A Study of JNJ-64281802 for the Prevention of Dengue Infection
- Summary
- 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.
- Short title
- A Study of JNJ-64281802 for the Prevention of Dengue Infection
- Official title
- A Phase 2, Randomized, Double-blind, Placebo-controlled, Double-dummy, Multicenter Trial Assessing the Efficacy and Safety of Two Dose Regimens of JNJ-64281802 for the Prevention of Dengue Infection
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Reason stopped
- The study was stopped due to portfolio reprioritization. This decision is not based on any safety concerns.
- Completion date
- 2024-06-26
- First posted
- 2022-01-21
- Registry last updated
- 2025-07-31
- Primary completion date
- 2024-06-26
- Start date
- 2023-02-22
- Actual participants
- 1,595
- Participants
- 1,595
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Janssen Research & Development, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT05201794
- ClinicalTrials.gov ID
- NCT05201794
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Prevention
- Masking
- Double masking
- Masked roles
- Participants, Investigators
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
Timeframe: Baseline (DB prophylactic Day 1) up to last day of dosing + 1 day (up to DB prophylactic Day 29)
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 \[RU/mL\]).
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)
Timeframe: 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 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).
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
Timeframe: 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 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).
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)
Timeframe: 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
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.
Number of Participants With Treatment-emergent (TE) Worst Grade (Grade 3 or 4) Abnormalities in Vital Signs
Timeframe: From start of drug administration (DB prophylactic Day 1) up to Day 50
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.
Number of Participants With Treatment-emergent Abnormalities in Electrocardiogram (ECG) Parameters
Timeframe: Day 28
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.
Number of Participants With Treatment-emergent Worst Grade (Grade 3 or 4) Abnormalities in Laboratory Parameters
Timeframe: From start of drug administration (DB prophylactic Day 1) up to Day 50
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.
Number of Participants With Clinically Significant Abnormalities in Physical Examinations
Timeframe: Day 50
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.
Plasma Concentrations of JNJ-64281802
Timeframe: Pre-dose on Day 1; post-dose on Days 3, 5,9, 13, 21, and 28 ; Days 40, 50, and 90
Plasma concentrations of JNJ-64281802 were reported. Plasma samples were analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) method.
- Sex
- All
- Age groups
- Children, Adults, Older adults
- Minimum age
- 16 Years
- Maximum age
- 65 Years
- Healthy volunteers
- Yes
- Healthy on the basis of physical examination, medical history, and vital signs performed at screening. If there are abnormalities, the participant may be included only if the investigator judges the abnormalities to be not clinically relevant. This determination must be recorded in the participant's source documents
- Must have a body mass index (BMI, weight in kilogram [kg] divided by the square of height in meters) between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive, and a body weight of greater than or equal to (>=) 40.0 kg at screening
- A woman must have a negative highly sensitive urine pregnancy test at screening
- A male participant must agree not to donate sperm for the purpose of reproduction during the study and for >= 90 days after receiving the last dose of study intervention
- Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that the participant understands the purpose of, and procedures required for, the study and is willing to participate in the study
- Having any dengue virus (DENV)-associated clinical signs and symptoms
- Known allergies, hypersensitivity, or intolerance to JNJ-64281802 or its excipients
- Any clinically relevant skin disease (as assessed by the investigator) in the past 3 months such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Reduced immune function to be: (a) Known or suspected congenital or acquired immunodeficiency; or (b) receipt of immunomodulation therapy within the last 6 months (such as anticancer chemotherapy or radiation therapy)
- Received an investigational intervention (including investigational vaccines other than a corona virus disease 2019 [COVID-19] vaccine) or used an invasive investigational medical device within 3 months before the planned first dose of study intervention or received an investigational biologic product within 3 months prior to enrollment or 5 half-lives, whichever is longer, before the planned first dose of study intervention, or is currently enrolled in an investigational study
- Universidade Federal De Minas Gerais - Hospital das ClínicasBelo Horizonte, Brazil
- HUJM - UFMT - Hospital Universitário Júlio Müller - Universidade Federal do Mato GrossoCuiabá, Brazil
- Hospital e Maternidade Sao Joao de DeusLaranjeiras do Sul, Brazil
- Fundacao De Medicina Tropical Doutor Heitor Vieira DouradoManaus, Brazil
- Fundacao Universidade Federal de Mato Grosso do SulMato Grosso Do Sul, Brazil
- Policlínica Regional Dr Sérgio AroucaNiterói, Brazil
- UPA Unidade de Pronto Atendimento Mário MonteiroNiterói, Brazil
- Instituto de Pesquisas em Patologias Tropicais de Rondônia - IPEPATROPorto Velho, Brazil
- Centro Bangu - Centro Municipal de Saude Waldyr FrancoRio de Janeiro, Brazil
- Fundacao Oswaldo Cruz Instituto Nacional de Infectologia Evandro ChagasRio de Janeiro, Brazil
- Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Hospital de BaseSão José do Rio Preto, Brazil
- CAIMED AcaciasAcacías, Colombia
- CAIMED AguazulAguazul, Colombia
- Centro de Reumatologia y OrtopediaBarranquilla, Colombia
- Hospital Universidad del NorteBarranquilla, Colombia
- Centre of Care and Diagnosis of the Infectious Diseases (CDI)Bucaramanga, Colombia
- Centro de Investigaciones Clinicas S A SCali, Colombia
- Programa de Estudio y Control de Enfermedades TropicalesMedellín, Colombia
- Centro de Atencion e Investigacion Medica S.A. - CAIMEDYopal - Casanare, Colombia
- Klinik Kesihatan KuangKuang, Malaysia
- Klinik Kesihatan PandamaranPort Klang, Malaysia
- Centro Medico JojutlaJojutla, Mexico
- Medical Care & Research SA de CVMérida, Mexico
- Unidad de Proyectos Clínicos de Oriente UPCOValladolid, Mexico
- FAICIC S. de R.L. de C.V.Veracruz, Mexico
And 13 more, listed on the interactive page.
- PubMed 42253092Related publication
Other registry identifiers
- 64281802DNG2004
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Dengue disease Primary condition