HIV InfectionsPhase 1NCT05781542
Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist-Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
A Phase 1 study testing sD-NP-GT8 DNA, IL-12 DNA and Trimer 4571 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
Trial summary
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- sD-NP-GT8 DNA, IL-12 DNA and Trimer 4571
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 10 Apr 2023to 14 Apr 2025
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit and willing to be contacted at least 12 months after the last vaccine administration.
- Willing to undergo leukapheresis.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
- In good general health according to the clinical judgement of the site investigator.
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- Physical examination and laboratory results without clinically significant findings that would interfere with assessment of safety or reactogenicity in the clinical judgement of the site investigator.
- Assessed as low risk for HIV acquisition per low-risk guidelines, agrees to discuss HIV-infection risks, agrees to risk-reduction counseling, and agrees to avoid behaviors associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking HIV pre-exposure prophylaxis (PrEP) as prescribed for 6 months or longer.
- Hemoglobin:
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth.
- ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months.
- ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months.
- For transgender participants who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth.
- Platelets = 125,000-550,000/mm3
- White blood cell (WBC) count = 2,500-12,000/mm3 (not exclusionary: if count greater than 12,000 with investigation showing general good health and PSRT approval). The Leukapheresis Center may impose a higher lower limit of 3,500/mm3
- Alanine aminotransferase (ALT) < 2.5 x upper limit of normal (ULN) based on the institutional normal range.
- Serum creatinine ≤ 1.1 x ULN based on the institutional normal range.
- Corrected total serum calcium level of > 8.5 mg/dL.
- Blood pressure in the range of 90 to < 140 mmHg systolic and 50 to < 90 mmHg diastolic.
- Negative results for HIV infection by a US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
- Negative for anti-Hepatitis C Abs (anti-HCV), or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
- Negative for Hepatitis B surface antigen.
- For a volunteer capable of becoming pregnant:
- Volunteers who were assigned female sex at birth and are of reproductive potential must agree to use effective means of birth control from at least 21 days prior to enrollment through 8 weeks after their last vaccination timepoint.
- Has negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment.
Who cannot join
- Volunteer who is breast-feeding or pregnant.
- Morbid obesity. Enrollment of individuals with body mass index (BMI) that is
- ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT on a case-by-case basis.
- Diabetes mellitus (DM). Type 2 DM, controlled with diet alone, or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well-controlled on hypoglycemic agent(s) may be considered, provided the HgbA1c is ≤ 8% within the last 6 months (sites may draw these at screening).
- Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded).
- Systemic glucocorticoid use equal to or greater than prednisone 10 mg/day within 3 months prior to enrollment, congenital or acquired immunodeficiency, or other systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator.
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- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval.
- Receipt of any live attenuated vaccine within 4 weeks prior to enrollment. (Note: ACAM2000 vaccine for Monkeypox received within 30 days prior to enrollment or receipt of study vaccine, or if ACAM2000 received greater than 30 days prior to enrollment, or prior to receipt of study vaccine and vaccination scab still present; or planned administration within 30 days after enrollment or receipt of study vaccine).
- Receipt of any vaccines that are not live attenuated within 14 days prior to enrollment; replication incompetent vaccines such as the Jynneos vaccine for the prevention of monkeypox disease are not considered to be live vaccines.
- Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 305 PSRT for vaccines that have subsequently undergone licensure or Emergency Use Authorization by the FDA or, if outside the United States, equivalent authorization by the national regulatory authority.
- Initiation of antigen-based immunotherapy for allergies within the previous year (stable immunotherapy is not exclusionary); inclusion of participants who initiated immunotherapy within the previous year requires PSRT approval.
- Receipt of investigational research agents with a half-life of 7 or fewer days within 4 weeks prior to enrollment. If a potential participant has received investigational agents with a half-life greater than 7 days (or unknown half-life) within the past year, PSRT approval is required for enrollment.
- Serious reactions to vaccines that preclude receipt of study injections as determined by the principal investigator (PI) or designee, including history of serious reaction (eg, hypersensitivity, anaphylaxis) to any or any component of the study vaccine.
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Idiopathic urticaria within the past year.
- Bleeding disorder diagnosed by a doctor (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions).
- Seizure disorder; febrile seizures as a child or seizures secondary to alcohol withdrawal more than 5 years ago are not exclusionary.
- Asplenia or functional asplenia.
- Active duty and reserve US military personnel.
- Any other chronic or clinically significant condition that in the clinical judgement of the investigator would jeopardize the safety or rights of the study participant, including, but not limited to: clinically significant forms of drug or alcohol abuse, serious psychiatric disorders, persons with any suicide attempt within the past one year (if between 1-2 years, consult PSRT) or cancer that, in the clinical judgment of the site investigator, has a potential for recurrence (excluding basal cell carcinoma).
- Asthma is excluded if the participant has ANY of the following:
- Required either oral or parenteral corticosteroids for an exacerbation two or more times within the past year; OR
- Required either oral or parenteral corticosteroids for an exacerbation 2 or more times within the past year; OR
- Needed emergency care, urgent care, hospitalization, or intubation for an acute asthma exacerbation within the past year (eg, would NOT exclude individuals with asthma who meet all other criteria but sought urgent/emergent care solely for asthma medication refills or coexisting conditions unrelated to asthma); OR
- Uses a short-acting rescue inhaler more than 2 days per week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
- Uses medium-to-high-dose inhaled corticosteroids (greater than 250 mcg fluticasone or therapeutic equivalent per day), whether in single-therapy or dual-therapy inhalers (ie, with a long-acting beta agonist [LABA]); OR
- Uses more than 1 medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than 1 medication for maintenance therapy daily for greater than 2 years requires PSRT approval.
- A participant with a history of an immune-mediated disease, either active or remote. Specific examples are listed in Appendix I (AESI index). Not exclusionary: 1) remote history of Bell's palsy (>2 years ago) not associated with other neurologic symptoms, 2) mild psoriasis that does not require ongoing systemic treatment.
- History of allergy to local anesthetic (Novocaine, Lidocaine).
- Investigator concern for difficulty with venous access based upon clinical history and physical examination. For example, history of IV drug abuse or substantial difficulty with previous blood draws.
- Presence of implanted electronic medical device (eg, pacemaker, implantable cardioverter defibrillator).
- Presence of surgical or traumatic metal implant in either upper arm and/or upper torso.
- History of cardiac arrhythmia (eg, supraventricular tachycardia, atrial fibrillation) (Not excluded: sinus arrhythmia).
- Tattoo overlying the injection sites preventing assessment of reactogenicity in the view of the investigator or skin condition at the injection sites.
- History or presence of keloid scar formation or hypertrophic scar
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Alabama CRS (Site ID: 31788)
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS [30007]
Boston, Massachusetts, 02115
Bridge HIV CRS
San Francisco, California, 94102
San Francisco Vaccine and Prevention CRS
San Francisco, California, 94102
South Africa4 sites
Groote Schuur HIV CRS (Site ID: 31708)
Cape Town, Western Cape, 7925
CAPRISA eThekwini CRS
Durban, KwaZulu-Natal, 4013
Durban Adult HIV CRS
Durban, KwaZulu-Natal
Soweto HVTN CRS
Johannesburg, Gauteng
About this study
Official title: A Phase-1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist- Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with this recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will elicit VRC01-class B-cell responses as well as antigen-specific T-cell responses.
- Conditions
- HIV Infections
- Being tested
- sD-NP-GT8 DNA, IL-12 DNA, Trimer 4571, 3M-052-AF, Alum
- Keywords
- HIV
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sD-NP-GT8 DNABiological
0.4 mg
sD-NP-GT8 DNABiological
1.6 mg
IL-12 DNABiological
0.1 mg
IL-12 DNABiological
0.4 mg
Trimer 4571Biological
100 mcg
3M-052-AFBiological
5 mcg
AlumDrug
500 mcg
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | a total of approximately 9 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 0.4 mg, coformulated with IL-12 DNA at a dose of 0.1 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm Receives: Biological: sD-NP-GT8 DNA; Biological: IL-12 DNA |
| Group 2 | Experimental | a total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm Receives: Biological: sD-NP-GT8 DNA; Biological: IL-12 DNA |
| Group 3 | Experimental | a total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. These doses will be administered intradermally via EP of the skin on each upper arm. All participants in Group 3 will also receive 2 administrations of Trimer 4571 at a dose of 100 mcg adjuvanted with 5 mcg of 3M-052-AF + 500 mcg Alum via IM injections into the deltoid muscle at days 85 and 169 Receives: Biological: sD-NP-GT8 DNA; Biological: IL-12 DNA; Biological: Trimer 4571; Biological: 3M-052-AF; Drug: Alum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Measured: Measured for 30 days after any receipt of study vaccination
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
The number (percentage) of Participants Reporting Medically Attended Adverse Events (MAAEs) was summarized by arm and severity grade
Measured: Measured through Month 12 following any receipt of study products
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Measured: Measured through Month 12 following any receipt of study products
Number of Participants With Early Study Termination and Reason for Early Study Termination
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Measured: Measured through Month 12 following any receipt of study products
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start10 Apr 2023
- Primary completion2 Oct 2024
- Study completion14 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HIV InfectionsStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, The Wistar Institute, The Betty and Dale Bumpers Vaccine Research Center (VRC), Inovio Pharmaceuticals, Access to Advanced Health Institute (AAHI), Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05781542
- Sponsor's protocol ID
- HVTN 305
- Status last verified
- Oct 2025
- First submitted
- 11 Jan 2023
- Last updated
- 14 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding NP-GT8 and IL-12, With or Without a TLR-agonist- Adjuvanted HIV Env Trimer 4571 Boost, in Adults Without HIV
- ClinicalTrials.gov ID
- NCT05781542
- Acronym / sponsor ID
- HVTN 305
- Conditions
- HIV Infections
- Keywords
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, The Wistar Institute, The Betty and Dale Bumpers Vaccine Research Center (VRC), Inovio Pharmaceuticals, Access to Advanced Health Institute (AAHI), Department of Health and Human Services
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 2 Oct 2024 (actual)
- Study completion
- 14 Apr 2025 (actual)
- First posted
- 23 Mar 2023 (actual)
- Results
- Posted 14 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study to examine the safety and immunogenicity of synthetic DNAs encoding NP-GT8 and IL-12 with or without a TLR-agonist-adjuvanted Env Trimer 4571 boost in adults without HIV. The primary hypothesis is that vaccination with this recombinant DNA vaccine encoding a germline-targeting epitope followed by a trimeric protein boost will elicit VRC01-class B-cell responses as well as antigen-specific T-cell responses.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: sD-NP-GT8 DNA, Biological: IL-12 DNAa total of approximately 9 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 0.4 mg, coformulated with IL-12 DNA at a dose of 0.1 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm |
| Group 2 | Experimental | Biological: sD-NP-GT8 DNA, Biological: IL-12 DNAa total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. Study products will be administered intradermally via EP of the skin on each upper arm |
| Group 3 | Experimental | Biological: sD-NP-GT8 DNA, Biological: IL-12 DNA, Biological: Trimer 4571, Biological: 3M-052-AF, Drug: Aluma total of approximately 18 participants will receive 3 administrations of sD-NP-GT8 DNA at a dose of 1.6 mg, coformulated with IL-12 DNA at a dose of 0.4 mg at days 1, 29, and 85. These doses will be administered intradermally via EP of the skin on each upper arm. All participants in Group 3 will also receive 2 administrations of Trimer 4571 at a dose of 100 mcg adjuvanted with 5 mcg of 3M-052-AF + 500 mcg Alum via IM injections into the deltoid muscle at days 85 and 169 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit and willing to be contacted at least 12 months after the last vaccine administration.
- Willing to undergo leukapheresis.
- Agrees not to enroll in another study of an investigational agent during participation in the trial.
Key exclusion criteria (35 listed)
- Volunteer who is breast-feeding or pregnant.
- Morbid obesity. Enrollment of individuals with body mass index (BMI) that is
- ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT on a case-by-case basis.
- Diabetes mellitus (DM). Type 2 DM, controlled with diet alone, or a history of isolated gestational diabetes are not exclusionary. Enrollment of individuals with Type 2 DM that is well-controlled on hypoglycemic agent(s) may be considered, provided the HgbA1c is ≤ 8% within the last 6 months (sites may draw these at screening).
- Previous or current recipient of an investigational HIV vaccine (previous placebo recipients are not excluded).
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 |
|---|---|---|
| sD-NP-GT8 DNA0.4 mg | Biological | Group 1 |
| sD-NP-GT8 DNA1.6 mg | Biological | Group 2, Group 3 |
| IL-12 DNA0.1 mg | Biological | Group 1 |
| IL-12 DNA0.4 mg | Biological | Group 2, Group 3 |
| Trimer 4571100 mcg | Biological | Group 3 |
| 3M-052-AF5 mcg | Biological | Group 3 |
| Alum500 mcg | Drug | Group 3 |
Primary outcome
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Time frame: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Time frame: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants Reporting Unsolicited Adverse Events (AEs), by Severity Grade
Time frame: Measured for 30 days after any receipt of study vaccination
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm and severity grade. Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Number of Participants Reporting Medically Attended Adverse Events (MAAEs), by Severity Grade
Time frame: Measured through Month 12 following any receipt of study products
The number (percentage) of Participants Reporting Medically Attended Adverse Events (MAAEs) was summarized by arm and severity grade
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Time frame: Measured through Month 12 following any receipt of study products
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Number of Participants With Early Study Termination and Reason for Early Study Termination
Time frame: Measured through Month 12 following any receipt of study products
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing sD-NP-GT8 DNA, IL-12 DNA and Trimer 4571 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in 2 countries.
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 25 inclusion and 35 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 14 Nov 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, South Africa. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness (time frame: Measured through 7 days following vaccine administration for INO-6172 alone and 14 days following vaccine administration for Trimer 4571 + 3M-052-AF/Alum). The study lists 7 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 14 Nov 2025.