HIV InfectionsPhase 1NCT06557785
A Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
A Phase 1 study testing CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in 2 countries.
Trial summary
This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). 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?
- CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 25 Nov 2024to 9 Mar 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit and willing to undergo FNA of an axillary lymph node and undergo leukapheresis.
- 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 312 Protocol Safety Review Team (PSRT) are required prior to enrollment into HVTN 312.
- 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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- For US sites: Agrees to discuss their potential for HIV acquisition and agrees to prevention counseling.
- For non-US sites: Assessed by clinical staff as having a low likelihood of acquiring HIV per guidelines, agrees to discuss their potential for HIV acquisition, agrees to prevention 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) as prescribed.
- Hemoglobin (Hgb):
- ≥ 11.0 g/dL for AFAB volunteers
- ≥ 13.0 g/dL for cisgender AMAB volunteers or for volunteers who have been on masculinizing hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for AMAB volunteers who have been on feminizing hormone therapy for more than 6 consecutive months
- For volunteers who have been on gender-affirming hormone therapy for less than 6 consecutive months, determine Hgb eligibility based on their sex assigned at birth.
- White blood cell (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.
- Alanine aminotransferase (ALT) < 2.5 x upper limit of institutional reference range.
- Serum creatinine ≤ 1.1 x upper limit of normal (ULN) based on the institutional normal range.
- Total measured or corrected serum calcium level of > 8.5 mg/dL. Corrected serum calcium should only be used if the total serum calcium is below the lower limit of normal.
- 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 ≥ 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 enzyme immunoassay (EIA)
- A chemiluminescent microparticle immunoassay (CMIA)
- A negative result on 2 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 or intersex at birth volunteers who 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 the day of enrollment.
- AFAB or intersex at birth volunteers 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/chestfeeding 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 or HIV mAb (previous placebo/control recipients are not excluded).
- Receipt of non-HIV investigational 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, ≥ 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.
- Receipt of any of the following within 4 weeks prior to enrollment:
- Live replicating vaccine
- Any mRNA-based vaccine with FDA licensure, FDA EUA, or WHO EUL
- ACAM2000 vaccine > 28 days prior with a vaccination scab still present.
- Receipt of any vaccine that is not covered in exclusion criterion #8 within 14 days prior to enrollment. Please note this includes replication-incompetent vaccines such as the Jynneos vaccine for the prevention of mpox disease.
- History of myocarditis and/or pericarditis.
- 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 more 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 mRNA vaccine, including Comirnaty® (Pfizer) and Spikevax® (Moderna), or to any drug administered systemically as a polyethylene glycol containing LNP, including doxorubicin (Doxil, Caelyx, ThermoDox), cisplatin (Lipoplatin) and irinotecan (Onivyde).
- Hereditary angioedema, acquired angioedema, or idiopathic forms of angioedema.
- Urticaria within the last year unless it was caused by a known, definable, and avoidable trigger (ie, urticaria by a known, definable and avoidable trigger would not be exclusionary).
- History of chronic urticaria or urticaria previously associated with immunization.
- Bleeding disorder diagnosed by a clinician that would make study procedures a contraindication.
- History of seizure(s) within the past 3 years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
- 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, hinder their ability to participate in the study, or affect their immune responses to study products. Such conditions include but not limited to: clinically significant forms of substance use or alcohol use disorder(s), serious psychiatric disorders, 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 per week for acute asthma symptoms (ie, not for preventive treatment prior to athletic activity); OR
- Uses medium- to high-dose inhaled corticosteroids (> 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 (Novocain, Lidocaine).
- Investigator concern for difficulty with venous access based on clinical history and physical examination. For example, persons with a history of IV drug use or substantial difficulty with previous blood draws.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Beth Israel Deaconess Medical Center (Site ID: 32077)
Boston, Massachusetts, 02215
Columbia P&S (Site ID: 30329)
New York, New York, 10032
New York Blood Center (Site ID: 31801)
New York, New York, 10065
Penn Prevention (Site ID: 30310)
Philadelphia, Pennsylvania, 19104
University of Pittsburgh (Site ID: 1001)
Pittsburgh, Pennsylvania, 15213
Seattle Vaccine and Prevention (Site ID: 30331)
Seattle, Washington, 98104
Thailand1 site
Vaccine Trial Centre, Mahidol University CRS (Site ID: 32021)
Bangkok, Ratchathewi, 10400
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
This is a multicenter, open-label, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are:
- the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors,
- the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and
- these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.
- Conditions
- HIV Infections
- Being tested
- CH505M5 N197D mRNA-gp160, CH505 TF mRNA-gp160
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CH505M5 N197D mRNA-gp160Biological
To be administered intramuscularly as a split dose
CH505 TF mRNA-gp160Biological
To be administered intramuscularly as a split dose
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (25 mcg) | Experimental | 25 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16.
Followed by:
25 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. Receives: Biological: CH505M5 N197D mRNA-gp160; Biological: CH505 TF mRNA-gp160 |
| Group 2 (50 mcg) | Experimental | 50 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16.
Followed by:
50 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. Receives: Biological: CH505M5 N197D mRNA-gp160; Biological: CH505 TF mRNA-gp160 |
| Group 3 (100 mcg) | Experimental | 100 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16.
Followed by:
100 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. Receives: Biological: CH505M5 N197D mRNA-gp160; Biological: CH505 TF mRNA-gp160 |
| Group 4 (150 mcg) | Experimental | 150 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16.
Followed by:
150 mcg CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. Receives: Biological: CH505M5 N197D mRNA-gp160; Biological: CH505 TF mRNA-gp160 |
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: Day 15, 71, 127 and 183 (14 days following receipt of any study vaccine)
Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine
Measured: Day 15, 71, 127 and 183 (14 days following receipt of any study vaccine)
Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation
Measured: 20 months
Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation
Measured: 20 months
Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation
Measured: 20 months
Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation
Measured: 20 months
Response rate of CD4-bs and CH505M5-specific IgG+ B cells as assessed by flow cytometry
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains, as measured by TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains, as measured by TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of differential serum antibody neutralization of precursor detection virus and corresponding epitope KO virus, as measured by the TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of differential serum antibody neutralization of precursor detection virus and corresponding epitope KO virus, as measured by the TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Secondary outcomes (11)
Response rate of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by BAMA
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of heterologous HIV-1 strains as measured by TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous HIV-1 strains as measured by TZM-bl assay
Measured: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Frequency of CD4-bs specific sequences, as measured by BCR single cell sequencing of CD4-bs and CH505M5-specific IgG+ B cells
Measured: 20 months
Epitope specific response rates as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Measured: Day 183 (2 weeks after the fourth vaccination)
Response rate of serum IgG binding Abs to Env Trimers and neutralizing epitopes as assessed by BAMA
Measured: Day 337 (24 weeks after the fourth vaccination)
Magnitude of serum IgG binding Abs to Env Trimers and neutralizing epitopes as assessed by BAMA
Measured: Day 337 (24 weeks after the fourth vaccination)
Response rate of serum Ab neutralization of autologous, heterologous and precursor HIV-1 strains as measured by TZM-bl assay
Measured: Day 337 (24 weeks after the fourth vaccination)
Magnitude of serum Ab neutralization of autologous, heterologous and precursor HIV-1 strains as measured by TZM-bl assay
Measured: Day 337 (24 weeks after the fourth vaccination)
Response rate of CD4-bs and CH505M5-specific IgG+ B cells as measured by flow cytometry
Measured: Day 337 (24 weeks after the fourth vaccination)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start25 Nov 2024
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Department of Health and Human Services
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557785
- Sponsor's protocol ID
- HVTN 312
- Other IDs
- 39019
- Status last verified
- Dec 2025
- First submitted
- 14 Aug 2024
- Last updated
- 14 Jan 2026
- 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 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of CH505M5 N197D mRNA-gp160 Followed by CH505 TF mRNA-gp160 in Adults in Overall Good Health Without HIV
- ClinicalTrials.gov ID
- NCT06557785
- Acronym / sponsor ID
- HVTN 312
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health (NIH), Department of Health and Human Services
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 16 Aug 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, non-randomized, dose escalation, first-in-human (FIH) trial to evaluate the safety and immunogenicity of CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160. Both products are mRNA encapsulated in lipid nanoparticles (LNPs) (subsequently referred to as mRNA-LNPs). The primary hypotheses are:
- the CH505M5 N197D mRNA-gp160 will expand CH235-like B cell precursors,
- the CH505 TF mRNA-gp160 will boost CH235-like bnAb B cell precursors to acquire more functional mutations needed for broadly neutralizing antibody (bnAb) development, and
- these mRNA-LNPs will be safe and well tolerated among individuals living without HIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 (25 mcg) | Experimental | Biological: CH505M5 N197D mRNA-gp160, Biological: CH505 TF mRNA-gp16025 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 25 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. |
| Group 2 (50 mcg) | Experimental | Biological: CH505M5 N197D mRNA-gp160, Biological: CH505 TF mRNA-gp16050 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 50 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. |
| Group 3 (100 mcg) | Experimental | Biological: CH505M5 N197D mRNA-gp160, Biological: CH505 TF mRNA-gp160100 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 100 mcg of CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. |
| Group 4 (150 mcg) | Experimental | Biological: CH505M5 N197D mRNA-gp160, Biological: CH505 TF mRNA-gp160150 mcg of CH505M5 N197D mRNA-gp160, to be administered as a split dose intramuscularly at weeks 0, 8, and 16. Followed by: 150 mcg CH505 TF mRNA-gp160, to be administered as a split dose intramuscularly at week 24. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (34 listed)
- Demonstrates an understanding of the study and is able and willing to complete the informed consent process.
- 18 to 55 years old, inclusive, on day of enrollment.
- Available for clinic follow-up through the last clinic visit and willing to undergo FNA of an axillary lymph node and undergo leukapheresis.
- 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 312 Protocol Safety Review Team (PSRT) are required prior to enrollment into HVTN 312.
- In good general health according to the clinical judgment of the site investigator.
Key exclusion criteria (33 listed)
- Volunteer who is breastfeeding/chestfeeding 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 or HIV mAb (previous placebo/control recipients are not excluded).
- Receipt of non-HIV investigational 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 |
|---|---|---|
| CH505M5 N197D mRNA-gp160To be administered intramuscularly as a split dose | Biological | Group 1 (25 mcg), Group 2 (50 mcg), Group 3 (100 mcg), Group 4 (150 mcg) |
| CH505 TF mRNA-gp160To be administered intramuscularly as a split dose | Biological | Group 1 (25 mcg), Group 2 (50 mcg), Group 3 (100 mcg), Group 4 (150 mcg) |
Primary outcome
Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine
Time frame: Day 15, 71, 127 and 183 (14 days following receipt of any study vaccine)
Frequency of systemic reactogenicity signs and symptoms after receipt of any study vaccine
Time frame: Day 15, 71, 127 and 183 (14 days following receipt of any study vaccine)
Number of serious adverse events (SAEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 20 months
Number of medically attended adverse events (MAAEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 20 months
Number of adverse events of special interest (AESIs) leading to early participant withdrawal or permanent discontinuation
Time frame: 20 months
Number of adverse events (AEs) leading to early participant withdrawal or permanent discontinuation
Time frame: 20 months
Response rate of CD4-bs and CH505M5-specific IgG+ B cells as assessed by flow cytometry
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of vaccine-matched tier 2 HIV-1 strains, as measured by TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of differential serum antibody neutralization of precursor detection virus and corresponding epitope KO virus, as measured by the TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of differential serum antibody neutralization of precursor detection virus and corresponding epitope KO virus, as measured by the TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
11 secondary outcomes
Response rate of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by binding antibody multiplex assay (BAMA)
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum IgG binding antibodies to autologous and heterologous HIV Env stabilized trimers, as assessed by BAMA
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Response rate of serum Ab neutralization of heterologous HIV-1 strains as measured by TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Magnitude of serum Ab neutralization of heterologous HIV-1 strains as measured by TZM-bl assay
Time frame: Day 127 and 183 (2 weeks after the third and fourth vaccinations)
Frequency of CD4-bs specific sequences, as measured by BCR single cell sequencing of CD4-bs and CH505M5-specific IgG+ B cells
Time frame: 20 months
Epitope specific response rates as measured by electron microscopy-based polyclonal epitope mapping (EMPEM)
Time frame: Day 183 (2 weeks after the fourth vaccination)
Response rate of serum IgG binding Abs to Env Trimers and neutralizing epitopes as assessed by BAMA
Time frame: Day 337 (24 weeks after the fourth vaccination)
Magnitude of serum IgG binding Abs to Env Trimers and neutralizing epitopes as assessed by BAMA
Time frame: Day 337 (24 weeks after the fourth vaccination)
Response rate of serum Ab neutralization of autologous, heterologous and precursor HIV-1 strains as measured by TZM-bl assay
Time frame: Day 337 (24 weeks after the fourth vaccination)
Magnitude of serum Ab neutralization of autologous, heterologous and precursor HIV-1 strains as measured by TZM-bl assay
Time frame: Day 337 (24 weeks after the fourth vaccination)
Response rate of CD4-bs and CH505M5-specific IgG+ B cells as measured by flow cytometry
Time frame: Day 337 (24 weeks after the fourth vaccination)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 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 CH505M5 N197D mRNA-gp160 and CH505 TF mRNA-gp160 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 34 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: under way, not looking for participants, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of local reactogenicity signs and symptoms after receipt of any study vaccine (time frame: Day 15, 71, 127 and 183 (14 days following receipt of any study vaccine)). The study lists 11 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 Jan 2026.