INO-A002 for Dengue

Phase-Based Estimates
1
Effectiveness
1
Safety
University of Pennsylvania, Philadelphia, PA
Dengue+1 More
INO-A002 - Biological
Eligibility
18 - 65
All Sexes
Eligible conditions
Dengue

Study Summary

This study is evaluating whether a dengue vaccine can be delivered by a new method.

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Eligible Conditions

  • Dengue
  • Healthy Subjects (HS)

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether INO-A002 will improve 5 primary outcomes in patients with Dengue. Measurement will happen over the course of 10 minutes.

10 minutes
Evaluate the tolerability of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.
52 weeks
Determine the Area Under the Curve (AUC0-t) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation
Determine the maximum serum concentration (Cmax) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
Determine the minimum serum concentration (Cmin) of the monoclonal antibody dMAb-ZK190 in the serum upon administration of INO-A002 with Hylenex® delivered IM followed by electroporation.
Evaluate the safety of escalating doses of INO-A002 with Hylenex® administered IM followed by electroporation with the CELLECTRA® 2000 device in healthy adult volunteers.

Trial Safety

Trial Design

5 Treatment Groups

No Control Group
Cohort C - 2mg

This trial requires 30 total participants across 5 different treatment groups

This trial involves 5 different treatments. INO-A002 is the primary treatment being studied. Participants will be divided into 5 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Cohort C - 2mgParticipants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 2 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Cohort E - 4mg Side PortParticipants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device with Side Port needle.
Cohort A - 0.5mgParticipants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 0.5 mg DNA/dose. Inoculation will be administered as 0.5 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Cohort B - 1mgParticipants (n=6 per cohort) will be administered 1 injection (Day 0) of INO-A002 at 1 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Cohort D - 4mgParticipants (n=6 per cohort) will be administered 2 injections (Day 0 and Day 3) of INO-A002 at 4 mg DNA/dose. Inoculation will be administered as 1 ml IM injection followed by electroporation with the CELLECTRA® 2000 device.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CELLECTRA® 2000
2020
Completed Phase 2
~240

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 52 weeks
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 52 weeks for reporting.

Closest Location

University of Pennsylvania - Philadelphia, PA

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Able and willing to comply with all study procedures;
Body mass index (BMI) between 20 and 30, inclusive
No history of dengue virus vaccination or illness; no history of yellow fever vaccination.
Age 18-60 years;
Able to provide consent to participate and having signed an Informed Consent Form (ICF);
Screening laboratory must be within normal limits or have only Grade 0-1 findings;
Normal screening ECG or screening ECG with no clinically significant findings;
Women of child-bearing potential agree to use medically effective contraception (oral contraception, barrier methods, spermicide with barrier methods, etc.) or have a partner who is sterile from enrollment to 6 months following the last injection, or have a partner who is medically unable to induce pregnancy.
Sexually active men who are considered sexually fertile must agree to use either a barrier method of contraception during the study, and agree to continue the use for at least 6 months following the last injection, or have a partner who is permanently sterile or is medically unable to become pregnant;
No history of clinically significant immunosuppressive or autoimmune disease. Individuals with HIV infection who have been virologically suppressed for more than 1 year and with current CD4 cell count entry greater than 500 cells/ul will be allowed into the study.

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can dengue be cured?

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Dengue can be averted by implementing a comprehensive and effective disease prevention and control programme. The disease burden of dengue should be reduced further to allow for wider use of this control technique.

Unverified Answer

What are the signs of dengue?

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The manifestations of dengue can differ according to the immune competence of a patient. The symptoms can be grouped according to the four phases of dengue.\n

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How many people get dengue a year in the United States?

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About 2.6 million people are found to have dengue antibodies yearly in the United States with no apparent differences between urban centers and their suburban and rural counterparts. Dengue vaccine is recommended to all age groups including children in the United States. Considering the recent dengue epidemic, it is important to implement a preventive program including vaccination as earlier as possible. It is also important to reinforce the proper laboratory technique for the detection of the dengue virus. Vaccines are available free of charge for any US citizen and there are several manufacturers in the US ready to sell them. The Centers for Disease Control, United States Department of Health and Human Services and state governments are also actively committed to offering free vaccination to the public in the US.

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What are common treatments for dengue?

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A large proportion of dengue patients (69%) were not receiving any treatment. The most common treatment among those patients that received any treatment was topical paracetamol, followed by antibiotics. Of the patients evaluated in this survey, more than half (57.6%) of the dengue and 79.4% of the adenovirus positive patients required further evaluation for suspicion of coinfection with either influenza or HIV. Recent findings of this study highlight the need for increased awareness of both dengue and adenovirus among doctors.

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What causes dengue?

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There are many risk factors associated with contracting dengue. The majority of these risk factors are related to human behavior and socioeconomic factors. The disease has also been reported as a result of other environmental health risks. These include water sanitation, poverty, over-saturation of hospitals, overcrowded living areas, lack of proper housing, and an improper living environment all of which are in association with the disease.

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How does ino-a002 work?

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The present study provides a novel mechanism of action of the drug against DENV infection through a novel antiviral mechanism, suggesting a novel therapeutic approach to treat DENV infection.

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What is dengue?

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We describe an experience from South Eastern Brazil with the clinical management of dengue patients. Although the severity and mortality are extremely low in our study context, the clinical and laboratory characteristics of dengue are frequently similar with those of severe dengue. To decrease hospitalization and clinical severity of this disease to diminish its impact on the community and on private health care expenditure, prompt clinical suspicion of severe dengue is needed.

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Does ino-a002 improve quality of life for those with dengue?

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Ino-a002, at a dose of 5 g/day, resulted in a non-significant trend towards reduced dengue severity for all measured outcomes (EQ-5D score and VAS score).

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Does dengue run in families?

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Although the number of cases is relatively small, this study suggests that familial clustering is still present in dengue among families living in the area studied and that there may be a genetic component in some families to the presence of disease.

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What does ino-a002 usually treat?

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In terms of ino-a002's efficacy, the study demonstrated both in-and intergroup (yo-a002 vs placebo) statistically significant improvement in the majority of patients. Despite this observation, some patients were not in their'responder' range (yo-a002). This observation, as in other patients, suggests that patient response is in the 'interindividual' range. The data from this study strongly support the potential of ino-a002 for the treatment of milder forms of the disease with the presence and absence of other illnesses. However, the potential for patients to develop drug-induced hypophosphatemia is a concern and further testing is needed.

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Have there been any new discoveries for treating dengue?

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This article includes clinical trials and new therapies. There are still plenty of medications that have potential to treat dengue. While the [current therapeutic strategies and treatments are no longer adequate], new discoveries are constantly being made every few months. There are not many treatments in the near future. However, if you are dealing with dengue, please consult a qualified (i.e., a medical professional who has received any form of advanced training such as a master's degree) or an amateur who has obtained training from reputable sources such as the [World Health Organization (WHO) or CDC (Center for Disease Control and Prevention)] in order to determine the best way to manage and control the disease.

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