A Phase 2 interventional study of JNJ-64281802 and Placebo in Dengue, sponsored by Janssen Research & Development, LLC. Terminated at 38 sites in 9 countries. Open to participants aged 16 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Janssen Research & Development, LLC · Phase 2, Interventional, and Prevention
The purpose of this study is to evaluate the prophylactic effect of JNJ-64281802 with respect to the prevention of laboratory-confirmed dengue virus (DENV) infection up to the last day of dosing among participants who have no evidence of current DENV infection at baseline.
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This study's enrollment of 1,595 is above the median of 123 across 195 interventional studies indexed under Dengue.
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Exclusion Criteria:
Participants will receive JNJ-64281802 400 milligrams (mg) loading dose (LD) twice daily for 48 hours (2 days), followed by JNJ-64281802 150 mg maintenance dose (MD) once daily for 26 days in fed conditions.
Drug: JNJ-64281802
Participants will receive JNJ-64281802 150 mg LD twice daily for 48 hours (2 days), followed by JNJ-64281802 50 mg MD once daily for 26 days in fed conditions.
Drug: JNJ-64281802
Participants will receive JNJ-64281802 matching placebo LD and MD from Day 1 to Day 28.
Drug: Placebo
JNJ-64281802 tablets will be administered orally as per the defined regimens.
Matching placebo for each dose level as tablet will be administered orally.
Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline
Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \[RT-PCR\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \[PCR\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \[\>=\] 11 relative units per milliliter \[RU/mL\]).
Time frame: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline)
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for \>=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
Time frame: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for \>=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
Time frame: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.
Time frame: DB prophylactic phase: From start of study treatment (Day 1) up to visit Day 50, considering the long half-life (~10 days) of the study intervention; Follow-up phase: From visit Day 50 up to Day 90
Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs
Vital signs: pulse and blood pressure (systolic blood pressure\[SBP\]/diastolic blood pressure\[DBP\]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury\[mmHg\]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (\>)150-155, G3(severe):\>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (\<)85, G3(severe):\<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):\>95-100, G3(severe):\>100; Pulse(beats per minutes\[bpm\]):Tachycardia: G1(mild):\>100-115, G2(moderate):\>115-130, G3(severe):\>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):\<50-45, G3(severe):\<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.
Time frame: From start of drug administration (DB prophylactic Day 1) up to Day 50
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: \< 45, high: \>=120; PR Interval (milliseconds \[ms\]): low: \<110, high: \>=220; QRS interval (ms): high: \>=120; QTcB and QTcF (ms): Borderline prolonged QT: 450\< QTc \<=480, 480 \<QTc \<=500, QTc \>500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
Time frame: Day 28
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
Time frame: From start of drug administration (DB prophylactic Day 1) up to Day 50
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion.
Time frame: Day 50
Plasma Concentrations of JNJ-64281802
Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
Time frame: Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90
Of 1595 enrolled participants (those who signed informed consent form \[ICF\]): 616 were index cases, 979 were household contacts (HHCs) identified from index cases. Of 616, 411 met the eligibility criteria for index case population (those who signed ICF and had a laboratory-confirmed dengue infection) and are reported below. Out of 979 HHCs, 128 were screen failures. Per plan, index cases were not included in any analysis and 851 randomized HHCs were included in the analysis.
| Milestone | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants |
|---|---|---|---|---|
| Started | 283 | 283 | 285 | 411 |
| Treated | 282 | 281 | 284 | 0 |
| Participants who entered into follow-up phase | 69 | 68 | 69 | 0 |
| Completed | 247 | 250 | 252 | 411 |
| Not completed | 36 | 33 | 33 | 0 |
| Withdrew: Withdrawal by subject | 13 | 12 | 14 | 0 |
| Withdrew: Adverse event | 5 | 5 | 4 | 0 |
| Withdrew: Protocol-specified withdrawal criterion met | 5 | 1 | 4 | 0 |
| Withdrew: Non-compliance with study drug | 2 | 3 | 3 | 0 |
| Withdrew: Physician decision | 1 | 3 | 2 | 0 |
| Withdrew: Lost to follow-up | 2 | 2 | 0 | 0 |
| Withdrew: Non-compliance with study schedule | 1 | 1 | 1 | 0 |
| Withdrew: Protocol violation | 2 | 0 | 1 | 0 |
| Withdrew: Death | 1 | 0 | 0 | 0 |
| Withdrew: Site terminated by sponsor | 0 | 1 | 0 | 0 |
| Withdrew: Other | 3 | 3 | 3 | 0 |
| Withdrew: Randomized but not treated | 1 | 2 | 1 | 0 |
Number of participants with DENV infection between baseline and the last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Presence of a laboratory-confirmed DENV infection was defined as a positive DENV ribonucleic acid (RNA) (assessed using a validated quantitative DENV reverse transcription polymerase chain reaction \[RT-PCR\]) or DENV non-structural protein 1 (NS1); assessed by enzyme-linked immunosorbent assay (ELISA) test result. A sample was considered positive for DENV RNA when the result was 'target detected' (when the result was above the limit of detection of the polymerase chain reaction \[PCR\] assay) or a sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result greater than or equal to \[\>=\] 11 relative units per milliliter \[RU/mL\]).
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Number of Participants With Laboratory-confirmed Dengue Virus (DENV) Infection Between Baseline and the Last Day of Dosing + 1 Day Among Household Contacts (HHC) Participants With No Evidence of DENV Infection at Baseline | 2 | 2 | 6 |
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among all HHC participants (with/without evidence of DENV infection at baseline) were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic adverse events (AEs; retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, rash), lasted for \>=1 day and occurred within +/-2 days time window around positive PCR or NS1 test, between baseline and last day of dosing. Sample was considered positive for DENV RNA when result was 'target detected' (when result was above the limit of detection of PCR assay) or sample considered DENV NS1 positive if qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among All HHC Participants (With or Without Evidence of DENV Infection at Baseline) | 1 | 3 | 8 |
Number of participants with laboratory-confirmed symptomatic DENV infection between baseline and last day of dosing + 1 day among HHC participants with no evidence of DENV infection at baseline were reported. Laboratory confirmed symptomatic DENV infection was defined as having at least 2 solicited systemic AEs (retro-orbital pain, fever, arthralgia, headache, myalgia, rash, abdominal pain, nausea, fatigue, loss of appetite, vomiting, and diarrhea) of which at least 1 was a most common dengue symptom (retro-orbital pain, fever, arthralgia, headache, myalgia, and rash), lasted for \>=1 day and occurred within a +/-2 days time window around the positive PCR or NS1 test, between baseline and the last day of dosing. A sample was considered positive for DENV RNA when the result was 'target detected' (when result was above the limit of detection of PCR assay) or sample was considered DENV NS1 positive if the qualitative DENV NS1 result was positive (quantitative DENV NS1 result \>=11 RU/mL).
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Number of Participants With Laboratory-confirmed Symptomatic DENV Infection Between Baseline and the Last Day of Dosing + 1 Day Among HHC Participants With No Evidence of DENV Infection at Baseline | 0 | 2 | 5 |
An adverse event (AE) was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Serious AE was the AE resulting in any of following outcomes/deemed significant for any other reason: death; initial/prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as any AE occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts. TEAEs included both serious and non-serious adverse events.
| Participants | DB Prophylactic Phase: JNJ-64281802: High Dose Regimen | DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | DB Prophylactic Phase: Placebo | Follow-up Phase: JNJ-64281802: High Dose Regimen | Follow-up Phase: JNJ-64281802: Low Dose Regimen | Follow-up Phase: Placebo |
|---|---|---|---|---|---|---|
| TEAE | 169 | 162 | 176 | 13 | 8 | 8 |
| TESAE | 3 | 0 | 1 | 0 | 0 | 0 |
Vital signs: pulse and blood pressure (systolic blood pressure\[SBP\]/diastolic blood pressure\[DBP\]). Abnormality grades determined per Division of Acquired Immunodeficiency Syndrome (DAIDS) for grading severity of adult and pediatric AEs: SBP(millimeters of mercury\[mmHg\]):Hypertension:Grade (G)1(mild):141-150, G2(moderate):greater than (\>)150-155, G3(severe):\>155; SBP(mmHg):Hypotension:G1(mild):85-89, G2(moderate):80 to less than (\<)85, G3(severe):\<80; DPB(mmHg):Hypertension:G1(mild):91-95, G2(moderate):\>95-100, G3(severe):\>100; Pulse(beats per minutes\[bpm\]):Tachycardia: G1(mild):\>100-115, G2(moderate):\>115-130, G3(severe):\>130; Pulse(bpm):Bradycardia:G1(mild):50-54, G2(moderate):\<50-45, G3(severe):\<45. Any abnormality occurring at/after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered TE. Worst TE toxicity grade=highest grade reached.
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs | 1 | 0 | 0 |
ECG variables: heart rate (HR), PR interval, RR interval, QRS interval, QT interval, and corrected QT (QTc) interval using both following correction methods: QT corrected according to Bazett's formula (QTcB), QT corrected according to Fridericia's formula (QTcF). Abnormalities were categorized as low or high. HR (bpm): low: \< 45, high: \>=120; PR Interval (milliseconds \[ms\]): low: \<110, high: \>=220; QRS interval (ms): high: \>=120; QTcB and QTcF (ms): Borderline prolonged QT: 450\< QTc \<=480, 480 \<QTc \<=500, QTc \>500. Any abnormality occurring at or after initial administration of study intervention until last study-related activity, or participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Heart Rate: Abnormally Low (<45) | 1 | 0 | 0 |
| PR Interval, Aggregate: Abnormally High (>=220) | 0 | 1 | 2 |
| PR Interval, Aggregate: Abnormally Low (<110) | 1 | 0 | 2 |
| QTcB Interval, Aggregate: Borderline prolonged QT (450< QTc <=480) | 1 | 2 | 0 |
| QTcF Interval, Aggregate: Borderline prolonged QT (450< QTc <=480) | 0 | 1 | 0 |
| QRS Duration, Aggregate: Abnormally High (>=120) | 1 | 1 | 0 |
Number of participants with treatment-emergent worst grade (Grade 3 or 4) abnormalities in laboratory parameters were reported. Laboratory assessments included clinical chemistry, hematology and urinalysis. Abnormality criterions were based on DAIDS: Grade 1= mild, Grade 2= moderate, Grade 3= severe, Grade 4= life-threatening. Any abnormality occurring at or after initial administration of study intervention until the last study-related activity, or until the participant had been deemed lost to follow-up after demonstration of due diligence of follow up efforts was considered treatment emergent.
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Hematology: Hemoglobin, Low: Grade 3 | 1 | 1 | 3 |
| Hematology: Hemoglobin, Low: Grade 4 | 1 | 2 | 0 |
| Hematology: Activated partial thromboplastin time (APTT), High: Grade 3 | 1 | 0 | 0 |
| Hematology: APTT, High: Grade 4 | 1 | 0 | 2 |
| Hematology: Prothrombin time (PT), High: Grade 3 | 1 | 0 | 0 |
| Hematology: PT, High: Grade 4 | 1 | 1 | 4 |
| Hematology: Platelets, Decrease: Grade 3 | 0 | 0 | 3 |
| Chemistry: Hyperglycemia: Grade 3 | 10 | 17 | 14 |
| Chemistry: Hypoglycemia: Grade 3 | 1 | 3 | 1 |
| Chemistry: Hypoglycemia: Grade 4 | 1 | 0 | 0 |
| Chemistry: Triglycerides (Fasting), High: Grade 3 | 2 | 2 | 1 |
| Chemistry: Cholesterol, High: Grade 3 | 22 | 17 | 20 |
| Chemistry: Low density lipoprotein (Fasting), High: Grade 3 | 4 | 3 | 8 |
| Chemistry: Hypernatremia: Grade 4 | 1 | 0 | 0 |
| Chemistry: Creatine Kinase, High: Grade 3 | 2 | 4 | 4 |
| Chemistry: Creatine Kinase, High: Grade 4 | 3 | 2 | 0 |
| Chemistry: Alanine aminotransferase or Serum glutamic pyruvic transaminase (SGPT), High: Grade 3 | 0 | 1 | 0 |
| Chemistry: Uric Acid, High: Grade 3 | 0 | 1 | 0 |
| Chemistry: Hyperkalemia: Grade 3 | 0 | 1 | 0 |
| Chemistry: Hypokalemia: Grade 3 | 1 | 0 | 2 |
| Chemistry: Gamma Glutamyl Transferase, High: Grade 3 | 1 | 0 | 0 |
| Chemistry: Amylase (Pancreatic), High: Grade 4 | 1 | 0 | 0 |
| Chemistry: Hypophosphatemia: Grade 3 | 2 | 0 | 0 |
| Chemistry: Aspartate aminotransferase or Serum glutamic-oxaloacetic transaminase, High: Grade 3 | 0 | 1 | 0 |
| Chemistry: Hyperbilirubinemia: Grade 4 | 1 | 0 | 0 |
| Chemistry: Hypercalcemia: Grade 3 | 0 | 1 | 0 |
| Chemistry: Hypocalcemia: Grade 4 | 0 | 1 | 0 |
| Chemistry: Lipase, High: Grade 3 | 2 | 0 | 0 |
| Urinalysis: Protein, High: Grade 3 | 0 | 1 | 2 |
| Urinalysis: Glycosuria: Grade 3 | 2 | 0 | 2 |
Number of participants with abnormalities in physical examination parameters (head/neck/thyroid, eyes/ears/nose/throat, respiratory, cardiovascular, lymph nodes, abdomen, skin, musculoskeletal, and neurological) were reported based on investigator's discretion.
| Participants | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo |
|---|---|---|---|
| Number of Participants With Clinically Significant Abnormalities in Physical Examinations | 7 | 9 | 13 |
Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
| Nanograms per milliliter (ng/mL) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen |
|---|---|---|
| Pre-dose on Day 1 | 1.9 ± 31.52 | 4.2 ± 69.03 |
| Post-dose on Day 3 | 4233.5 ± 1534.79 | 1777.1 ± 732.09 |
| Post-dose on Day 5 | 2735.0 ± 1370.95 | 1037.1 ± 505.93 |
| Post-dose on Day 9 | 2583.1 ± 1311.77 | 909.1 ± 469.41 |
| Post-dose on Day 13 | 2657.4 ± 1380.73 | 865.8 ± 439.79 |
| Post-dose on Day 21 | 2649.4 ± 1606.28 | 846.9 ± 495.83 |
| Post-dose on Day 28 | 2614.1 ± 1653.06 | 816.1 ± 535.34 |
| Day 40 | 1194.8 ± 858.11 | 325.4 ± 238.77 |
| Day 50 | 640.2 ± 543.84 | 165.4 ± 143.87 |
| Day 90 | 57.3 ± 82.76 | 12.0 ± 18.82 |
Collected over All Cause Mortality: DB prophylactic phase: From randomization (pre-dose, DB prophylactic Day 1) up to Day 50, Follow up phase: From Day 50 up to end of trial (Day 90); Serious and Other AEs: DB prophylactic phase: From start of study treatment (DB prophylactic Day 1) up to Day 50, Follow-up phase: From Day 50 up to End of trial (Day 90). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DB Prophylactic Phase: JNJ-64281802: High Dose Regimen | 1/283 (0.4%) | 3/282 (1.1%) | 107/282 (37.9%) |
| DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | 0/283 (0%) | 0/281 (0%) | 106/281 (37.7%) |
| DB Prophylactic Phase: Placebo | 0/285 (0%) | 1/284 (0.4%) | 109/284 (38.4%) |
| Follow-up Phase: JNJ-64281802: High Dose Regimen | 0/69 (0%) | 0/69 (0%) | 9/69 (13%) |
| Follow-up Phase: JNJ-64281802: Low Dose Regimen | 0/68 (0%) | 0/68 (0%) | 6/68 (8.8%) |
| Follow-up Phase: Placebo | 0/69 (0%) | 0/69 (0%) | 8/69 (11.6%) |
| Event | DB Prophylactic Phase: JNJ-64281802: High Dose Regimen | DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | DB Prophylactic Phase: Placebo | Follow-up Phase: JNJ-64281802: High Dose Regimen | Follow-up Phase: JNJ-64281802: Low Dose Regimen | Follow-up Phase: Placebo |
|---|---|---|---|---|---|---|
| Angina UnstableCardiac disorders | 1/282 | 0/281 | 0/284 | 0/69 | 0/68 | 0/69 |
| Hypertensive Heart DiseaseCardiac disorders | 1/282 | 0/281 | 0/284 | 0/69 | 0/68 | 0/69 |
| HaemorrhoidsGastrointestinal disorders | 1/282 | 0/281 | 0/284 | 0/69 | 0/68 | 0/69 |
| Crush InjuryInjury, poisoning and procedural complications | 1/282 | 0/281 | 0/284 | 0/69 | 0/68 | 0/69 |
| Hypertensive CrisisVascular disorders | 1/282 | 0/281 | 0/284 | 0/69 | 0/68 | 0/69 |
| Cholecystitis AcuteHepatobiliary disorders | 0/282 | 0/281 | 1/284 | 0/69 | 0/68 | 0/69 |
| Event | DB Prophylactic Phase: JNJ-64281802: High Dose Regimen | DB Prophylactic Phase: JNJ-64281802: Low Dose Regimen | DB Prophylactic Phase: Placebo | Follow-up Phase: JNJ-64281802: High Dose Regimen | Follow-up Phase: JNJ-64281802: Low Dose Regimen | Follow-up Phase: Placebo |
|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 54/282 | 61/281 | 67/284 | 4/69 | 5/68 | 4/69 |
| PyrexiaGeneral disorders | 22/282 | 25/281 | 39/284 | 4/69 | 3/68 | 5/69 |
| DiarrhoeaGastrointestinal disorders | 35/282 | 23/281 | 23/284 | 1/69 | 1/68 | 1/69 |
| FatigueGeneral disorders | 16/282 | 25/281 | 26/284 | 1/69 | 1/68 | 0/69 |
| MyalgiaMusculoskeletal and connective tissue disorders | 13/282 | 15/281 | 25/284 | 1/69 | 1/68 | 0/69 |
| NauseaGastrointestinal disorders | 18/282 | 21/281 | 24/284 | 1/69 | 0/68 | 0/69 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 17/282 | 17/281 | 23/284 | 3/69 | 3/68 | 4/69 |
| Abdominal PainGastrointestinal disorders | 16/282 | 13/281 | 20/284 | 1/69 | 0/68 | 1/69 |
| Decreased AppetiteMetabolism and nutrition disorders | 6/282 | 9/281 | 20/284 | 0/69 | 0/68 | 2/69 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 19/282 | 15/281 | 20/284 | 0/69 | 0/68 | 0/69 |
For randomized HHC participants: Safety analysis set included all randomized participants who received at least 1 dose of study intervention. For index case participants: Index case analysis set included all participants enrolled as an index case, with a laboratory-confirmed dengue virus (DENV) infection.
| Age, Continuous(Years) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants | Total |
|---|---|---|---|---|---|
| Mean | 34.8 ± 12.07 | 33.3 ± 11.67 | 34.7 ± 11.57 | 28.2 ± 16.54 | 32.3 ± 13.81 |
| Sex/Gender, Customized(Participants) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants | Total |
|---|---|---|---|---|---|
| Female | 152 | 153 | 166 | 193 | 664 |
| Male | 130 | 128 | 118 | 217 | 593 |
| Undifferentiated | 0 | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 235 | 233 | 236 | 312 | 1016 |
| Not Hispanic or Latino | 47 | 47 | 47 | 91 | 232 |
| Unknown or Not Reported | 0 | 1 | 1 | 8 | 10 |
| Race (NIH/OMB)(Participants) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 159 | 158 | 159 | 167 | 643 |
| Asian | 47 | 47 | 48 | 75 | 217 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 19 | 17 | 21 | 20 | 77 |
| White | 11 | 9 | 7 | 36 | 63 |
| More than one race | 15 | 16 | 18 | 20 | 69 |
| Unknown or Not Reported | 31 | 34 | 31 | 93 | 189 |
| Region of Enrollment(Participants) | JNJ-64281802: High Dose Regimen | JNJ-64281802: Low Dose Regimen | Placebo | Index Case Participants | Total |
|---|---|---|---|---|---|
| Brazil | 34 | 34 | 35 | 109 | 212 |
| Colombia | 132 | 129 | 131 | 110 | 502 |
| Mexico | 33 | 33 | 33 | 78 | 177 |
| Panama | 18 | 18 | 18 | 28 | 82 |
| Philippines | 23 | 23 | 23 | 28 | 97 |
| Thailand | 24 | 24 | 25 | 47 | 120 |
| Peru | 18 | 20 | 19 | 11 | 68 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
This study is terminated, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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