DenguePhase 1NCT01110551
Tetravalent Chimeric Dengue Vaccine Trial
A Phase 1 study testing Modified Live Tetravalent Chimeric Dengue Vaccine (SC) and Modified Live Tetravalent Chimeric Dengue Vaccine (ID) in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Dengue
- What is being tested?
- Modified Live Tetravalent Chimeric Dengue Vaccine (SC) and Modified Live Tetravalent Chimeric Dengue Vaccine (ID)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Male or female at least 18 and less than or equal to 45 years old at time of screening.
- In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal.
- Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations.
- Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen.
- No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial.
- 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).
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- Willing and able to give written informed consent to participate.
- Willing and able to communicate with the investigator and understand the requirements of the study.
- Electrocardiogram (ECG) in absence of clinical significance (e.g., complete left or right bundle branch block, incomplete left bundle branch block or sustained ventricular arrhythmia, or two premature ventricular contraction's (PVC's) in a row, or ST elevation consistent with ischemia).
- Weight: greater than or equal to 110 lb.
- Access to a fixed or mobile telephone.
Who cannot join
- Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator.
- Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders
- Any history of malignancy with the exception of basal cell carcinoma.
- Previous history , or current diagnosis of diabetes mellitus.
- Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest.
- History of allergy to penicillin, neomycin, streptomycin or gentamicin.
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- History of hypersensitivity to any vaccine.
- History of previous vaccination with Yellow Fever (YF) vaccine or Japanese Encephalitis (JE) vaccine or planned receipt of either YF or JE vaccine during the course of the study.
- Previous history of infection with dengue or West Nile or seropositive antibody status to dengue or West Nile virus or participation in a vaccine trial for either of these.
- Travel or planned travel to a dengue-endemic area including the Caribbean, Mexico, Central America, South America or Asia during the study period or in the month prior to screening. An updated map of dengue endemic areas is available at the CDC Yellow Book 2010 website (http://wwwnc.cdc.gov/travel/yellowbook/2010/chapter-5/dengue-fever-dengue-hemorrhagic-fever.aspx) and a list of dengue endemic countries is provided in the Manual of Procedures (MOP).
- Travel to a dengue endemic area within 1 month of screening. Volunteers who have a history of recent travel to a dengue endemic area may screen if they have returned to the US 30 or more days prior to the screening visit.
- Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term (at least 2 weeks within the previous 3 months) systemic corticosteroids therapy (at a dose of at least 0.5 mg/kg/day). Intranasal or topical prednisone (or equivalent) are allowed.
- Personal history of recurring migraines or on prescription medication for treatment of recurring headaches or migraines.
- Use of any non-steroidal anti-inflammatory drugs (NSAIDs), including any aspirin-containing products, acetaminophen or systemic, topical, or intranasal antihistamines for the 3 days immediately prior to each vaccination. Systemic antihistamines may not be used at all during the first 21 days after each vaccination.
- During the first 14 days after each vaccination, anti-inflammatory drugs (NSAIDs) or acetaminophen may be used only if the subject has a fever >/= 100 F or if the subject has significant arm pain, myalgia, arthralgia, or headache and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines may be used during the first 14 days after each vaccination only if the subject has significant allergy symptoms such as rhinitis, cough, eye inflammation, or pruritis and only after documenting the symptom in the memory aid. Intranasal or topical antihistamines, NSAIDs or acetaminophen should only be taken after documentation of symptoms or fever in the memory aid and should not be taken prophylactically.
- Receipt of any other investigational product in the month before study entry and during the entire study duration.
- Receipt or planned receipt of any licensed vaccine in the 4 weeks preceding either trial vaccination (2 weeks for inactivated vaccines) or planned receipt of any vaccine in the 4 weeks following each of the trial vaccinations.
- Concurrent or planned participation in any other clinical study during the conduct of this study.
- Receipt of blood products or immunoglobulins 8 weeks before study entry or planned use during the study period.
- Donation of blood 6 weeks before study entry or at any time during the study.
- Laboratory screening test result that is not within protocol specified normal range (Table 3 of protocol).
- Females who are pregnant or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Double-Blind Randomized, Placebo-Controlled, Phase I Dose Escalation Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers
The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.
Read the detailed description
The purpose of this study is to evaluate the safety and immunogenicity of a tetravalent dengue vaccine administered subcutaneously or intradermally. The hypotheses being tested in this study is whether or not a tetravalent dengue vaccine may be safely administered to healthy normal individuals by intradermal (ID) or subcutaneous (SC) injection and provide measurable levels of serum neutralizing antibodies against all four dengue virus serotypes. The study is also designed to compare safety and immunogenicity between routes of administration and dose levels. The primary objective of this study is to evaluate the safety and tolerability of a two-dose regimen tetravalent dengue vaccine administered either SC or ID to healthy adult volunteers. Two dose levels will be tested in a dose-escalation format. Safety and tolerability will be measured by conducting post-vaccination safety assessments including physical examinations, injection site examinations, adverse event monitoring, hematology, blood chemistry, and urine dipstick. The secondary objective of this study is to assess the immunogenicity of the vaccine, in terms of neutralizing antibodies, against all four dengue serotypes when administered at two dose levels by two routes of administration in healthy adults. Titers of serum neutralizing antibodies will be measured at pre-vaccination, after prime and boost vaccinations and assessed by comparing titers at the two dose levels as well as the two routes of administration. In addition, viremia deriving from the attenuated vaccine viruses will be measured on days 0 (baseline), 2, 4, 5/6, 7, 9, 11, and 14 after both prime and boost vaccinations. Levels of neutralizing antibodies will also be measured in samples to be obtained on days 180 and 270 for analysis and submission in a supplement to the study report. This study will enroll 72 healthy flavivirus-negative male and female subjects between the ages of 18 and 45.
- Conditions
- Dengue
- Being tested
- Placebo (SC), Placebo (ID), Modified Live Tetravalent Chimeric Dengue Vaccine (SC), Modified Live Tetravalent Chimeric Dengue Vaccine (ID)
- Keywords
- Dengue, vaccine, flavivirus
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo (SC)Drug
Phosphate buffered saline administered subcutaneously.
Placebo (ID)Drug
Phosphate buffered saline administered intradermally.
Modified Live Tetravalent Chimeric Dengue Vaccine (SC)Biological
DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered subcutaneously.
Modified Live Tetravalent Chimeric Dengue Vaccine (ID)Biological
DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered intradermally.
| Study group | Role | What they receive |
|---|---|---|
| Group 2: low dose ; ID | Experimental | D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, D4: 2 x 10^5 or placebo intradermally on Days 0 and 90. Receives: Drug: Placebo (ID); Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (ID) |
| Group 1: low dose; SC | Experimental | D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, D4: 2 x 10^5 or placebo subcutaneously on Days 0 and 90. Receives: Drug: Placebo (SC); Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (SC) |
| Group 4: high dose; ID | Experimental | D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, D4: 3 x 10^5 or placebo intradermally on Days 0 and 90. Receives: Drug: Placebo (ID); Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (ID) |
| Group 3: high dose; SC | Experimental | D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, D4: 3 x 10^5 or placebo subcutaneously on Days 0 and 90. Receives: Drug: Placebo (SC); Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (SC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group.
Measured: From time the first dose of vaccine is administered until the end of the study (Study Days 0-270 or through termination visit, if terminated early).
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments.
Measured: Through 14 days after prime or boost vaccination.
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs).
Measured: From time the first dose of vaccine is administered (Day0) until the end of the study (Day 270).
Secondary outcomes (4)
Immunogenicity: geometric mean neutralizing antibody titers (GMT) to each of the 4 dengue serotypes.
Measured: At 14, 30, 60, and 90 days after the prime vaccination on Day 0, and at 14 and 30 days after the boost vaccination on Day 90.
Viremia: incidence, duration, and titer of viremia for each of the DENVax vaccine components.
Measured: Days 0, 2, 4, 5/6, 7, 9, 11, and 14 after each vaccination.
Immunogenicity: durability of vaccine-induced immune responses based on neutralizing antibody titers to all 4 dengue serotypes.
Measured: At 90 days and 180 days after the boost vaccination will be analyzed for inclusion in a supplemental study report.
Immunogenicity: proportion of subjects seroconverting to each of the 4 dengue serotypes, where seroconversion is defined as plaque reduction neutralization assay (PRNT)50 titer greater than or equal to 10.
Measured: Days 0 (pre-prime dose), 14, 30, 60, 90 (pre-booster dose), 104 and 120.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionApr 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DengueStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01110551
- Sponsor's protocol ID
- 09-0055
- Other IDs
- N01AI80003C
- Status last verified
- Jan 2013
- First submitted
- 22 Apr 2010
- Last updated
- 4 Feb 2013
- Results posted
- No
Publications
George SL, Wong MA, Dube TJ, Boroughs KL, Stovall JL, Luy BE, Haller AA, Osorio JE, Eggemeyer LM, Irby-Moore S, Frey SE, Huang CY, Stinchcomb DT. Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial. J Infect Dis. 2015 Oct 1;212(7):1032-41. doi: 10.1093/infdis/jiv179. Epub 2015 Mar 19.
PubMed 25791116
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Randomized, Placebo-Controlled, Phase I Dose Escalation Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT01110551
- Acronym / sponsor ID
- 09-0055
- Conditions
- Dengue
- Keywords
- Dengue, vaccine, flavivirus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- May 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the safety and immune response to a live attenuated dengue vaccine that could protect people against all 4 types of dengue virus. Live attenuated means that while this vaccine contains 4 live dengue viruses the viruses have been attenuated (weakened) so as not to cause dengue disease in people. Dengue virus is spread to people by mosquitoes and can cause sickness and even death. Seventy-two subjects between the ages of 18-45 years old will be enrolled in this research study at Saint Louis University Center for Vaccine Development. Participants will be randomly assigned to 1 of 4 groups to receive 2 doses of the study vaccine or placebo (inactive substance). Study procedures include: maintaining a diary to record temperature and side effects, physical exam, electrocardiogram (ECG) (measures the activity of the heart), and blood samples. Participants will be involved in study related procedures for about 10 months.
Detailed description
The purpose of this study is to evaluate the safety and immunogenicity of a tetravalent dengue vaccine administered subcutaneously or intradermally. The hypotheses being tested in this study is whether or not a tetravalent dengue vaccine may be safely administered to healthy normal individuals by intradermal (ID) or subcutaneous (SC) injection and provide measurable levels of serum neutralizing antibodies against all four dengue virus serotypes. The study is also designed to compare safety and immunogenicity between routes of administration and dose levels. The primary objective of this study is to evaluate the safety and tolerability of a two-dose regimen tetravalent dengue vaccine administered either SC or ID to healthy adult volunteers. Two dose levels will be tested in a dose-escalation format. Safety and tolerability will be measured by conducting post-vaccination safety assessments including physical examinations, injection site examinations, adverse event monitoring, hematology, blood chemistry, and urine dipstick. The secondary objective of this study is to assess the immunogenicity of the vaccine, in terms of neutralizing antibodies, against all four dengue serotypes when administered at two dose levels by two routes of administration in healthy adults. Titers of serum neutralizing antibodies will be measured at pre-vaccination, after prime and boost vaccinations and assessed by comparing titers at the two dose levels as well as the two routes of administration. In addition, viremia deriving from the attenuated vaccine viruses will be measured on days 0 (baseline), 2, 4, 5/6, 7, 9, 11, and 14 after both prime and boost vaccinations. Levels of neutralizing antibodies will also be measured in samples to be obtained on days 180 and 270 for analysis and submission in a supplement to the study report. This study will enroll 72 healthy flavivirus-negative male and female subjects between the ages of 18 and 45.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 2: low dose ; ID | Experimental | Drug: Placebo (ID), Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (ID)D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, D4: 2 x 10^5 or placebo intradermally on Days 0 and 90. |
| Group 1: low dose; SC | Experimental | Drug: Placebo (SC), Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (SC)D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, D4: 2 x 10^5 or placebo subcutaneously on Days 0 and 90. |
| Group 4: high dose; ID | Experimental | Drug: Placebo (ID), Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (ID)D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, D4: 3 x 10^5 or placebo intradermally on Days 0 and 90. |
| Group 3: high dose; SC | Experimental | Drug: Placebo (SC), Biological: Modified Live Tetravalent Chimeric Dengue Vaccine (SC)D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, D4: 3 x 10^5 or placebo subcutaneously on Days 0 and 90. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female at least 18 and less than or equal to 45 years old at time of screening.
- In good health as determined by medical history, physical examination including height and weight, and clinical safety laboratory examinations. For creatinine and alkaline phosphatase levels the applicable cut-offs for determination are the upper limits of normal only, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values. For aspartate aminotransferase (AST) and alanine aminotransferase (ALT), the applicable cut-offs for determination are less than 1.5 times the upper limits of normal, as there is no clinical significance associated with results below the lower limits of normal for these laboratory values or with mild elevations above the upper limits of normal.
- Laboratory values not listed in Table 3 which are obtained as part of a reference laboratory pre-determined panel will be considered as acceptable for enrollment if they are either within reference laboratory normal range or within the ranges specified for a grade I AE per the protocol Toxicology Tables in Appendix B. Values within reference laboratory normal ranges or within ranges specified for a grade I AE per the Toxicology Tables in Appendix B will be considered as discussed with the medical monitor and may be enrolled with no further discussion. Values with deviations outside the ranges specified for a grade 1 AE in the Toxciology Tables in Appendix B will be discussed further between the PI and the medical monitor prior to vaccination and assessed for impact on volunteer safety. Urinalyses obtained from female volunteers on their menses may be repeated after their menses have concluded without discussion with the medical monitor. Laboratory values which are not listed in the Toxicology Tables in Appendix B and which are out of the reference laboratory normal range will be discussed with the DMID medical monitor to determine its relevance for safety and impact on enrollment and follow-up vaccinations.
- Blood tests negative for antibodies to human immunodeficiency virus (HIV)-1, Hepatitis C, dengue, West Nile, and negative for Hepatitis B surface antigen.
- No history of dengue or West Nile infection or participation in a previous dengue or West Nile vaccine trial.
Key exclusion criteria (22 listed)
- Any condition which would limit the subject's ability to complete the study in the opinion of the Investigator.
- Clinically significant hematological, renal, hepatic, pulmonary, central nervous, cardiovascular, thromboembolic, autoimmune, coagulopathic, or gastrointestinal disorders or history of such disorders
- Any history of malignancy with the exception of basal cell carcinoma.
- Previous history , or current diagnosis of diabetes mellitus.
- Pulse >95 or <40 at rest or irregular, systolic blood pressure (bp) >170 or <90 at rest or diastolic bp >90 or <50 at rest, body temperature >100 F, respirations >25 per minute at rest.
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 |
|---|---|---|
| Placebo (SC)Phosphate buffered saline administered subcutaneously. | Drug | Group 1: low dose; SC, Group 3: high dose; SC |
| Placebo (ID)Phosphate buffered saline administered intradermally. | Drug | Group 2: low dose ; ID, Group 4: high dose; ID |
| Modified Live Tetravalent Chimeric Dengue Vaccine (SC)DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered subcutaneously. | Biological | Group 1: low dose; SC, Group 3: high dose; SC |
| Modified Live Tetravalent Chimeric Dengue Vaccine (ID)DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered intradermally. | Biological | Group 2: low dose ; ID, Group 4: high dose; ID |
Primary outcome
Number of volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group.
Time frame: From time the first dose of vaccine is administered until the end of the study (Study Days 0-270 or through termination visit, if terminated early).
Number of volunteers overall and in each dose group with local or systemic vaccine reactogenicity, based on evaluation of solicited adverse events (AEs) recorded on subject memory aids or during clinical assessments.
Time frame: Through 14 days after prime or boost vaccination.
Number of volunteers overall and in each dose group with vaccine-associated serious adverse events (SAEs).
Time frame: From time the first dose of vaccine is administered (Day0) until the end of the study (Day 270).
4 secondary outcomes
Immunogenicity: geometric mean neutralizing antibody titers (GMT) to each of the 4 dengue serotypes.
Time frame: At 14, 30, 60, and 90 days after the prime vaccination on Day 0, and at 14 and 30 days after the boost vaccination on Day 90.
Viremia: incidence, duration, and titer of viremia for each of the DENVax vaccine components.
Time frame: Days 0, 2, 4, 5/6, 7, 9, 11, and 14 after each vaccination.
Immunogenicity: durability of vaccine-induced immune responses based on neutralizing antibody titers to all 4 dengue serotypes.
Time frame: At 90 days and 180 days after the boost vaccination will be analyzed for inclusion in a supplemental study report.
Immunogenicity: proportion of subjects seroconverting to each of the 4 dengue serotypes, where seroconversion is defined as plaque reduction neutralization assay (PRNT)50 titer greater than or equal to 10.
Time frame: Days 0 (pre-prime dose), 14, 30, 60, 90 (pre-booster dose), 104 and 120.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2013.
- Derived from this study: PubMed 25791116George SL, Wong MA, Dube TJ, Boroughs KL, Stovall JL, Luy BE, Haller AA, Osorio JE, Eggemeyer LM, Irby-Moore S, Frey SE, Huang CY, Stinchcomb DT. Safety and Immunogenicity of a Live Attenuated Tetravalent Dengue Vaccine Candidate in Flavivirus-Naive Adults: A Randomized, Double-Blinded Phase 1 Clinical Trial. J Infect Dis. 2015 Oct 1;212(7):1032-41. doi: 10.1093/infdis/jiv179. Epub 2015 Mar 19.
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RecruitingPhase 2
Adaptive Dengue Antiviral Platform Trial
Dengue, Antiviral Drugs
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Modified Live Tetravalent Chimeric Dengue Vaccine (SC) and Modified Live Tetravalent Chimeric Dengue Vaccine (ID) in people with Dengue, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 11 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 4 Feb 2013. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 volunteers overall and in each dose group with unsolicited vaccine-associated adverse events (AEs) in each dose group. (time frame: From time the first dose of vaccine is administered until the end of the study (Study Days 0-270 or through termination visit, if terminated early).). The study lists 3 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 NCT01110551, 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 4 Feb 2013.