NCT05423418

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2022

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 6, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 21, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

September 8, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 29, 2024

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

2.1 years

First QC Date

June 6, 2022

Last Update Submit

February 4, 2026

Conditions

AIDS VirusHuman Immunodeficiency Virus (HIV)

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Days 0 to 14 post vaccination

Secondary Outcomes (1)

  • Number of Participants with HIV-specific Binding Antibodies

    Day 0 to 336

Study Arms (3)

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).

Biological: A244Biological: B.63521Biological: 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).

Biological: A244Biological: B.63521Biological: 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).

Biological: A244Biological: B.63521Biological: 50μg ALFQ

Interventions

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).

A244/B.63521 + 100 μg of ALFQ adjuvantA244/B.63521 + 200 μg of ALFQ adjuvantA244/B.63521 + 50 μg of ALFQ adjuvant
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).

A244/B.63521 + 100 μg of ALFQ adjuvantA244/B.63521 + 200 μg of ALFQ adjuvantA244/B.63521 + 50 μg of ALFQ adjuvant
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).

A244/B.63521 + 50 μg of ALFQ adjuvant
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).

A244/B.63521 + 100 μg of ALFQ adjuvant
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).

A244/B.63521 + 200 μg of ALFQ adjuvant

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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)
  • 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:
  • +7 more criteria

You may not qualify if:

  • 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
  • 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
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Walter Reed Army Institute of Research, Clinical Trials Center

Silver Spring, Maryland, 20910, United States

Location

Related Publications (6)

  • 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.

    PMID: 23175357BACKGROUND

  • 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.

    PMID: 31151801BACKGROUND

  • 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.

    PMID: 33761206BACKGROUND

  • 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.

    PMID: 21570355BACKGROUND

  • 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.

    PMID: 23365441BACKGROUND

  • 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.

    PMID: 32035516BACKGROUND

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV InfectionsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesSlow Virus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Brennan Cebula, MD

    Research Physician at U.S. Military HIV Research Program

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
PREVENTION
Intervention Model
SEQUENTIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2022

First Posted

June 21, 2022

Study Start

September 8, 2022

Primary Completion

October 29, 2024

Study Completion

October 29, 2024

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)