DenguePhase 2NCT00350337

Safety and Immunogenicity of Various Formulations of Live Attenuated Tetravalent Dengue Vaccine in Healthy US Adults

A Phase 2 study testing Pre-transfection F17, Post-transfection F17 and Post-transfection F19 in people with Dengue, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

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

Official record

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Trial summary

This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo. 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?: Pre-transfection F17, Post-transfection F17 and Post-transfection F19
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 86 participants
Where: 1 siteUnited States
Study dates: 5 Apr 2006to 13 Mar 2008
Phase: Phase 2
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

A healthy male or female adult 18-45 years at the time of vaccination;
Free of obvious health problems as established by medical history and physical examination before entering into the study;
Written informed consent obtained from the subject;
Able to read the Subject Information Sheet and Consent Form;
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) should be enrolled in the study;
If the subject is female, she must be of non-childbearing potential, i.e. either surgically sterilized or one year post-menopausal; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (i.e. intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception, e.g. progestin implantable, cutaneous hormonal patch or injectable contraceptives) for 30 days prior to vaccination, have a negative pregnancy test within 48 hours prior to vaccination and must agree to continue such precautions for 60 days after completion of the vaccination series.

Who cannot join

Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
History of drug abuse or alcohol consumption (more than 2 drinks per day);
History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;
History of urticaria related to mosquito bites requiring medical attention;

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Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic, renal, hematologic or endocrine functional defect, as determined by physical examination or laboratory tests;
Any confirmed or suspected immunosuppressive or immunodeficient condition;
Subject seropositive for HBsAg, anti-HCV or anti-HIV;
Acute disease at the time of enrollment (acute disease is defined as the presence of a moderate or severe illness with or without fever);
(Vaccine can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection with or without low-grade febrile illness, i.e., oral temperature <37.5°C/<99.5°F.)
Chronic hepatomegaly, right upper quadrant abdominal pain or tenderness;
Chronic splenomegaly, left upper quadrant abdominal pain or tenderness;
Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the study vaccine (includes placebo) or planned use during the study period;
Planned administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of the study vaccine and ending 30 days after;
A planned move to a location that will prohibit participating in the trial for 9 months after the initial vaccination;
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 90 days preceding the first dose or planned administration during the study period. For corticosteroids, this will mean prednisone, or equivalent, 0.5 mg/kg/day. Inhaled and topical steroids are allowed;
Administration of immunoglobulins and/or blood products within 90 days preceding the first dose or planned administration during the study period;
Any chronic systemic drug therapy to be continued during the study period (except for vitamin/mineral supplements, a single anti-hypertension medication or routine treatment for gastro-esophageal reflux).

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed Army Institute of Research
Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: Phase II, Randomized, Observer-Blind, Single Center, Controlled Study of Two Doses of Various Formulations of WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to Placebo Control Administered on 0-6-Month Schedule to Healthy Adults

This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.

Read the detailed description

Subjects will be randomized into one of 4 groups. One group will receive a placebo vaccine and the others will receive one of 3 different dengue vaccine formations. Each subject will receive two doses six months apart. Study subjects who elect to participate in a mosquito transmissibility component of the study will undergo mosquito feedings during each of the two assigned follow-up visits after vaccine dose 1. All subjects will have 11 venipunctures during 11 visits (i.e., screening plus 10 study visits) over a period of nine months.

A third (booster) dose of post transfection F17 or F19 will be administered approximately 5 to 12 months after dose 2 to all subjects who received one of these formulation for their first two doses. Volunteers will return for a single visit 6 months after receiving their booster dose (long term follow-up)

Conditions: Dengue
Being tested: Pre-transfection F17, Post-transfection F17, Post-transfection F19, Placebo
Medical subject headings: Dengue

What participants receive

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

Pre-transfection F17Biological
Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection
Post-transfection F17Biological
Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
Post-transfection F19Biological
Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.
PlaceboOther
Sterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection

Study groups in NCT00350337
Study group	Role	What they receive
Pre-transfection F17	Experimental	4 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine Receives: Biological: Pre-transfection F17
Post-transfection F17	Experimental	4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection Receives: Biological: Post-transfection F17
Post-transfection F19	Experimental	4 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection Receives: Biological: Post-transfection F19
Placebo	Placebo comparator	A sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine. Receives: Other: Placebo

What is being measured

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

N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4
GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Measured: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4
Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Measured: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine
Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.
Measured: 21 days following 1st vaccination dose

Secondary outcomes (8)

Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine;
Measured: within 21 days after vaccination
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose
Summary of Unsolicited Adverse Events within 31 days after each dose of study vaccine dose (Primary total vaccinated cohort)
Measured: within 31 days of study vaccine
Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period.
Serious adverse events will be recorded throughout the entire study period. Subjects instructed to contact the investigator immediately should they manifest any signs or symptoms they perceive as serious. An identification card and a set of phone numbers to contact study staff 24 hours a day, 7 days a week given to subjects.
Measured: Days 0 to 270
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose
Abnormal findings at DEN physical examination were defined as:
rash, generalized rash, hemorrhages (skin, conjunctival or mucosal), conjunctival injection, hepatomegaly, splenomegaly or lymphadenopathy; generalized lymphadenopathy (palpable lymph nodes in 4 or more of the following locations: cervical, axillary, inguinal or other with right and left sides considered as separate locations) positive tourniquet test (WHO criterion of 20 or more petechiae per 2.5 cm square)Results were reported positive/negative using the WHO criterion.
Measured: throughout the 202 day study
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort)
The case definition of confirmed dengue used in this protocol requires fever (equivalent to an oral temperature ≥38.0ºC/≥ 100.4ºF) for three or more successive days, at least two of the signs or symptoms consistent with "suspected dengue" occurring during the period of fever, at least one clinical laboratory abnormality, and DEN viremia detected by RTqPCR. Cases not meeting all criteria were not considered "confirmed dengue." The percentage of subjects with suspected or confirmed dengue were tabulated by group after each vaccination.
Measured: Days 0-30 post vaccination periods (total vaccinated cohort)
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose
Sero-response defined as:
For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer
Measured: Days 0 to 270
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued)
Sero-response defined as:
For initially seronegative(S-) subjects, antibody titer >=10 DE50 at PI(M1) For initially seropositive(S+) subjects, antibody titer at PI(M1) >=4 fold the pre-vacciniation neut. antibody titer
Measured: Days 0 to 270
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose.
For vireimia:
Negative = GEQ/µl result is equal to zero Undetermined = GEQ/µL result is below LOD Positive = GEQ/µL result is >= LOD
Measured: Days 0 to 270

Timeline

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

5 Apr 200613 Mar 2008

First posted10 Jul 2006 (estimated)
Study start5 Apr 2006
Primary completion20 Jun 2007
Study completion13 Mar 2008

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 DengueStudies 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 86 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00350337
Sponsor's protocol ID: WRAIR 1151
Other IDs: GSK 103996, HSRRB A-13291
Status last verified: Feb 2021
First submitted: 6 Jul 2006
Last updated: 12 Feb 2021
Results posted: Yes, on ClinicalTrials.gov

Publications

Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, Putnak R, Toussaint JF, Sun W, Bauer K, Gibbons RV, Innis BL. A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults. Am J Trop Med Hyg. 2013 Jan;88(1):73-88. doi: 10.4269/ajtmh.2012.12-0361. Epub 2012 Dec 3.
PubMed 23208878

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

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All Dengue trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II, Randomized, Observer-Blind, Single Center, Controlled Study of Two Doses of Various Formulations of WRAIR Live Attenuated Tetravalent Dengue Vaccine Compared to Placebo Control Administered on 0-6-Month Schedule to Healthy Adults
ClinicalTrials.gov ID: NCT00350337
Acronym / sponsor ID: WRAIR 1151
Conditions: Dengue
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 86 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: GlaxoSmithKline, Walter Reed Army Institute of Research (WRAIR)
Study start: 5 Apr 2006 (actual)
Primary completion: 20 Jun 2007 (actual)
Study completion: 13 Mar 2008 (actual)
First posted: 10 Jul 2006 (estimated)
Results: Posted 26 Oct 2018

Clinical summary

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

This descriptive study will evaluate the safety and immunogenicity of 3 different formulations of the WRAIR dengue vaccine compared to a placebo.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Pre-transfection F17	Experimental	Biological: Pre-transfection F174 monovalent vaccine lots: DEN type 1 45AZ5 PDK-27, Lot 1-1-90 DEN type 2 S16803 PDK-50, Lot 1-1-90 DEN type 3 CH53489 PDK-20 DEN type 4 341750 PDK-6, Lot 1-1-90 in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Freeze-dried monovalent dengue vaccines were rehydrated with sterile water for injection diluted to match viral concentration of the F17 Post vaccine
Post-transfection F17	Experimental	Biological: Post-transfection F174 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2 : 5.3 log10 FFU/mL DEN type 3: 4.7 log10 FFU/mL DEN type 4: 5.0 log10 FFU/mL in 50% EMEM stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection
Post-transfection F19	Experimental	Biological: Post-transfection F194 monovalent vaccine lots: DEN type 1: 4.9 log10 FFU/mL DEN type 2: 5.2 log10 FFU/mL DEN type 3: 4.6 log10 FFU/mL DEN type 4: 4.4 log10 FFU/mL (1:10 dilution) in 50% EMEM-stabilizer, streptomycin, neomycin and vegetable-derived carbohydrates and amino acids stabilizers for injection. Lyophilized, single dose vials and sterile water for injection
Placebo	Placebo comparator	Other: PlaceboA sterile solution of the same EMEM, with phenol red (1:1) and the same virus stabilizer contained in the vaccine. The phenol red dye (phenolsulfonphthalein) is an FDA-accepted vaccine excipient used in vaccines as a pH indicator. The placebo was identical in appearance to the dengue vaccine.

Who may qualify

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

Key inclusion criteria (6 listed)

A healthy male or female adult 18-45 years at the time of vaccination;
Free of obvious health problems as established by medical history and physical examination before entering into the study;
Written informed consent obtained from the subject;
Able to read the Subject Information Sheet and Consent Form;
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) should be enrolled in the study;

Key exclusion criteria (19 listed)

Pregnant or lactating female;
Female planning to become pregnant or planning to discontinue abstinence or contraceptive precautions;
History of any neurological or behavioral disorder or seizures, with the exception of a single febrile seizure in childhood;
History of drug abuse or alcohol consumption (more than 2 drinks per day);
History of allergic disease/reaction likely to be exacerbated by any component of the vaccine;

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
Pre-transfection F17Dengue tetravalent Vaccine F17 Pre transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection	Biological	Pre-transfection F17
Post-transfection F17Dengue tetravalent Vaccine F17 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Biological	Post-transfection F17
Post-transfection F19Dengue tetravalent Vaccine F19 Post transfection: 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection. For the booster phase of the study, a booster dose was administered at five months to one year following the second dose.	Biological	Post-transfection F19
PlaceboSterile solution of buffered water (0.9% NaCl), U.S. FDA accepted vaccine excipient, phenol red dye(phenolsulfonphthalein, used in vaccines as a pH indicator); 0.5 mL volume per dose, administered at 0 and 6 months via subcutaneous injection	Other	Placebo

Primary outcome

N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4
Time frame: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
GMTs for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4
Time frame: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3
Serpositivity rates for DEN neut. antibodies -unprimed subjects (primary and booster ATP Cohort for immunogenicity) PRE = Pre dose PI(M1) = Post dose 1, month 1 PII(M7) = Post dose 2, month 7 PRE III = Pre dose 3 PIII(M1) = Post dose 3, month 1
Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine
Time frame: 21 days following 1st vaccination dose
Diary cards, digital thermometers, and small rulers were provided to subjects to record local and general solicited symptoms(pain, redness and swelling at the injection site, fatigue, headache, pain behind the eyes, abdominal pain, nausea, vomiting, muscle aches, joint aches, rash, photophobia and pruritis) and oral temperature taken daily for 21 days (days 0 through 20). The observations were to be recorded each evening and account for the previous 24 hours. If multiple temperature measurements were taken throughout the day, the maximum temperature was to be recorded.

8 secondary outcomes

Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 2 of Study Vaccine;
Time frame: within 21 days after vaccination
Unsolicited Adverse Events Within 31 Days After Each Dose of Study Vaccine Dose
Time frame: within 31 days of study vaccine
Occurrence of Serious Adverse Events (SAEs) Throughout the Entire Study Period.
Time frame: Days 0 to 270
Occurrence of Abnormal Findings at Physical Examination After Each Vaccine Dose
Time frame: throughout the 202 day study
Percentage of Subjects With Suspected and Confirmed Dengue Reported During the 31-day Post-vaccination Period (Total Vaccinated Cohort)
Time frame: Days 0-30 post vaccination periods (total vaccinated cohort)
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose
Time frame: Days 0 to 270
Neutralizing Antibody Sero-response to Each Dengue Serotype After Each Dose (Continued)
Time frame: Days 0 to 270
Occurrence of Measurable Dengue Viremia at Specified Time Points Following Each Vaccine Dose.
Time frame: Days 0 to 270

Results and safety

Results posted to the registry on 26 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pre-transfection F17	22	17
Post-transfection F17	22	19
Post-transfection F19	21	18
Placebo	21	21

Primary outcome: N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4

Time frame: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3. Mean (95% Confidence Interval). Unit: GMT value

Measure	Pre-transfection F17 n = 16	Post-transfection F17 n = 16	Post-transfection F19 n = 15
DEN-1: PRE	2 (2 to 2)	2 (2 to 2)	2 (2 to 2)
DEN-1: PI(M1)	13 (3 to 53)	8 (4 to 17)	55 (11 to 281)
DEN-1: PII(M7)	195 (57 to 665)	46 (12 to 175)	98 (25 to 387)
DEN-1: PRE III	NA (NA to NA)	10.2 (1.7 to 61.6)	30.3 (4.6 to 197)
DEN-1: PIII(M1)	NA (NA to NA)	42.7 (8.4 to 217)	73.3 (19.1 to 280)
DEN-2: PRE	2 (2 to 2)	2 (2 to 2)	2 (1 to 2)
DEN-2: P1(M1)	141 (43 to 460)	49 (14 to 169)	168 (41 to 680)
DEN-2: PII(M7)	666 (376 to 1179)	125 (30 to 523)	226 (70 to 729)

Population analysed: Number of subjects with titer within specified range

Primary outcome: Percentage of Subjects Seropositive for Dengue Serotypes 1, 2, 3 and 4

Time frame: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pre-transfection F17 n = 16	Post-transfection F17 n = 16	Post-transfection F19 n = 15
DEN-1: PRE	0.0 (0.0 to 20.6)	0.0 (0.0 to 20.6)	0.0 (0.0 to 21.8)
DEN-1: PI(M1)	43.8 (19.8 to 70.1)	37.5 (15.2 to 64.6)	66.7 (38.4 to 88.2)
DEN-1: PII(M7)	92.9 (66.1 to 99.8)	73.3 (44.9 to 92.2)	83.3 (51.6 to 97.9)
DEN-1: PRE III	NA (NA to NA)	66.7 (22.3 to 95.7)	71.4 (29.0 to 96.3)
DEN-1: PIII(M1)	NA (NA to NA)	83.3 (35.9 to 99.6)	100 (59.0 to 100)
DEN-2: PRE	0.0 (0.0 to 20.6)	0.0 (0.0 to 20.6)	0.0 (0.0 to 21.8)
DEN-2: PI(M1)	87.5 (61.7 to 98.4)	68.8 (41.3 to 89.0)	86.7 (59.5 to 98.3)
DEN-2: PII(M7)	100 (76.8 to 100)	80.0 (51.9 to 95.7)	100 (73.5 to 100)

Population analysed: Vaccinated subjects for whom assay results were available.

Primary outcome: Occurrence of Any, and Grade 3 Solicited Adverse Events (AEs) Within 21 Days Follow-up After Dose 1 of Study Vaccine

Time frame: 21 days following 1st vaccination dose. Number. Unit: participants

Measure	Pre-transfection F17 n = 22	Post-transfection F17 n = 22	Post-transfection F19 n = 21	Placebo n = 21
Any Grade 3 symptoms	1	1	4	3
General Grade 3 symptoms	0	0	3	2
Local Grade 3 symptoms	1	1	1	2

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general symptoms were assessed within the 21 day follow-up period (primary and booster total vaccinated cohort). Unsolicited symptoms were assessed within the 31 day post vaccination period (total vaccinated cohort).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pre-transfection F17	0 of 22 (0%)	19 of 22 (86.4%)	0 of 22
Post-transfection F17	2 of 22 (9.1%)	19 of 22 (86.4%)	0 of 22
Post-transfection F19	1 of 21 (4.8%)	16 of 21 (76.2%)	0 of 21
Placebo	1 of 21 (4.8%)	13 of 21 (61.9%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 23208878Thomas SJ, Eckels KH, Carletti I, De La Barrera R, Dessy F, Fernandez S, Putnak R, Toussaint JF, Sun W, Bauer K, Gibbons RV, Innis BL. A phase II, randomized, safety and immunogenicity study of a re-derived, live-attenuated dengue virus vaccine in healthy adults. Am J Trop Med Hyg. 2013 Jan;88(1):73-88. doi: 10.4269/ajtmh.2012.12-0361. Epub 2012 Dec 3.

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Dengue
RecruitingPhase 2/3
Emetine for Viral Outbreaks (a.k.a. EVOLVE Antiviral Initiative)
Dengue
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.

Stephen J Thomas, MD, FACP principal investigator

Walter Reed Army Institute of Research (WRAIR)

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

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 19 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 12 Feb 2021. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Oct 2018). 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?

N Antibody, Geometric Mean Titer(GMT) to Dengue Serotypes 1, 2, 3 and 4 (time frame: Pre dose 1, 1 month post dose 1, 7 months post dose 2, Pre dose 3 and 1 month post dose 3). 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 NCT00350337, 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 12 Feb 2021.