A Phase 1 interventional study of rDEN3Δ30/31-7164 in Response To Dengue Exposure, sponsored by National Institutes of Health Clinical Center (CC). Completed at 1 site in United States. Open to participants aged 18 Years to 59 Years. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by National Institutes of Health Clinical Center (CC) · Phase 1, Interventional, and Prevention
Background:
Dengue is a disease caused by a virus transmitted by mosquitoes in tropical and subtropical regions. Dengue is a leading cause of hospital stays and death in parts of Asia and Latin America, and outbreaks have occurred in the US. Currently, dengue vaccines are limited and do not protect all people equally. One vaccine actually increased the risk of severe disease in some people and was taken off the market. Better vaccines are needed.
Objectives:
To test a potential new vaccine against dengue. To see if side effects and immune responses are different depending on a person's previous exposure to dengue.
Eligibility: Healthy people aged 18 to 59 years.
Design:
Participants will visit the clinic 11 times in 7 months; 9 of those visits will be in the first 2 months. Two additional visits are optional.
Participants will be screened. They will have a physical exam with urine and blood tests. They will complete a survey about their travel history.
Participants may opt to have a lymph node aspiration before receiving the study vaccine. An area in the left armpit will be numbed. A needle will be inserted to remove some cells from a lymph node.
The vaccine will be injected into the fat under the skin of the participant's upper left arm.
Participants will return for a provider visit and blood draws every 3 days for about the first 2 weeks. Then they will return for a provider visit and blood draws after longer intervals up to 7 months. The lymph node aspiration may be repeated at later visits.
Participants may opt to return for a last visit after 12 months.
Study Description:
Phase 1 trial wherein healthy adults with no (naive), one (primary heterotypic), or more than one (polytypic) previous natural dengue virus (DENV) infection(s) will be immunized with the DENV3 monovalent vaccine rDEN3Δ30/31-7164. We aim to examine how pre-vaccine host immunity influences the safety and immunogenicity of monovalent DENV3 vaccination in a non-endemic population. We hypothesize that the vaccine will be safe and well tolerated, and all groups will have evidence of infection with the vaccine strain as indicated by a significant increase in the DENV neutralizing antibody geometric mean titer (GMT) between days 0 and 28. However, due to the immunity conferred by prior dengue exposure(s), the polytypic group will have the lowest and the heterotypic group will have the highest mean peak viremia, indicating protection and enhancement, respectively. Additionally, the polytypic group will have the strongest CD8+ T-cell responses at day 15 and will only have a transient rise in GMT with no difference in GMT between days 0 and 57. In contrast, the change in GMT will persist at day 57 in the heterotypic and naive groups. Finally, we expect that prior immunity will influence the vaccine response as evidenced by a significant association between the day 0 GMT and GMT at days 28 and 57.
Primary Objective:
Evaluate the safety of monovalent DENV3 vaccination in those with distinct natural DENV infection histories living in non-endemic areas, and how prior DENV immunity influences protection against vaccine strain infection evaluated by the change in GMT and mean peak viremia.
Secondary Objective:
Further evaluate how DENV infection history impacts the immunogenicity of the vaccine.
Primary Endpoints:
Secondary Endpoints:
57 studies on the registry are indexed under Viremia; 12 are open to participants now.
This study's enrollment of 127 is above the median of 87 across 45 interventional studies indexed under Viremia.
Browse Viremia studies →National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
To be eligible to participate in this study, an individual must meet all the following criteria:
Serologic evidence of previous dengue virus infection indicative of either one previous DENV1, 2, or 4 infection or infection with at least two different serotypes.
Contraceptive requirements: Participants who can get pregnant must agree to use highly effective contraception as outlined below from the invitation to participate in the study (approximately 2 weeks after screening) through day 60. Day 0 will be scheduled at least 28 days after the initiation of effective contraception. Participants who can get pregnant must have a negative pregnancy test on day 0 before receiving rDEN3Δ30/31-7164. If a participant becomes pregnant or suspects they are pregnant by day 60, then they should inform the study staff and their primary care physician immediately. Acceptable forms of contraception are:
Pregnancy after day 60 will not be exclusionary as this will not impact our primary or secondary endpoints. Although we may observe pregnancy-associated differences in the transcriptome, these endpoints are exploratory and we have chosen to prioritize safety and inclusivity for people who can become pregnant. Study blood draw volumes after day 28 are less than the recommended volumes for research blood in critically ill patients. Pregnant participants will be excluded from LN FNA due to the potential risks of anesthetics that may be used. Pregnancy testing will be performed on each LN FNA day, with a negative result required to proceed to aspiration.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Has any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants were classified as flavivirus-naive if they met any of the following criteria: a 50% plaque reduction neutralization test (PRNT50) titer \<10 for all dengue serotypes, no history of flavivirus vaccination, or no travel history associated with an increased risk of other flavivirus infections. If there was any concern regarding prior flavivirus exposure, antibody testing was performed to confirm the absence of exposure. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Drug: rDEN3Δ30/31-7164
Participants were considered dengue immune if they had a 50% plaque reduction neutralization test (PRNT50) titer of ≥10 against any dengue serotype. Among these participants, those whose highest PRNT50 titer was \<4-fold higher than the second-highest serotype were further categorized as follows: participants with PRNT50 titers ≥60 for at least two serotypes were classified as "polytypic", whereas those with PRNT50 titers between 10 and 60 were classified as "expanded polytypic". Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Drug: rDEN3Δ30/31-7164
Participants where the highest plaque reduction neutralization test (PRNT50) titer is ≥4-fold higher than the second highest serotype (or one serotype ≥10 and others \<10) were considered monotypic. Of these, participants with their highest titer to DENV3 were excluded, and all others were included in the heterotypic group. Participants received a single 0.5 mL subcutaneous injection of 10\^3.3 PFU/mL rDEN3Δ30/31-7164 vaccine formulated in Plasma-Lyte A (pH 7.4) diluent in the deltoid region on day 0.
Drug: rDEN3Δ30/31-7164
The rDEN3Δ30/31-7164 vaccine is a live attenuated virus constructed by creating two deletions in the 3' untranslated region (UTR) of the DENV-3 Sleman/78 strain. The vaccine dose consists of 0.5 mL of 10\^3.3 PFU/mL of rDEN3Δ30/31-7164 plus Plasma-Lyte A pH 7.4 diluent delivered subcutaneously into the deltoid area on day 0.
Number of Participants With Local Adverse Events (AEs)
Number of participants with at least one solicited local adverse events occurring within twenty-eight days of vaccine administration. Local reactogenicity included injection site pain, injection site tenderness, injection site bruising, injection site redness, injection site erythema, injection site swelling/induration, and injection site pruritus. Adverse events were captured by investigator examination and history from participants.
Time frame: Through day 28 after vaccine administration
Number of Participants With Systemic Adverse Events (AEs)
Number of participants with systemic adverse events occurring within twenty-eight days of vaccine administration. Systemic reactogenicity events included fever, headache, eye pain (retro-orbital pain), photophobia, nausea, fatigue, myalgia, arthralgia, and maculo-papular rash (dengue-like rash). Adverse events were captured by investigator examination and history from participants.
Time frame: Through day 28 after vaccine administration
Severity of Local Adverse Events (AEs) by Grade
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain, Pruritis = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness, Bruising = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain, Pruritis = Some interference with activity or requires \>1 dose of medication; Tenderness= Discomfort with movement; Erythema/Redness, Bruising = 5.1-10 cm; Induration/Swelling = 5.1-10 cm or interferes with activity. Grade 3: Pain, Pruritis= Prevents daily activity and requires medical intervention; Tenderness = Significant discomfort at rest; Erythema/Redness, Bruising = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis; Bruising, Pruritus: Requiring medical attention
Time frame: Through day 28 after vaccine administration
Severity of Systemic Adverse Events (AEs)
The severity of systemic AEs was assessed using the grading scale below: Grade 1: Fever = 100.4-101.1\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = No interference with activity, may require one dose of medication/treatment; Dengue-like rash: Rash is present but asymptomatic. Grade 2: Fever = 101.2-102.0\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Some interference with activity or requires \>1 dose of medication/treatment; Dengue-like rash: Rash is symptomatic but does not interfere with activity. Grade 3: Fever = 102.1-104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Prevents daily activity and requires medical intervention; Dengue-like rash: Rash is symptomatic and interferes with activity. Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization.
Time frame: Through day 28 after vaccine administration
Number of Participants With Unexpected Adverse Events (AEs)
Number of participants with unexpected adverse (AE) events occurring up to 28 days after vaccine administration of vaccine. Unexpected adverse event is defined as an AE that is not listed in the investigator's brochure at the frequency, AND specificity, AND severity that has been observed.
Time frame: Through day 28 after vaccine administration
Number of Participants With Serious Adverse Events (AEs)
Number of participants with serious adverse events defined as any grade 4 or higher local or systemic adverse events based on the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Local AEs: Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis requiring medical attention; Bruising: Hematoma requiring medical attention; Pruritis: Pruritis requiring medical attention Systemic AEs: Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization. Grade 5: Death
Time frame: Through day 180 after vaccine administration
Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 28
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 28 was analyzed as GMT Day 28/GMT Day 0.
Time frame: Day 28 and day 0
Mean Peak Viremia
The mean peak viremia was measured by viral quantitative reverse transcription polymerase chain reaction (qRT-PCR) for days 3, 6, 9, 12, and 15. Analysis was done as the average of the log mean of the peak value for each participant.
Time frame: Day 3 through day 15
Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 57
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 57 was analyzed as GMT Day 57/GMT Day 0.
Time frame: Day 57 and day 0
Mean Titer for Dengue Virus Neutralizing Antibody
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes. GMT for the DENV1-4 neutralizing antibody titer was assessed for days 0, 28, and 57.
Time frame: Day 0, Day 28, and Day 57
Percent Dengue-specific CD8+ T-cells
Percent dengue virus (DENV)-specific CD8+ T-cells among total CD8+ T-cells at day 15 was measured through flow cytometric analyses using the Activation-Induced Marker (AIM) assays.
Time frame: Day 15
| Milestone | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Started | 14 | 13 | 18 |
| Completed | 14 | 13 | 18 |
| Not completed | 0 | 0 | 0 |
Number of participants with at least one solicited local adverse events occurring within twenty-eight days of vaccine administration. Local reactogenicity included injection site pain, injection site tenderness, injection site bruising, injection site redness, injection site erythema, injection site swelling/induration, and injection site pruritus. Adverse events were captured by investigator examination and history from participants.
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Injection site pain | 0 | 0 | 4 |
| Injection site bruising | 0 | 0 | 0 |
| Injection site redness | 1 | 0 | 1 |
| Injection site erythema | 0 | 0 | 1 |
| Injection site swelling/induration | 0 | 0 | 0 |
| Injection site pruritus | 0 | 0 | 0 |
Number of participants with systemic adverse events occurring within twenty-eight days of vaccine administration. Systemic reactogenicity events included fever, headache, eye pain (retro-orbital pain), photophobia, nausea, fatigue, myalgia, arthralgia, and maculo-papular rash (dengue-like rash). Adverse events were captured by investigator examination and history from participants.
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Fever | 0 | 0 | 0 |
| Headache | 7 | 4 | 5 |
| Eye pain (Retro-orbital pain) | 0 | 1 | 2 |
| Photophobia | 0 | 0 | 2 |
| Nausea | 2 | 2 | 3 |
| Fatigue | 8 | 5 | 9 |
| Myalgia | 1 | 2 | 7 |
| Arthralgia | 1 | 1 | 4 |
| Maculo-papular rash (Dengue-like rash) | 11 | 3 | 8 |
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Grade 1: Pain, Pruritis = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness, Bruising = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain, Pruritis = Some interference with activity or requires \>1 dose of medication; Tenderness= Discomfort with movement; Erythema/Redness, Bruising = 5.1-10 cm; Induration/Swelling = 5.1-10 cm or interferes with activity. Grade 3: Pain, Pruritis= Prevents daily activity and requires medical intervention; Tenderness = Significant discomfort at rest; Erythema/Redness, Bruising = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis; Bruising, Pruritus: Requiring medical attention
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Grade 1 | 1 | 0 | 5 |
| Grade 2 | 0 | 0 | 0 |
| Grade 3 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 |
The severity of systemic AEs was assessed using the grading scale below: Grade 1: Fever = 100.4-101.1\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = No interference with activity, may require one dose of medication/treatment; Dengue-like rash: Rash is present but asymptomatic. Grade 2: Fever = 101.2-102.0\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Some interference with activity or requires \>1 dose of medication/treatment; Dengue-like rash: Rash is symptomatic but does not interfere with activity. Grade 3: Fever = 102.1-104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia = Prevents daily activity and requires medical intervention; Dengue-like rash: Rash is symptomatic and interferes with activity. Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization.
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Grade 1 | 13 | 8 | 15 |
| Grade 2 | 5 | 2 | 8 |
| Grade 3 | 0 | 0 | 0 |
| Grade 4 | 0 | 0 | 0 |
Number of participants with unexpected adverse (AE) events occurring up to 28 days after vaccine administration of vaccine. Unexpected adverse event is defined as an AE that is not listed in the investigator's brochure at the frequency, AND specificity, AND severity that has been observed.
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Number of Participants With Unexpected Adverse Events (AEs) | 0 | 0 | 0 |
Number of participants with serious adverse events defined as any grade 4 or higher local or systemic adverse events based on the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials. Local AEs: Grade 4: Pain, Tenderness = Hospitalization; Erythema/Redness, Induration/Swelling = Necrosis or exfoliative dermatitis requiring medical attention; Bruising: Hematoma requiring medical attention; Pruritis: Pruritis requiring medical attention Systemic AEs: Grade 4: Fever = \>104\^oF; Fatigue, Retro-orbital pain, Photophobia, Nausea, Headache, Myalgia, Arthralgia, Dengue-like rash: Hospitalization. Grade 5: Death
| Participants | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Grade 4 | 0 | 0 | 0 |
| Grade 5 | 0 | 0 | 0 |
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 28 was analyzed as GMT Day 28/GMT Day 0.
| Ratio | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 28 | 7.2 (4.3 to 12) | 5.3 (1.6 to 17) | 40.2 (22.2 to 72.5) |
The mean peak viremia was measured by viral quantitative reverse transcription polymerase chain reaction (qRT-PCR) for days 3, 6, 9, 12, and 15. Analysis was done as the average of the log mean of the peak value for each participant.
| log copies/mL | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Mean Peak Viremia | 3.5 (3.3 to 3.6) | 3.5 (3.1 to 3.8) | 4.3 (4.1 to 4.5) |
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes before and after vaccination obtained using plaque reduction neutralization tests (PRNT). The fold change in the DENV1-4 neutralizing antibody GMT between days 0 and 57 was analyzed as GMT Day 57/GMT Day 0.
| Ratio | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Mean Fold-change in Dengue virus1-4 Neutralizing Antibody Mean Titer Between Days 0 and 57 | 3.9 (2.4 to 6.2) | 5 (1.8 to 13.7) | 25 (15 to 41.9) |
The dengue virus (DENV) geometric mean titer (GMT) is a measure of average humoral immunity against all four dengue virus (DENV1-4) serotypes. GMT for the DENV1-4 neutralizing antibody titer was assessed for days 0, 28, and 57.
| titer | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Day 0 | 5 (5 to 5) | 62.3 (33.7 to 115.1) | 28.5 (16.5 to 49.2) |
| Day 28 | 35.9 (21.4 to 60.1) | 328.8 (133.8 to 807.9) | 1144.6 (804 to 1629.4) |
| Day 57 | 19.5 (12.2 to 31.2) | 310.4 (154 to 625.6) | 713.3 (485.2 to 1048.8) |
Percent dengue virus (DENV)-specific CD8+ T-cells among total CD8+ T-cells at day 15 was measured through flow cytometric analyses using the Activation-Induced Marker (AIM) assays.
| percentage of dengue-specific CD8+ cells | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Percent Dengue-specific CD8+ T-cells | 0.3 (0.1 to 0.8) | 0.3 (0.1 to 0.9) | 1.4 (0.5 to 3.4) |
Collected over Through day 180 for all participants and up to day 365 for participants who opt for long-term follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Flavivirus naïve | 0/14 (0%) | 1/14 (7.1%) | 14/14 (100%) |
| Polytypic Dengue Virus Antibody Profile | 0/13 (0%) | 0/13 (0%) | 13/13 (100%) |
| Primary Heterotypic Dengue Virus Antibody Profile | 0/18 (0%) | 0/18 (0%) | 18/18 (100%) |
| Event | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Skin infectionInfections and infestations | 1/14 | 0/13 | 0/18 |
| Event | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile |
|---|---|---|---|
| Rash maculo-papularSkin and subcutaneous tissue disorders | 11/14 | 3/13 | 8/18 |
| HyperglycaemiaMetabolism and nutrition disorders | 9/14 | 7/13 | 7/18 |
| FatigueGeneral disorders | 8/14 | 6/13 | 9/18 |
| HeadacheNervous system disorders | 8/14 | 4/13 | 6/18 |
| AnaemiaBlood and lymphatic system disorders | 4/14 | 6/13 | 10/18 |
| Procedural painInjury, poisoning and procedural complications | 7/14 | 5/13 | 7/18 |
| NeutropeniaBlood and lymphatic system disorders | 3/14 | 4/13 | 8/18 |
| LeukopeniaBlood and lymphatic system disorders | 3/14 | 4/13 | 7/18 |
| MyalgiaMusculoskeletal and connective tissue disorders | 3/14 | 2/13 | 7/18 |
| HypokalaemiaMetabolism and nutrition disorders | 5/14 | 4/13 | 2/18 |
| Age, Categorical(Participants) | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 13 | 18 | 45 |
| >=65 years | 0 | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile | Total |
|---|---|---|---|---|
| Female | 7 | 6 | 15 | 28 |
| Male | 7 | 7 | 3 | 17 |
| Ethnicity (NIH/OMB)(Participants) | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile | Total |
|---|---|---|---|---|
| Hispanic or Latino | 4 | 3 | 5 | 12 |
| Not Hispanic or Latino | 10 | 10 | 13 | 33 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Flavivirus naïve | Polytypic Dengue Virus Antibody Profile | Primary Heterotypic Dengue Virus Antibody Profile | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 2 | 5 | 4 | 11 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 1 | 0 | 2 |
| White | 8 | 4 | 11 | 23 |
| More than one race | 1 | 1 | 1 | 3 |
| Unknown or Not Reported | 2 | 2 | 2 | 6 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Human data generated in this study may be shared for future research as follows: De-identified data in an NIH-funded or supported public repository. De-identified data in another public repository. Identified data in the Biomedical Translational Research Information System (automatic for activities in the CC) and/or the NIAID Genomic Research Integration System. De-identified data with approved outside collaborators under appropriate agreements. De-identified data in publications and/or public presentations.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Data will be shared at the time of or shortly after publication.
Access criteria: Data associated with manuscripts will be publicly available. Additional data will be by request to investigator.
This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
National Institutes of Health Clinical Center (CC) →