Primary Heterotypic DENV Antibody Profile for Dengue Fever

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Institutes of Health Clinical Center, Bethesda, MDDengue FeverrDENdelta30/31-7164 - Drug
Eligibility
18 - 59
All Sexes
What conditions do you have?
Select

Study Summary

This trial tests a potential new vaccine against dengue in healthy people aged 18-59; 11 visits over 7 months. Blood, urine tests & survey; optional lymph node aspiration & 12mo follow-up.

Eligible Conditions
  • Dengue Fever

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Days 3, 6, 9, 12 and 15

Days 0 and 28
Change in the DENV neutralizing antibody GMT between days 0 and 28.
Day 0
Change in DENV3 neutralizing antibody titer between day 0 and peak titer (measured at days 28, 57, or 90).
DENV neutralizing antibody GMT at days 0, 28, 57, and 90.
Day 0
Change in DENV neutralizing antibody GMT between days 0 and 57 and days 0 and 90.
Days 28 and 180
The frequency and severity of local and systemic reactogenicity signs and symptoms during the 28 day period after each vaccination, unexpected AEs up to 28 days after each vaccination, and SAEs through day 180.
Day 3
Mean peak viremia among groups as measured by viral qRT-PCR between days 3 and 15.

Trial Safety

Safety Progress

1 of 3

Trial Design

3 Treatment Groups

Primary Heterotypic DENV Antibody Profile
1 of 3
Flavivirus Naive
1 of 3
Polytypic DENV Antibody Profile
1 of 3

Experimental Treatment

200 Total Participants · 3 Treatment Groups

Primary Treatment: Primary Heterotypic DENV Antibody Profile · No Placebo Group · Phase 1

Primary Heterotypic DENV Antibody Profile
Drug
Experimental Group · 1 Intervention: rDENdelta30/31-7164 · Intervention Types: Drug
Flavivirus Naive
Drug
Experimental Group · 1 Intervention: rDENdelta30/31-7164 · Intervention Types: Drug
Polytypic DENV Antibody Profile
Drug
Experimental Group · 1 Intervention: rDENdelta30/31-7164 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: days 3, 6, 9, 12 and 15

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,165 Previous Clinical Trials
4,936,821 Total Patients Enrolled
8 Trials studying Dengue Fever
4,748 Patients Enrolled for Dengue Fever
Camila D Odio, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

Age 18 - 59 · All Participants · 16 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You cannot receive any vaccination 28 days before or after the study vaccine. If you choose to have a lymph node biopsy on day 57, you cannot have any vaccine until after the biopsy.
You agree to let the study keep your samples and information for future research.

Frequently Asked Questions

Is this experiment open to octogenarians?

"The necessary qualifications for participants of this trial are those aged between 18 and 59. For minors, there are 13 clinical trials available, while seniors can look towards 12 options." - Anonymous Online Contributor

Unverified Answer

How can individuals assess the potential risks of Flavivirus Naive?

"While there is limited data backing both safety and efficacy, due to the nature of this Phase 1 trial, our team at Power has rated Flavivirus Naive's security a score of 1." - Anonymous Online Contributor

Unverified Answer

Are there still open slots for enrollment in this experiment?

"As per the data available on clinicaltrials.gov, this particular trial is no longer accepting candidates for participation; it was initially posted to the website in late January of 2023 and saw its last update a week prior. Nevertheless, there are 26 other trials that remain open to enrollment at present time." - Anonymous Online Contributor

Unverified Answer

Is my eligibility sufficient to participate in this experiment?

"This trial is seeking two hundred individuals who have already been exposed to dengue, aged 18-59 years old. Furthermore, participants must be in good health and agree to forgo any other vaccines or travel to an endemic area throughout the study's duration. They also must commit to using a highly effective form of contraception if applicable and provide informed consent before taking part. Additionally, their absolute neutrophil count (ANC) should exceed 750 cells/microliter and creatinine levels should remain below 1.5 mg/dL." - Anonymous Online Contributor

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