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

• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT03934541
• Collaborator: (none)
• Enrollment: 24
• Locations: 6
• Arms: 4
• Actual Duration (Months): 21
• Patients Per Site: 4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infections	Biological: MPER-656 Liposome Vaccine; Biological: Placebo for MPER-656 Liposome Vaccine	Phase 1

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: Aug 26, 2019
• Actual Primary Completion Date: Feb 5, 2021
• Actual Study Completion Date: May 26, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group 1 (Treatment 1): MPER-656 Liposome Vaccine 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; Administered by intramuscular injection
Placebo Comparator: Group 1 (Control 1): Placebo for MPER-656 Liposome Vaccine 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; Administered by intramuscular injection
Experimental: Group 2 (Treatment 2): MPER-656 Liposome Vaccine 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; Administered by intramuscular injection
Placebo Comparator: Group 2 (Control 2): Placebo for MPER-656 Liposome Vaccine 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; Administered by intramuscular injection

Outcome Measures

Primary Outcome Measures

1. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness [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

2. Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration [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

3. Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms [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.

4. Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L [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.

5. Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL [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.

6. Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL [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.

7. Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm [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.

8. Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm [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.

9. 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]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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,

• 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

Exclusion Criteria:

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

• 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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alabama CRS	Birmingham	Alabama	United States	35294
2	Brigham and Women's Hospital Vaccine CRS (BWH VCRS)	Boston	Massachusetts	United States	02115-6110
3	Fenway Health (FH) CRS	Boston	Massachusetts	United States	02215-4302
4	Columbia P&S CRS	New York	New York	United States	10032-3732
5	New York Blood Center CRS	New York	New York	United States	10065
6	Seattle Vaccine and Prevention CRS	Seattle	Washington	United States	98109-1024

Sponsors and Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

• Study Chair: Lindsey Baden, Brigham and Women's Hospital
• Study Chair: Nathan Erdmann, University of Alabama at Birmingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 13, 2019
• Informed Consent Form - Jul 10, 2019

More Information

Publications

None provided.

• Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
• ClinicalTrials.gov Identifier: NCT03934541
• Other Study ID Numbers: HVTN 133; 12047
• First Posted: May 2, 2019
• Last Update Posted: Jul 6, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: HIV Infections; Vaccines

Study Results

Participant Flow

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Period Title: Overall Study
STARTED	5	15	1	3
COMPLETED	5	14	1	3
NOT COMPLETED	0	1	0	0

Baseline Characteristics

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)	Total
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Total of all reporting groups
Overall Participants	5	15	1	3	24
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	24	29	30	23	27
Age, Customized (Count of Participants)
Less than 18 years	0 0%	0 0%	0 0%	0 0%	0 0%
18 - 20 years	0 0%	1 6.7%	0 0%	0 0%	1 4.2%
21 - 30 years	3 60%	7 46.7%	1 100%	2 66.7%	13 54.2%
31 - 40 years	2 40%	7 46.7%	0 0%	1 33.3%	10 41.7%
41 - 50 years	0 0%	0 0%	0 0%	0 0%	0 0%
Above 50 years	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	2 40%	12 80%	0 0%	2 66.7%	16 66.7%
Male	3 60%	3 20%	1 100%	1 33.3%	8 33.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%	1 33.3%	1 4.2%
Not Hispanic or Latino	5 100%	15 100%	1 100%	2 66.7%	23 95.8%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	0 0%	3 20%	0 0%	0 0%	3 12.5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	1 20%	1 6.7%	0 0%	0 0%	2 8.3%
White	4 80%	11 73.3%	1 100%	2 66.7%	18 75%
More than one race	0 0%	0 0%	0 0%	1 33.3%	1 4.2%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	5 100%	15 100%	1 100%	3 100%	24 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Description	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
Time Frame	Measured through 7 days after each vaccine dose at Months (0,2,6,12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
None	1 20%	0 0%	1 100%	3 100%
Mild	2 40%	11 73.3%	0 0%	0 0%
Moderate	2 40%	4 26.7%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%

2. Primary Outcome

Title	Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Description	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
Time Frame	Measured through 7 days after each vaccine dose at Months (0,2,6,12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
None	3 60%	14 93.3%	1 100%	3 100%
Not Gradable	1 20%	1 6.7%	0 0%	0 0%
Gr 1: 2.5 to less than 5 cm dim.	0 0%	0 0%	0 0%	0 0%
Gr 2: 5 to less than 10 cm dim.	0 0%	0 0%	0 0%	0 0%
Gr 3: >=10 cm dim.	1 20%	0 0%	0 0%	0 0%
Gr 3: Complications AE	0 0%	0 0%	0 0%	0 0%
Gr 4: Complications AE	0 0%	0 0%	0 0%	0 0%
None	3 60%	12 80%	1 100%	3 100%
Not Gradable	1 20%	1 6.7%	0 0%	0 0%
Gr 1: 2.5 to less than 5 cm dim.	0 0%	2 13.3%	0 0%	0 0%
Gr 2: 5 to less than 10 cm dim.	0 0%	0 0%	0 0%	0 0%
Gr 3: >=10 cm dim.	1 20%	0 0%	0 0%	0 0%
Gr 3: Complications AE	0 0%	0 0%	0 0%	0 0%
Gr 4: Complications AE	0 0%	0 0%	0 0%	0 0%
None	2 40%	12 80%	1 100%	3 100%
Not Gradable	2 40%	1 6.7%	0 0%	0 0%
Gr 1: 2.5 to less than 5 cm dim.	0 0%	2 13.3%	0 0%	0 0%
Gr 2: 5 to less than 10 cm dim.	0 0%	0 0%	0 0%	0 0%
Gr 3: >=10 cm dim.	1 20%	0 0%	0 0%	0 0%
Gr 3: Complications AE	0 0%	0 0%	0 0%	0 0%
Gr 4: Complications AE	0 0%	0 0%	0 0%	0 0%

3. Primary Outcome

Title	Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Description	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.
Time Frame	Measured through 7 days after each vaccine dose at Months (0,2,6,12)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
None	3 60%	13 86.7%	1 100%	3 100%
Mild	2 40%	2 13.3%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	4 80%	14 93.3%	1 100%	2 66.7%
Mild	1 20%	1 6.7%	0 0%	1 33.3%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	3 60%	9 60%	1 100%	1 33.3%
Mild	2 40%	5 33.3%	0 0%	2 66.7%
Moderate	0 0%	1 6.7%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	1 20%	8 53.3%	1 100%	2 66.7%
Mild	4 80%	5 33.3%	0 0%	1 33.3%
Moderate	0 0%	2 13.3%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	3 60%	10 66.7%	1 100%	3 100%
Mild	2 40%	4 26.7%	0 0%	0 0%
Moderate	0 0%	1 6.7%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	4 80%	10 66.7%	1 100%	2 66.7%
Mild	1 20%	5 33.3%	0 0%	1 33.3%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	1 20%	3 20%	1 100%	1 33.3%
Mild	4 80%	9 60%	0 0%	2 66.7%
Moderate	0 0%	3 20%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%
None	5 100%	15 100%	1 100%	3 100%
Mild	0 0%	0 0%	0 0%	0 0%
Moderate	0 0%	0 0%	0 0%	0 0%
Severe	0 0%	0 0%	0 0%	0 0%
Potentially life-threatening	0 0%	0 0%	0 0%	0 0%

4. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT) in U/L
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 70, 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
Alanine Aminotransferase (U/L)-Baseline	14	15	17	14
Alanine Aminotransferase (U/L)-Day 14	21	11	15	12
Alanine Aminotransferase (U/L)-Day 70	14	14	15	9
Alanine Aminotransferase (U/L)-Day 182	19	16	16	13

5. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 70, 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
Creatinine (mg/dL)-Baseline	0.97	0.73	0.68	0.7
Creatinine (mg/dL)-Day 14	1	0.7	0.74	0.82
Creatinine (mg/dL)-Day 70	0.92	0.72	0.76	0.83
Creatinine (mg/dL)-Day 182	0.88	0.78	0.82	0.71

6. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 70, 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
Hemoglobin (g/dL)-Baseline	14	14	14	14
Hemoglobin (g/dL)-Day 14	13	13	13	13
Hemoglobin (g/dL)-Day 70	13	13	15	12
Hemoglobin (g/dL)-Day 182	14	12	14	14

7. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000 Cells/Cubic mm
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 70, 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
Lymphocytes (1000 cells/cubic mm)-Baseline	2.44	2.09	2.39	2.587
Lymphocytes (1000 cells/cubic mm)-Day 14	2.25	2.027	1.87	1.876
Lymphocytes (1000 cells/cubic mm)-Day 70	2.27	2.017	1.88	1.811
Lymphocytes (1000 cells/cubic mm)-Day 182	2.53	2.335	1.77	2.67
Neutrophils (1000 cells/cubic mm)-Baseline	4.42	3.79	4.48	5.216
Neutrophils (1000 cells/cubic mm)-Day 14	3.99	3.76	1.99	5.7
Neutrophils (1000 cells/cubic mm)-Day 70	3.8	3.47	1.55	5.412
Neutrophils (1000 cells/cubic mm)-Day 182	4.135	3.93	1.91	5.78

8. Primary Outcome

Title	Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Description	For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Time Frame	Measured during screening, Days 14, 70, 182

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
WBC (1000 cells/cubic mm)-Baseline	7.61	6.51	7.6	8.4
WBC (1000 cells/cubic mm)-Day 14	7.28	6.54	4.53	9.83
WBC (1000 cells/cubic mm)-Day 70	6.93	6.38	4.04	8.3
WBC (1000 cells/cubic mm)-Day 182	7.91	7.12	4.32	9.19
Platelets (1000 cells/cubic mm)-Baseline	229	250	242	290
Platelets (1000 cells/cubic mm)-Day 14	218	277	227	306
Platelets (1000 cells/cubic mm)-Day 70	237	278	260	298
Platelets (1000 cells/cubic mm)-Day 182	235.8	285.5	231	317

9. Primary Outcome

Title	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
Description	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

Outcome Measure Data

Analysis Population Description

Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory

Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)	Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)	Control 1: Placebo for MPER-656 mo(0,2,6,12)	Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.	MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.	Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
Measure Participants	5	15	1	3
Alanine Aminotransferase (U/L)-Baseline	0 0%	0 0%	0 0%	0 0%
Alanine Aminotransferase (U/L)-Day 14	0 0%	0 0%	0 0%	0 0%
Alanine Aminotransferase (U/L)-Day 70	0 0%	0 0%	0 0%	0 0%
Alanine Aminotransferase (U/L)-Day 182	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Baseline	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 14	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 70	0 0%	0 0%	0 0%	0 0%
Hemoglobin (g/dL)-Day 182	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)-Baseline	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)-Day 14	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)-Day 70	0 0%	0 0%	0 0%	0 0%
Creatinine (mg/dL)-Day 182	0 0%	0 0%	0 0%	0 0%
WBC (1000 cells/cubic mm)-Baseline	0 0%	0 0%	0 0%	0 0%
WBC (1000 cells/cubic mm)-Day 14	0 0%	0 0%	0 0%	0 0%
WBC (1000 cells/cubic mm)-Day 70	0 0%	0 0%	0 0%	0 0%
WBC (1000 cells/cubic mm)-Day 182	0 0%	0 0%	0 0%	0 0%
Platelets (1000 cells/cubic mm)-Baseline	0 0%	0 0%	0 0%	0 0%
Platelets (1000 cells/cubic mm)-Day 14	0 0%	0 0%	0 0%	0 0%
Platelets (1000 cells/cubic mm)-Day 70	0 0%	0 0%	0 0%	0 0%
Platelets (1000 cells/cubic mm)-Day 182	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000 cells/cubic mm)-Baseline	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000 cells/cubic mm)-Day 14	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000 cells/cubic mm)-Day 70	0 0%	0 0%	0 0%	0 0%
Lymphocytes (1000 cells/cubic mm)-Day 182	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000 cells/cubic mm)-Baseline	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000 cells/cubic mm)-Day 14	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000 cells/cubic mm)-Day 70	0 0%	0 0%	0 0%	0 0%
Neutrophils (1000 cells/cubic mm)-Day 182	0 0%	0 0%	0 0%	0 0%

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).
Arm/Group Title	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)		Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)		Control 1: Placebo for MPER-656 mo(0,2,6,12)		Control 2: Placebo for MPER-656 mo(0,2,6,12)
Arm/Group Description	MPER-656 liposomes, 500 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses intramuscularly (IM) at months 0, 2, 6, and 12.		MPER-656 liposomes, 2000 mcg, admixed with Aluminum Hydroxide Suspension, to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.		Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.		Placebo for MPER-656 liposomes (Sodium Chloride for Injection USP, 0.9%) to be administered as two 0.5 mL doses IM at months 0, 2, 6, and 12.
All Cause Mortality
	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)		Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)		Control 1: Placebo for MPER-656 mo(0,2,6,12)		Control 2: Placebo for MPER-656 mo(0,2,6,12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/15 (0%)		0/1 (0%)		0/3 (0%)
Serious Adverse Events
	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)		Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)		Control 1: Placebo for MPER-656 mo(0,2,6,12)		Control 2: Placebo for MPER-656 mo(0,2,6,12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		1/15 (6.7%)		0/1 (0%)		0/3 (0%)
Immune system disorders
Any Event in SOC	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Hypersensitivity	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Other (Not Including Serious) Adverse Events
	Treatment 1: 500 mcg MPER-656 mo(0,2,6,12)		Treatment 2: 2000 mcg MPER-656 mo(0,2,6,12)		Control 1: Placebo for MPER-656 mo(0,2,6,12)		Control 2: Placebo for MPER-656 mo(0,2,6,12)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/5 (80%)		10/15 (66.7%)		0/1 (0%)		2/3 (66.7%)
Gastrointestinal disorders
Any Event in SOC	1/5 (20%)	1	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Abdominal pain lower	1/5 (20%)	1	0/15 (0%)	0	0/1 (0%)	0	0/3 (0%)	0
Nausea	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
General disorders
Any Event in SOC	0/5 (0%)	0	2/15 (13.3%)	2	0/1 (0%)	0	0/3 (0%)	0
Influenza like illness	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Injection site pruritus	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Infections and infestations
Any Event in SOC	1/5 (20%)	1	8/15 (53.3%)	8	0/1 (0%)	0	1/3 (33.3%)	1
COVID-19	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Gastroenteritis	1/5 (20%)	1	0/15 (0%)	0	0/1 (0%)	0	0/3 (0%)	0
Upper respiratory tract infection	0/5 (0%)	0	4/15 (26.7%)	4	0/1 (0%)	0	1/3 (33.3%)	1
Viral infection	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Viral upper respiratory tract infection	0/5 (0%)	0	2/15 (13.3%)	2	0/1 (0%)	0	0/3 (0%)	0
Injury, poisoning and procedural complications
Any Event in SOC	0/5 (0%)	0	0/15 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1
Skin laceration	0/5 (0%)	0	0/15 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1
Investigations
Any Event in SOC	1/5 (20%)	1	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Blood pressure increased	1/5 (20%)	1	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Metabolism and nutrition disorders
Any Event in SOC	0/5 (0%)	0	0/15 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1
Abnormal loss of weight	0/5 (0%)	0	0/15 (0%)	0	0/1 (0%)	0	1/3 (33.3%)	1
Musculoskeletal and connective tissue disorders
Any Event in SOC	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Musculoskeletal pain	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Nervous system disorders
Any Event in SOC	1/5 (20%)	1	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Dizziness	1/5 (20%)	1	0/15 (0%)	0	0/1 (0%)	0	0/3 (0%)	0
Headache	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Psychiatric disorders
Any Event in SOC	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Anxiety	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Respiratory, thoracic and mediastinal disorders
Any Event in SOC	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Cough	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Skin and subcutaneous tissue disorders
Any Event in SOC	1/5 (20%)	1	3/15 (20%)	3	0/1 (0%)	0	0/3 (0%)	0
Dermatitis	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Pityriasis rosea	1/5 (20%)	1	0/15 (0%)	0	0/1 (0%)	0	0/3 (0%)	0
Pruritus	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0
Urticaria papular	0/5 (0%)	0	1/15 (6.7%)	1	0/1 (0%)	0	0/3 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.