AzTrials
AzTrials

Human Immunodeficiency VirusPhase 1RV591NCT06205056

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

A Phase 1 study testing Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a] and Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a] in people with Human Immunodeficiency Virus, run by U.S. Army Medical Research and Development Command at 1 site in Uganda.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Human Immunodeficiency Virus
What is being tested?
Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a] and Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
78 participants
Where
1 siteUganda
Study dates
30 Jan 2024to Jun 2026
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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for participation:
  • Male or female, aged 18 to 50 years, inclusive, at the time of enrollment
  • Willing and able to read, sign, and date the informed consent form
  • 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
  • Willing and able to comply with study requirements and be available to attend visits for the duration of study participation
  • Must have the means to be contacted by telephone for the duration of study participation
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  • Willing to have photo or fingerprint taken for identification purposes
  • At low risk for HIV acquisition per investigator assessment
  • Agrees to refrain from donating blood or plasma outside of this study for at least the duration of study participation
  • 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:
  • first diagnosed within the 12 weeks prior to screening; or
  • worsening in terms of clinical outcome in the 24 weeks prior to screening; or
  • 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.
  • Laboratory criteria within 45 days prior to enrollment:
  • Hemoglobin ≥11.0 g/dL for females; ≥12.5 g/dL for males
  • White blood cells (WBC) range: 3,500-9,000 cells/mm^3
  • Platelets between 150,000 - 450,000 cells/µL
  • Normal liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤1.25x upper limit of normal
  • Serum creatinine ≤1.25x upper limit of normal
  • Urinalysis: blood and protein less than 1+ and negative glucose
  • 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.
  • Negative hepatitis B surface antigen (HbsAg)
  • 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.
  • Biological Male-Specific Criteria:
  • Must agree to refrain from donating sperm from screening until at least 12 weeks after the last study injection
  • Must agree to consistently use a method of contraception from screening until at least 12 weeks after the last study injection
  • Biological Female-Specific Criteria:
  • 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
  • Must have a negative human chorionic gonadotropin (β-HCG) pregnancy test (urine) at screening and at timepoints throughout the study, if of childbearing potential
  • 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

Who cannot join

  • Volunteers will be excluded if any of the following apply:
  • Body mass index (BMI) <18.0 kg/m^2 and >35.1 kg/m^2
  • Has a condition which affects immune function, including but not limited to:
  • Known or suspected congenital or acquired immunodeficiency
  • 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.
  • Thyroid disease
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  • Asplenia, defined as any condition resulting in the absence of a functional spleen
  • Conditions and diagnoses defined as potential immune-mediated medical conditions
  • 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.
  • 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
  • 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
  • Has a personal or family history of a bleeding disorder, such as factor deficiency, coagulopathy, or platelet disorder requiring special precautions
  • 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
  • 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)
  • Hepatitis B surface antigen positive at any time in the past
  • Untreated syphilis infection as confirmed by RPR or a similar quantitative nontreponemal test such as VDRL
  • Prior receipt or plans to receive any of the following:
  • 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.
  • Blood products within 120 days prior to enrollment or at any time during participation in this study
  • Immunoglobulins within 90 days prior to enrollment or at any time during participation in this study
  • 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
  • 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
  • Any investigational study products for conditions other than HIV within 90 days prior to enrollment or at any time during participation in this study
  • An investigational HIV vaccine or HIV antibody at any time prior to or during participation in this study
  • 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].
  • Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine, vaccine component, or latex
  • 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
  • Has tattoos, scars, or other marks that would, in the opinion of the physician investigator, interfere with the assessment of the injection sites
  • Current or history of substance abuse within 12 months prior to enrollment that, in the physician investigator's opinion, could interfere with reliable participation
  • 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
  • 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
  • Study site employee
  • Final evaluation of eligibility will be based on the medical judgment of the physician investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Grace Mirembe, MBChB, MMed contact

+256 312 330400

gmirembe@muwrp.org

Hannah Kibuuka, MBChB, MMed, MPH contact

+256 312 330400

hkibuuka@muwrp.org

Uganda1 site, 1 recruiting

  • Makerere University Walter Reed Project (MUWRP)

    Kampala

    Grace Mirembe, MBChB, MMed, +256 312 330400, gmirembe@muwrp.org

    Betty Mwesigwa, MBChB, MSc, +256 312 330400, bmwesigwa@muwrp.org

    Recruiting

Other trials in Uganda

About this study

Official title: 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

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

Read the detailed description

This study is exploratory and will be a randomized, placebo-controlled, double-blind trial. A total of 78 healthy male and female participants, aged 18 to 50 years, who are at low risk for Human Immunodeficiency Virus (HIV) acquisition will be enrolled and randomized across four Arms (1a, 2a, 1b, and 2b). Enrollment will be completed in two parts, dubbed Part A and Part B. In Part A, up to 28 participants will be randomized across Arms 1a and 2a, with up to 14 participants per Arm. Within these Arms, participants will be randomized 11:3 to active vaccine versus placebo (normal saline) and followed for up to 18 months. In Part B, participants will be randomized across Arms 1b and 2b, with 25 individuals per Arm. Within these Arms, participants will be randomized 4:1 to active study vaccine versus placebo (normal saline) and followed for up to 18 months. All products will be administered by intramuscular (IM) injection into the same quadriceps muscle at each product administration visit.

Participants randomized to receive active study vaccines in Arm 1a will receive dose-consistent injections of Ad26.Mos4.HIV (5x1010 viral particles [vp]/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) co administered on Study Days 1 and 57, followed by a dose-consistent injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) on Day 169.

Participants randomized to receive active study vaccines in Arm 2a will receive a lower dose of Ad26.Mos4.HIV (2.5x1010 vp/0.25 mL) and CH505 TF chTrimer (30 µg)+ALFQ (50 µg MPLA/25 µg QS 21) on Study Day 1, followed by rapid dose escalating injections of CH505 TF chTrimer (100 µg, 150 µg, and 300 µg)+ALFQ (50 µg MPLA/25 µg QS 21) through Study Day 15, followed by injections of Ad26.Mos4.HIV (5x1010 vp/0.5 mL) and CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) on Study Day 57, followed by an injection of CH505 TF chTrimer (300 µg)+ALFQ (200 µg MPLA/100 µg QS 21) on Study Day 169.

Participants randomized to receive active study vaccines in Arm 1b will have a similar dosing regimen as participants in Arm 1a but without Ad26.Mos4.HIV on Study Days 1 and 57.

Participants randomized to receive active study vaccines in Arm 2b will have a similar dosing regimen as participants in Arm 2a but without Ad26.Mos4.HIV on Study Days 1 and 57.

Enrollment into Arms 1a and 2a will be concurrent. Sentinel groups, comprised of the first eight participants enrolled across Arms 1a and 2a (4 participants per Arm; 3:1 active vaccine to placebo in each Arm), will be included to facilitate an assessment of the safety of the combination of products and vaccination regimens. For each sentinel group, the Safety Monitoring Committee (SMC) will review safety data, covering a period of 7 days post-injection, to determine if it is safe to continue enrollment in that Arm. For participants in Arm 1a, this includes safety data from immediately after the first study injection through Day 8. For participants in Arm 2a, this includes safety data from immediately after the first injection through Day 22 (i.e., through 7 days post-Day 15 injection). While Arm 1a and Arm 2a sentinel safety reviews can occur separately, safety data from both Arms will be considered. For Arms 1a and 2a, the remaining 20 participants (10 per Arm) will be enrolled at a rate of up to 3 participants per week (up to 2 in the first week after re-initiation of enrollment) only after the SMC confirms that it is safe to continue, and the Sponsor gives their approval to proceed.

Enrollment in Part B (i.e., Arms 1b and 2b) will be initiated after enrollment in Part A (i.e., Arms 1a and 2a) has concluded, the SMC confirms that it is safe to continue after reviewing 7- or 21-days of post injection safety data from all Part A participants, and the Sponsor gives their approval to proceed. Part B enrollment will be similar to that in Part A, including concurrent enrollment into Arms 1b and 2b; the inclusion of sentinel groups, comprised of the first eight participants enrolled across Arms 1b and 2b (4 participants per Arm; 3:1 active vaccine to placebo in each Arm); and SMC review once 7- or 21-days of post-injection safety data is available from Arm 1b and 2b sentinel groups, respectively. Enrollment of the remaining 42 participants (21 per Arm) will occur only after the SMC confirms that it is safe to continue, and the Sponsor gives their approval to proceed.

Enrollment in Part B will be restricted to a rate of up to 3 participants per week; however, the rate of enrollment may increase if, based on available safety data the risk to participants will not be negatively impacted, and only if approved by the Sponsor.

Inguinal lymph node biopsies will be performed on Study Day 71 in a subset of participants from all four study Arms who provide consent for the optional procedure.

Being tested
Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a], Placebo [Arm 1a], Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a], CH505 TF chTrimer +ALFQ [Arm 2a]
Medical subject headings
Acquired Immunodeficiency Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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

  • CH505 TF chTrimer + ALFQ [Arm 1a]Biological

    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.

  • Placebo [Arm 1a]Biological

    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.

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

    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.

  • CH505 TF chTrimer +ALFQ [Arm 2a]Biological

    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.

  • Placebo [Arm 2a]Biological

    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.

  • CH505 TF chTrimer + ALFQ [Arm 1b]Biological

    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.

  • Placebo [Arm 1b]Biological

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

  • CH505 TF chTrimer + ALFQ [Arm 2b]Biological

    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.

  • Placebo [Arm 2b]Biological

    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.

Study groups in NCT06205056
Study groupRoleWhat they receive
Ad26.Mos4.HIV and CH505 TF chTrimer + ALFQ [Arm 1a]ExperimentalArm 1a [Co-administration]: 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, followed by 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 (11 participants) OR a 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 (3 participants)
Receives: Biological: Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a]; Biological: CH505 TF chTrimer + ALFQ [Arm 1a]; Biological: Placebo [Arm 1a]
CH505 TF chTrimer + ALFQ [Arm 1b]ExperimentalArm 1b [Trimer Bolus Administration]: 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 (20 participants) OR a 1.1 mL injection of Placebo on Study Days 1, 57, and 169 (5 participants)
Receives: Biological: CH505 TF chTrimer + ALFQ [Arm 1b]; Biological: Placebo [Arm 1b]
Ad26.Mos4.HIV and CH505 TF chTrimer + ALFQ [Arm 2a]ExperimentalArm 2a [Rapidvax]: A lower dose of Ad26.Mos4.HIV (2.5x10^10 vp/0.25mL) in a 0.25mL injection volume (InjV) + lower dose of CH505 TF chTrimer (30 µg)+ALFQ (50µg MPLA/25µg QS-21) in a 0.5mL InjV [Study Day (SD) 1]; followed by rapid, dose escalating injections of CH505 TF chTrimer (100µg, 150µg, and 300µg)+ALFQ (50µg MPLA/25µg QS-21) on SD's 4, 8 (0.5mL InjV), and 15 (0.9mL InjV); followed by injections of Ad26.Mos4.HIV (5x10^10 vp/0.5mL) in a 0.5mL InjV + CH505 TF chTrimer (300µg)+ALFQ (200µg MPLA/100µg QS 21) in a 1.1mL InjV on SD 57; followed by an injection of CH505 TF chTrimer (300µg)+ALFQ (200µg MPLA/100µg QS 21) in a 1.1mL InjV on SD 169 (11 participants) OR a 0.25mL injection and a 0.5mL injection of Placebo [P] on SD 1; followed by 0.5mL, 0.5mL, and 0.9 mL injections of [P] on SD's 4, 8, and 15, respectively; followed by a 0.5mL injection + 1.1mL injection of [P] on SD 57; followed by a 1.1mL injection of [P] on SD 169 (3 participants)
Receives: Biological: Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a]; Biological: CH505 TF chTrimer +ALFQ [Arm 2a]; Biological: Placebo [Arm 2a]
CH505 TF chTrimer + ALFQ [Arm 2b]ExperimentalArm 2b [Trimer Rapidvax]: 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; followed by 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); followed by 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 (20 participants); OR 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 (5 participants)
Receives: Biological: CH505 TF chTrimer + ALFQ [Arm 2b]; Biological: Placebo [Arm 2b]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurrence and severity of solicited local and systemic adverse events (AEs) following candidate vaccine administration

    Occurrence and severity of solicited local and systemic adverse events (AEs) following candidate vaccine administration.

    Measured: Day 0 - Day 505

  2. Occurrence, severity, and relationship to vaccination of unsolicited adverse events after candidate vaccine administration

    Occurrence, severity, and relationship to vaccination of unsolicited adverse events after candidate vaccine administration.

    Measured: Day 0 - Day 505

  3. Occurrence of serious adverse events (SAEs) following candidate vaccine administration

    Occurrence of serious adverse events (SAEs) following candidate vaccine administration.

    Measured: Day 0 - Day 505

  4. Occurrence of adverse events of special interest (AESIs) following candidate vaccine administration

    Occurrence of adverse events of special interest (AESIs) following candidate vaccine administration.

    Measured: Day 0 - Day 505

Secondary outcomes (2)

  1. Quantify IgG binding antibodies to HIV Env in terms of magnitude, breadth, and durability between Arms

    Quantify IgG binding antibodies to HIV Env in terms of magnitude between Arms. HIV-specific Binding Antibody ELISA Assays will be performed to detect plasma IgG and IgA binding antibodies to HIV-1 Envelope antigens and assess their magnitude between Arms.

    Measured: Visit Days 1, 4, 8, 15, 29, 57, 71, 85,169, 183, and 337

  2. Quantify neutralizing antibodies to HIV Env in terms of magnitude, breadth, and durability between Arms

    Quantify rate of neutralizing antibodies to HIV Env in terms of magnitude between Arms. Neutralizing Antibody Assays will be measured as a function of reductions in luciferase (Luc) reporter gene expression after a single round of infection in TZM-bl cells using high throughput analysis.

    Measured: Visit Days 1, 4, 8, 15, 29, 57, 71, 85,169, 183, and 337

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2024
  2. Study start30 Jan 2024
  3. Primary completionDec 2025 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06205056
Sponsor's protocol ID
S-22-03
Other IDs
W81XWH-18-2-0040
Acronym
RV591
Status last verified
Oct 2025
First submitted
10 Oct 2023
Last updated
7 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pitisuttithum P, Gilbert P, Gurwith M, Heyward W, Martin M, van Griensven F, Hu D, Tappero JW, Choopanya K; Bangkok Vaccine Evaluation Group. Randomized, double-blind, placebo-controlled efficacy trial of a bivalent recombinant glycoprotein 120 HIV-1 vaccine among injection drug users in Bangkok, Thailand. J Infect Dis. 2006 Dec 15;194(12):1661-71. doi: 10.1086/508748. Epub 2006 Nov 3.

    PubMed 17109337

  • Pauthner M, Havenar-Daughton C, Sok D, Nkolola JP, Bastidas R, Boopathy AV, Carnathan DG, Chandrashekar A, Cirelli KM, Cottrell CA, Eroshkin AM, Guenaga J, Kaushik K, Kulp DW, Liu J, McCoy LE, Oom AL, Ozorowski G, Post KW, Sharma SK, Steichen JM, de Taeye SW, Tokatlian T, Torrents de la Pena A, Butera ST, LaBranche CC, Montefiori DC, Silvestri G, Wilson IA, Irvine DJ, Sanders RW, Schief WR, Ward AB, Wyatt RT, Barouch DH, Crotty S, Burton DR. Elicitation of Robust Tier 2 Neutralizing Antibody Responses in Nonhuman Primates by HIV Envelope Trimer Immunization Using Optimized Approaches. Immunity. 2017 Jun 20;46(6):1073-1088.e6. doi: 10.1016/j.immuni.2017.05.007.

    PubMed 28636956

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Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ad26.Mos4.HIV in CH505 TF chTrimer + ALFQ [Arm 1a], CH505 TF chTrimer + ALFQ [Arm 1a] and Ad26.Mos4.HIV in CH505 TF chTrimer +ALFQ [Arm 2a] in people with Human Immunodeficiency Virus, run by U.S. Army Medical Research and Development Command at 1 site in Uganda.

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 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: looking for participants now, as of the sponsor's last update on 7 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Uganda. 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?

Contact Grace Mirembe, MBChB, MMed (+256 312 330400, gmirembe@muwrp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurrence and severity of solicited local and systemic adverse events (AEs) following candidate vaccine administration (time frame: Day 0 - Day 505). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06205056, which also lists 6 linked publications.

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 7 Oct 2025.

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