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Evaluating the Safety and Immunogenicity of EnvSeq-1 Envs Adjuvanted With GLA-SE, Administered Alone or With DNA Mosaic-Tre Env, in Healthy, HIV-Uninfected Adults

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ClinicalTrials.gov Identifier: NCT03220724
Recruitment Status : Recruiting
First Posted : July 18, 2017
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 Envs adjuvanted with GLA-SE, administered with or without DNA Mosaic-Tre env, in healthy, HIV-uninfected adults.

Condition or disease Intervention/treatment Phase
HIV Infections Biological: CH505TF Biological: CH505w53 Biological: CH505w78 Biological: CH505w100 Biological: DNA Mosaic-Tre Biological: GLA-SE adjuvant Biological: Placebo Phase 1

Detailed Description:

This study will evaluate the safety, tolerability, and immunogenicity of EnvSeq-1 Envs adjuvanted with GLA-SE, administered with or without DNA Mosaic-Tre env, in healthy, HIV-uninfected adults. The four individual EnvSeq-1 HIV vaccine Envs used in this study are called CH505TF, CH505w53, CH505w78, and CH505w100. DNA Mosaic-Tre env is also an HIV vaccine.

This study will take place in two parts: Part A and Part B. Participants in Part A will be randomly assigned to one of four groups. Participants in each group will receive CH505TF (admixed with GLA-SE) or placebo by intramuscular (IM) injection at Months 0, 2, 4, 8, and 12.

Study researchers will evaluate participant data from Part A of the study prior to enrolling participants into Part B of the study. Researchers will also evaluate data from Part A to determine the dosing for Part B.

Participants in Part B will be randomly assigned to one of five groups. Participants in each group will receive IM injections at Months 0, 2, 4, 8, 12, and 16. Injections for Part B, Groups 1, 2, 3, and 4, will follow an additive and a sequential approach to EnvSeq-1 vaccine administration, both with and without the DNA Mosaic-Tre env vaccine. The sequential approach will start with administration of the CH505TF vaccine at Month 0, then CH505w53 at Month 2, CH505w78 at Month 4, and CH505w100 at Months 8, 12, and 16. Part B, Group 5 participants will receive placebo injections at each time point.

Additional study visits will occur through Month 18 for participants in Part A and through Month 22 for participants in Part B. Visits may include physical examinations and clinical assessments; blood, urine, and stool collection; HIV testing; risk reduction counseling; and interviews/questionnaires. Study staff will contact participants for follow-up health monitoring at Month 24 for participants in Part A and at Month 28 for participants in Part B.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 132 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 EnvSeq-1 Envs Adjuvanted With GLA-SE, Administered Alone or With DNA Mosaic-Tre Env, in Healthy, HIV-Uninfected Adult Participants
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Part A: Group 1
Participants will receive 20 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Experimental: Part A: Group 2
Participants will receive 100 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Experimental: Part A: Group 3
Participants will receive 400 mcg of CH505TF (admixed with GLA-SE) at Months 0, 2, 4, 8, and 12.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Placebo Comparator: Part A: Group 4
Participants will receive placebo at Months 0, 2, 4, 8, and 12.
Biological: Placebo
Administered by IM injection in the thigh

Experimental: Part B: Group 5
Participants will receive CH505TF (admixed with GLA-SE) and placebo at Month 0; CH505w53 (admixed with GLA-SE) and placebo at Month 2; CH505w78 (admixed with GLA-SE) and placebo at Month 4; and CH505w100 (admixed with GLA-SE) and placebo at Months 8, 12, and 16.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: CH505w53
Administered by IM injection in the thigh
Other Name: CH505w53 gp120

Biological: CH505w78
Administered by IM injection in the thigh
Other Name: CH505w78 gp120

Biological: CH505w100
Administered by IM injection in the thigh
Other Name: CH505w100 gp120

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Biological: Placebo
Administered by IM injection in the thigh

Experimental: Part B: Group 6
Participants will receive CH505TF (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 0; CH505w53 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 2; CH505w78 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 4; CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Months 8, 12, and 16.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: CH505w53
Administered by IM injection in the thigh
Other Name: CH505w53 gp120

Biological: CH505w78
Administered by IM injection in the thigh
Other Name: CH505w78 gp120

Biological: CH505w100
Administered by IM injection in the thigh
Other Name: CH505w100 gp120

Biological: DNA Mosaic-Tre
Administered by IM injection in the thigh
Other Name: DNA Mosaic-Tre env

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Experimental: Part B: Group 7
Participants will receive CH505TF (admixed with GLA-SE) and placebo at Month 0; CH505TF + CH505w53 (admixed with GLA-SE) and placebo at Month 2; CH505TF + CH505w53 + CH505w78 (admixed with GLA-SE) and placebo at Month 4; CH505w53 + CH505w78 + CH505w100 (admixed with GLA-SE) and placebo at Month 8; CH505w78 + CH505w100 (admixed with GLA-SE) and placebo at Month 12; and CH505w100 (admixed with GLA-SE) and placebo at Month 16.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: CH505w53
Administered by IM injection in the thigh
Other Name: CH505w53 gp120

Biological: CH505w78
Administered by IM injection in the thigh
Other Name: CH505w78 gp120

Biological: CH505w100
Administered by IM injection in the thigh
Other Name: CH505w100 gp120

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Biological: Placebo
Administered by IM injection in the thigh

Experimental: Part B: Group 8
Participants will receive CH505TF (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 0; CH505TF + CH505w53 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 2; CH505TF + CH505w53 + CH505w78 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 4; CH505w53 + CH505w78 + CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 8; CH505w78 + CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 12; and CH505w100 (admixed with GLA-SE) and 4 mg of DNA Mosaic-Tre at Month 16.
Biological: CH505TF
Administered by intramuscular (IM) injection in the thigh
Other Name: CH505TF gp120

Biological: CH505w53
Administered by IM injection in the thigh
Other Name: CH505w53 gp120

Biological: CH505w78
Administered by IM injection in the thigh
Other Name: CH505w78 gp120

Biological: CH505w100
Administered by IM injection in the thigh
Other Name: CH505w100 gp120

Biological: DNA Mosaic-Tre
Administered by IM injection in the thigh
Other Name: DNA Mosaic-Tre env

Biological: GLA-SE adjuvant
Admixed with all CH505 gp120 proteins

Placebo Comparator: Part B: Group 9
Participants will receive two injections of placebo at Months 0, 2, 4, 8, 12, and 16.
Biological: Placebo
Administered by IM injection in the thigh




Primary Outcome Measures :
  1. Part A: Frequency of local reactogenicity signs and symptoms [ Time Frame: Measured through Month 24 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  2. Part A: Frequency of systemic reactogenicity signs and symptoms [ Time Frame: Measured through Month 24 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  3. Part A: Frequency of adverse events (AEs) [ Time Frame: Measured through Month 24 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  4. Part A: Frequency of severe adverse events (SAEs) [ Time Frame: Measured through Month 24 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  5. Part A: Frequency of HIV-specific binding Ab responses [ Time Frame: Measured through Month 24 ]
    As assessed by binding Ab multiplex assay

  6. Part B: Frequency of local reactogenicity signs and symptoms [ Time Frame: Measured through Month 28 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  7. Part B: Frequency of systemic reactogenicity signs and symptoms [ Time Frame: Measured through Month 28 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  8. Part B: Frequency of AEs [ Time Frame: Measured through Month 28 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  9. Part B: Frequency of SAEs [ Time Frame: Measured through Month 28 ]
    Graded according to the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, March 2017

  10. Part B: Magnitude of neutralizing antibody response [ Time Frame: Measured through Month 28 ]
    As assessed against autologous viral isolates

  11. Part B: Magnitude of neutralizing antibody responses [ Time Frame: Measured through Month 28 ]
    As assessed against a panel of heterologous isolates


Secondary Outcome Measures :
  1. Part A: Magnitude of differential binding to CH505 gp120 compared to CH505 I delta 371 protein [ Time Frame: Measured through Month 24 ]
    As assessed by flow cytometry analysis of the frequency of the differential binding memory B cells

  2. Part A: Magnitude of neutralizing antibody responses against autologous viral isolates [ Time Frame: Measured through Month 24 ]
    As assessed by area under the magnitude-breadth curves

  3. Part A: Magnitude of neutralizing antibody responses [ Time Frame: Measured through Month 24 ]
    As assessed against a cross-clade panel of isolates

  4. Part A: Response rate of CD4+ T-cell responses [ Time Frame: Measured through Month 24 ]
    As assessed by intracellular cytokine staining assays (ICS)

  5. Part A: Monoclonal antibody binding and neutralization response rates [ Time Frame: Measured through Month 24 ]
    Including evaluating tier 2 virus broadly neutralizing antibody (bnAb) activity and CD4 binding site loop binding, neutralization of autologous TF or mutant CH505 viruses

  6. Part B: Frequency of HIV-specific binding antibody (Ab) responses [ Time Frame: Measured through Month 28 ]
    As assessed by binding Ab multiplex assay

  7. Part B: Response rate of CD4+ T-cell responses [ Time Frame: Measured through Month 28 ]
    As assessed by ICS assays

  8. Part B: Monoclonal antibody binding response rates [ Time Frame: Measured through Month 28 ]
    Including evaluating tier 2 virus bnAb activity and CD4 binding site loop binding and differential binding to CH505 gp120 compared to CH505 I delta 371 protein

  9. Part B: Monoclonal antibody neutralization response rates [ Time Frame: Measured through Month 28 ]
    Including evaluating tier 2 virus bnAb activity and neutralization of autologous TF or mutant CH505 viruses



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 before the last required protocol clinic visit
  • Willing to be contacted by phone, text message, or e-mail 6 months after completion of the scheduled clinic visits
  • 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.

Laboratory Inclusion Values:

Hemogram/Complete Blood Count (CBC):

  • Hemoglobin greater than or equal to 11.5 g/dL for volunteers who were born female, greater than or equal to 13.0 g/dL for volunteers who were born male
  • White blood cell count equal to 3,300 to 12,000 cells/mm^3
  • Total lymphocyte count greater than or equal to 800 cells/mm^3
  • Remaining differential either within institutional normal range or with site physician approval
  • Platelets equal to 125,000 to 550,000/mm^3

Chemistry:

  • Chemistry panel: alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase less than 1.25 times the institutional upper limit of normal; creatinine less than or equal to institutional upper limit of normal.

Virology:

  • Negative HIV-1 and -2 blood test: Volunteers must have a negative Food and Drug Administration (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 urine glucose, and
    • Negative or trace urine protein, and
    • Negative or trace urine hemoglobin (if trace hemoglobin is present on dipstick, a microscopic urinalysis with red blood cells levels within institutional normal range).

Reproductive Status:

  • Volunteers who were born female: negative serum or urine beta human chorionic gonadotropin (beta-HCG) pregnancy test performed prior to vaccination on the day of initial vaccination. Persons who are NOT of reproductive potential due to having undergone total hysterectomy or bilateral oophorectomy (verified by medical records), are not required to undergo pregnancy testing.
  • Reproductive status: A volunteer who was born female must:

    • Agree to consistently use effective contraception (see the protocol for more information) 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, or
    • Any other contraceptive method approved by the HVTN 115 Protocol Safety Review Team (PSRT)
    • Successful vasectomy in the male partner (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, bilateral oophorectomy, or tubal ligation;
    • Or be sexually abstinent.
  • Volunteers who were born female 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 115 study
  • Pregnant or breastfeeding
  • Active duty and reserve U.S. 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 115 PSRT will determine eligibility on a case-by-case basis.
  • Non-HIV experimental vaccine(s) received within the last 5 years in a prior vaccine trial. Exceptions may be made for vaccines that have subsequently undergone licensure by the FDA or by the national regulatory authority where the volunteer is enrolling. For volunteers who have received control/placebo in an experimental vaccine trial, the HVTN 115 PSRT will determine eligibility on a case-by-case basis. For volunteers who have received an experimental vaccine(s) greater than 5 years ago, eligibility for enrollment will be determined by the HVTN 115 PSRT on a case-by-case basis.
  • Live attenuated vaccines received within 30 days before first vaccination or scheduled within 14 days after injection (e.g., 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 (e.g., 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 dermatitis; or [4] a single course of oral/parenteral corticosteroids at doses less than 2 mg/kg/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
  • Autoimmune disease
  • Immunodeficiency

Clinically Significant Medical Conditions:

  • Untreated or incompletely treated syphilis infection
  • 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
  • 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 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, including cases controlled with diet alone. (Not excluded: history of isolated gestational diabetes.)
  • Thyroidectomy, or thyroid disease requiring medication during the last 12 months
  • 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 as consistently less than or equal to 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 diagnosed by a doctor (e.g., 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 3 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 hereditary angioedema, acquired angioedema, or idiopathic angioedema.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220724


Locations
United States, Alabama
Alabama CRS Recruiting
Birmingham, Alabama, United States, 35294
Contact: Edgar T. Overton, M.D.    205-934-5191    eoverton@uabmc.edu   
United States, New York
Columbia P&S CRS Recruiting
New York, New York, United States, 10032-3732
Contact: Steven Palmer, P.A. -C    212-342-2958    sp500@cumc.columbia.edu   
New York Blood Center CRS Recruiting
New York, New York, United States, 10065
Contact: Debbie Lucy    212-388-0008    dlucy@nybc.org   
University of Rochester Vaccines to Prevent HIV Infection CRS Recruiting
Rochester, New York, United States, 14642
Contact: Catherine A. Bunce, R.N., M.S., C.C.R.C.    1-585-275-5871    catherine_bunce@urmc.rochester.edu   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Study Chair: Magda Sobieszczyk Columbia University
Study Chair: James Kobie URMC-Rochester

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT03220724     History of Changes
Other Study ID Numbers: HVTN 115
12042 ( Registry Identifier: DAIDS-ES Registry Number )
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: November 8, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases