutaneous: TDV	21	19
High Dose Subcutaneous: Placebo	4	4
High Dose Intradermal: TDV	18	17
High Dose Intradermal: Placebo	5	3

Primary outcome: Number of Participants With Local Injection Site Reaction by Severity

Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination). Number. Unit: participants

Measure	Low Dose Subcutaneous: TDV n = 19	Low Dose Subcutaneous: Placebo n = 5	Low Dose Intradermal: TDV n = 21	Low Dose Intradermal: Placebo n = 3	High Dose Subcutaneous: TDV n = 21	High Dose Subcutaneous: Placebo n = 4	High Dose Intradermal: TDV n = 18	High Dose Intradermal: Placebo n = 5
Pain: Mild	12	1	8	2	8	0	10	1
Pain: Moderate	1	0	0	0	0	0	2	0
Redness: Mild	1	0	12	0	1	1	5	0
Redness: Moderate	1	0	8	0	5	0	9	0
Redness: Severe	4	0	0	0	7	0	3	0
Swelling: Mild	0	0	10	0	2	0	5	0
Swelling: Moderate	2	0	4	0	2	0	5	0
Swelling: Severe	4	0	0	0	3	0	0	0

Population analysed: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.

Primary outcome: Number of Participants With Systemic Adverse Events (AEs) by Severity

Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination). Number. Unit: participants

Measure	Low Dose Subcutaneous: TDV n = 19	Low Dose Subcutaneous: Placebo n = 5	Low Dose Intradermal: TDV n = 21	Low Dose Intradermal: Placebo n = 3	High Dose Subcutaneous: TDV n = 21	High Dose Subcutaneous: Placebo n = 4	High Dose Intradermal: TDV n = 18	High Dose Intradermal: Placebo n = 5
Fever: Mild	2	1	2	0	0	0	1	0
Fever: Moderate	1	0	0	1	1	1	1	0
Fever: Severe	0	0	1	0	0	0	0	0
Headache: Mild	4	1	12	2	9	0	6	2
Headache: Moderate	7	1	4	0	2	1	5	1
Headache: Severe	1	0	0	0	1	0	1	0
Muscle pain: Mild	10	0	3	2	4	0	6	0
Muscle pain: Moderate	0	0	0	0	1	0	1	0

Population analysed: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.

Primary outcome: Number of Participants With Solicited Local and Systemic AEs

Time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination). Number. Unit: participants

Measure	Low Dose Subcutaneous: TDV n = 19	Low Dose Subcutaneous: Placebo n = 5	Low Dose Intradermal: TDV n = 21	Low Dose Intradermal: Placebo n = 3	High Dose Subcutaneous: TDV n = 21	High Dose Subcutaneous: Placebo n = 4	High Dose Intradermal: TDV n = 18	High Dose Intradermal: Placebo n = 5
Local solicited AEs	15	1	20	2	14	1	18	1
Systemic solicited AEs	17	4	17	2	17	3	17	4

Population analysed: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.

Primary outcome: Number of Participants With Unsolicited Local and Systemic AEs

Time frame: Baseline up to 30 days after second vaccination (Day 120). Number. Unit: participants

Measure	Low Dose Subcutaneous: TDV n = 19	Low Dose Subcutaneous: Placebo n = 5	Low Dose Intradermal: TDV n = 21	Low Dose Intradermal: Placebo n = 3	High Dose Subcutaneous: TDV n = 21	High Dose Subcutaneous: Placebo n = 4	High Dose Intradermal: TDV n = 18	High Dose Intradermal: Placebo n = 5
Local unsolicited AEs	0	0	3	0	1	0	4	0
Systemic unsolicited AEs	18	5	16	3	16	2	14	3

Population analysed: The safety population included all randomized participants who received at least one dose of study vaccine and for whom post-dosing safety data was obtained.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events are adverse events that started after the first dose of double-blind study vaccine and up to Day 120. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Dose Subcutaneous: TDV	0 of 19 (0%)	12 of 19 (63.2%)	Not reported
Low Dose Subcutaneous: Placebo	0 of 5 (0%)	5 of 5 (100%)	Not reported
Low Dose Intradermal: TDV	0 of 21 (0%)	13 of 21 (61.9%)	Not reported
Low Dose Intradermal: Placebo	1 of 3 (33.3%)	3 of 3 (100%)	Not reported
High Dose Subcutaneous: TDV	1 of 21 (4.8%)	15 of 21 (71.4%)	Not reported
High Dose Subcutaneous: Placebo	0 of 4 (0%)	2 of 4 (50%)	Not reported
High Dose Intradermal: TDV	0 of 18 (0%)	13 of 18 (72.2%)	Not reported
High Dose Intradermal: Placebo	0 of 5 (0%)	3 of 5 (60%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25087476Osorio JE, Velez ID, Thomson C, Lopez L, Jimenez A, Haller AA, Silengo S, Scott J, Boroughs KL, Stovall JL, Luy BE, Arguello J, Beatty ME, Santangelo J, Gordon GS, Huang CY, Stinchcomb DT. Safety and immunogenicity of a recombinant live attenuated tetravalent dengue vaccine (DENVax) in flavivirus-naive healthy adults in Colombia: a randomised, placebo-controlled, phase 1 study. Lancet Infect Dis. 2014 Sep;14(9):830-8. doi: 10.1016/S1473-3099(14)70811-4. Epub 2014 Jul 23.

Related trials for Dengue Fever

Active, not recruitingPhase 3
A Study of Dengue Tetravalent Vaccine (TDV) in Adults (Age 45 to 60 and >60 to 79 Years)
Dengue Fever
RecruitingPhase 2
Clinical Trial Evaluating Safety and Efficacy of Resomelagon on Dengue Infection (RESOVIR-2)
Dengue Fever
Enrolling by invitation
Smart Analysis and Decision-Making for Emerging Infectious Diseases
Emerging Infectious Diseases, COVID-19
Active, not recruitingObservational study
Bridging Economics and Public Trust: A Study of Dengue Vaccine Cost-effectiveness and Acceptance in Thais Visiting Hospital
Dengue Fever
RecruitingObservational study
Gut Leakage' in Dengue
Dengue, Dengue Hemorrhagic Fever

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ivan D Velez, MD, Ph.D. principal investigator

PECET, Universidad the Antioquia, Medellin, Colombia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TDV - Low Dose and TDV - High Dose in people with Dengue Fever, run by Inviragen Inc. at 1 site in Colombia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Local Injection Site Reaction by Severity (time frame: Within 14 days after either of the vaccination given on Day 1 or 90 (Day 14 for first vaccination, Day 104 for second vaccination)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01224639, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018; AzTrials last refreshed its copy on 6 Nov 2026.