DENV-3 Controlled Human Infection ModelPhase 2NCT06799741
A Study to Evaluate the Safety and Efficacy of AV-1 Against Dengue Virus 3 (DENV-3) Infection
A Phase 2 study testing AV-1 100 mg, AV-1 300 mg and AV-1 900 mg in people with DENV-3 Controlled Human Infection Model, run by AbViro LLC at 3 sites in United States.
Trial summary
The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM) Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- DENV-3 Controlled Human Infection Model
- What is being tested?
- AV-1 100 mg, AV-1 300 mg and AV-1 900 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 85 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Jan 2025to 11 Mar 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Males or nonpregnant, nonlactating females who were assigned males and females at birth, of any race, between 18 and 55 years of age
- Body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening or Study Day -1 (Cohort A) or Study Day 0 (Cohort B)
- Normal 12-lead electrocardiogram (ECG). Normal ECG is defined as the absence of:
- QTcF >450 ms in men or >460 ms in women
- PR >220 ms ventricular or atrial premature contractions in couplets or higher in grouping
- Complete left or right bundle branch block
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- 2nd or 3rd degree atrioventricular block
- Sustained ventricular or atrial arrhythmia
- ST elevation consistent with cardiac ischemia
- Potential subjects with non-clinical sinus arrhythmia could be included in the study
- Subjects in good health as determined by past medical history, medication use, physical examination, vital signs, and 12-lead ECG at Screening
- Females of childbearing potential must agree to use effective contraception through study duration
- Reliable methods of contraception include: long acting, reversible contraception (LARC), hormonal birth control* (implantable device, hormonal patch, hormonal vaginal ring, oral contraception, Depo-Provera injection, etc.), surgical sterilization (hysterectomy, tubal ligation, or tubal coil at least 90 days prior to Investigational Product [IP] dosing)
- Must agree to not donate ova or oocytes during the study
- Postmenopausal women must have had ≥12 months of spontaneous amenorrhea without an alternative medical cause for amenorrhea, with follicle-stimulating hormone (FSH) concentration ≥40 mIU/mL at Screening and must have a negative pregnancy test result at Screening and Day-1 (Cohort A) or Day 0 (Cohort B)
- Surgically sterile women (defined as those who have had a hysterectomy, bilateral salpingectomy, bilateral oophorectomy, tubal ligation, or an Essure placement with radiological confirmation test at least 90 days after procedure) must have a negative pregnancy test result at Screening and Study Day -1 (Cohort A) or Study Day 0 (Cohort B). *Subjects on hormonal birth control must not be on medications or other agents that decrease the effectiveness of hormonal birth control
- Male subjects having sexual intercourse with biologic females and who are biologically capable of fathering children must agree and commit to use male condoms from Study Day -1 until the follow-up visit on Study Day 155 (± 7). A male subject is considered capable of fathering children even if his sexual partner is sterile or using contraceptives
- Male subjects must refrain from sperm donation from Study Day -1 until the follow-up visit on Study Day 155 (± 7)
- Understands study and agrees to and is available for all procedures throughout the study
- Agree to follow study restrictions and are able to sign an informed consent form
Who cannot join
- Any significant medical condition who, in the opinion of the investigator, would interfere with the ability to participate in the study or increase the risk of participating for that subject based on the Investigator's Brochures and the safety profiles of AV-1 and rDEN3Δ30
- Any psychiatric condition or history of psychiatric condition that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of the participation for that subject
- History of significant alcoholism or drug/chemical abuse within 12 months prior to Study Day -1 that has caused medical, occupational, or family problems as indicated by subject history
- Currently being treated for peptic ulcer disease or Helicobacter pylori or has been treated within the 6 months prior to Day -1
- 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 once 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
- History of or suspected coagulopathy
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- Alcohol consumption of >21 units* per week for males and >14 units per week for females (*1 unit of alcohol equals 12 oz [360 mL] beer, 1.5 oz [45 mL] liquor, or 5 oz [150 mL] wine) through Study Day 28
- Positive urine drug screen at Screening for drugs of abuse defined as Amphetamines, Barbiturates, Benzodiazepines, Cocaine Metabolite, Opiates, Oxycodone, Phencyclidine without confirmation of medical need verified by prescription (ie, anxiolytics or pain medications).
- Women with positive pregnancy test at either Screening visit, Study Day -1, or Study Day 0
- Seropositive for Hepatitis B surface antigen (HBsAg) or positive for Hepatitis C RNA at Screening
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including, but not limited to, human immunodeficiency virus infection, or use of anti-cancer chemotherapy or radiation therapy (cytotoxic) in the 3 years prior to Screening
- Plan to travel to an area with active Zika virus (ZIKV) or DENV, transmission during the study or returned from travel to an area with active transmission within 30 days of Screening. (*Refer to the Centers for Disease Control and Prevention [CDC] website for areas with active ZIKV or DENV)
- History of vaccination with a licensed or investigational ZIKV vaccine, DENV vaccine*, yellow fever virus (YFV) vaccine, or Japanese encephalitis vaccine or reportedly diagnosed with a ZIKV or DENV infection or disease. (*Includes subject's verbal history of vaccination or disease).
- Positive serology to DENV, ZIKV, West Nile virus (WNV), YFV, or St. Louis encephalitis virus (SLE) within 60 days of Screening
- History of anaphylaxis to any drug compound, (including citrate or polysorbate), food, or other substance, unless approved by the investigator
- Major non-elective surgery within the last 3 months
- Previously treated with a licensed or investigational monoclonal or polyclonal antibody within the past 18 months prior to Study Day -1
- Received any investigational drug product within that last 28 days of Study Day -1
- Any prohibited medication within the past 28 days or plans to use prohibited medication during the study. Prohibited medications include oral/systemic anti-neoplastic agents, medications/supplements known to alter drug absorption, metabolism, or elimination processes (eg, St. John's wort), immunosuppressive drugs
- Use of any aspirin product in the 7 days prior to Study Day -1 through 14 days post-challenge
- Use of an NSAID from 48 hours prior to challenge through 14 days post-challenge
- Participants who have received or plan to receive any vaccination (live), experimental or otherwise, within the past 28 days or after Study Day -1 and 14 days (2 weeks) for inactivated vaccines and mRNA vaccines
- Has received blood products within 60 days (2 months) prior to Study Day -1 (Cohort A) or Day 0 (Cohort B)
- Has donated or lost in excess of 450 mL of blood or plasma within 56 days (8 weeks) of Study Day -1. The subject must also agree to refrain from donating blood or plasma during the study
- Has poor peripheral venous access during screening
- Has previously completed or was withdrawn from this study
- Is a current study site staff paid entirely or partially by the contract for this study, or staff who are supervised by the principal or sub-investigators
- Subjects, who in the opinion of the investigator, should not participate in this study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Center for Immunization Research (CIR) JHBSPH
Baltimore, Maryland, 21205
Center for Immunization Research Inpatient Unit
Baltimore, Maryland, 21224
UVM Larner College of Medicine Department of MMG
Burlington, Vermont, 05405
About this study
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Safety and Efficacy of 3 Dose Levels of AV-1 in Healthy Adults Challenged With a Controlled Human Infection Strain of DENV-3
The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)
- Conditions
- DENV-3 Controlled Human Infection Model
- Being tested
- AV-1 100 mg, AV-1 300 mg, AV-1 900 mg, Placebo
- Keywords
- Healthy Volunteers, Monoclonal antibody, AV-1, Safety, Dengue, Efficacy
- Medical subject headings
- Dengue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV-1 100 mgDrug
human monoclonal antibody (mAb) intravenous solution
or
AV-1 300 mgDrug
human monoclonal antibody (mAb) intravenous solution
or
AV-1 900 mgDrug
human monoclonal antibody (mAb) intravenous solution
or
PlaceboDrug
(0.9% saline intravenous solution) 12:2
| Study group | Role | What they receive |
|---|---|---|
| Group 1A prophylaxis | Experimental | Not described Receives: Drug: AV-1 100 mg; Drug: Placebo |
| Group 2A prophylaxis | Experimental | Not described Receives: Drug: AV-1 300 mg; Drug: Placebo |
| Group 3A prophylaxis | Experimental | Not described Receives: Drug: AV-1 900 mg; Drug: Placebo |
| Group 1B treatment | Experimental | Not described Receives: Drug: AV-1 100 mg; Drug: Placebo |
| Group 2B treatment | Experimental | Not described Receives: Drug: AV-1 300 mg; Drug: Placebo |
| Group 3B treatment | Experimental | Not described Receives: Drug: AV-1 900 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs)
Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related
Measured: Through day 155 (±7 days)
Severity of AEs
Measured: Through day 155 (±7 days)
Incidence of Serious Adverse Events (SAEs)
Defined as an AE that is unexpected and serious as determined by the Sponsor
Measured: Through day 155 (±7 days)
Severity of SAEs
Measured: Through day 155 (±7 days)
Anti-AV-1 antibodies (ADA) Immunogenicity Testing
Measured: Through day 155 (±7 days)
Frequency of viremia
Detected by direct serum titration
Measured: Through day 155 (±7 days)
Duration of viremia
Defined as the time from the first infection to the time of the last infection
Measured: Through day 155 (±7 days)
Viral load
Measured by qRT-PCR
Measured: Through day 155 (±7 days)
Viral load
Measured by plaque assay
Measured: Through day 155 (±7 days)
Change from baseline values of diastolic blood pressure
Measured: Through day 155 (±7 days)
Change from baseline values of systolic blood pressure
Measured: Through day 155 (±7 days)
Change in baseline values of temperature
Measured: Through day 155 (±7 days)
Change in baseline values of respiration rate
Measured: Through day 155 (±7 days)
Change in baseline values of heart rate
Measured: Through day 155 (±7 days)
Secondary outcomes (13)
Number of participants with detectable DENV-specific IgM antibodies
Measured: Baseline through day 155 (±7 days)
Percentage of participants with detectable DENV-specific IgM antibodies
Measured: Baseline through day 155 (±7 days)
Number of participants with detectable anti-DENV NS1 IgG antibodies
Measured: Baseline through day 155 (±7 days)
Percentage of participants with detectable anti-DENV NS1 IgG antibodies
Measured: Baseline through day 155 (±7 days)
Measure AV-1 concentration in human serum by anti-idiotype enzyme-linked immunosorbent assay (ELISA)
Measured: Through day 155 (±7 days)
Area under the serum concentration-time curve (AUC) from time 0 to 48 hours post-dose of AV-1 (AUC0-48)
Measured: Up today 155 (±7 days)
AUC from time 0 to infinity of AV-1 (AUC0-inf)
Measured: Up to day 155 (±7 days)
AUC from time 0 to the time of the last quantifiable concentration of AV-1 (AUC 0- tlast)
Measured: Baseline through day 155 (±7 days)
Maximum observed serum concentration of AV-1 (Cmax)
Measured: Baseline through day 155 (±7 days)
Time to Cmax of AV-1 (Tmax)
Measured: Baseline through day 155 (±7 days)
Apparent serum terminal elimination half-life of AV-1 (t1/2)
Measured: Baseline through day 155 (±7 days)
Total serum clearance of AV-1 (CL)
Measured: Baseline through day 155 (±7 days)
Volume of distribution during the terminal phase of AV-1 (Vz)
Measured: Baseline through day 155 (±7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start7 Jan 2025
- Primary completion11 Mar 2026
- Study completion11 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DENV-3 Controlled Human Infection ModelStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbViro LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Urban Ramstedt, PhD, Study director, AbViro LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799741
- Sponsor's protocol ID
- AV1-PPD-0006
- Status last verified
- Mar 2026
- First submitted
- 24 Jan 2025
- Last updated
- 31 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Compare the Safety and Efficacy of 3 Dose Levels of AV-1 in Healthy Adults Challenged With a Controlled Human Infection Strain of DENV-3
- ClinicalTrials.gov ID
- NCT06799741
- Acronym / sponsor ID
- AV1-PPD-0006
- Conditions
- DENV-3 Controlled Human Infection Model
- Keywords
- Healthy Volunteers, Monoclonal antibody, AV-1, Safety, Dengue, Efficacy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- AbViro LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- 11 Mar 2026 (actual)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine the prophylactic and therapeutic effect of AV-1 in healthy adults using a DENV-3 controlled human infection model (CHIM)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Group 1A prophylaxis | Experimental | Drug: AV-1 100 mg, Drug: Placebo |
| Group 2A prophylaxis | Experimental | Drug: AV-1 300 mg, Drug: Placebo |
| Group 3A prophylaxis | Experimental | Drug: AV-1 900 mg, Drug: Placebo |
| Group 1B treatment | Experimental | Drug: AV-1 100 mg, Drug: Placebo |
| Group 2B treatment | Experimental | Drug: AV-1 300 mg, Drug: Placebo |
| Group 3B treatment | Experimental | Drug: AV-1 900 mg, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Males or nonpregnant, nonlactating females who were assigned males and females at birth, of any race, between 18 and 55 years of age
- Body mass index between 18.5 and 34.9 kg/m², inclusive, at Screening or Study Day -1 (Cohort A) or Study Day 0 (Cohort B)
- Normal 12-lead electrocardiogram (ECG). Normal ECG is defined as the absence of:
- Subjects in good health as determined by past medical history, medication use, physical examination, vital signs, and 12-lead ECG at Screening
- Females of childbearing potential must agree to use effective contraception through study duration
Key exclusion criteria (28 listed)
- Any significant medical condition who, in the opinion of the investigator, would interfere with the ability to participate in the study or increase the risk of participating for that subject based on the Investigator's Brochures and the safety profiles of AV-1 and rDEN3Δ30
- Any psychiatric condition or history of psychiatric condition that, in the opinion of the investigator or sponsor, would interfere with the subject's ability to participate in the study or increase the risk of the participation for that subject
- History of significant alcoholism or drug/chemical abuse within 12 months prior to Study Day -1 that has caused medical, occupational, or family problems as indicated by subject history
- Currently being treated for peptic ulcer disease or Helicobacter pylori or has been treated within the 6 months prior to Day -1
- 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 once 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV-1 100 mghuman monoclonal antibody (mAb) intravenous solution or | Drug | Group 1A prophylaxis, Group 1B treatment |
| AV-1 300 mghuman monoclonal antibody (mAb) intravenous solution or | Drug | Group 2A prophylaxis, Group 2B treatment |
| AV-1 900 mghuman monoclonal antibody (mAb) intravenous solution or | Drug | Group 3A prophylaxis, Group 3B treatment |
| Placebo(0.9% saline intravenous solution) 12:2 | Drug | Group 1A prophylaxis, Group 1B treatment, Group 2A prophylaxis, Group 2B treatment, Group 3A prophylaxis, Group 3B treatment |
Primary outcome
Incidence of Adverse Events (AEs)
Time frame: Through day 155 (±7 days)
Defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related
Severity of AEs
Time frame: Through day 155 (±7 days)
Incidence of Serious Adverse Events (SAEs)
Time frame: Through day 155 (±7 days)
Defined as an AE that is unexpected and serious as determined by the Sponsor
Severity of SAEs
Time frame: Through day 155 (±7 days)
Anti-AV-1 antibodies (ADA) Immunogenicity Testing
Time frame: Through day 155 (±7 days)
Frequency of viremia
Time frame: Through day 155 (±7 days)
Detected by direct serum titration
Duration of viremia
Time frame: Through day 155 (±7 days)
Defined as the time from the first infection to the time of the last infection
Viral load
Time frame: Through day 155 (±7 days)
Measured by qRT-PCR
Viral load
Time frame: Through day 155 (±7 days)
Measured by plaque assay
Change from baseline values of diastolic blood pressure
Time frame: Through day 155 (±7 days)
Change from baseline values of systolic blood pressure
Time frame: Through day 155 (±7 days)
Change in baseline values of temperature
Time frame: Through day 155 (±7 days)
Change in baseline values of respiration rate
Time frame: Through day 155 (±7 days)
Change in baseline values of heart rate
Time frame: Through day 155 (±7 days)
13 secondary outcomes
Number of participants with detectable DENV-specific IgM antibodies
Time frame: Baseline through day 155 (±7 days)
Percentage of participants with detectable DENV-specific IgM antibodies
Time frame: Baseline through day 155 (±7 days)
Number of participants with detectable anti-DENV NS1 IgG antibodies
Time frame: Baseline through day 155 (±7 days)
Percentage of participants with detectable anti-DENV NS1 IgG antibodies
Time frame: Baseline through day 155 (±7 days)
Measure AV-1 concentration in human serum by anti-idiotype enzyme-linked immunosorbent assay (ELISA)
Time frame: Through day 155 (±7 days)
Area under the serum concentration-time curve (AUC) from time 0 to 48 hours post-dose of AV-1 (AUC0-48)
Time frame: Up today 155 (±7 days)
AUC from time 0 to infinity of AV-1 (AUC0-inf)
Time frame: Up to day 155 (±7 days)
AUC from time 0 to the time of the last quantifiable concentration of AV-1 (AUC 0- tlast)
Time frame: Baseline through day 155 (±7 days)
Maximum observed serum concentration of AV-1 (Cmax)
Time frame: Baseline through day 155 (±7 days)
Time to Cmax of AV-1 (Tmax)
Time frame: Baseline through day 155 (±7 days)
Apparent serum terminal elimination half-life of AV-1 (t1/2)
Time frame: Baseline through day 155 (±7 days)
Total serum clearance of AV-1 (CL)
Time frame: Baseline through day 155 (±7 days)
Volume of distribution during the terminal phase of AV-1 (Vz)
Time frame: Baseline through day 155 (±7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urban Ramstedt, PhD study director
AbViro LLC
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AV-1 100 mg, AV-1 300 mg and AV-1 900 mg in people with DENV-3 Controlled Human Infection Model, run by AbViro LLC at 3 sites 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 28 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: finished, as of the sponsor's last update on 31 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of Adverse Events (AEs) (time frame: Through day 155 (±7 days)). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.