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AzTrials

Randomised Clinical TrialPhase 1NCT07831473

Phase I Study of VLPDEN-02 Dengue Vaccine in Healthy Adults

A Phase 1 study testing VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant and VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant in people with Randomised Clinical Trial and Double Blind, run by VLP Therapeutics at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study. Forty-two flavivirus-naïve adults will be enrolled and will receive 3 administrations of VLPDEN-02 or control at days 0, 28, and 56. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Randomised Clinical Trial, Double Blind, Dengue
What is being tested?
VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant and VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
42 participants
Where
1 siteUnited States
Study dates
4 Jan 2027to 15 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Male or female between 18 and 55 years of age, inclusive, at the time of screening.
  • Able and willing to comply with all research requirements, in the opinion of the investigator.
  • Good general health as determined by physical examination, laboratory screening, and review of medical history.
  • Available for the duration of the study, which is approximately 50 weeks.
  • Willingness to participate in the study as evidenced by signing the informed consent document.
  • Participant has 12-lead electrocardiogram (ECG*) and clinical laboratory evaluations at screening with no clinically significant abnormalities, as assessed by the investigator. *A normal ECG is defined as the presence of normal sinus rhythm (heart rate 45-100 beats per minute [bpm], inclusive) and the absence of:
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  • QT interval corrected by Fridericia (QTcF) >450 milliseconds (ms) in male participants or >460 ms in female participants;
  • PR interval >220 ms;
  • QRS duration ≧ 110ms;
  • Complete left or right bundle branch block;
  • 2nd or 3rd degree atrioventricular block;
  • Sustained ventricular or atrial arrhythmia;
  • ST elevation consistent with cardiac ischemia;
  • Ventricular or atrial premature contractions in couplets or higher order groupings.
  • Females only: Female participants must meet one of the following two (2) criteria:
  • No reproductive potential due to post-menopausal status (12 months of natural) [spontaneous] amenorrhea or surgical procedure such as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, tubal coil/Essure or tubal ligation, females in a monogamous relationship with a vasectomized male partner or females who exclusively have sex with female partners.
  • Female participants of childbearing potential agree to practice highly effective contraception before enrollment and through 60 days post-DENV-3 challenge using one of the following methods: condoms (male or female) with spermicide; diaphragm, or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, injection, intravaginal ring or other FDA-approved contraceptive method; male partner has previously undergone a vasectomy; abstinence (> 6 months since last sexual encounter). Vasectomized partner is a highly effective contraceptive method provided that the partner is the sole sexual partner of the person of childbearing potential and the absence of sperm has been confirmed. If not, additional highly effective method(s) of contraception should be used.
  • Male participants are encouraged but not required to practice highly effective contraception to avoid pregnancy in their partner from 30 days prior to enrollment through 60 days post-DENV-3 challenge.
  • Females of childbearing potential must agree to not donate ova or oocytes during the study. Males must refrain from sperm donation during the study
  • Have an available phone running iOS 15.0 or later or Android phone running software v7.0 or higher, willing to download the myMedidata app, and willing to complete daily electronic diaries when required.

Who cannot join

  • Females only: Currently pregnant, as determined by positive beta-human choriogonadotropin (beta-HCG) test, or breast-feeding.
  • The participant has a history of significant alcoholism or drug/chemical abuse within 12 months prior to enrollment that has caused medical, occupational, or family problems as indicated by participant history.
  • Any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a participant's ability to give informed consent.
  • A participant with a confirmed screening laboratory value of Grade 1 or above for absolute neutrophil count (ANC), alanine aminotransferase (ALT), or serum creatinine. Values of Grade 1 or above for these tests may be repeated to confirm a Grade 1 or above value. Abnormal laboratory values other than those specified will not be exclusionary if the clinician deems them not clinically significant.
  • Any other significant disease, disorder or finding which may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study or impair interpretation of the study data, in the judgment of the Investigator.
  • Asplenia (absence of normal spleen function).
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  • History of confirmed or suspected immunodeficiency.
  • Asthma that is unstable requiring emergent care, urgent care, hospitalization or intubation during the past 6 months.
  • Diabetes mellitus (type I or II) currently requiring medication for control.
  • Hypertension that is not well controlled by medication prior to enrollment. Two repeat measurements are allowed more than 10 minutes apart in the absence of any other concerning health screening issues.
  • Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular injections or blood draws.
  • History of chronic or active neurologic diseases including seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than three [3] years ago.
  • Participants receiving any of the following substances:
  • Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment [with the exception of a short course of corticosteroids (≤14 days duration or a single injection) for a self-limited condition at least two (2) weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary].
  • Receipt of any live-attenuated vaccines within 28 days before or after VLP vaccination.
  • Receipt of medically indicated non-live vaccine, (e.g. influenza, pneumococcal), or allergy treatment with antigen injections, planned for administration seven (7) days before or after study vaccine administration.
  • Participant has a positive urine drug toxicology at screening for drugs of abuse defined as Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolite, Opiates, Oxycodone, Phencyclidine without confirmation of medical need (e.g. anxiolytics or pain medications).
  • Women with a positive pregnancy test at screening, vaccination day or challenge day.
  • HIV infection, by screening and confirmatory assays.
  • Participant is seropositive for Hepatitis B surface antigen (HBsAg) or positive for Hepatitis C RNA at screening.
  • Participant has definite plans to travel to a dengue-endemic area during the study.
  • Participant has history or documentation of previous infection with DENV, ZIKV, WNV, JEV, YFV, or St. Louis encephalitis virus (SLEV). Previous infection with DENV, ZIKV, WNV or YFV will be determined by neutralizing antibody assay performed within 60 days of enrollment, medical record, or vaccination record. JEV or SLEV infection will be assessed based on participant history and available medical records. JEV vaccination history will also be reviewed.
  • History of a severe allergic reaction or anaphylaxis.
  • History of allergy to hygromycin.
  • Receipt of blood products within the past 6 months, including transfusions or immunoglobulin or anticipated receipt of any blood products or immunoglobulin during the 28 days following vaccination.
  • Anticipated receipt of any investigational agent in the 28 days before or through the duration of the trial.
  • Refusal to allow storage of specimens for future research.
  • Participant is a JHU student currently enrolled in a coursework, an internship, or clinical hours where the supervisor or instructor of record is employed by the Center for Immunization Research.
  • Participant is faculty or staff currently employed by the Center for Immunization Research.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Johns Hopkins University

    Baltimore, Maryland, 21218

Other trials in United States

About this study

Official title: A Phase I Study of the Safety, Immunogenicity and Efficacy of a Tetravalent Dengue VLP Vaccine (VLPDEN-02) Against DENV-3 Challenge in Healthy Adults

This is a Phase 1, randomized, double-blind, placebo-controlled, dose escalation study. Forty-two flavivirus-naïve adults will be enrolled and will receive 3 administrations of VLPDEN-02 or control at days 0, 28, and 56. Three dose-cohorts of VLPDEN-02 will be evaluated (1 µg, 10 µg, and 100 µg) in a dose-escalation strategy. Each dose cohort will enroll 14 participants (10 VLPDEN-02 recipients and 4 control recipients).

Read the detailed description

VLPDEN-02 is a non-infectious vaccine candidate comprised of four VLPs, each corresponding to a different dengue serotype (DENV-1-4), mixed in equal quantities.

Being tested
VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant, ALFQ adjuvant + Saline, rDEN3Delta30
Keywords
Dengue, VLP, Dengue fever, DENV, challenge model, reactogenicity, ALFQ
Medical subject headings
Dengue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvantBiological

    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).

  • VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvantBiological

    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).

  • VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvantBiological

    VLPDEN-02 is comprised of 4 virus-like particles (VLPs) each containing the Pre-membrane (prM), and envelope (E) of either DENV-1, DENV-2, DENV-3 or DENV-4. Mixed 1:1 with Army Liposome Formulation containing QS21 saponin (ALFQ).

  • ALFQ adjuvant + SalineBiological

    Army Liposome Formulation containing QS21 saponin (ALFQ) adjuvant mixed 1:1 with saline

  • rDEN3Delta30Biological

    rDEN3Delta30 is an under-attenuated DENV-3 derived from the naturally attenuated DENV-3 Sleman/78 strain. It will be administered subcutaneously (SC) at a dose of 1,000 plaque-forming units (PFU).

Study groups in NCT07831473
Study groupRoleWhat they receive
Cohort AExperimentalVLPDEN-02 1.0 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart
Receives: Biological: VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant; Biological: ALFQ adjuvant + Saline; Biological: rDEN3Delta30
Cohort BExperimentalVLPDEN-02 10 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart
Receives: Biological: VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant; Biological: ALFQ adjuvant + Saline; Biological: rDEN3Delta30
Cohort CExperimentalVLPDEN-02 100.0 µg + ALFQ adjuvant vs. Control ALFQ adjuvant alone - 3 doses 28 days apart
Receives: Biological: VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant; Biological: ALFQ adjuvant + Saline; Biological: rDEN3Delta30

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Reactogenicity Assessment

    The primary objective of this Phase 1 clinical trial is to assess the safety and reactogenicity of three doses of VLPDEN-02 for 7 days post vaccination compared with placebo control as determined by solicited local and systemic reactogenicity.

    Measured: Injection to 7 days post vaccination

Secondary outcomes (3)

  1. Immunogenicity Assessment

    To assess the immunogenicity of VLPDEN-02 vaccine after each vaccination.

    Measured: Initial injection to day 168

  2. Protective Efficacy to Dengue 3 Challenge

    To assess the protective efficacy of VLPDEN-02 vaccine against viremia induced by 10^3 PFU of the DENV-3 challenge strain rDEN3Delta30 administered approximately 4 months post-third vaccination.

    Measured: Day 168 to Day 348

  3. Protective efficacy against rash induction

    To assess the protective efficacy of VLPDEN-02 against rash induced by 10^3 PFU of the DENV-3 challenge strain rDEN3Delta30 administered approximately 4 months post-third vaccination.

    Measured: Day 168 to Day 348

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2026
  2. Study start4 Jan 2027 (estimated)
  3. Primary completion15 Mar 2028 (estimated)
  4. Study completion15 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
42 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07831473
Sponsor's protocol ID
VLPDEN-02
Status last verified
Sep 2026
First submitted
15 Sep 2026
Last updated
21 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: VLPDEN-02 is proprietary vaccine in early development

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VLPDEN-02 1.0 µg (0.25 µg of each VLP) + ALFQ adjuvant, VLPDEN-02 10 µg (2.5 µg of each VLP) + ALFQ adjuvant and VLPDEN-02 100 µg (25 µg of each VLP) + ALFQ adjuvant in people with Randomised Clinical Trial and Double Blind, run by VLP Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Reactogenicity Assessment (time frame: Injection to 7 days post vaccination). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07831473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.

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