HIV-1-infectionPhase 1NCT05828095
A Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
A Phase 1 study testing INO-6160, 2 mg and Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum. 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?
- INO-6160, 2 mg and Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesUnited States
- Study dates
- 5 Apr 2023to 23 Jan 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: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly
- 18-55 years old, inclusive, on day of enrollment
- Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last vaccine administration
- Agrees not to enroll in another study of an investigational agent during participation in the trial
- In good general health according to the clinical judgment of the site investigator
- 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
Show all 24Show fewer
- 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 behavior associated with high risk of HIV exposure through the final study visit. Low risk may include persons stably taking 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 men who have been on hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for transgender women 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 their sex assigned at birth
- 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)
- Platelets = 125,000-550,000/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
- Blood pressure in the range of 90 to < 140 mmHg systolic and 50 to < 90 mmHg diastolic
- Negative results for HIV infection by a Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA)
- Negative for anti-Hepatitis C antibodies (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV antibodies 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 scheduled fifth vaccination timepoint
- Has negative β-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment.
- Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination or in vitro fertilization through 8 weeks after their last scheduled vaccination timepoint
Who cannot join
- Volunteer who is breast-feeding or pregnant
- Body mass index (BMI). Enrollment of individuals with BMI ≥ 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 diet alone or 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)
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator such as glucocorticoid use equal to or greater than prednisone 10 mg/day within 3 months prior to enrollment
- Blood products or immunoglobulin within 16 weeks prior to enrollment; receipt of immunoglobulin within 16 weeks prior to enrollment requires PSRT approval
Show all 33Show fewer
- Receipt of any live attenuated vaccine within 4 weeks prior to enrollment
- ACAM2000 vaccine for Monkeypox received within 30 days prior to enrollment or receipt of study product, or if ACAM2000 received greater than 30 days prior to enrollment, or prior to receipt of study product, vaccination scab still present; or planned administration within 30 days after enrollment or receipt of study product
- 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
- Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions may be made by the PSRT for vaccines that have subsequently undergone licensure or Emergency Use Authorization by the FDA or, if outside the United States, by the national regulatory authority or World Health Organization. For volunteers who have received control/placebo in an experimental vaccine trial, the PSRT will determine eligibility on a case-by-case basis
- 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
- History of serious reaction (eg, hypersensitivity, anaphylaxis) to any related vaccine or component of the study vaccine regimen
- 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
- 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 co-existing conditions unrelated to asthma); OR
- Uses a short-acting rescue inhaler more than 2 days/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 one medication for maintenance therapy daily. Inclusion of anyone on a stable dose of more than one medication for maintenance therapy daily for greater than two years requires PSRT approval.
- A participant with a history of an immune-mediated disease, either active or remote. Specific examples are listed in protocol (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
- 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
3 sites in 1 country.
United States3 sites
Vanderbuilt Vaccine (VV) CRS
Nashville, Tennessee, 37232
New York Blood Center CRS
New York, New York, 10065
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Phase 1 Open-label Clinical Trial to Evaluate the Safety and Immunogenicity of Synthetic DNAs Encoding a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
This is a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum. The primary hypothesis is that the vaccine regimen will elicit HIV-1 envelope protein-specific binding antibody (Ab) and T-cell responses
- Conditions
- HIV-1-infection
- Being tested
- INO-6160, 2 mg, Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INO-6160, 2 mgBiological
ID EP at month 0,1,3 and 6
Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)Biological
IM at month 3 and 6
| Study group | Role | What they receive |
|---|---|---|
| Group #1: INO-6160/ 2.0 mg | Experimental | The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm Receives: Biological: INO-6160, 2 mg |
| Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) | Experimental | The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm.
The dose of Trimer 4571, 100 mcg, will be administered as 2 injections delivered intramuscularly (IM), one in each arm. Receives: Biological: INO-6160, 2 mg; Biological: Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) |
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 for 14 days after each injection
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 for 14 days after each injection
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
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 for 14 days after each injection
Number of Participants Reporting Unsolicited Adverse Events (AEs)
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Measured: Measured for 30 days after any receipt of study vaccination.
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 6
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 10
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination
The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Positivity criteria include (1) the net Mean Fluorescence Intensity (MFI), or MFI - Blank, values are ≥ antigen-specific cutoff at the 1:50 dilution level for IgG (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI minus Blank), (2) the net MFI values are greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values are greater than 3 times the baseline MFI values. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.
Measured: Measured at Months 1.5, 3.5, and 6.5
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination
The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Epitope specificities are assessed via wildtype-mutant pairs. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.
Measured: Measured at Months 1.5, 3.5, and 6.5
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.
Measured: Measured at Months 3.5 and 6.5
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay
Measured: Measured at Months 3.5 and 6.5
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.
Measured: Measured at Months 3.5 and 6.5
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay
Measured: Measured at Months 3.5 and 6.5
Secondary outcomes (15)
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations
Neutralization assays were used to measure titers in TZM-bl cells against BG505/T332N and MW965.26
Measured: Measured at baseline (screening), Month 3.5, and Month 6.5
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations
Neutralization assays were used to measure titers in TZM-bl cells against BG505/T332N and MW965.26. Positivitity call is an unrounded titer >= 10
Measured: Measured at baseline (screening), Month 3.5, and Month 6.5
Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay
Epitope specificities are assessed via wildtype-mutant pairs. Serum samples from post-enrollment visits were declared to have positive differential binding responses if they met the following conditions: 1) positive direct binding response, 2) MFI ratio (wild type/mutant type) ≥ 2.5, and wild type at least 250 MFI at selected dilution, 3) net MFI ratio (wild type/mutant type) ≥ 2.5, and wild type at least 250 net MFI at selected dilution. Basespecific binding antibody Area Under the Curve (AUC) values for participants with a positive differential binding response were calculated by subtracting the AUC values of the mutant (BG505-MD39.3 Base-KO untagged) from the AUC values of the wildtype (BG505-MD39.3 untagged)
Measured: Measured at Months 1.5, 3.5, and 6.5
Epitope Specificity of HIV-1 Specific IgG Binding Ab Responses
assessed by multiplex assay
Measured: 2 weeks following third vaccination
Response Rate of CD4 +T-cell Responses
measured by flow cytometry, to HIV-1-specific Env peptide pools
Measured: 2 weeks following third vaccination
Magnitude of CD4 +T-cell Responses
measured by flow cytometry, to HIV-1-specific Env peptide pools
Measured: 2 weeks following third vaccination
Response Rate of CD8+T-cell Responses
measured by flow cytometry, to HIV-1-specific Env peptide pools
Measured: 2 weeks following third vaccination
Magnitude of CD8+T-cell Responses
measured by flow cytometry, to HIV-1-specific Env peptide pools
Measured: 2 weeks following third vaccination
Magnitude of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Measured: 6 months post last vaccination
Response Rate of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Measured: 6 months post last vaccination
Magnitude of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Measured: 6 months post last vaccination
Response Rate of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Measured: 6 months post last vaccination
Response Rate of HIV-1 Specific IgG Binding Ab Response
assessed by multiplex assay
Measured: 6 months post last vaccination
Magnitude of HIV-1 Specific IgG Binding Ab Response
assessed by multiplex assay
Measured: 6 months post last vaccination
Neutralizing Ab Magnitude and Breadth Against Autologous Tier 2 HIV-1 Isolates
assessed by TZM-bl neutralization assay
Measured: 6 months post last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start5 Apr 2023
- Primary completion23 Jan 2025
- Study completion23 Jan 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-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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05828095
- Sponsor's protocol ID
- HVTN 304
- Status last verified
- Jul 2025
- First submitted
- 13 Apr 2023
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 2 Sep 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 a Native-like HIV Env Trimer and Interleukin-12 (INO-6160), Alone or in a Prime-boost Regimen With 3M-052-AF + Alum Adjuvanted VRC HIV Env Trimer 4571 in Adult Participants Without HIV
- ClinicalTrials.gov ID
- NCT05828095
- Acronym / sponsor ID
- HVTN 304
- Conditions
- HIV-1-infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 23 Jan 2025 (actual)
- Study completion
- 23 Jan 2025 (actual)
- First posted
- 25 Apr 2023 (actual)
- Results
- Posted 4 Jul 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 a randomized open-label trial to examine the safety and immunogenicity of INO-6160 (synthetic DNAs encoding a native-like HIV Env Trimer and Interleukin-12), alone or in a prime-boost regimen with VRC HIV Env Trimer 4571 adjuvanted with 3M-052-AF + Alum. The primary hypothesis is that the vaccine regimen will elicit HIV-1 envelope protein-specific binding antibody (Ab) and T-cell responses
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group #1: INO-6160/ 2.0 mg | Experimental | Biological: INO-6160, 2 mgThe dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm |
| Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) | Experimental | Biological: INO-6160, 2 mg, Biological: Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)The dose of INO-6160, 2 mg, will be administered as 2 separate intradermal (ID) injections, one in each arm. The dose of Trimer 4571, 100 mcg, will be administered as 2 injections delivered intramuscularly (IM), one in each arm. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (24 listed)
- Able and willing to complete the informed consent process, including an Assessment of Understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of questionnaire items that were answered incorrectly
- 18-55 years old, inclusive, on day of enrollment
- Available for clinic follow-up through the last clinic visit and willing to be contacted 12 months after the last vaccine administration
- Agrees not to enroll in another study of an investigational agent during participation in the trial
- In good general health according to the clinical judgment of the site investigator
Key exclusion criteria (33 listed)
- Volunteer who is breast-feeding or pregnant
- Body mass index (BMI). Enrollment of individuals with BMI ≥ 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 diet alone or 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)
- Congenital or acquired immunodeficiency, including systemic medication use likely to impair immune response to vaccine in the opinion of the site investigator such as glucocorticoid use equal to or greater than prednisone 10 mg/day within 3 months prior to enrollment
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 |
|---|---|---|
| INO-6160, 2 mgID EP at month 0,1,3 and 6 | Biological | Group #1: INO-6160/ 2.0 mg, Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) |
| Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg)IM at month 3 and 6 | Biological | Group #2: INO-6160/ 2.0 mg with Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) |
Primary outcome
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured for 14 days after each injection
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 for 14 days after each injection
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 Systemic Solicited Adverse Events Signs and Symptoms
Time frame: Measured for 14 days after each injection
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)
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
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Time frame: Measured through Month 6
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 10
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Response Rate of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Fourth Vaccination
Time frame: Measured at Months 1.5, 3.5, and 6.5
The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Positivity criteria include (1) the net Mean Fluorescence Intensity (MFI), or MFI - Blank, values are ≥ antigen-specific cutoff at the 1:50 dilution level for IgG (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI minus Blank), (2) the net MFI values are greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values are greater than 3 times the baseline MFI values. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.
Magnitude of Vaccine-matched IgG Binding Antibody (Ab) Responses as Assessed by Multiplex Assay 2 Weeks Following the Third and Fourth Vaccination
Time frame: Measured at Months 1.5, 3.5, and 6.5
The Binding Antibody Multiplex Assay (BAMA) assay was used to evaluate binding antibody responses of each serum specimen against BG505 SOSIP (vaccine trimer immunogen) and Trimer 4571 (vaccine matched immunogen). Epitope specificities are assessed via wildtype-mutant pairs. The AB05 antigen was used to assess binding antibody responses to the vaccine-matched trimer INO-6160. The wildtype antigen (BG505 MD39.3) captured both base and non-base specific antibodies, whereas the mutant antigen (BG505 MD39.3-BaseKO), captured only non-base specific antibodies.
Response Rate of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Time frame: Measured at Months 3.5 and 6.5
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.
Magnitude of CD4 + T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Time frame: Measured at Months 3.5 and 6.5
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay
Response Rate of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Time frame: Measured at Months 3.5 and 6.5
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated Intracellular Cytokine Staining (ICS) assay. To determine positivity, a one-sided Fisher's exact test is applied to a two-by-two contingency table, testing whether the number of cytokine-producing cells for the stimulated data is equal to that for the negative control data.
Magnitude of CD8+ T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools, 2 Weeks Following the Third and Fourth Vaccination
Time frame: Measured at Months 3.5 and 6.5
Flow cytometry is employed to examine HIV-1-specific CD4+ and CD8+ T-cell responses using a validated ICS assay
15 secondary outcomes
Neutralizing Ab Magnitude Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations
Time frame: Measured at baseline (screening), Month 3.5, and Month 6.5
Neutralizing Ab Response Rate Against Autologous and Tier 1a HIV-1 Isolates as Assessed by TZM-bl Neutralization Assay Following the Third and Fourth Vaccinations
Time frame: Measured at baseline (screening), Month 3.5, and Month 6.5
Differential Binding Response Rates of HIV-1 Specific IgG Binding Ab Responses as Assessed by Multiplex Assay
Time frame: Measured at Months 1.5, 3.5, and 6.5
Epitope Specificity of HIV-1 Specific IgG Binding Ab Responses
Time frame: 2 weeks following third vaccination
Response Rate of CD4 +T-cell Responses
Time frame: 2 weeks following third vaccination
Magnitude of CD4 +T-cell Responses
Time frame: 2 weeks following third vaccination
Response Rate of CD8+T-cell Responses
Time frame: 2 weeks following third vaccination
Magnitude of CD8+T-cell Responses
Time frame: 2 weeks following third vaccination
Magnitude of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Time frame: 6 months post last vaccination
Response Rate of CD4 +T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Time frame: 6 months post last vaccination
Magnitude of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Time frame: 6 months post last vaccination
Response Rate of CD8+T-cell Responses Measured by Flow Cytometry, to HIV-1-specific Env Peptide Pools
Time frame: 6 months post last vaccination
Response Rate of HIV-1 Specific IgG Binding Ab Response
Time frame: 6 months post last vaccination
Magnitude of HIV-1 Specific IgG Binding Ab Response
Time frame: 6 months post last vaccination
Neutralizing Ab Magnitude and Breadth Against Autologous Tier 2 HIV-1 Isolates
Time frame: 6 months post last vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 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.
3 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 INO-6160, 2 mg and Trimer-4571 / 100 mcg 3M-052-AF (5 mcg) + Alum (500 mcg) in people with HIV-1-infection, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 24 inclusion and 33 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 2 Sep 2025. 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 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 4 Jul 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 for 14 days after each injection). The study lists 12 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 2 Sep 2025.