Skip to main content
TTrialFinderData
TrialFinderData is for informational purposes only and does not provide medical advice. Always talk to your doctor.

Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults

Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of an Ad26.Mos4.HIV and CH505 TF chTrimer (Env) Combination to Mimic Acute HIV Viral Replication Kinetics in Healthy Adults

Evaluation of Safety and Immunogenicity of Ad26.Mos4.HIV and CH505 TF chTrimer Combination in Healthy Adults (NCT06205056) is a Phase 1 interventional studying Human Immunodeficiency Virus, sponsored by U.S. Army Medical Research and Development Command. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Human Immunodeficiency Virus, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 78 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Human Immunodeficiency Virus subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: Participants must meet all of the following criteria to be eligible for participation: 1. Male or female, aged 18 to 50 years, inclusive, at the time of enrollment 2. Willing and able to read, sign, and date the willing to sign a consent form form 3. Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed 4. Willing and able to comply with study requirements and be available to attend visits for the duration of study participation 5. Must have the means to be contacted by telephone for the duration of study participation 6. Willing to have photo or fingerprint taken for identification purposes 7. At low risk for HIV acquisition per investigator assessment 8. Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation 9. Healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination Note: Good health is defined by the absence of any medical condition described in the exclusion criteria in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the exclusion criteria, the condition cannot meet any of the following criteria: 1. first diagnosed within the 12 weeks prior to screening; or 2. worsening in terms of clinical outcome in the 24 weeks prior to screening; or 3. involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they participate in the study. Note: Vital signs must be normal by Adverse Event Grading Scales, local normal ranges, or determined to be a normal variant by the physician investigator. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: Participants must meet all of the following criteria to be eligible for participation: 1. Male or female, aged 18 to 50 years, inclusive, at the time of enrollment 2. Willing and able to read, sign, and date the informed consent form 3. Demonstrates an understanding of the study with a passing score (90% or greater) on the TOU by the third attempt, before study-related procedures are performed 4. Willing and able to comply with study requirements and be available to attend visits for the duration of study participation 5. Must have the means to be contacted by telephone for the duration of study participation 6. Willing to have photo or fingerprint taken for identification purposes 7. At low risk for HIV acquisition per investigator assessment 8. Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation 9. Healthy based on the physician investigator's clinical judgment after review of past medical history, medication use, vital signs, and an abbreviated physical examination Note: Good health is defined by the absence of any medical condition described in the exclusion criteria in a participant with a normal abbreviated physical exam and vital signs. If the participant has a preexisting chronic condition not listed in the exclusion criteria, the condition cannot meet any of the following criteria: 1. first diagnosed within the 12 weeks prior to screening; or 2. worsening in terms of clinical outcome in the 24 weeks prior to screening; or 3. involves the need for medication that may pose a risk to the participant's safety or impede assessment of adverse events or immunogenicity if they participate in the study. Note: Vital signs must be normal by Adverse Event Grading Scales, local normal ranges, or determined to be a normal variant by the physician investigator. Note: An abbreviated physical exam differs from a complete exam in that it does not include a genitourinary and rectal exam. 10. Laboratory criteria within 45 days prior to enrollment: 1. Hemoglobin ≥11.0 g/dL for females; ≥12.5 g/dL for males 2. White blood cells (WBC) range: 3,500-9,000 cells/mm\^3 3. Platelets between 150,000 - 450,000 cells/µL 4. Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.25x upper limit of normal 5. Serum creatinine ≤1.25x upper limit of normal 6. Urinalysis: blood and protein less than 1+ and negative glucose 7. Negative HIV serology Note: HIV serology testing will be done via enzyme immunoassay with confirmatory testing of reactive results through a repeat enzyme immunoassay followed by an antibody differentiation immunoassay. After the repeat enzyme immunoassay, if an antibody differentiation immunoassay cannot be done for any reason, then confirmatory testing will be done via Western Blot. HIV rapid testing will not be performed in this study. 8. Negative hepatitis B surface antigen (HbsAg) 9. Negative hepatitis C serology or negative hepatitis C RNA (viral load) if antibodies are detected Note: Each laboratory screening test that is out of acceptable range can be repeated one time during the screening window if there is a possible alternative explanation for the out of range value or if the out of range value is due to a temporary condition that resolves within the screening visit window. A second screening visit may be conducted outside of the initial screening visit window for volunteers who meet certain criteria if study enrollment and/or participant replacement is ongoing. 11. Biological Male-Specific Criteria: 1. Must agree to refrain from donating sperm from screening until at least 12 weeks after the last study injection 2. Must agree to consistently use a method of contraception from screening until at least 12 weeks after the last study injection 12. Biological Female-Specific Criteria: 1. Not pregnant within 12 weeks prior to screening, not pregnant or breastfeeding at screening, and not planning to become pregnant or breastfeed at any time from screening until 12 weeks after the last study injection 2. Must have a negative human chorionic gonadotropin (β-HCG) pregnancy test (urine) at screening and at timepoints throughout the study, if of childbearing potential 3. Must agree to consistently practice a highly effective method of contraception at least 45 days prior to enrollment and for 12 weeks after the final injection, if of childbearing potential Exclusion Criteria: Volunteers will be excluded if any of the following apply: 1. Body mass index (BMI) \<18.0 kg/m\^2 and \>35.1 kg/m\^2 2. Has a condition which affects immune function, including but not limited to: 1. Known or suspected congenital or acquired immunodeficiency 2. Diabetes mellitus type 1 or type 2 (including cases controlled with diet alone) Note: A history of isolated gestational diabetes is not an exclusion criterion. 3. Thyroid disease 4. Asplenia, defined as any condition resulting in the absence of a functional spleen 5. Conditions and diagnoses defined as potential immune-mediated medical conditions 3. Has a history of other chronic or clinically significant diseases or medical conditions that in the opinion of the investigator would jeopardize the safety or rights of the participant Note: Includes but is not limited to sickle cell anemia, chronic hepatitis or cirrhosis, chronic urticaria, chronic cardiac disease, hypertension not controlled by medication, severe asthma, chronic pulmonary disease, renal failure, and lymphatic filariasis. 4. Has a history of malignancy other than squamous cell or basal cell skin cancer, unless there has been definitive surgical and/or medical treatment that is considered to have achieved a cure 5. Had major surgery (per the physician investigator's judgment) within the 28 days prior to screening or has plans to have major surgery during the study 6. Has a personal or family history of a bleeding disorder, such as factor deficiency, coagulopathy, or platelet disorder requiring special precautions 7. Has a personal or family history of a blood clotting disorder, such as thrombosis with thrombocytopenia syndrome (TTS), heparin-induced thrombocytopenia and thrombosis (HITT), deep vein thrombosis, pulmonary embolism, acute myocardial infarction, and stroke 8. Has a condition known to increase risk of blood clotting, including but not limited to autoimmune disease, connective tissue and other inflammatory conditions, immobility, recent infection, and recent head trauma including cerebrovascular accidents (stroke) 9. Hepatitis B surface antigen positive at any time in the past 10. Untreated syphilis infection as confirmed by RPR or a similar quantitative nontreponemal test such as VDRL 11. Prior receipt or plans to receive any of the following: 1. Chronic use of therapies that may modify immune response, such as high dose inhaled and sprayed corticosteroids (\>440 µg/twice daily doses of inhaled fluticasone equivalent) and systemic corticosteroids (\>20 mg/day doses of prednisone equivalent for periods exceeding 10 days) within 14 days prior to enrollment or at any time during participation in this study Note: The following exceptions are permitted and will not exclude study participation: use of stable low/medium doses (\<440 µg/twice daily doses of inhaled fluticasone equivalent) of inhaled and sprayed corticosteroids, topical corticosteroids for an acute uncomplicated dermatitis; or a short course (duration of 10 days or less, or a single injection) of corticosteroid for a non-chronic condition (based on the physician investigator's clinical judgment) at least 14 days prior to enrollment in this study. Includes other medications, which, in the opinion of the physician investigator(s), will impact the participant's immune response. 2. Blood products within 120 days prior to enrollment or at any time during participation in this study 3. Immunoglobulins within 90 days prior to enrollment or at any time during participation in this study 4. Therapy for active tuberculosis within 90 days prior to enrollment, unless the therapy is considered to have achieved a cure, or at any time during participation in this study 5. Licensed or authorized vaccine from 30 days prior to enrollment until 42 days (6 weeks) after the last study injection Note: Participants may receive inactivated seasonal influenza vaccine or COVID-19 vaccine during their participation in this study but not within 14 days prior or 6 weeks after each study injection 6. Any investigational study products for conditions other than HIV within 90 days prior to enrollment or at any time during participation in this study 7. An investigational HIV vaccine or HIV antibody at any time prior to or during participation in this study 8. Medications that increase the risk of bleeding (warfarin, clopidogrel, ticagrelor, dabigatran, rivaroxaban, apixaban, heparin and other heparinoids) or blood clots (heparin in participants who have a prior history of heparin-induced coagulopathy) within 30 days prior to enrollment or at any time during participation in this study. \[Note: Volunteers determined to be ineligible at screening due to receipt of the above listed substances may be re-screened once the applicable window of receipt has expired if study enrollment and/or participant replacement is ongoing\]. 12. Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex 13. Current or planned participation in another study requiring blood draws or exposure to investigational or non-investigational vaccine/product (pharmaceutical or device) throughout the study period 14. Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection sites 15. Current or history of substance abuse within 12 months prior to enrollment that, in the physician investigator's opinion, could interfere with reliable participation 16. In the physician investigator's opinion, is unable to communicate reliably, is unlikely to adhere to study requirements, or has a condition that would limit completion of the study 17. Any other chronic or clinically significant medical condition that in the opinion of investigator would jeopardize the safety or rights of the participant or potentially impairs immune response or threatens conduct of the study according to protocol 18. Study site employee Final evaluation of eligibility will be based on the medical judgment of the physician investigator.

Treatments Being Tested

BIOLOGICAL

Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a]

Participants in Arm 1a will receive dose consistent injections (5x10\^10 vp/0.5 mL) of Ad26.Mos4.HIV in a 0.5 mL injection volume and dose consistent injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) in a 1.1 mL injection volume on Study Days 1 and 57

BIOLOGICAL

CH505 TF chTrimer + ALFQ [Arm 1a]

Participants in Arm 1a will receive a dose-consistent injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 169.

BIOLOGICAL

Placebo [Arm 1a]

Participants in Arm 1a will receive dose-consistent 0.5 mL injection and a 1.1 mL injection of Placebo on Study Days 1 and 57, followed by a 1.1 mL injection of Placebo on Study Day 169.

BIOLOGICAL

Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]

Participants in Arm 2a will receive a lower dose of Ad26.Mos4.HIV (2.5x10\^10 vp/0.25 mL) in a 0.25 mL injection volume and a lower dose of CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS-21) in a 0.5 mL injection volume on Study Day 1. Participants in Arm 2a will receive an injection Ad26.Mos4.HIV (5x10\^10 vp/0.5 mL) in a 0.5 mL injection volume and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 57.

BIOLOGICAL

CH505 TF chTrimer +ALFQ [Arm 2a]

Participants in Arm 2a will receive a rapid, dose escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/ 25 µg QS-21) on Study Days 4 (0.5 mL injection volume), 8 (0.5 mL injection volume), and 15 (0.9 mL injection volume). Participants in Arm 2a will receive a injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Day 169.

BIOLOGICAL

Placebo [Arm 2a]

Participants in Arm 2a will receive a 0.25 mL injection and a 0.5 mL injection of Placebo on Study Day 1; followed by 0.5 mL, 0.5 mL, and 0.9 mL injections of Placebo on Study Days 4, 8, and 15, respectively; followed by a 0.5 mL injection and a 1.1 mL injection of Placebo on Study Day 57; followed by a 1.1 mL injection of Placebo on Study Day 169.

BIOLOGICAL

CH505 TF chTrimer + ALFQ [Arm 1b]

Participants in Arm 1b will receive dose consistent injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS-21) in a 1.1 mL injection volume on Study Days 1, 57, and 169.

BIOLOGICAL

Placebo [Arm 1b]

Participants in Arm 1b will receive a 1.1 mL injection of Placebo on Study Days 1, 57, and 169.

BIOLOGICAL

CH505 TF chTrimer + ALFQ [Arm 2b]

Participants in Arm 2b will receive a lower dose of CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS 21) in a 0.5 mL injection volume on Study Day 1. Participants in Arm 2b will receive a rapid, dose escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/ 25 µg QS-21) on Study Days 4 (0.5 mL injection volume), 8 (0.5 mL injection volume), and 15 (0.9 mL injection volume). Participants in Arm 2b will receive a injections of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) in a 1.1 mL injection volume on Study Days 57 and 169.

BIOLOGICAL

Placebo [Arm 2b]

Participants in Arm 2b will receive a 0.5 mL injection of Placebo on Study Days 1, 4, and 8; followed by a 0.9 mL injection of Placebo on Study Day 15; followed by a 1.1 mL injection of Placebo on Study Days 57 and 169.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Makerere University Walter Reed Project (MUWRP)
Kampala, Uganda

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06205056), the sponsor (U.S. Army Medical Research and Development Command), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06205056 clinical trial studying?

This is a Phase I, randomized, double-blind, placebo-controlled clinical study to define the safety and immunogenicity resulting from a rapid dose-escalating vaccination schedule as compared to that of a co-administered, dose-consistent vaccination schedule. Participants randomized to receive vaccines will get either dose-consistent injections of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV or rapid, dose-escalating injections of CH505 TF chTrimer+ALFQ with an Ad26.Mos4.HIV prime, followed by dose-consistent injection of CH505 TF chTrimer+ALFQ co-administered with Ad26.Mos4.HIV The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06205056?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06205056?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06205056. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06205056. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.