HIV InfectionsPhase 1NCT03934541

Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants

A Phase 1 study testing MPER-656 Liposome Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

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 evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults. Read more about this study

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections
What is being tested?: MPER-656 Liposome Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 6 sitesUnited States
Study dates: 26 Aug 2019to 26 May 2021
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

General and Demographic Criteria
Age of 18 to 50 years
Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Agrees not to enroll in another study of an investigational research agent while in this study

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Good general health as shown by medical history, physical exam, and screening laboratory tests
HIV-Related Criteria:
Willingness to receive HIV test results
Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see study protocol for more information)
Laboratory Inclusion Values
Hemogram/Complete blood count (CBC)
Hemoglobin greater than or equal to 11.0 g/dL for volunteers who were assigned female sex at birth, greater than or equal to 13.0 g/dL for volunteers who were assigned male sex at birth. For transgender participants who have been on hormone therapy for more than 6 consecutive months, determine hemoglobin eligibility based on the gender with which they identify (ie, a transgender female who has been on hormone therapy for more than 6 consecutive months should be assessed for eligibility using the hemoglobin parameters for persons assigned female sex at birth)
White blood cell count equal to 2,500 to 12,000 cells/mm^3 with normal differential, or differential approved by Investigator of Record (IoR) as not clinically significant
Total lymphocyte count greater than or equal to 650 cells/mm^3 with normal differential, or differential approved by IoR as not clinically significant
Remaining differential either within institutional normal range or with site physician approval
Platelets equal to 125,000 to 550,000 cells/mm^3
Chemistry
Chemistry panel: alanine aminotransferase (ALT) less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to 1.1 times the institutional upper limit of normal
Clotting and autoantibodies
Anticardiolipin IgG antibodies below the upper limit of normal
Negative antinuclear antibodies
Virology
Negative HIV-1 and -2 blood test: US volunteers must have a negative FDA-approved enzyme immunoassay (EIA)
Negative Hepatitis B surface antigen (HBsAg)
Negative anti-Hepatitis C virus antibodies (anti-HCV), or negative HCV polymerase chain reaction (PCR) if the anti-HCV is positive
Urine
Normal urine:
Negative or trace urine protein, and
Negative, trace, or 1+ blood urine hemoglobin (if +1 hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range)
Reproductive Status
Volunteers who were assigned female sex at birth: negative serum or urine beta human chorionic gonadotropin (β-HCG) pregnancy test at screening (ie, prior to randomization) and prior to study product administration on the day of study product administration. Persons who are NOT of reproductive potential due to having undergone hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
Reproductive status: A volunteer who was assigned female sex at birth:
Must agree to use effective contraception for sexual activity that could lead to pregnancy from at least 21 days prior to enrollment through the last required protocol clinic visit
Effective contraception is defined as using the following methods:
Condoms (male or female) with or without a spermicide,
Diaphragm or cervical cap with spermicide,
Intrauterine device (IUD),
Hormonal contraception,
Tubal ligation, or
Any other contraceptive method approved by the HVTN 133 Protocol Safety Review Team (PSRT),
Successful vasectomy in any partner assigned male sex at birth (considered successful if a volunteer reports that a male partner has [1] documentation of azoospermia by microscopy, or [2] a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity postvasectomy);
Or not be of reproductive potential, such as having reached menopause (no menses for 1 year) or having undergone hysterectomy, or bilateral oophorectomy,
Or be sexually abstinent.
Volunteers who were assigned female sex at birth must also agree not to seek pregnancy through alternative methods, such as artificial insemination or in vitro fertilization until after the last required protocol clinic visit

Who cannot join

General
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 133 study
Pregnant or breastfeeding

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Active duty and reserve US military personnel
Vaccines and other Injections
HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 133 PSRT will determine eligibility on a case-by-case basis.
Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 133 PSRT will determine eligibility on a case-by-case basis.
Non-HIV experimental vaccine(s) received within the last 1 year in a prior vaccine trial. Exceptions may be made by the HVTN 133 PSRT for vaccines that have subsequently undergone licensure by the FDA. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 133 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 1 year ago, eligibility for enrollment will be determined by the HVTN 133 PSRT on a case-by-case basis.
Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (eg, measles, mumps, and rubella [MMR]; oral polio vaccine [OPV]; varicella; yellow fever; live attenuated influenza vaccine)
Any vaccines that are not live attenuated vaccines and were received within 14 days prior to first vaccination (eg, tetanus, pneumococcal, Hepatitis A or B)
Allergy treatment with antigen injections within 30 days before first vaccination or that are scheduled within 14 days after first vaccination
Immune System
Immunosuppressive medications received within 168 days before first vaccination (Not exclusionary: [1] corticosteroid nasal spray; [2] inhaled corticosteroids; [3] topical corticosteroids for mild, uncomplicated dermatologic condition; or [4] a single course of oral/parenteral prednisone or equivalent at doses less than or equal to 60 mg/day and length of therapy less than 11 days with completion at least 30 days prior to enrollment)
Serious adverse reactions to vaccines or to vaccine components including history of anaphylaxis and related symptoms such as hives, respiratory difficulty, angioedema, and/or abdominal pain. (Not excluded from participation: a volunteer who had a nonanaphylactic adverse reaction to pertussis vaccine as a child.)
Immunoglobulin received within 60 days before first vaccination (for mAb see criterion above)
Autoimmune disease, current or history, (Not exclusionary: mild, wellcontrolled psoriasis)
Adverse event of special interest (AESIs): Volunteers who currently have, or have a history of any condition that could be considered an AESI for the products administered in this protocol (representative examples are listed in the study protocol)
Immunodeficiency
Clinically significant medical conditions
Clinically significant medical condition, physical examination findings, clinically significant abnormal laboratory results, or past medical history with clinically significant implications for current health. A clinically significant condition or process includes but is not limited to:
A process that would affect the immune response,
A process that would require medication that affects the immune response,
Any contraindication to repeated injections or blood draws,
A condition that requires active medical intervention or monitoring to avert grave danger to the volunteer's health or well-being during the study period,
A condition or process for which signs or symptoms could be confused with reactions to vaccine, or
Any condition specifically listed among the exclusion criteria below.
Any medical, psychiatric, occupational, or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence, assessment of safety or reactogenicity, or a volunteer's ability to give informed consent
Any contraindication that would preclude injections into both left and right deltoids
Psychiatric condition that precludes compliance with the protocol. Specifically excluded are persons with psychoses within the past 3 years, ongoing risk for suicide, or history of suicide attempt or gesture within the past 3 years.
Current anti-tuberculosis (TB) prophylaxis or therapy
Asthma exclusion criteria: Asthma other than mild, well-controlled asthma. (Symptoms of asthma severity as defined in the most recent National Asthma Education and Prevention Program (NAEPP) Expert Panel report). Exclude a volunteer who:
Uses a short-acting rescue inhaler (typically a beta 2 agonist) daily, or
Uses moderate/high dose inhaled corticosteroids, or
In the past year has had either of the following:
Greater than 1 exacerbation of symptoms treated with oral/parenteral corticosteroids;
Needed emergency care, urgent care, hospitalization, or intubation for asthma.
Diabetes mellitus type 1 or type 2. (Not exclusionary: type 2 cases controlled with diet alone or a history of isolated gestational diabetes.)
Thyroidectomy, or thyroid disease requiring medication during the last 12 months (Not exclusionary: well-controlled non-autoimmune thyroid disease)
Hypertension:
If a person has been found to have elevated blood pressure or hypertension during screening or previously, exclude for blood pressure that is not well controlled. Well-controlled blood pressure is defined in this protocol as consistently less than 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be less than or equal to 150 mm Hg systolic and less than or equal to 100 mm Hg diastolic. For these volunteers, blood pressure must be less than or equal to 140 mm Hg systolic and less than or equal to 90 mm Hg diastolic at enrollment.
If a person has NOT been found to have elevated blood pressure or hypertension during screening or previously, exclude for systolic blood pressure greater than or equal to 150 mm Hg at enrollment or diastolic blood pressure greater than or equal to 100 mm Hg at enrollment.
Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
Asplenia: any condition resulting in the absence of a functional spleen
History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.)

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

Alabama CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
Fenway Health (FH) CRS
Boston, Massachusetts, 02215-4302
Columbia P&S CRS
New York, New York, 10032-3732
New York Blood Center CRS
New York, New York, 10065
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024

Other trials in United States

About this study

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants

The purpose of this study is to evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.

Read the detailed description

This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.

Participants will be randomly assigned to four groups. Participants in Group 1 (Treatment 1) will receive 500 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 1 (Control 1) will receive placebo at Months 0, 2, and 6. Participants in Group 2 (Treatment 2) will receive 2000 mcg of MPER-656 liposome vaccine at Months 0, 2, and 6. Participants in Group 2 (Control 2) will receive placebo at Months 0, 2, and 6. Study staff will review safety data from Group 1 before deciding whether to enroll Group 2.

Participants will attend several study visits through Month 12. Visits may include physical examinations, blood and urine collection, HIV testing, risk reduction counseling, and questionnaires. Study staff will contact participants at Month 18 for follow-up health monitoring.

As of May 2020, vaccinations were discontinued for all participants.

Conditions: HIV Infections
Being tested: MPER-656 Liposome Vaccine, Placebo for MPER-656 Liposome Vaccine
Medical subject headings: HIV Infections

What participants receive

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

MPER-656 Liposome VaccineBiological
Administered by intramuscular injection
Placebo for MPER-656 Liposome VaccineBiological
Administered by intramuscular injection

Study groups in NCT03934541
Study group	Role	What they receive
Group 1 (Treatment 1): MPER-656 Liposome Vaccine	Experimental	Participants will receive 500 mcg of MPER-656 liposomes, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses at Months 0, 2, and 6. Receives: Biological: MPER-656 Liposome Vaccine
Group 1 (Control 1): Placebo for MPER-656 Liposome Vaccine	Placebo comparator	Participants will receive placebo to be administered as two 0.5 mL doses at Months 0, 2, and 6. Receives: Biological: Placebo for MPER-656 Liposome Vaccine
Group 2 (Treatment 2): MPER-656 Liposome Vaccine	Experimental	Participants will receive 2000 mcg of MPER-656 liposomes, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses at Months 0, 2, and 6. Receives: Biological: MPER-656 Liposome Vaccine
Group 2 (Control 2): Placebo for MPER-656 Liposome Vaccine	Placebo comparator	Participants will receive placebo to be administered as two 0.5 mL doses at Months 0, 2, and 6. Receives: Biological: Placebo for MPER-656 Liposome Vaccine

What is being measured

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

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Measured: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Measured: Measured during screening, Days 14, 70, 182
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Measured: Measured during screening, Days 14, 70, 182
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Measured: Measured during screening, Days 14, 70, 182
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Measured: Measured during screening, Days 14, 70, 182
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Measured: Measured during screening, Days 14, 70, 182
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm.
Measured: Measured during screening, Days 14, 70, 182
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)

Secondary outcomes (4)

Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl and TZM-bl/Fcg RI cells . Assays in both cell lines measured neutralization titers as a function of a reduction in Tat-induced luciferase reporter gene expression after a single round of infection with Env-pseudotyped viruses. Test samples were assayed against a panel of HIV-1 strains that exhibit heightened susceptible to neutralization by MPER bnAbs in TZM-bl/Fcg RI cells.
Measured: Measured at Month 2.5(V5) and Month 6.5(V7)

Timeline

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

26 Aug 201926 May 2021

First posted2 May 2019
Study start26 Aug 2019
Primary completion5 Feb 2021
Study completion26 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HIV InfectionsStudies of the same condition, open and under way.
More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
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: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03934541
Sponsor's protocol ID: HVTN 133
Other IDs: 12047
Status last verified: May 2025
First submitted: 29 Apr 2019
Last updated: 25 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Erdmann N, Williams WB, Walsh SR, Cain DW, Clark M, Tuck R, Holmes S, Clardy B, Foulger A, Parks R, Barr M, Eaton A, Saunders KO, Grunenberg N, Edlefsen P, Goepfert PA, Cohen KW, Maenza J, Mayer K, Van Tieu H, Sobieszczyk ME, Swann E, Lu H, De Rosa SC, Sagawa ZK, Lin BC, Carrol RE, McKee K, Doria-Rose NA, Louder MK, Moody MA, Fox CB, Ferrari G, Edwards RJ, Acharya P, Alam SM, Tomaras GD, Montefiori DC, Gilbert PB, McElrath MJ, Corey L, Haynes BF, Baden LR; NIAID HVTN 133 Study Group. An HIV-1 gp41 peptide-liposome vaccine elicits neutralizing epitope-targeted antibody responses in healthy individuals. medRxiv [Preprint]. 2025 Aug 22:2024.03.15.24304305. doi: 10.1101/2024.03.15.24304305.
PubMed 38562833

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?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants
ClinicalTrials.gov ID: NCT03934541
Acronym / sponsor ID: HVTN 133
Conditions: HIV Infections
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
Study start: 26 Aug 2019 (actual)
Primary completion: 5 Feb 2021 (actual)
Study completion: 26 May 2021 (actual)
First posted: 2 May 2019 (actual)
Results: Posted 12 May 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.

Detailed description

This study will evaluate the safety and immunogenicity of an HIV-1 gp41 MPER-656 liposome vaccine in healthy, HIV-uninfected adults.

As of May 2020, vaccinations were discontinued for all participants.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Group 1 (Treatment 1): MPER-656 Liposome Vaccine	Experimental	Biological: MPER-656 Liposome VaccineParticipants will receive 500 mcg of MPER-656 liposomes, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses at Months 0, 2, and 6.
Group 1 (Control 1): Placebo for MPER-656 Liposome Vaccine	Placebo comparator	Biological: Placebo for MPER-656 Liposome VaccineParticipants will receive placebo to be administered as two 0.5 mL doses at Months 0, 2, and 6.
Group 2 (Treatment 2): MPER-656 Liposome Vaccine	Experimental	Biological: MPER-656 Liposome VaccineParticipants will receive 2000 mcg of MPER-656 liposomes, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses at Months 0, 2, and 6.
Group 2 (Control 2): Placebo for MPER-656 Liposome Vaccine	Placebo comparator	Biological: Placebo for MPER-656 Liposome VaccineParticipants will receive placebo to be administered as two 0.5 mL doses at Months 0, 2, and 6.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (46 listed)

General and Demographic Criteria
Age of 18 to 50 years
Access to a participating HIV Vaccine Trials Network (HVTN) clinical research site (CRS) and willingness to be followed for the planned duration of the study
Ability and willingness to provide informed consent
Assessment of understanding: volunteer demonstrates understanding of this study; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly

Key exclusion criteria (49 listed)

General
Blood products received within 120 days before first vaccination
Investigational research agents received within 30 days before first vaccination
Body mass index (BMI) greater than or equal to 40; or BMI greater than or equal to 35 with 2 or more of the following: age greater than 45, systolic blood pressure greater than 140 mm Hg, diastolic blood pressure greater than 90 mm Hg, current smoker, known hyperlipidemia
Intent to participate in another study of an investigational research agent or any other study that requires non-HVTN HIV antibody testing during the planned duration of the HVTN 133 study

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
MPER-656 Liposome VaccineAdministered by intramuscular injection	Biological	Group 1 (Treatment 1): MPER-656 Liposome Vaccine, Group 2 (Treatment 2): MPER-656 Liposome Vaccine
Placebo for MPER-656 Liposome VaccineAdministered by intramuscular injection	Biological	Group 1 (Control 1): Placebo for MPER-656 Liposome Vaccine, Group 2 (Control 2): Placebo for MPER-656 Liposome Vaccine

Primary outcome

Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The following symptoms are considered as systemic reactogenicity if the onset date was within the periods of assessment specified in the protocol: malaise and/or fatigue, myalgia, headache, nausea, vomiting, chills, arthralgia, and body temperature. The item Max. Systemic Symptoms is the maximum of the individual systemic reactogenicities excluding body temperature for a participant.
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Time frame: Measured during screening, Days 14, 70, 182
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Time frame: Measured during screening, Days 14, 70, 182
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Time frame: Measured during screening, Days 14, 70, 182
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Time frame: Measured during screening, Days 14, 70, 182
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Time frame: Measured during screening, Days 14, 70, 182
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
The Number (Percentage) of Participants With Lab Grade > 1 for Alanine Aminotransferase (ALT), Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC) Was Summarized by Arm
Time frame: Measured during screening, Days 14, 70, 182
The number (percentage) of participants with lab grade > 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm.
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Response Rates
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.
Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Serum HIV-1-specific IgG responses against antigens listed below were on a Bio-Plex instrument (Bio-Rad) using a standardized custom HIV-1 Luminex assay, run at 1:50 dilution. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen minus reference antigen MFI. Net MFI below 1 is set to 1, and Net MFI above 22,000 is set to 22,000. Samples from post-baseline visits have positive responses if they meet three criteria: (1) net MFI >= antigen-specific threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI > 3 times baseline net MFI, and (3) experimental antigen MFI > 3 times baseline MFI. Data are excluded if the blood draw date was outside the allowable window, a participant was HIV-infected, or the reference antigen exceeds 6500 MFI.

4 secondary outcomes

Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)
Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes
Time frame: Measured at Month 2.5(V5) and Month 6.5(V7)

Results and safety

Results posted to the registry on 12 May 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	5	5
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	15	14
Control 1: Placebo for MPER-656 mo(0,2,6,12)	1	1
Control 2: Placebo for MPER-656 mo(0,2,6,12)	3	3

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness

Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12). Count of participants. Unit: Participants

Measure	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) n = 5	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) n = 15	Control 1: Placebo for MPER-656 mo(0,2,6,12) n = 1	Control 2: Placebo for MPER-656 mo(0,2,6,12) n = 3
None	1	0	1	3
Mild	2	11	0	0
Moderate	2	4	0	0
Severe	0	0	0	0
Potentially life-threatening	0	0	0	0

Primary outcome: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration

Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12). Count of participants. Unit: Participants

Measure	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) n = 5	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) n = 15	Control 1: Placebo for MPER-656 mo(0,2,6,12) n = 1	Control 2: Placebo for MPER-656 mo(0,2,6,12) n = 3
Erythema/redness: None	3	14	1	3
Erythema/redness: Not Gradable	1	1	0	0
Erythema/redness: Gr 1: 2.5 to less than 5 cm dim.	0	0	0	0
Erythema/redness: Gr 2: 5 to less than 10 cm dim.	0	0	0	0
Erythema/redness: Gr 3: >=10 cm dim.	1	0	0	0
Erythema/redness: Gr 3: Complications AE	0	0	0	0
Erythema/redness: Gr 4: Complications AE	0	0	0	0
Induration/swelling: None	3	12	1	3

Primary outcome: Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms

Time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12). Count of participants. Unit: Participants

Measure	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) n = 5	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) n = 15	Control 1: Placebo for MPER-656 mo(0,2,6,12) n = 1	Control 2: Placebo for MPER-656 mo(0,2,6,12) n = 3
Arthralgia: None	3	13	1	3
Arthralgia: Mild	2	2	0	0
Arthralgia: Moderate	0	0	0	0
Arthralgia: Severe	0	0	0	0
Arthralgia: Potentially life-threatening	0	0	0	0
Chills: None	4	14	1	2
Chills: Mild	1	1	0	1
Chills: Moderate	0	0	0	0

Primary outcome: Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L

Time frame: Measured during screening, Days 14, 70, 182. Median (Inter-Quartile Range). Unit: U/L

Measure	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12) n = 5	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12) n = 15	Control 1: Placebo for MPER-656 mo(0,2,6,12) n = 1	Control 2: Placebo for MPER-656 mo(0,2,6,12) n = 3
Alanine Aminotransferase (U/L)-Baseline	14 (13 to 20)	15 (11 to 20)	17 (17 to 17)	14 (11 to 17)
Alanine Aminotransferase (U/L)-Day 14	21 (10 to 23)	11 (10 to 19)	15 (15 to 15)	12 (8 to 14)
Alanine Aminotransferase (U/L)-Day 70	14 (11 to 27)	14 (11 to 16)	15 (15 to 15)	9 (9 to 13)
Alanine Aminotransferase (U/L)-Day 182	19 (13.5 to 40.5)	16 (14 to 18)	16 (16 to 16)	13 (13 to 13)

Population analysed: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Serious adverse events of more than 30 days were collected through month 12. All other AEs were collected through 30 days after each vaccination (vaccinations were given at Months 0, 2, 6,12).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	0 of 5 (0%)	4 of 5 (80%)	0 of 5
Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	1 of 15 (6.7%)	10 of 15 (66.7%)	0 of 15
Control 1: Placebo for MPER-656 mo(0,2,6,12)	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Control 2: Placebo for MPER-656 mo(0,2,6,12)	0 of 3 (0%)	2 of 3 (66.7%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38562833Erdmann N, Williams WB, Walsh SR, Cain DW, Clark M, Tuck R, Holmes S, Clardy B, Foulger A, Parks R, Barr M, Eaton A, Saunders KO, Grunenberg N, Edlefsen P, Goepfert PA, Cohen KW, Maenza J, Mayer K, Van Tieu H, Sobieszczyk ME, Swann E, Lu H, De Rosa SC, Sagawa ZK, Lin BC, Carrol RE, McKee K, Doria-Rose NA, Louder MK, Moody MA, Fox CB, Ferrari G, Edwards RJ, Acharya P, Alam SM, Tomaras GD, Montefiori DC, Gilbert PB, McElrath MJ, Corey L, Haynes BF, Baden LR; NIAID HVTN 133 Study Group. An HIV-1 gp41 peptide-liposome vaccine elicits neutralizing epitope-targeted antibody responses in healthy individuals. medRxiv [Preprint]. 2025 Aug 22:2024.03.15.24304305. doi: 10.1101/2024.03.15.24304305.

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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.

Lindsey Baden study chair

Brigham and Women's Hospital

Nathan Erdmann study chair

University of Alabama at Birmingham

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MPER-656 Liposome Vaccine in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 6 sites in United States.

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 46 inclusion and 49 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 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. 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?

Yes. Results are posted in the registry (first posted 12 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness (time frame: Measured through 7 days after each vaccine dose at Months (0,2,6,12)). The study lists 11 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 NCT03934541, which also lists 1 linked publication.

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 25 Sep 2025.