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Antiviral
JNJ-64281802 for Dengue Fever
Phase 2
Recruiting
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have a normal ECG and blood pressure at screening
Healthy based on physical examination, medical history, vital signs, and clinical laboratory tests at screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 99 weeks
Awards & highlights
Study Summary
This trial is testing a new drug to see if it can prevent or treat dengue infection. The hypothesis is that the highest dose of the new drug will be better than a placebo at fighting the virus.
Who is the study for?
Healthy adults aged 18-55 with normal clinical tests, ECGs, and blood pressure can join this trial. They must not be pregnant or planning pregnancy, agree to use contraception, avoid donating blood or sperm for a certain period, and refrain from drug abuse. Exclusion includes HIV/HBV/HCV infection, recent travel to dengue regions, immunodeficiency conditions, significant alcohol/drug abuse history.Check my eligibility
What is being tested?
The study is testing JNJ-64281802's effectiveness in preventing/treating dengue fever compared to a placebo. Participants will receive different dosing regimens of the drug (weekly Y1/Z2 or daily X) including high and medium/low doses versus placebo after being exposed to Dengue Serotype 3 virus.See study design
What are the potential side effects?
Potential side effects are not detailed but may include typical reactions related to oral medications such as digestive issues or allergic responses specific to the components of JNJ-64281802.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart test (ECG) and blood pressure are normal.
Select...
I am healthy according to recent medical exams and tests.
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I am between 18 and 55 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 99 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~99 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess the antiviral activity of the study drug (JNJ 64281802) versus placebo in terms of reduction of dengue infection.
Secondary outcome measures
12-lead ECG with measurement of PR interval to assess the safety and tolerability of the study drug (JNJ 64281802).
12-lead ECG with measurement of QRS interval to assess the safety and tolerability of the study drug (JNJ 64281802).
12-lead ECG with measurement of QTcF to assess the safety and tolerability of the study drug (JNJ 64281802).
+28 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: JNJ-64281802Experimental Treatment6 Interventions
There are two cohorts and three groups in each cohort. Cohort 1 consists of Group 1a, Group 1b and Group 2. Cohort 2 consists of Group 3, Group 4, and Group 5. Within each group, participants will either be randomized to receive study drug or placebo.
Four participants will be enrolled in Group 1a before enrolling the remaining participants to Group 1b (12 participants) and Group 2 (14 participants) in Cohort 1.
Based on the interim analysis results of Cohort 1, three groups for Cohort 2 were created. Eight participants will be enrolled in each of the three groups (Group 3, Group 4, and Group 5).
Group II: PlaceboPlacebo Group1 Intervention
There are two cohorts and three groups in each cohort. Cohort 1 consists of Group 1a, Group 1b and Group 2. Cohort 2 consists of Group 3, Group 4, and Group 5. Within each group, participants will either be randomized to receive study drug or placebo.
Four participants will be enrolled in Group 1a before enrolling the remaining participants to Group 1b (12 participants) and Group 2 (14 participants) in Cohort 1.
Based on the interim analysis results of Cohort 1, three groups for Cohort 2 were created. Eight participants will be enrolled in each of the three groups (Group 3, Group 4, and Group 5).
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,270 Previous Clinical Trials
5,485,183 Total Patients Enrolled
8 Trials studying Dengue Fever
4,748 Patients Enrolled for Dengue Fever
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,936 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,822 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your heart's electrical activity must be normal, as shown in a test called an electrocardiogram (ECG).My heart test (ECG) and blood pressure are normal.I am at risk for serious heart rhythm problems.I am healthy based on my recent physical exam and medical history.I am healthy according to recent medical exams and tests.I have a weak immune system or am taking medication that affects my immune response.I have a history of serious health issues.I can understand and agree to the study's details on my own.I can participate in the study for about 85 days after getting a dengue virus injection.I have recently traveled to areas known for dengue or have certain infections.I have a record of my recent vaccinations and future plans.I have not received a dengue virus injection.If you are able to become pregnant, you must have a negative pregnancy test before joining the study.I am between 18 and 55 years old.Your lab tests show that you are healthy.I am either male or female.My BMI is between 18 and 35, and I weigh at least 50 kg.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: JNJ-64281802
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this research investigation still taking place?
"Affirmative. Records hosted on clinicaltrials.gov demonstrate that, as of May 11th 2022, this trial is actively seeking participants. Initially posted in February 3rd 2022, the medical study requires 54 volunteers to be split between two sites."
Answered by AI
What is the uppermost capacity of participants involved in this clinical examination?
"Affirmative, according to clinicaltrials.gov the trial that was published on February 3rd 2022 is now recruiting participants. As of May 11th 2022, 54 individuals from two research sites are being sought for enrollment."
Answered by AI
Is this medical trial only accessible to individuals aged 85 or younger?
"This clinical experiment is looking for individuals aged between 18 and 55 to participate."
Answered by AI
What potential threats are associated with prolonged exposure to JNJ-64281802 at an elevated dosage?
"As JNJ-64281802 is still in Phase 2 trials, there is some evidence of its safety but none regarding its efficacy - thus it receives a rating of two."
Answered by AI
To which demographic does this study cater?
"54 people affected by dengue virus, aged between 18 to 55 years old are being recruited for this trial. The following criteria must be satisfied in order to qualify: Male or female., Physically and medically healthy as indicated by physical examination, medical history review and vital signs., Body mass index ranging from 18.0-35.0 kg/m2 with a body weight of over 50kg at screening., Normal ECG results at screening., Must independently sign their consent form indicating understanding the study's purpose, procedures and risks involved after comprehending all information given during discussion with investigator or designee.. Negative pregnancy test result for those who"
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
Johns Hopkins University, Bloomberg School of Public Health
What portion of applicants met pre-screening criteria?
Met criteria
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