HIV Vaccine in HIV-uninfected Adults

NCT04658667 | Completed Phase 1 DMC FDA Drug

• 3 other identifiers: S-19-01RV 546WRAIR 1920
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to test whether delayed boosting (an extra administration of a vaccine) with the IHV01 (FLSC) protein and A244/AHFG with or without ALFQ will cause the body to make higher amounts of antibodies or different types of antibodies after the vaccination.

Conditions

HIV

Keywords

HIV Vaccines

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Local and Systemic Reactions

  Post-vaccination reactions including erythema, induration, pain/tenderness, swelling and limitation of leg movement, fever, tiredness, chills, myalgia, arthralgia, headache, nausea, and rash will be assessed and recorded on diary cards on Days 0 through 7.

  Days 0 to 7 post vaccination

• Incidence of Adverse Events, Serious Adverse Events, and Adverse Events of Special Interest (AESIs) as assessed by DAIDS

  Number of participants with Adverse Events on Day 0 through Day 336 as Assessed by Division of AIDS (DAIDS) grading scale and possible attribution to Investigational Product.

  Days 0 to 336

Secondary Outcomes (2)

• Number of Participants with HIV-specific Binding Antibodies

  Days 0, 14, 168, and 336.

• Number of Participants with HIV-specific Antigens

  Weeks 0, 2, 24, and 48

Study Arms (5)

Full dose IHV01 and A244

EXPERIMENTAL

Participants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg).

Biological: IHV01; Biological: A244

Fractional dose IHV01 and A244

EXPERIMENTAL

Participants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg).

Biological: IHV01; Biological: A244

Full dose IHV01 and A244 + ALFQ

EXPERIMENTAL

Participants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg) plus ALFQ (approximately 0.5mL).

Biological: IHV01; Biological: A244; Biological: ALFQ

Fractional dose IHV01 and A244 + ALFQ

EXPERIMENTAL

Participants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg) plus ALFQ (approximately 0.5mL).

Biological: IHV01; Biological: A244; Biological: ALFQ

Placebo

PLACEBO COMPARATOR

Normal saline will serve as a placebo for the trial. All placebo injection volumes will match the study vaccine injection volumes for the group in which a participant has been randomized.

Other: Placebo

Interventions

IHV01 BIOLOGICAL

IHV01 consists of the Full-Length Single Chain (FLSC) gp120-CD4 chimera subunit HIV-1 vaccine formulated in aluminum phosphate adjuvant. It is encoded by a synthetic gene, which contains a human codon-optimized HIV (BaL) gp120 sequence followed by human CD4D1D2, with a flexible 20-amino acid linker.

Fractional dose IHV01 and A244; Fractional dose IHV01 and A244 + ALFQ; Full dose IHV01 and A244; Full dose IHV01 and A244 + ALFQ

A244 BIOLOGICAL

A244 consists of the gp120 envelope glycoprotein HIV-1 subtype CRF\_01AE A244 derived from the CM244 CRF\_01AE. The A244 gp120 envelope has an 11 amino N-terminal deletion, similar to the A244 protein used in AIDSVAX B/E. The aluminum hydroxide fluid gel (AHFG) adjuvant that is mixed with A244 consists of Rehydragel HPA that is diluted with sterile water for injection to a concentration of 5 + /- 1mg/mL.

Fractional dose IHV01 and A244; Fractional dose IHV01 and A244 + ALFQ; Full dose IHV01 and A244; Full dose IHV01 and A244 + ALFQ

ALFQ BIOLOGICAL

ALFQ (Army Liposomal Formulation) is a liposomal adjuvant containing a synthetic monophosphoryl lipid A (MPLA) with the addition of QS-21.

Fractional dose IHV01 and A244 + ALFQ; Full dose IHV01 and A244 + ALFQ

Placebo OTHER

Normal saline (Sodium Chloride for injection USP, 0.9%) will be used as placebo.

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, HIV-uninfected male and female participants
• Prior RV306 recipients who were randomized to receive active vaccine with late boosting at month 12, 15, or 18 and who completed all vaccinations
• Have a Thai identity card
• Must be at low risk for HIV infection per investigator assessment
• Must be able to understand and complete the informed consent process
• Must be capable of reading Thai
• Must successfully complete a Test of Understanding prior to enrollment
• Must be in good general health without clinically significant medical history
• HIV-uninfected per diagnostic algorithm within 45 days of enrollment
• Laboratory screening analysis:
• Hemoglobin: Women ≥11.0 g/dL, Men ≥11.5 g/dL
• White cell count: 4,000 to 11,000 cells/mm3
• Platelets: 150,000 to 450,000/mm3
• ALT and AST ≤1.25 institutional upper limit of reference range
• Creatinine: ≤1.25 institutional upper limit of reference range

You may not qualify if:

• Asplenia: any condition resulting in the absence of a functional spleen
• Bleeding disorder diagnosed by a medical doctor (e.g., factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
• History of allergic reaction, anaphylaxis, or other serious adverse reaction to vaccines or components of the vaccines
• Volunteer has received any of the following substances:
• Chronic use of therapies that may modify immune response, such as IV immune globulin and systemic corticosteroids (in doses of \> 20 mg/day prednisone equivalent for periods exceeding 10 days) Note: The following exceptions are permitted and will not exclude study participation: use of corticosteroid nasal spray for rhinitis, 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 investigator clinical judgment) at least 14 days prior to enrollment in this study
• Blood products within 120 days prior to HIV screening
• Immunoglobulins within 30 days prior to HIV screening
• Any licensed vaccine within 14 days prior to study vaccine administration in the present study
• Receipt of any investigational HIV vaccine other than RV306 products
• Investigational research agents or vaccine within 30 days prior to enrollment in the present study
• Receipt of a Coronavirus disease 2019 (COVID-19) vaccine that has been given Emergency Use Authorization (or those that become licensed) by the Thai FDA within 14 days prior to study vaccine administration in the present study Note: Volunteers receiving a COVID-19 vaccine that requires 2 doses will not be enrolled until 14 days after the second dose has been administered
• Anti-tuberculosis prophylaxis or therapy during the past 90 days prior to enrollment
• Active sexually transmitted infection confirmed by clinical exam and diagnostic test
• Any medical, psychiatric, social condition, occupational reason, or other responsibility that, in the judgment of the investigator, is a contradiction to protocol compliance or impairs a volunteer's ability to give informed consent
• Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder; disorder requiring lithium; or within 5 years prior to enrollment, a history of suicide ideation or attempt

Sponsors & Collaborators

• U.S. Army Medical Research and Development Command: lead
• Duke University: collaborator
• University of Maryland, Baltimore: collaborator
• Case Western Reserve University: collaborator

Study Sites (2)

Armed Forces Research Institute of Medical Sciences

Bangkok, 10400, Thailand

Location

Mahidol University

Bangkok, 10400, Thailand

Location

Related Publications (2)

• 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: 32035516 BACKGROUND

• Rerks-Ngarm S, Pitisuttithum P, Excler JL, Nitayaphan S, Kaewkungwal J, Premsri N, Kunasol P, Karasavvas N, Schuetz A, Ngauy V, Sinangil F, Dawson P, deCamp AC, Phogat S, Garunathan S, Tartaglia J, DiazGranados C, Ratto-Kim S, Pegu P, Eller M, Karnasuta C, Montefiori DC, Sawant S, Vandergrift N, Wills S, Tomaras GD, Robb ML, Michael NL, Kim JH, Vasan S, O'Connell RJ; RV305 Study Team. Randomized, Double-Blind Evaluation of Late Boost Strategies for HIV-Uninfected Vaccine Recipients in the RV144 HIV Vaccine Efficacy Trial. J Infect Dis. 2017 Apr 15;215(8):1255-1263. doi: 10.1093/infdis/jix099.

  PMID: 28329190 BACKGROUND

Study Officials

• Punnee Pitisuttithum, MD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Sorachai Nitayaphan, MD

  Armed Forces Research Institute of Medical Sciences, Thailand

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 8, 2020
• Study Start: February 3, 2022
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (2)