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

NCT03934541 | Completed Phase 1 Results DMC FDA Drug

• 2 other identifiers: HVTN 13312047
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

HIV Infections

Outcome Measures

Primary Outcomes (11)

• 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 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 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 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 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 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 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 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 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 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 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 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

  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

  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

  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

  Measured at Month 2.5(V5) and Month 6.5(V7)

Study Arms (4)

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.

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.

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.

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.

Biological: Placebo for MPER-656 Liposome Vaccine

Interventions

MPER-656 Liposome Vaccine BIOLOGICAL

Administered by intramuscular injection

Group 1 (Treatment 1): MPER-656 Liposome Vaccine; Group 2 (Treatment 2): MPER-656 Liposome Vaccine

Placebo for MPER-656 Liposome Vaccine BIOLOGICAL

Administered by intramuscular injection

Group 1 (Control 1): Placebo for MPER-656 Liposome Vaccine; Group 2 (Control 2): Placebo for MPER-656 Liposome Vaccine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (6)

Alabama CRS

Birmingham, Alabama, 35294, United States

Location

Brigham and Women's Hospital Vaccine CRS (BWH VCRS)

Boston, Massachusetts, 02115-6110, United States

Location

Fenway Health (FH) CRS

Boston, Massachusetts, 02215-4302, United States

Location

Columbia P&S CRS

New York, New York, 10032-3732, United States

Location

New York Blood Center CRS

New York, New York, 10065, United States

Location

Seattle Vaccine and Prevention CRS

Seattle, Washington, 98109-1024, United States

Location

Related Publications (1)

• 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.

  PMID: 38562833 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Results Point of Contact

• Title: Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
• Organization: Fred Hutchinson Cancer Research Center

jandries@fredhutch.org

206-667-5812

Study Officials

• Lindsey Baden

  Brigham and Women's Hospital

  STUDY CHAIR

• Nathan Erdmann

  University of Alabama at Birmingham

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: April 29, 2019
• First Posted: May 2, 2019
• Study Start: August 26, 2019
• Primary Completion: February 5, 2021
• Study Completion: May 26, 2021
• Last Updated: September 25, 2025
• Results First Posted: May 12, 2022

Record last verified: 2025-05

Locations

US (6)