HIVPhase 1NCT06267872
A Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum
A Phase 1 study testing CD4BS CH505M5 Pr-NP1, CH505TF chTrimer and 3M-052-AF (labeled as AP 60-702) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in 2 countries.
Trial summary
This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV
- What is being tested?
- CD4BS CH505M5 Pr-NP1, CH505TF chTrimer and 3M-052-AF (labeled as AP 60-702)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 7 Oct 2024to 12 Sep 2026
- Phase
- Phase 1
- 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
- Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to signing the informed consent form(s) with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit, willing to undergo FNA and leukapheresis (for Part C only), and willing to be contacted 12 months after the last study-product administration.
- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 309 PSRT are required prior to enrollment into HVTN 309.
- 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.
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- Assessed by clinical staff as having a low likelihood of acquiring HIV per guidelines and agrees to discuss their potential for HIV acquisition, agrees to risk-reduction counseling, and agrees to avoid behaviors associated with a higher likelihood of acquiring HIV through the final study visit. Low likelihood may include persons stably taking pre-exposure prophylaxis (PrEP).
- Hemoglobin (Hgb):
- ≥ 11.0 g/dL for AFAB volunteers
- ≥ 13.0 g/dL for cisgender AMAB volunteers and for 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 volunteers who have been on hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth.
- WBC count = 2,500 to 12,000/mm3 (WBC over 12,000/mm3 is not exclusionary if further evaluation shows general good health and if PSRT approval is granted).
- Platelets = 125,000 to 550,000/mm3.
- 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.
- For Part C, total serum calcium level of > 8.5 mg/dL.
- Systolic blood pressure of 90 to <140 mmHg and diastolic blood pressure of 50 to <90 mmHg at screening visit. The average blood pressure between the screening visit and the enrollment visit must be below 140 mmHg systolic and 90 mmHg diastolic. A single measurement greater than or equal to 160 systolic mmHg or 100 mmHg diastolic during the current study evaluation is exclusionary.
- Negative HIV test results by one of the following options:
- For US volunteers:
- US Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA)
- Chemiluminescent microparticle immunoassay (CMIA)
- Two negative results on HIV rapid tests (one of which must be FDA-approved CMIA)
- For non-US volunteers:
- A negative European Conformity (CE)-marked EIA
- A CMIA
- A negative result on two HIV rapid tests (one of these rapid tests must be CE-marked)
- Negative for anti-Hepatitis C virus (HCV) Abs (anti-HCV) or negative HCV nucleic acid test (NAT) if anti-HCV Abs are detected.
- Negative for Hepatitis B surface Ag.
- For AFAB volunteers or volunteers who were intersex at birth and are capable of becoming pregnant (hereafter referred to as "persons of pregnancy potential"):
- Must agree to use effective means of contraception from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint.
- Must have a negative beta human chorionic gonadotropin (β-HCG) pregnancy test (urine or serum) on day of enrollment.
- AFAB volunteers or volunteers who were intersex at birth must agree to not seek pregnancy through alternative methods, such as oocyte retrieval, artificial insemination, or in vitro fertilization from at least 21 days prior to enrollment through 8 weeks after their last scheduled vaccination timepoint.
Who cannot join
- Volunteer who is breastfeeding or pregnant.
- Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
- Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) 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 by the PSRT on a case-by-case basis, provided that 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/ control recipients are not excluded).
- Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national regulatory authority (RA) authorizing this clinical trial.
- 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.
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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.
- History of myocarditis and/or pericarditis.
- Receipt of any vaccine within 4 weeks prior to enrollment.
- Initiation of Ag-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 of 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. Of note, the study proposed vaccine regimen includes components similar to components of the licensed COMIRNATY (Pfizer) and SPIKEVAX (Moderna) mRNA vaccines; severe reaction to these vaccines is therefore exclusionary.
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Idiopathic urticaria within the past year.
- Bleeding disorder diagnosed by a clinician which would make study procedures a contraindication.
- 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 judgment of the investigator, would jeopardize the safety or rights of the study participant, including but not limited to: clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, persons with any suicide attempt within the past 1 year (if between 1 and 2 years, consult PSRT for approval), or cancer that, in the clinical judgement of the site investigator, has 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 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/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 a potential immune-mediated medical condition (PIMMC), either active or remote. Not exclusionary: 1) Remote history of Bell's palsy (> 2 years ago) not associated with other neurologic symptoms and 2) Mild psoriasis or other mild, uncomplicated, localized or dermatologic condition that does not require ongoing systemic treatment.
- History of allergy to local anesthetic (Novocaine, Lidocaine).
- Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of intravenous drug use or substantial difficulty with previous blood draws.
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States3 sites
The Ponce de Leon Center CRS (Site ID: 5802)
Atlanta, Georgia, 30308
Alabama CRS (Site ID: 31788)
Birmingham, Alabama, 35222
Vanderbilt Vaccine (VV) CRS (Site ID: 30352)
Nashville, Tennessee, 37232
South Africa3 sites
Isipingo CRS (Site ID: 31635)
Isipingo, KwaZulu-Natal, 4110
Klerksdorp CRS (Site ID: 30325)
Klerksdorp, North West, 2571
Setshaba Research Centre CRS (Site ID: 31829)
Soshanguve, Gauteng, 0152
About this study
Official title: A Phase 1 Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum
This is a multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.
- Conditions
- HIV
- Being tested
- CD4BS CH505M5 Pr-NP1, CH505TF chTrimer, 3M-052-AF (labeled as AP 60-702), Aluminum Hydroxide Suspension (Alum), ACU-026-001-1 (labeled as empty LNP)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD4BS CH505M5 Pr-NP1Biological
A ferritin NP expressing 8 copies of an HIV-1 Env protein trimer. To be administered intramuscularly (IM).
CH505TF chTrimerBiological
A stabilized chimeric SOSIP Env trimer protein with the N-terminal sequence of CH505 TF gp120 Env transplanted into the BG505 SOSIP sequence. To be administered IM.
3M-052-AF (labeled as AP 60-702)Biological
An aqueous formulation (AF) of the small molecule imidazoquinoline immune response modifier (IRM) 3M-052; toll-like receptor (TLR)7/8 agonist.
Aluminum Hydroxide Suspension (Alum)Biological
Also called Alhydrogel
Alum to be administered IM as 500 mcg (aluminum content) admixed with 3M-052-AF (5 mcg) along with CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer.
ACU-026-001-1 (labeled as empty LNP)Biological
An AF consisting of 4 lipid components.
| Study group | Role | What they receive |
|---|---|---|
| Part A - Group 1 | Experimental | • 60 mcg of CD4BS CH505M5 Pr-NP1, to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4. Receives: Biological: CD4BS CH505M5 Pr-NP1 |
| Part B - Group 2 | Experimental | * 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 1.0 mcg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: ACU-026-001-1 (labeled as empty LNP) |
| Part B - Group 3 | Experimental | * 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: ACU-026-001-1 (labeled as empty LNP) |
| Part B - Group 4 | Experimental | * 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: 3M-052-AF (labeled as AP 60-702); Biological: Aluminum Hydroxide Suspension (Alum) |
| Part C - Group 5 | Experimental | Low dose:
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 1mg empty LNP adjuvant to be administered at months 6 and 8.
OR,
High Dose:
* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-01 adjuvant to be administered as two 0.5 mL doses intramuscularly at month 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: ACU-026-001-1 (labeled as empty LNP) |
| Part C - Group 6 | Experimental | * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4,
* Followed by 300 mcg of CH505TF chTrimer, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: 3M-052-AF (labeled as AP 60-702); Biological: Aluminum Hydroxide Suspension (Alum) |
| Part C - Group 7 | Experimental | * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4
* Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. Receives: Biological: CD4BS CH505M5 Pr-NP1; Biological: CH505TF chTrimer; Biological: 3M-052-AF (labeled as AP 60-702); Biological: Aluminum Hydroxide Suspension (Alum) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine
Measured: Part A: Day 15, 71, and 127; Part B: Day 15, 71, 127, 183, and 239; Part C: 15, 71, 127, 183, and 239 (14 days following receipt of any study vaccine)
Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine
Measured: Part A: Day 15, 71, and 127; Part B: Day 15, 71, 127, 183, and 239; Part C: 15, 71, 127, 183, and 239 (14 days following receipt of any study vaccine)
Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation
Measured: 31 months
Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation
Measured: 31 months
Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation
Measured: 31 months
Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation
Measured: 31 months
Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry
Measured: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay
Measured: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay
Measured: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Secondary outcomes (11)
Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay
Measured: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay
Measured: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry
Measured: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry
Measured: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start7 Oct 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion12 Sep 2026 (estimated)
Why it stopped: FDA Clinical Hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIVStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Department of Health and Human Services, Duke University, Access to Advanced Health Institute (AAHI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06267872
- Sponsor's protocol ID
- HVTN 309
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2024
- Last updated
- 26 Mar 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 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial in Adult Participants Without HIV and in Overall Good Health to Evaluate the Safety and Immunogenicity of CD4BS CH505M5 Pr-NP1 Followed by CH505 TF chTrimer Boost Both Adjuvanted With Either Lipid Nanoparticles (LNPs) or 3M-052-AF + Alum
- ClinicalTrials.gov ID
- NCT06267872
- Acronym / sponsor ID
- HVTN 309
- Conditions
- HIV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA Clinical Hold
- Enrolment
- 0 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, Duke University, Access to Advanced Health Institute (AAHI)
- Study start
- 7 Oct 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 12 Sep 2026 (estimated)
- First posted
- 20 Feb 2024 (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 multicenter, open-label, phase 1 clinical trial to test two human immunodeficiency virus (HIV) vaccines with two adjuvants. An adjuvant is an ingredient used with some vaccines that may help people make an immune response. HIV is the virus that causes acquired immunodeficiency syndrome (AIDS).
About 42 people will take part in the HVTN 309 clinical trial. This clinical trial will take place at multiple sites in the US and South Africa and the clinical trial is divided into 3 parts: Part A, Part B and Part C. About 3 people will participate in Part A of this study. After results from Part A are reviewed, it will be determined whether or not Part B and Part C of the clinical trial will proceed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Part A - Group 1 | Experimental | Biological: CD4BS CH505M5 Pr-NP1• 60 mcg of CD4BS CH505M5 Pr-NP1, to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4. |
| Part B - Group 2 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: ACU-026-001-1 (labeled as empty LNP)* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 1.0 mcg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. |
| Part B - Group 3 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: ACU-026-001-1 (labeled as empty LNP)* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. |
| Part B - Group 4 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: 3M-052-AF (labeled as AP 60-702), Biological: Aluminum Hydroxide Suspension (Alum)* 60 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. |
| Part C - Group 5 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: ACU-026-001-1 (labeled as empty LNP)Low dose: * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 1.0 mg of ACU-026-001-1 adjuvant to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 1mg empty LNP adjuvant to be administered at months 6 and 8. OR, High Dose: * 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 2.0 mg of ACU-026-001-01 adjuvant to be administered as two 0.5 mL doses intramuscularly at month 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 2.0 mg of ACU-026-001-1 adjuvant to be administered at months 6 and 8. |
| Part C - Group 6 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: 3M-052-AF (labeled as AP 60-702), Biological: Aluminum Hydroxide Suspension (Alum)* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4, * Followed by 300 mcg of CH505TF chTrimer, admixed with 3 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. |
| Part C - Group 7 | Experimental | Biological: CD4BS CH505M5 Pr-NP1, Biological: CH505TF chTrimer, Biological: 3M-052-AF (labeled as AP 60-702), Biological: Aluminum Hydroxide Suspension (Alum)* 100 mcg of CD4BS CH505M5 Pr-NP1, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered as two 0.5 mL doses intramuscularly at months 0, 2, and 4 * Followed by 300 mcg of CH505TF chTrimer, admixed with 5 mcg of 3M-052-AF adjuvant along with 500 mcg of Alum to be administered to be administered at months 6 and 8. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (33 listed)
- Able and willing to complete the informed consent process, including an Assessment of Understanding (AoU): Volunteer demonstrates an understanding of this study and completes a questionnaire prior to signing the informed consent form(s) with verbal demonstration of understanding of questionnaire items that were answered incorrectly.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit, willing to undergo FNA and leukapheresis (for Part C only), and willing to be contacted 12 months after the last study-product administration.
- Agrees not to enroll in another study of an investigational agent during participation in the trial. If a potential participant is already enrolled in another clinical trial, approvals from the other trial sponsor and the HVTN 309 PSRT are required prior to enrollment into HVTN 309.
- In good general health according to the clinical judgment of the site investigator.
Key exclusion criteria (28 listed)
- Volunteer who is breastfeeding or pregnant.
- Body mass index (BMI) ≥ 40. Enrollment of individuals with BMI ≥ 40, whom the site investigator assesses are in good health, may be considered by PSRT approval.
- Diabetes mellitus (DM). Type 2 DM controlled with diet alone (and confirmed by HgbA1c ≤ 8% within the last 6 months) 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 by the PSRT on a case-by-case basis, provided that 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/ control recipients are not excluded).
- Receipt of non-HIV experimental vaccine(s) received within the last 1 year. Exceptions include vaccines that have subsequently undergone licensure or Emergency Use Authorization (EUA) by the FDA or World Health Organization (WHO) Emergency Use Listing (EUL), or if outside the US, by the national regulatory authority (RA) authorizing this clinical trial.
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 |
|---|---|---|
| CD4BS CH505M5 Pr-NP1A ferritin NP expressing 8 copies of an HIV-1 Env protein trimer. To be administered intramuscularly (IM). | Biological | Part A - Group 1, Part B - Group 2, Part B - Group 3, Part B - Group 4, Part C - Group 5, Part C - Group 6, Part C - Group 7 |
| CH505TF chTrimerA stabilized chimeric SOSIP Env trimer protein with the N-terminal sequence of CH505 TF gp120 Env transplanted into the BG505 SOSIP sequence. To be administered IM. | Biological | Part B - Group 2, Part B - Group 3, Part B - Group 4, Part C - Group 5, Part C - Group 6, Part C - Group 7 |
| 3M-052-AF (labeled as AP 60-702)An aqueous formulation (AF) of the small molecule imidazoquinoline immune response modifier (IRM) 3M-052; toll-like receptor (TLR)7/8 agonist. | Biological | Part B - Group 4, Part C - Group 6, Part C - Group 7 |
| Aluminum Hydroxide Suspension (Alum)Also: AlhydrogelAlum to be administered IM as 500 mcg (aluminum content) admixed with 3M-052-AF (5 mcg) along with CD4BS CH505M5 Pr-NP1 and CH505 TF chTrimer. | Biological | Part B - Group 4, Part C - Group 6, Part C - Group 7 |
| ACU-026-001-1 (labeled as empty LNP)An AF consisting of 4 lipid components. | Biological | Part B - Group 2, Part B - Group 3, Part C - Group 5 |
Primary outcome
Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine
Time frame: Part A: Day 15, 71, and 127; Part B: Day 15, 71, 127, 183, and 239; Part C: 15, 71, 127, 183, and 239 (14 days following receipt of any study vaccine)
Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine
Time frame: Part A: Day 15, 71, and 127; Part B: Day 15, 71, 127, 183, and 239; Part C: 15, 71, 127, 183, and 239 (14 days following receipt of any study vaccine)
Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 31 months
Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 31 months
Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation
Time frame: 31 months
Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 31 months
Part C only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry
Time frame: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part C only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay
Time frame: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part C only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by TZM-bl assay
Time frame: Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
11 secondary outcomes
Parts B and C: Response rate of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of serum IgG binding Abs to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Part B only: Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay
Time frame: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Part B only: Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains as measured by the TZM-bl assay
Time frame: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Parts B and C: Response rate of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of differential serum Ab neutralization of precursor detection virus and corresponding epitope KO virus, as measured by TZM-bl assay
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Response rate of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of serum Ab neutralization of heterologous HIV-1 strains, as measured by TZM-bl assay
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Response rate of CD4+ and CD8+ T-cell responses, as measured by flow cytometry
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Parts B and C: Magnitude of CD4+ and CD8+ T-cell responses, as measured by flow cytometry
Time frame: Part B: Day 127 and 239; Part C: Day 127 and 239 (2 weeks after the third and fifth vaccinations, respectively, in each part)
Part B only: Frequency of the CD4BS and CH505M5, G458Y, GNT1-specific, N280D KO IgG+ memory B cells, as assessed by flow cytometry
Time frame: Part B: Day 127 and 239 (2 weeks after the third and fifth vaccinations respectively)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 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.
6 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 CD4BS CH505M5 Pr-NP1, CH505TF chTrimer and 3M-052-AF (labeled as AP 60-702) in people with HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 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 33 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: withdrawn, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine (time frame: Part A: Day 15, 71, and 127; Part B: Day 15, 71, 127, 183, and 239; Part C: 15, 71, 127, 183, and 239 (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 26 Mar 2025.