← Back to Search

Virus Therapy

Dengue Vaccine for Dengue Fever

Phase 1
Recruiting
Led By Camila D Odio, M.D.
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
Aged 18 to 59 years
Willing to forgo receipt of any vaccine in the 28 days preceding the vaccine or in the 28 days following the dose of vaccine. For participants opting for LN FNA on day 57, they must be willing to forgo any vaccine through final LN FNA
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 3, 6, 9, 12 and 15
Awards & highlights

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.

Who is the study for?
Healthy adults aged 18 to 59 can join this trial. They must not have had certain vaccines recently, avoid travel to dengue areas, and use effective contraception if they can get pregnant. Excluded are those with severe allergies, uncontrolled health conditions like asthma or diabetes, drug abuse issues, or a history of serious vaccine reactions.Check my eligibility
What is being tested?
The trial is testing a new dengue vaccine called rDENdelta30/31-7164. Participants will visit the clinic multiple times over seven months for injections into their upper arm fat and follow-up blood tests. Some may choose to have lymph node aspirations before and after vaccination.See study design
What are the potential side effects?
While specific side effects aren't listed here, common vaccine-related side effects could include pain at the injection site, fever, fatigue, headache, muscle pain. More serious risks might involve allergic reactions or immune system responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 59 years old.
Select...
I agree not to get any vaccines 28 days before or after receiving the trial vaccine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 3, 6, 9, 12 and 15
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 3, 6, 9, 12 and 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the DENV neutralizing antibody GMT between days 0 and 28.
Mean peak viremia among groups as measured by viral qRT-PCR between days 3 and 15.
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.
Secondary outcome measures
Change in DENV neutralizing antibody GMT between days 0 and 57 and days 0 and 90.
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.

Trial Design

3Treatment groups
Experimental Treatment
Group I: Primary Heterotypic DENV Antibody ProfileExperimental Treatment1 Intervention
Those who have a >=70% neutralization or plaques at a 1:40 dilution for a single serotype, either DENV1, DENV2, or DENV4.
Group II: Polytypic DENV Antibody ProfileExperimental Treatment1 Intervention
Those considered immune (a >=70% neutralization or plaques at a 1:40 dilution) to at least two serotypes.
Group III: Flavivirus NaiveExperimental Treatment1 Intervention
Those with <=50% neutralization at a 1:10 dilution to all four DENV serotypes, no history of flavivirus vaccination, or travel history that increases the likelihood of other flavivirus infections.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,265 Previous Clinical Trials
5,483,852 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)

Media Library

rDENdelta30/31-7164 (Virus Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05691530 — Phase 1
Dengue Fever Research Study Groups: Primary Heterotypic DENV Antibody Profile, Polytypic DENV Antibody Profile, Flavivirus Naive
Dengue Fever Clinical Trial 2023: rDENdelta30/31-7164 Highlights & Side Effects. Trial Name: NCT05691530 — Phase 1
rDENdelta30/31-7164 (Virus Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05691530 — Phase 1

Frequently Asked Questions

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

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI
~104 spots leftby May 2025