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HIVPhase 1RV546NCT04658667

HIV Vaccine in HIV-uninfected Adults

A Phase 1 study testing IHV01, A244 and ALFQ in people with HIV, run by U.S. Army Medical Research and Development Command at 2 sites in Thailand.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
HIV
What is being tested?
IHV01, A244 and ALFQ
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
2 sitesThailand
Study dates
3 Feb 2022to 1 Jul 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 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Urinalysis blood and protein no greater than 1+ and negative glucose
  • Female-Specific Criteria:
  • Not currently pregnant or breastfeeding and not planning to become pregnant during the first 3 months after study vaccine/placebo injections
  • Negative pregnancy test for women at screening, prior to vaccination (same day), and prior to any of the invasive procedures
  • Be using an adequate birth control method for 45 days prior to receipt of vaccine/placebo and for at least 3 months after receipt of the vaccine/placebo. Adequate birth control is defined as follows: Contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), condoms, diaphragms, intrauterine device, or abstinence
  • Male-Specific Criteria:
  • Be using an adequate birth control method for at least 3 months after receipt of the vaccine/placebo. For non-vasectomized male participants with female partners of child-bearing potential this includes the use of condoms or abstinence and/or their partner's use of contraceptive medications delivered orally, intramuscularly, vaginally, or implanted, underneath the skin, surgical methods (hysterectomy or bilateral tubal ligation), diaphragms, or intrauterine device.

Who cannot join

  • 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
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  • 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
  • Study site employees who are involved in the protocol and/or may have direct access to study related area
  • Determination of a participants eligibility will be completed at screening. Final evaluation of eligibility will be based on the medical judgment of the principal investigator or designee based on his/her medical and research experience.

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Armed Forces Research Institute of Medical Sciences

    Bangkok, 10400

  • Mahidol University

    Bangkok, 10400

Other trials in Thailand

About this study

Official title: Randomized, Double Blind Evaluation of Late Boost Strategies With IHV01 (FLSC in Aluminum Phosphate) and A244 With or Without ALFQ for HIV-uninfected Participants in the HIV Vaccine Trial RV306 / WRAIR 1920

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.

Read the detailed description

The purpose of this study is to define the safety and immunogenicity of IHV01 and A244/AHFG with and without ALFQ at a full dose and at a fractional dose (one-fifth of a full dose) in a late boost setting for participants who had previously received a late boost of AIDSVAX®B/E with or without ALVAC in RV306. Safety will be assessed through the frequency of the overall and specific post-vaccination reactions. Blood, lymph nodes, sigmoid tissue, and mucosal specimens/secretions will be collected to assess humoral, cell-mediated, innate, and mucosal immune responses.

Healthy, HIV-uninfected participants, at a low risk for HIV infection, available for 12 months, who were randomized to receive active vaccine in RV306 and completed all vaccinations will be enrolled. A total of 120 participants will be enrolled across four vaccination groups. In each group, 25 participants will receive IHV01 and A244/AHFG at a full or fractional dose with or without ALFQ and 5 participants will receive placebo. Participants will receive 2 intramuscular (IM) injections into the quadriceps muscle at Day 0. The same quadriceps muscle will be used for both injections. Participants randomized to receive the vaccines will have one injection of IHV01 and one injection of A244/AHFG at a full or fractional dose with or without ALFQ, whereas participants randomized to receive placebo will get 2 separate injections of Normal Saline. All placebo injection volumes will match the vaccine injection volumes for the group in which a participant has been randomized. Participants will be followed-up for up to 12 months after enrollment. Mucosal secretion collections and endocervical cytobrush/swab procedures will be performed at Days 0, 14, 168, and 336 on consenting participants. Leukapheresis, sigmoid biopsy, and lymph node biopsy procedures will be performed only at Day 14 on consenting participants.

Conditions
HIV
Being tested
IHV01, A244, ALFQ, Placebo
Keywords
HIV Vaccines

What participants receive

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

  • IHV01Biological

    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.

  • A244Biological

    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.

  • ALFQBiological

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

  • PlaceboOther

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

Study groups in NCT04658667
Study groupRoleWhat they receive
Full dose IHV01 and A244ExperimentalParticipants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg).
Receives: Biological: IHV01; Biological: A244
Fractional dose IHV01 and A244ExperimentalParticipants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg).
Receives: Biological: IHV01; Biological: A244
Full dose IHV01 and A244 + ALFQExperimentalParticipants will receive a full dose of IHV01 (approximately 300μg) and A244 (approximately 300μg) plus ALFQ (approximately 0.5mL).
Receives: Biological: IHV01; Biological: A244; Biological: ALFQ
Fractional dose IHV01 and A244 + ALFQExperimentalParticipants will receive a fractional dose of IHV01 (approximately 60μg) and A244 (approximately 60μg) plus ALFQ (approximately 0.5mL).
Receives: Biological: IHV01; Biological: A244; Biological: ALFQ
PlaceboPlacebo comparatorNormal 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.
Receives: Other: Placebo

What is being measured

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

  1. 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.

    Measured: Days 0 to 7 post vaccination

  2. 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.

    Measured: Days 0 to 336

Secondary outcomes (2)

  1. Number of Participants with HIV-specific Binding Antibodies

    Vaccine-induced humoral immune responses are assessed using enzyme-linked immunosorbent assay (ELISA) to detect serum or plasma IgG and IgA binding antibodies to HIV at Days 0, 14, 168, and 336.Humoral mucosal immune responses in the rectal, semen and cervico-vaginal compartments will be assessed using non-invasive sampling methods (sponge, menstrual disc, and masturbation) at the same time points. Cell-mediated immune responses will be assessed utilizing invasive sigmoid and lymph node biopsies that will be performed at Day 14.

    Measured: Days 0, 14, 168, and 336.

  2. Number of Participants with HIV-specific Antigens

    Vaccine-induced immune responses are assessed using intracellular cytokine staining (ICS) assays to determine antigen-specific T-cell responses by IFN-gamma and IL-2 at Baseline and weeks 2, 24, and 48.

    Measured: Weeks 0, 2, 24, and 48

Timeline

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

  1. First posted8 Dec 2020
  2. Study start3 Feb 2022
  3. Primary completion1 Jul 2024
  4. Study completion1 Jul 2024

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
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04658667
Sponsor's protocol ID
S-19-01
Other IDs
RV 546, WRAIR 1920
Acronym
RV546
Status last verified
Jul 2025
First submitted
23 Nov 2020
Last updated
30 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 28329190

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IHV01, A244 and ALFQ in people with HIV, run by U.S. Army Medical Research and Development Command at 2 sites in Thailand.

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 17 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 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. 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. Some participants in this study may receive a placebo. 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?

Number of Participants with Local and Systemic Reactions (time frame: Days 0 to 7 post vaccination). 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 NCT04658667, which also lists 2 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 30 Jul 2025.

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