Human Immunodeficiency Virus (HIV)Phase 1RV575NCT05423418

Safety, Tolerability, and Immunogenicity of ALFQ in a HIV Vaccine Containing A244 and B.65321 in Healthy Adults

A Phase 1 study testing A244, B.63521 and 50μg ALFQ in people with Human Immunodeficiency Virus (HIV) and AIDS Virus, run by U.S. Army Medical Research and Development Command at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Human Immunodeficiency Virus (HIV), AIDS Virus
What is being tested?: A244, B.63521 and 50μg ALFQ
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 65 participants
Where: 1 siteUnited States
Study dates: 8 Sep 2022to 29 Oct 2024
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

Healthy adults between the ages 18-55 years (inclusive)
Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
Able and willing to provide written, informed consent
Able and willing to comply with all research requirements, in the opinion of the Investigator
Agreement to refrain from blood donation during the course of the study
Minimum body weight of 110 pounds (lbs) (50kg)

Show all 22Show fewer

Laboratory Criteria within 30 days before enrollment:
Hemoglobin ≥ 12.0 g/dL for women; ≥ 12.5 g/dL for men
White Blood Cell count = 3,500-10,800 cells/mm3
Platelets ≥140,000/mm3 and ≤ 450,000/mm3
Alanine aminotransferase (ALT; SGPT) <1.25 x Upper Limit of Normal (ULN)
Serum creatinine ≤ 1.25 x institutional upper limit of the reference range
Negative HIV testing (HIV Ab / antigen 4th generation screen with reflex confirmatory RNA testing)
Negative HBsAg and hepatitis C antibody testing Note: As above, Grade 1 lab abnormalities detected on screening may be repeated at PI discretion. Persistent Grade 1 abnormalities that are felt to represent the non-pathologic baseline for the subject will be documented before a subject is enrolled in the trial and are allowable per discretion of the PI.
Birth control requirements:
All participants assigned female at birth must meet one of the following 2 criteria:
No reproductive potential due to post-menopausal status (12 months of natural [spontaneous] amenorrhea) or hysterectomy, bilateral oophorectomy, or tubal ligation
People of childbearing potential should agree to practice highly effective contraception at least 30 days before enrollment and through 3 months post-last vaccination, using one of the following methods: condoms (male or female) with spermicide; diaphragm, or cervical cap with spermicide; intrauterine device; contraceptive pills, patch, injection, intravaginal ring or other FDA-approved contraceptive method; male partner has previously undergone a vasectomy; abstinence
All participants are encouraged to engage in safe sex practices to prevent HIV acquisition
For all participants assigned female at birth, except those with a history of hysterectomy or bilateral oophorectomy, a negative β-human chorionic gonadotropin (HCG) pregnancy test (urine) on the day of enrollment and each vaccination day is required. Because tubal ligations have a failure rate that is not insignificant, and because 12 months of spontaneous amenorrhea can be a result of polycystic ovarian syndrome and does not completely preclude pregnancy, a negative β- HCG pregnancy test at enrollment and on each vaccination day is also required for participants assigned female at birth with a history of either of these).
No plans to travel outside the Washington DC metro area (DC, Maryland, and Virginia) that would prevent compliance with planned study visits
Test of Understanding (TOU) (minimum passing score of 80% with 2 attempts permitted)

Who cannot join

Receipt of any investigational HIV vaccine or investigational adjuvant
Received an investigational product in the 30 days before enrollment, or planned to receive during the study period. This does not include products with emergency use authorization.
Concurrent participation in another clinical research study
Any serious medical illness or condition
Receipt of immunoglobulins or blood products within 3 months before enrollment
Any history of anaphylaxis or allergy to study product

Show all 33Show fewer

History of sickle cell trait or disease
Pregnancy, lactation, or intention to become pregnant during the study
History of active/recent cancer still within treatment or active surveillance follow-up (except basal cell carcinoma of the skin and cervical carcinoma in situ). Treated/resolved cancers with no likelihood of recurrence may be deemed acceptable at Principal Investigator (PI) discretion.
History of autoimmune disease
History of Potentially Immune-Mediated Medical Conditions (PIMMCs)
Suspected or known current alcohol or drug abuse as defined by an alcohol intake of greater than 3 drinks a day on average for a man, and greater than 2 drinks a day on average for a woman
Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to give informed consent, participate in the study, or impair interpretation of the study data, in the opinion of the Investigator
History of splenectomy
History of confirmed or suspected immunodeficiency
History of hereditary angioedema (HAE) acquired angioedema (AAE), or idiopathic forms of angioedema
History of asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years
History of diabetes mellitus (type I or II), with the exception of gestational diabetes
History of thyroid disease (except for well controlled hypothyroidism)
History of idiopathic urticaria within the past year
History of hypertension that is not well controlled by medication or that is persistently greater than 140/95 at screening
History of bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with IM injections or blood draws
History of chronic or active neurologic disease to include seizure disorder and chronic migraine headaches. Exceptions are: i) childhood febrile seizures, or ii) seizures secondary to alcohol withdrawal more than 3 years ago
Subjects receiving any of the following substances:
Systemic immunosuppressive medications or cytotoxic medications within 12 weeks before enrollment [with the exception of a short course of corticosteroids (≤ 14 days duration or a single injection) for a self-limited condition at least 2 weeks before enrollment; inhaled, intranasal or topical steroids are not considered exclusionary
Treatment with known immunomodulators including allergy immunotherapy (other than nonsteroidal anti-inflammatory drugs [NSAIDs] or stable maintenance immunotherapy (doses not in the process of being increased), at the discretion of the Protocol Safety Review Team (PSRT)) for any reason
Live attenuated vaccines within 30 days before initial study vaccine administration
Medically indicated subunit, messenger ribonucleic acid (mRNA), or killed vaccines, e.g., influenza, pneumococcal, vaccines with Quillaja saponaria-21 (QS-21) as an adjuvant, or allergy treatment with antigen injections, planned for administration 14 days before or after study vaccine administration
History of arthritis diagnosis other than osteoarthritis
History of other diagnosed rheumatoid disorders
Has an acute illness or temperature ≥38.0 degrees Celsius (C)/100.4 degrees Fahrenheit (F) on any study injection day or within 48 hours of planned study injection.
Note: Participants will not be excluded from further consideration for enrollment and study injections. Volunteers with fever or an acute illness on the day of study injection or in the 2 days before the study injection may be re-assessed by a study physician for resolution of the condition and enrolled and receive the study injection so long as the injection is within allowable windows. Military personnel will be excluded from participation in this study, regardless of leave status due to the potential for a false-positive HIV test result on mandatory HIV testing. This could have adverse effects on deployment status.
Final evaluation of eligibility will be based on the medical judgment of the investigator based on his/her medical and research experience.

Trial locations and contacts

1 site in 1 country.

United States1 site

Walter Reed Army Institute of Research, Clinical Trials Center
Silver Spring, Maryland, 20910

Other trials in United States

About this study

Official title: A Phase 1 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of ALFQ Adjuvant in a Candidate HIV Vaccine Containing A244 and B.65321

This study will evaluate the safety and tolerability (including reactogenicity) of candidate vaccine A244/B.63521 with Army Liposome Formulation (ALF) mixed with the saponin QS-21(Quillaja saponaria-21) (ALFQ) adjuvant. The purpose of this phase I randomized, double-blind clinical trial is to optimize vaccine adjuvant ALFQ dosing by assessing safety, reactogenicity, and immunogenicity. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Sixty human immunodeficiency virus (HIV) negative participants will be enrolled to one of three arms. Vaccinations via intramuscular (IM) injection will occur at months 0, 1, and 2. All participants will receive A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ.

Read the detailed description

The purpose of this Phase I randomized, double-blind clinical trial is to optimize ALFQ dosing. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood will be collected to assess humoral, cell-mediated, and innate immune responses.

Healthy adults not living with HIV who are available for 14 months will be enrolled. A total of 60 participants will be enrolled to one of three arms, each comprised of 20 candidate vaccine recipients. Each arm will receive identical doses of A244 and B.63521 (300 micrograms of each). In addition, Arm 1 will receive 200 micrograms of ALFQ. Arm 2 will receive 100 micrograms of ALFQ. Arm 3 will receive 50 micrograms of ALFQ. The safety, reactogenicity, and immunogenicity will then be compared among the three arms to determine the optimal dose of ALFQ.

All vaccinations will be split into 2 half doses which will both be administered intramuscularly (IM) into the same deltoid muscle. Vaccinations will occur at months 0, 1, and 2. The second vaccination will be administered into the contralateral deltoid at study month 1 compared to the first vaccination at study month 0. The third vaccination at study month 2 will be administered into the same deltoid as the first vaccination at study month 0. Participants will be followed for 12 months following the last study vaccination. Safety and tolerability will be assessed with both clinical and laboratory monitoring. Vaccine- related reactions will be observed and solicited for 30 minutes post-vaccination and with the aid of a diary card and interview of participants during the 14 days post vaccination.

The information gained from the review of the diary card and the interview with the participants will be documented in the clinical study chart. In addition, adverse events (AEs) will be documented at each clinical encounter. AEs will be graded for seriousness, severity, and relationship to the investigational product.

Conditions: Human Immunodeficiency Virus (HIV), AIDS Virus
Being tested: A244, B.63521, 50μg ALFQ, 100μg ALFQ, 200μg ALFQ
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.

A244Biological
Dose of A244 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
B.63521Biological
Dose of B.63521 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
50μg ALFQBiological
Dose of ALFQ is 50μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
100μg ALFQBiological
Dose of ALFQ is 100μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).
200μg ALFQBiological
Dose of ALFQ is 200μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).

Study groups in NCT05423418
Study group	Role	What they receive
A244/B.63521 + 200 μg of ALFQ adjuvant	Active comparator	Arm 1: An injection containing 300 μg A244 plus 300 μg B.63521 with 200 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57). Receives: Biological: A244; Biological: B.63521; Biological: 200μg ALFQ
A244/B.63521 + 100 μg of ALFQ adjuvant	Active comparator	Arm 2: An injection containing 300 μg A244 plus 300 μg B.63521 with 100 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57). Receives: Biological: A244; Biological: B.63521; Biological: 100μg ALFQ
A244/B.63521 + 50 μg of ALFQ adjuvant	Active comparator	Arm 3: An injection containing 300 μg of A244 plus 300 μg B.63521 with 50 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57). Receives: Biological: A244; Biological: B.63521; Biological: 50μg ALFQ

What is being measured

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

Incidence of Adverse Events (AEs), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and unsolicited AEs
The number of participants with AEs, SAEs, AESIs, and unsolicited AEs on Day 0 through Day 337 as assessed by the Division of AIDS (DAIDS) grading scale and possible attribution to Investigational Product. The number of participants with medically attended AE will be followed until Day 393.
Measured: Days 0 to 393
Number of Participants with Local and Systemic Reactions
Post-vaccination reactions, including redness/erythema, induration, pain/tenderness, itching, warmth, fever, chills, myalgia, arthralgia, headache, nausea, fatigue, rash, and dizziness, will be assessed and recorded on diary cards on Days 0 through 14.
Measured: Days 0 to 14 post vaccination

Secondary outcomes (1)

Number of Participants with HIV-specific Binding Antibodies
Vaccine-induced humoral immune responses will be assessed by HIV-specific binding antibody assays, HIV-specific neutralizing antibody assays, and non-neutralizing antibody function assays. HIV-specific cell-mediated responses will be assessed by intracellular cytokine staining, cluster of differentiation 4 (CD4) and cluster of differentiation 8 (CD8) T cell proliferation, and related assays. Innate immune responses and genetic responses will be assessed with flow cytometric panels, DNA microarrays, and RNA sequencing. Blood draws to complete assessments will be obtained at each study visit.
Measured: Day 0 to 336

Timeline

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

8 Sep 202229 Oct 2024

First posted21 Jun 2022
Study start8 Sep 2022
Primary completion29 Oct 2024
Study completion29 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Human Immunodeficiency Virus (HIV)Studies of the same condition, open and under way.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05423418
Sponsor's protocol ID: S-21-03
Other IDs: RV575, W81XWH1120174
Acronym: RV575
Status last verified: Feb 2026
First submitted: 6 Jun 2022
Last updated: 9 Feb 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Alam SM, Liao HX, Tomaras GD, Bonsignori M, Tsao CY, Hwang KK, Chen H, Lloyd KE, Bowman C, Sutherland L, Jeffries TL Jr, Kozink DM, Stewart S, Anasti K, Jaeger FH, Parks R, Yates NL, Overman RG, Sinangil F, Berman PW, Pitisuttithum P, Kaewkungwal J, Nitayaphan S, Karasavva N, Rerks-Ngarm S, Kim JH, Michael NL, Zolla-Pazner S, Santra S, Letvin NL, Harrison SC, Haynes BF. Antigenicity and immunogenicity of RV144 vaccine AIDSVAX clade E envelope immunogen is enhanced by a gp120 N-terminal deletion. J Virol. 2013 Feb;87(3):1554-68. doi: 10.1128/JVI.00718-12. Epub 2012 Nov 21.
PubMed 23175357
Cawlfield A, Genito CJ, Beck Z, Bergmann-Leitner ES, Bitzer AA, Soto K, Zou X, Hadiwidjojo SH, Gerbasi RV, Mullins AB, Noe A, Waters NC, Alving CR, Matyas GR, Dutta S. Safety, toxicity and immunogenicity of a malaria vaccine based on the circumsporozoite protein (FMP013) with the adjuvant army liposome formulation containing QS21 (ALFQ). Vaccine. 2019 Jun 27;37(29):3793-3803. doi: 10.1016/j.vaccine.2019.05.059. Epub 2019 May 28.
PubMed 31151801
Gray GE, Bekker LG, Laher F, Malahleha M, Allen M, Moodie Z, Grunenberg N, Huang Y, Grove D, Prigmore B, Kee JJ, Benkeser D, Hural J, Innes C, Lazarus E, Meintjes G, Naicker N, Kalonji D, Nchabeleng M, Sebe M, Singh N, Kotze P, Kassim S, Dubula T, Naicker V, Brumskine W, Ncayiya CN, Ward AM, Garrett N, Kistnasami G, Gaffoor Z, Selepe P, Makhoba PB, Mathebula MP, Mda P, Adonis T, Mapetla KS, Modibedi B, Philip T, Kobane G, Bentley C, Ramirez S, Takuva S, Jones M, Sikhosana M, Atujuna M, Andrasik M, Hejazi NS, Puren A, Wiesner L, Phogat S, Diaz Granados C, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, McElrath MJ, Gilbert PB, Janes H, Corey L; HVTN 702 Study Team. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults. N Engl J Med. 2021 Mar 25;384(12):1089-1100. doi: 10.1056/NEJMoa2031499.
PubMed 33761206
Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, Nchabeleng M, Mlisana K, Metch B, de Bruyn G, Latka MH, Roux S, Mathebula M, Naicker N, Ducar C, Carter DK, Puren A, Eaton N, McElrath MJ, Robertson M, Corey L, Kublin JG; HVTN 503/Phambili study team. Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. Lancet Infect Dis. 2011 Jul;11(7):507-15. doi: 10.1016/S1473-3099(11)70098-6. Epub 2011 May 11.
PubMed 21570355
Liao HX, Tsao CY, Alam SM, Muldoon M, Vandergrift N, Ma BJ, Lu X, Sutherland LL, Scearce RM, Bowman C, Parks R, Chen H, Blinn JH, Lapedes A, Watson S, Xia SM, Foulger A, Hahn BH, Shaw GM, Swanstrom R, Montefiori DC, Gao F, Haynes BF, Korber B. Antigenicity and immunogenicity of transmitted/founder, consensus, and chronic envelope glycoproteins of human immunodeficiency virus type 1. J Virol. 2013 Apr;87(8):4185-201. doi: 10.1128/JVI.02297-12. Epub 2013 Jan 30.
PubMed 23365441
Pitisuttithum P, Nitayaphan S, Chariyalertsak S, Kaewkungwal J, Dawson P, Dhitavat J, Phonrat B, Akapirat S, Karasavvas N, Wieczorek L, Polonis V, Eller MA, Pegu P, Kim D, Schuetz A, Jongrakthaitae S, Zhou Y, Sinangil F, Phogat S, Diazgranados CA, Tartaglia J, Heger E, Smith K, Michael NL, Excler JL, Robb ML, Kim JH, O'Connell RJ, Vasan S; RV306 study group. Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e238-e248. doi: 10.1016/S2352-3018(19)30406-0. Epub 2020 Feb 6.
PubMed 32035516

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingPhase 2/3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV

All Human Immunodeficiency Virus (HIV) trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Randomized Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of ALFQ Adjuvant in a Candidate HIV Vaccine Containing A244 and B.65321
ClinicalTrials.gov ID: NCT05423418
Acronym / sponsor ID: RV575 / S-21-03
Conditions: Human Immunodeficiency Virus (HIV), AIDS Virus
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: U.S. Army Medical Research and Development CommandUS federal agency
Collaborators: US Military HIV Research Program, Henry M. Jackson Foundation for the Advancement of Military Medicine, National Institute of Allergy and Infectious Diseases (NIAID)
Study start: 8 Sep 2022 (actual)
Primary completion: 29 Oct 2024 (actual)
Study completion: 29 Oct 2024 (actual)
First posted: 21 Jun 2022 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Sequential
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
A244/B.63521 + 200 μg of ALFQ adjuvant	Active comparator	Biological: A244, Biological: B.63521, Biological: 200μg ALFQArm 1: An injection containing 300 μg A244 plus 300 μg B.63521 with 200 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).
A244/B.63521 + 100 μg of ALFQ adjuvant	Active comparator	Biological: A244, Biological: B.63521, Biological: 100μg ALFQArm 2: An injection containing 300 μg A244 plus 300 μg B.63521 with 100 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).
A244/B.63521 + 50 μg of ALFQ adjuvant	Active comparator	Biological: A244, Biological: B.63521, Biological: 50μg ALFQArm 3: An injection containing 300 μg of A244 plus 300 μg B.63521 with 50 μg of ALFQ adjuvant will be administered as an IM injection into the deltoid muscle at visits 1, 3, and 5 (corresponding to Day 1, Day 29, and Day 57).

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (22 listed)

Healthy adults between the ages 18-55 years (inclusive)
Must be at low risk for HIV infection per investigator assessment and using the study risk assessment tool.
Able and willing to provide written, informed consent
Able and willing to comply with all research requirements, in the opinion of the Investigator
Agreement to refrain from blood donation during the course of the study

Key exclusion criteria (33 listed)

Receipt of any investigational HIV vaccine or investigational adjuvant
Received an investigational product in the 30 days before enrollment, or planned to receive during the study period. This does not include products with emergency use authorization.
Concurrent participation in another clinical research study
Any serious medical illness or condition
Receipt of immunoglobulins or blood products within 3 months before enrollment

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
A244Dose of A244 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).	Biological	A244/B.63521 + 100 μg of ALFQ adjuvant, A244/B.63521 + 200 μg of ALFQ adjuvant, A244/B.63521 + 50 μg of ALFQ adjuvant
B.63521Dose of B.63521 is 300μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).	Biological	A244/B.63521 + 100 μg of ALFQ adjuvant, A244/B.63521 + 200 μg of ALFQ adjuvant, A244/B.63521 + 50 μg of ALFQ adjuvant
50μg ALFQDose of ALFQ is 50μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).	Biological	A244/B.63521 + 50 μg of ALFQ adjuvant
100μg ALFQDose of ALFQ is 100μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).	Biological	A244/B.63521 + 100 μg of ALFQ adjuvant
200μg ALFQDose of ALFQ is 200μg. Vaccine will be administered via IM injection into the same deltoid muscle (same side) for all injections at Month 0 (Day 1), Month 1 (Day 29), and Month 2 (Day 57).	Biological	A244/B.63521 + 200 μg of ALFQ adjuvant

Primary outcome

Incidence of Adverse Events (AEs), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and unsolicited AEs
Time frame: Days 0 to 393
The number of participants with AEs, SAEs, AESIs, and unsolicited AEs on Day 0 through Day 337 as assessed by the Division of AIDS (DAIDS) grading scale and possible attribution to Investigational Product. The number of participants with medically attended AE will be followed until Day 393.
Number of Participants with Local and Systemic Reactions
Time frame: Days 0 to 14 post vaccination
Post-vaccination reactions, including redness/erythema, induration, pain/tenderness, itching, warmth, fever, chills, myalgia, arthralgia, headache, nausea, fatigue, rash, and dizziness, will be assessed and recorded on diary cards on Days 0 through 14.

1 secondary outcome

Number of Participants with HIV-specific Binding Antibodies
Time frame: Day 0 to 336

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
Background: PubMed 23175357Alam SM, Liao HX, Tomaras GD, Bonsignori M, Tsao CY, Hwang KK, Chen H, Lloyd KE, Bowman C, Sutherland L, Jeffries TL Jr, Kozink DM, Stewart S, Anasti K, Jaeger FH, Parks R, Yates NL, Overman RG, Sinangil F, Berman PW, Pitisuttithum P, Kaewkungwal J, Nitayaphan S, Karasavva N, Rerks-Ngarm S, Kim JH, Michael NL, Zolla-Pazner S, Santra S, Letvin NL, Harrison SC, Haynes BF. Antigenicity and immunogenicity of RV144 vaccine AIDSVAX clade E envelope immunogen is enhanced by a gp120 N-terminal deletion. J Virol. 2013 Feb;87(3):1554-68. doi: 10.1128/JVI.00718-12. Epub 2012 Nov 21.
Background: PubMed 31151801Cawlfield A, Genito CJ, Beck Z, Bergmann-Leitner ES, Bitzer AA, Soto K, Zou X, Hadiwidjojo SH, Gerbasi RV, Mullins AB, Noe A, Waters NC, Alving CR, Matyas GR, Dutta S. Safety, toxicity and immunogenicity of a malaria vaccine based on the circumsporozoite protein (FMP013) with the adjuvant army liposome formulation containing QS21 (ALFQ). Vaccine. 2019 Jun 27;37(29):3793-3803. doi: 10.1016/j.vaccine.2019.05.059. Epub 2019 May 28.
Background: PubMed 33761206Gray GE, Bekker LG, Laher F, Malahleha M, Allen M, Moodie Z, Grunenberg N, Huang Y, Grove D, Prigmore B, Kee JJ, Benkeser D, Hural J, Innes C, Lazarus E, Meintjes G, Naicker N, Kalonji D, Nchabeleng M, Sebe M, Singh N, Kotze P, Kassim S, Dubula T, Naicker V, Brumskine W, Ncayiya CN, Ward AM, Garrett N, Kistnasami G, Gaffoor Z, Selepe P, Makhoba PB, Mathebula MP, Mda P, Adonis T, Mapetla KS, Modibedi B, Philip T, Kobane G, Bentley C, Ramirez S, Takuva S, Jones M, Sikhosana M, Atujuna M, Andrasik M, Hejazi NS, Puren A, Wiesner L, Phogat S, Diaz Granados C, Koutsoukos M, Van Der Meeren O, Barnett SW, Kanesa-Thasan N, Kublin JG, McElrath MJ, Gilbert PB, Janes H, Corey L; HVTN 702 Study Team. Vaccine Efficacy of ALVAC-HIV and Bivalent Subtype C gp120-MF59 in Adults. N Engl J Med. 2021 Mar 25;384(12):1089-1100. doi: 10.1056/NEJMoa2031499.
Background: PubMed 21570355Gray GE, Allen M, Moodie Z, Churchyard G, Bekker LG, Nchabeleng M, Mlisana K, Metch B, de Bruyn G, Latka MH, Roux S, Mathebula M, Naicker N, Ducar C, Carter DK, Puren A, Eaton N, McElrath MJ, Robertson M, Corey L, Kublin JG; HVTN 503/Phambili study team. Safety and efficacy of the HVTN 503/Phambili study of a clade-B-based HIV-1 vaccine in South Africa: a double-blind, randomised, placebo-controlled test-of-concept phase 2b study. Lancet Infect Dis. 2011 Jul;11(7):507-15. doi: 10.1016/S1473-3099(11)70098-6. Epub 2011 May 11.
Background: PubMed 23365441Liao HX, Tsao CY, Alam SM, Muldoon M, Vandergrift N, Ma BJ, Lu X, Sutherland LL, Scearce RM, Bowman C, Parks R, Chen H, Blinn JH, Lapedes A, Watson S, Xia SM, Foulger A, Hahn BH, Shaw GM, Swanstrom R, Montefiori DC, Gao F, Haynes BF, Korber B. Antigenicity and immunogenicity of transmitted/founder, consensus, and chronic envelope glycoproteins of human immunodeficiency virus type 1. J Virol. 2013 Apr;87(8):4185-201. doi: 10.1128/JVI.02297-12. Epub 2013 Jan 30.
Background: PubMed 32035516Pitisuttithum P, Nitayaphan S, Chariyalertsak S, Kaewkungwal J, Dawson P, Dhitavat J, Phonrat B, Akapirat S, Karasavvas N, Wieczorek L, Polonis V, Eller MA, Pegu P, Kim D, Schuetz A, Jongrakthaitae S, Zhou Y, Sinangil F, Phogat S, Diazgranados CA, Tartaglia J, Heger E, Smith K, Michael NL, Excler JL, Robb ML, Kim JH, O'Connell RJ, Vasan S; RV306 study group. Late boosting of the RV144 regimen with AIDSVAX B/E and ALVAC-HIV in HIV-uninfected Thai volunteers: a double-blind, randomised controlled trial. Lancet HIV. 2020 Apr;7(4):e238-e248. doi: 10.1016/S2352-3018(19)30406-0. Epub 2020 Feb 6.
Individual participant dataSharing planned: No

Related trials for Human Immunodeficiency Virus (HIV)

Enrolling by invitation
Promoting Aging and Thriving With HIV
HIV (Human Immunodeficiency Virus), Geriatric
RecruitingObservational study
Cohort of Women Living With HIV-1 and Receiving Bictegravir/Emtricitabine/Tenofovir Alafenamide
HIV (Human Immunodeficiency Virus), Pregnancy
Recruiting
The Trans-Led Care Study
Substance Abuse, Substance Addiction
RecruitingPhase 2/3
A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062)
Human Immunodeficiency Virus Type 1 (HIV-1) Infection
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV

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.

Brennan Cebula, MD principal investigator

Research Physician at U.S. Military HIV Research Program

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 22 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Feb 2026. 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 United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Incidence of Adverse Events (AEs), Serious Adverse Events (SAE), Adverse Events of Special Interest (AESI), and unsolicited AEs (time frame: Days 0 to 393). The study lists 2 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 NCT05423418, 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 9 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.