HIV-1-infectionPhase 1NCT06919016
A Study to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA Followed by DV701B1.1-RNA in Adults Without HIV
A Phase 1 study testing DV700P-RNA and DV701B1.1-RNA in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people. The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV-1-infection
- What is being tested?
- DV700P-RNA and DV701B1.1-RNA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 8 sitesUnited States
- Study dates
- 6 Aug 2025to 25 Mar 2027
- 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
- Understands the study and agrees to complete the consent process.
- Can attend all clinic visits until the end of the study.
- Agrees to follow all study procedures.
- Will not join another study with experimental treatments during this trial, unless approved by both study sponsors.
- Generally healthy according to the study doctor.
- Physical exam and lab results show no major issues that could affect safety or study results.
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- Agrees to discuss HIV risk and prevention.
- Hemoglobin levels: at least 11.0 g/dL for women and 13.0 g/dL for men.
- White blood cell count between 2,500 to 12,000/mm³ (higher levels okay if health is otherwise good and approved).
- Platelet count between 125,000 to 550,000/mm³.
- ALT enzyme level less than 2.5 times the upper limit of normal.
- Serum creatinine level within 1.1 times the upper limit of normal.
- Serum calcium level at least 8.5 mg/dL.
- Blood pressure within acceptable range (systolic 90-140 mmHg, diastolic 50-90 mmHg), with average below 140/90 mmHg and no single reading over 160/100 mmHg.
- Negative HIV test.
- Negative for Hepatitis C.
- Negative for Hepatitis B.
- Women who can become pregnant must use effective contraception from 21 days before joining the study until 8 weeks after the last vaccination and must have a negative pregnancy test on enrollment day.
- Women of pregnancy potential must agree not to seek pregnancy through methods like IVF from 21 days before joining the study until 8 weeks after the last vaccination.
Who cannot join
- Breastfeeding or pregnant.
- Body mass index (BMI) of 40 or higher, unless in good health and approved.
- Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes.
- Previous or current investigational HIV vaccine recipients (placebo recipients are allowed).
- Received non-HIV investigational vaccines within the last year, unless they are now licensed or authorized.
- Immunodeficiency or medications that impair immune response, such as high-dose steroids.
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- Received blood products or immunoglobulin within 16 weeks before enrollment.
- Received certain vaccines within the last 4 weeks before enrollment.
- Received other vaccines within 14 days before enrollment.
- History of myocarditis or pericarditis.
- Started allergy immunotherapy in the past year (unless stable and approved).
- Taken investigational research agents recently.
- Serious allergic reactions to any mRNA vaccine or drugs containing polyethylene glycol.
- History of hereditary or acquired angioedema.
- Any episode of hives (urticaria) within the past year.
- Chronic hives (urticaria).
- Hives previously caused by immunization.
- Bleeding disorder that would make study procedures unsafe.
- Seizures or use of seizure medications in the past 3 years.
- Absence of spleen or non-functional spleen.
- Active duty and reserve US military personnel.
- Any other significant condition that could affect safety or participation, including substance use, psychiatric disorders, recent suicide attempts, or cancer with potential for recurrence.
- Asthma that requires frequent or high-dose medication, recent emergency care, or multiple daily medications.
- History of certain immune-mediated conditions (mild, localized conditions may be okay).
- Allergy to local anesthetics like Novocaine or Lidocaine.
- Difficulty with venous access, such as history of intravenous drug use or problems with blood draws.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama Medical Center (Site ID: 31788)
Birmingham, Alabama, 35222
Brigham and Women's Hospital (Site ID: 30007)
Boston, Massachusetts, 02215
The Hope Clinic of the Emory Vaccine Center CRS (Site ID: 31440)
Decatur, Georgia, 30030
Vanderbilt University Medical Center (Site ID: 30352)
Nashville, Tennessee, 37232
Columbia P&S CRS (Site ID: 30329)
New York, New York, 10032
University of Pittsburgh (Site ID: 1001)
Pittsburgh, Pennsylvania, 15213
University of Rochester Medical Center (Site ID: 31467)
Rochester, New York, 14642
Seattle Vaccine and Prevention CRS (Site ID: 30331)
Seattle, Washington, 98104
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA (Prime) Followed by DV701B1.1-RNA (Boost) in Adult Participants Without HIV
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people.
The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease).
Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
- Conditions
- HIV-1-infection
- Being tested
- DV700P-RNA, DV701B1.1-RNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DV700P-RNABiological
Intramuscular (IM) injection
DV701B1.1-RNABiological
IM injection
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | DV700P-RNA: 50 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 50 mcg at week 40 Receives: Biological: DV700P-RNA; Biological: DV701B1.1-RNA |
| Group 2 | Experimental | DV700P-RNA: 100 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 100 mcg at week 40 Receives: Biological: DV700P-RNA; Biological: DV701B1.1-RNA |
| Group 3 | Experimental | DV700P-RNA: 150 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 150 mcg at week 40 Receives: Biological: DV700P-RNA; Biological: DV701B1.1-RNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local reactogenicity signs and symptoms
Measured: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Incidence of systemic reactogenicity signs and symptoms
Measured: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Number of participants experiencing Serious adverse events (SAEs)
Measured: Baseline through Month 22
Number of participants experiencing medically attended adverse events (MAAEs)
Measured: Baseline through Month 22
Number of participants experiencing adverse events of special interest (AESIs)
Measured: Baseline through Month 22
Number of participants experiencing adverse events (AEs) leading to early participant withdrawal or permanent discontinuation will be collected throughout the study
Measured: Baseline through Month 22
Response rate of V3G-specific IgG+ B cells, as assessed by flow cytometry
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Secondary outcomes (6)
Response rate of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by BAMA
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of serum antibody (Ab) neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Measured: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Frequency of V3G bnAb lineage sequences, as measured by B-cell receptor (BCR) single-cell sequencing of V3G-specific IgG+ B cells
Measured: Baseline though Month 22
Epitope-specific response rates, as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Measured: At week 42 (2 weeks after the fourth vaccinations)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start6 Aug 2025
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1-infectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06919016
- Sponsor's protocol ID
- HVTN 321
- Status last verified
- Dec 2025
- First submitted
- 2 Apr 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of the V3-region Directed Immunogens DV700P-RNA (Prime) Followed by DV701B1.1-RNA (Boost) in Adult Participants Without HIV
- ClinicalTrials.gov ID
- NCT06919016
- Acronym / sponsor ID
- HVTN 321
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 45 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Department of Health and Human Services
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 9 Apr 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.
This is a phase 1, first-in-human (FIH) trial for two vaccines, DV700P-RNA and DV701B1.1-RNA. This means it is the first time these study products are being tested in people.
The purpose of this study is to see if the study products are safe, if people are able to take them without becoming too uncomfortable, and how a person's immune system responds to them (a person's immune system protects them from infections and disease).
Forty-five volunteers without HIV and in overall good health, aged 18 to 55 years, will be enrolled and be in this study for about 16 months (about 12 visits), Study procedures will include blood draws, injections, and the collection of white blood cells and cells from their lymph nodes.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: DV700P-RNA, Biological: DV701B1.1-RNADV700P-RNA: 50 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 50 mcg at week 40 |
| Group 2 | Experimental | Biological: DV700P-RNA, Biological: DV701B1.1-RNADV700P-RNA: 100 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 100 mcg at week 40 |
| Group 3 | Experimental | Biological: DV700P-RNA, Biological: DV701B1.1-RNADV700P-RNA: 150 mcg at weeks 0, 8, and 24 DV701B1.1-RNA: 150 mcg at week 40 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- Understands the study and agrees to complete the consent process.
- Can attend all clinic visits until the end of the study.
- Agrees to follow all study procedures.
- Will not join another study with experimental treatments during this trial, unless approved by both study sponsors.
- Generally healthy according to the study doctor.
Key exclusion criteria (26 listed)
- Breastfeeding or pregnant.
- Body mass index (BMI) of 40 or higher, unless in good health and approved.
- Diabetes, unless it is well-controlled Type 2 diabetes or gestational diabetes.
- Previous or current investigational HIV vaccine recipients (placebo recipients are allowed).
- Received non-HIV investigational vaccines within the last year, unless they are now licensed or authorized.
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 |
|---|---|---|
| DV700P-RNAIntramuscular (IM) injection | Biological | Group 1, Group 2, Group 3 |
| DV701B1.1-RNAIM injection | Biological | Group 1, Group 2, Group 3 |
Primary outcome
Incidence of local reactogenicity signs and symptoms
Time frame: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Incidence of systemic reactogenicity signs and symptoms
Time frame: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)
Number of participants experiencing Serious adverse events (SAEs)
Time frame: Baseline through Month 22
Number of participants experiencing medically attended adverse events (MAAEs)
Time frame: Baseline through Month 22
Number of participants experiencing adverse events of special interest (AESIs)
Time frame: Baseline through Month 22
Number of participants experiencing adverse events (AEs) leading to early participant withdrawal or permanent discontinuation will be collected throughout the study
Time frame: Baseline through Month 22
Response rate of V3G-specific IgG+ B cells, as assessed by flow cytometry
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of differential serum antibody neutralization of precursor detection viruses and corresponding epitope knock-out mutant forms of the viruses as measured by the TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
6 secondary outcomes
Response rate of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by BAMA
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Response rate of serum antibody (Ab) neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: At weeks 26 and 42 (2 weeks after the third and fourth vaccinations)
Frequency of V3G bnAb lineage sequences, as measured by B-cell receptor (BCR) single-cell sequencing of V3G-specific IgG+ B cells
Time frame: Baseline though Month 22
Epitope-specific response rates, as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Time frame: At week 42 (2 weeks after the fourth vaccinations)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing DV700P-RNA and DV701B1.1-RNA in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 19 inclusion and 26 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: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Incidence of local reactogenicity signs and symptoms (time frame: At days 15, 71, 183 and 295 (14 days following receipt of any study vaccine)). The study lists 9 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 16 Dec 2025.