Phase 1
Completed N=24
Evaluating the Safety and Immunogenicity of an HIV-1 gp41 MPER-656 Liposome Vaccine in Healthy, HIV-uninfected Adult Participants
Source: ClinicalTrials.gov NCT03934541 ↗Enrolled (actual)
24
Serious AEs
4.2%
Results posted
May 2022
Primary outcomePrimary: Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness — 1; 0; 1; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness |
1; 0; 1; 3; 2; 11 | — |
| PRIMARY Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration |
3; 14; 1; 3; 1; 1 | — |
| PRIMARY Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms |
3; 13; 1; 3; 2; 2 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L |
14; 15; 17; 14; 21; 11 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL |
0.97; 0.73; 0.68; 0.7; 1; 0.7 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL |
14; 14; 14; 14; 13; 13 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm |
2.44; 2.09; 2.39; 2.587; 2.25; 2.027 | — |
| PRIMARY Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm |
7.61; 6.51; 7.6; 8.4; 7.28; 6.54 | — |
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Occurrence and Level of MPER-peptide-specific IgG Binding Ab Responses as Assessed by Binding Ab Multiplex Assay With MPER-656 Liposome Vaccine - Magnitudes |
6.25; 4.75; 7.75; 1; 5.38; 1 | — |
| SECONDARY Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Response Rates |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Occurrence and Level of TZM-bl Cells Responses Against HIV-1 Viral Isolates - Magnitudes |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Response |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Occurrence and Level of TZMbl/FcgRI Cells Responses Against HIV-1 Viral Isolates - Magnitudes |
NA; NA; NA; NA; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
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)
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,
*
Data sourced from ClinicalTrials.gov (NCT03934541). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.