HIV InfectionsPhase 1NCT04177355
Evaluating the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Alum Adjuvants in Healthy, HIV-uninfected Adults
A Phase 1 study testing BG505 SOSIP.664 gp140, 3M-052-AF and CpG 1018 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- HIV Infections
- What is being tested?
- BG505 SOSIP.664 gp140, 3M-052-AF and CpG 1018
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Jan 2020to 4 Nov 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- General and Demographic Criteria
- Age of 18 through 50 years, inclusive
- 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; 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 until after the final study contact.
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- Good general health as shown by medical history, physical exam, and screening laboratory tests
- HIV-Related Criteria:
- Willingness to receive HIV test results
- Willingness to discuss HIV infection risks and amenable to HIV risk reduction counseling
- Assessed by the clinic staff as being at "low risk" for HIV infection and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit (see study protocol for more information)
- Laboratory Inclusion Values
- Hemogram/Complete blood count (CBC)
- Hemoglobin
- ≥ 11.0 g/dL for volunteers who were assigned female sex at birth
- ≥ 13.0 g/dL for volunteers who were assigned male sex at birth and transgender males who have been on hormone therapy for more than 6 consecutive months
- ≥ 12.0 g/dL for transgender females who have been on hormone therapy for more than 6 consecutive months
- For transgender volunteers who have been on hormone therapy for less than 6 consecutive months, determine hemoglobin eligibility based on the sex assigned at birth.
- White blood cell count = 2,500 to 12,000 cells/mm^3 with normal differential, or differential approved by Investigator of Record (IoR) or designee as not clinically significant
- Total lymphocyte count ≥ 650 cells/mm^3 with normal differential, or differential approved by IoR or designee as not clinically significant
- Remaining differential either within institutional normal range or with IoR or designee approval
- Platelets = 125,000 to 550,000 cells/mm^3
- Chemistry
- Alanine aminotransferase (ALT) < 1.25 times the institutional upper limit of normal
- Creatinine < 1.1 times the institutional upper limit of normal
- Virology
- Negative HIV-1 and -2 blood test: US volunteers must have a negative U.S. Food and Drug Administration (FDA)-approved enzyme immunoassay (EIA) or chemiluminescent microparticle immunoassay (CMIA).
- 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 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 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 or any optional study procedure (eg, leukapheresis, fine needle aspirate, bone marrow aspiration, mucosal secretion collection or mucosal biopsy) on the day of study product administration or procedure. 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 until 6 months after the final study vaccination. 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 137 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 6 months after the last vaccination.
Who cannot join
- General
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age > 45, systolic blood pressure > 140 mm Hg, diastolic blood pressure > 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 137 study
- Pregnant or breastfeeding
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- Active duty and reserve US military personnel
- Vaccines and other Injections
- HIV vaccine(s) received in a prior HIV vaccine trial. For volunteers who have received control/placebo in an HIV vaccine trial, the HVTN 137 PSRT will determine eligibility on a case-by-case basis.
- Previous receipt of monoclonal antibodies (mAbs), whether licensed or investigational; the HVTN 137 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 137 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 137 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 137 PSRT on a case-by-case basis.
- Live attenuated vaccines received within 30 days before first vaccination or scheduled within 30 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 or scheduled for 14 days after injection (eg, tetanus, pneumococcal, hepatitis virus A or B)
- Previous receipt of HEPLISAV, Shingrix, or RTS,S/AS01B/Mosquirix vaccine received within 30 days prior to first vaccination or scheduled for 30 days after injection.
- 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 ≤ 60 mg/day and length of therapy < 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 non-anaphylactic 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
- AESIs: Volunteers who currently have, or have a history of, any condition that could be considered an AESI for the product(s) 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
- 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 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 (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
- 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 < 140 mm Hg systolic and ≤ 90 mm Hg diastolic, with or without medication, with only isolated, brief instances of higher readings, which must be ≤ 150 mm Hg systolic and ≤ 100 mm Hg diastolic. For these volunteers, blood pressure must be ≤ 140 mm Hg systolic and ≤ 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 ≥ 150 mm Hg at enrollment or diastolic blood pressure ≥ 100 mm Hg at enrollment.
- Bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder requiring special precautions)
- Malignancy (Not excluded from participation: Volunteer who has had malignancy excised surgically and who, in the investigator's estimation, has a reasonable assurance of sustained cure, or who is unlikely to experience recurrence of malignancy during the period of the study)
- Seizure disorder: History of seizure(s) within past three years. Also exclude if volunteer has used medications in order to prevent or treat seizure(s) at any time within the past 3 years.
- Asplenia: any condition resulting in the absence of a functional spleen
- History of generalized urticaria, angioedema, or anaphylaxis. (Not exclusionary: angioedema or anaphylaxis to a known trigger with at least 5 years since last reaction to demonstrate satisfactory avoidance of trigger.)
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
The Ponce de Leon Center CRS
Atlanta, Georgia, 30308-2012
Alabama CRS
Birmingham, Alabama, 35294
Brigham and Women's Hospital Vaccine CRS (BWH VCRS)
Boston, Massachusetts, 02115-6110
The Hope Clinic of the Emory Vaccine Center CRS
Decatur, Georgia, 30030
Columbia P&S CRS
New York, New York, 10032
New York Blood Center CRS (Site 31801)
New York, New York, 10065
Penn Prevention CRS
Philadelphia, Pennsylvania, 19104
University of Pittsburgh CRS
Pittsburgh, Pennsylvania, 15213
University of Rochester Vaccines to Prevent HIV Infection CRS
Rochester, New York, 14642
Seattle Vaccine and Prevention CRS
Seattle, Washington, 98109-1024
About this study
Official title: A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
Read the detailed description
This study will evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
The study will be conducted in three parts (Part A, B and C). Part A will include two groups (Groups 1 and 2), Part B will include four groups (Groups 3, 4, 5, and 6) and Part C will include two groups (Groups 7 and 8).
Participants in Part A will be randomly assigned to receive the BG505 SOSIP.664 gp140 vaccine admixed with 3M-052-AF and alum adjuvant or to receive placebo. Part A participants will be enrolled sequentially in Groups 1 and 2 for dose escalation.
Participants in Part B will be randomly assigned to Groups 3, 4, 5, or 6, to receive the BG505 SOSIP.664 gp140 vaccine with an adjuvant (the specific adjuvant will vary by group) or to receive placebo.
Participants in Part C will be randomly assigned to Groups 7 or 8 to receive:
Group 7: The same BG505 SOSIP immunogen but with a lower dose (3mcg) of 3M-052-AF + Alum, Group 8: The Trimer 4571 with 5mcg 3M-052-AF + Alum, or to receive placebo.
Participants in Part A will attend 8 months of scheduled clinic visits, and they will be contacted by study staff at Month 14 for follow-up health monitoring. Upon protocol amendment, subjects in Part A were invited to receive a third immunization.
Participants in Part B will attend 18 months of scheduled clinic visits. Participants in Part C will attend 18 months of scheduled clinic visits.
- Conditions
- HIV Infections
- Being tested
- BG505 SOSIP.664 gp140, Placebo, 3M-052-AF, CpG 1018, GLA-LSQ
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BG505 SOSIP.664 gp140Biological
Administered by IM injection
PlaceboBiological
Administered by IM injection
3M-052-AFBiological
Administered by IM injection
CpG 1018Biological
Administered by IM injection
GLA-LSQBiological
Administered by IM injection
Alum (Aluminum Hydroxide Suspension)Biological
Administered by IM injection
Trimer 4571Biological
Administered by IM injection
| Study group | Role | What they receive |
|---|---|---|
| Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2, with optional second boost at Month 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: 3M-052-AF; Biological: Alum (Aluminum Hydroxide Suspension) |
| Part A, Group 1 (P1): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. Receives: Biological: Placebo |
| Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2, with optional second boost at Month 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: 3M-052-AF; Biological: Alum (Aluminum Hydroxide Suspension) |
| Part A, Group 2 (P2): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. Receives: Biological: Placebo |
| Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: CpG 1018; Biological: Alum (Aluminum Hydroxide Suspension) |
| Part B, Group 3 (P3): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
| Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: 3M-052-AF; Biological: Alum (Aluminum Hydroxide Suspension) |
| Group 4 (P4): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
| Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: GLA-LSQ |
| Part B, Group 5 (P5): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
| Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum | Experimental | Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: Alum (Aluminum Hydroxide Suspension) |
| Part B, Group 6 (P6): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
| Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum | Experimental | Participants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6. Receives: Biological: BG505 SOSIP.664 gp140; Biological: 3M-052-AF; Biological: Alum (Aluminum Hydroxide Suspension) |
| Part C, Group 7 (P7): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
| Part C, Group 8 (T8): Trimer 4571 + Alum | Experimental | Participants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6. Receives: Biological: 3M-052-AF; Biological: Alum (Aluminum Hydroxide Suspension); Biological: Trimer 4571 |
| Part C, Group 8 (P8): Placebo | Placebo comparator | Participants will receive placebo as one IM injection at Months 0, 2, and 6. Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Measured: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants Reporting Systemic Solicited Adverse Events 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 maximum grade observed for each symptom over the time frame is presented
Measured: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
Measured: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Number of Participants Reporting Unsolicited Adverse Events (AEs)
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Measured: Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C)
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Measured: Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C)
Number of Participants With Early Study Termination and Reason for Early Study Termination
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Measured: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start13 Jan 2020
- Primary completion4 Nov 2024
- Study completion4 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HIV InfectionsStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, International AIDS Vaccine Initiative, Access to Advanced Health Institute (AAHI), Dynavax Technologies Corporation, Fred Hutchinson Cancer Center
- Responsible party
- Sponsor
- Investigators
- M. Juliana McElrath, Study chair, Seattle Vaccine Trials UnitNadine Rouphael, Study chair, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177355
- Sponsor's protocol ID
- HVTN 137
- Other IDs
- 38559
- Status last verified
- May 2025
- First submitted
- 22 Nov 2019
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hahn WO, Parks KR, Shen M, Ozorowski G, Janes H, Ballweber-Fleming L, Woodward Davis AS, Duplessis C, Tomai M, Dey AK, Sagawa ZK, De Rosa SC, Seese A, Kallur Siddaramaiah L, Stamatatos L, Lee WH, Sewall LM, Karlinsey D, Turner HL, Rubin V, Furth S, MacPhee K, Duff M, Corey L, Keefer MC, Edupuganti S, Frank I, Maenza J, Baden LR, Hyrien O, Sanders RW, Moore JP, Ward AB, Tomaras GD, Montefiori DC, Rouphael N, McElrath MJ. Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine induces human autologous neutralizing antibodies. J Exp Med. 2024 Oct 7;221(10):e20240604. doi: 10.1084/jem.20240604. Epub 2024 Sep 5.
PubMed 39235529
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Clinical Trial to Evaluate the Safety and Immunogenicity of HIV-1 BG505 SOSIP.664 gp140 With TLR Agonist and/or Aalum Adjuvants and VRC HIV Env Trimer 4571 and 3M-052-AF With Alum in Healthy, HIV-uninfected Adults
- ClinicalTrials.gov ID
- NCT04177355
- Acronym / sponsor ID
- HVTN 137
- Conditions
- HIV Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- HIV Vaccine Trials Network, International AIDS Vaccine Initiative, Access to Advanced Health Institute (AAHI), Dynavax Technologies Corporation, Fred Hutchinson Cancer Center
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 4 Nov 2024 (actual)
- Study completion
- 4 Nov 2024 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Posted 27 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
Detailed description
This study will evaluate the safety and immunogenicity of HIV-1 BG505 SOSIP.664 gp140 with TLR agonist and/or alum adjuvants in healthy, HIV-uninfected adults.
The study will be conducted in three parts (Part A, B and C). Part A will include two groups (Groups 1 and 2), Part B will include four groups (Groups 3, 4, 5, and 6) and Part C will include two groups (Groups 7 and 8).
Participants in Part A will be randomly assigned to receive the BG505 SOSIP.664 gp140 vaccine admixed with 3M-052-AF and alum adjuvant or to receive placebo. Part A participants will be enrolled sequentially in Groups 1 and 2 for dose escalation.
Participants in Part B will be randomly assigned to Groups 3, 4, 5, or 6, to receive the BG505 SOSIP.664 gp140 vaccine with an adjuvant (the specific adjuvant will vary by group) or to receive placebo.
Participants in Part C will be randomly assigned to Groups 7 or 8 to receive:
Group 7: The same BG505 SOSIP immunogen but with a lower dose (3mcg) of 3M-052-AF + Alum, Group 8: The Trimer 4571 with 5mcg 3M-052-AF + Alum, or to receive placebo.
Participants in Part A will attend 8 months of scheduled clinic visits, and they will be contacted by study staff at Month 14 for follow-up health monitoring. Upon protocol amendment, subjects in Part A were invited to receive a third immunization.
Participants in Part B will attend 18 months of scheduled clinic visits. Participants in Part C will attend 18 months of scheduled clinic visits.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: 3M-052-AF, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 1 mcg of 3M-052-AF and 500 mcg of Aluminum Hydroxide Suspension (Alum), as one intramuscular (IM) injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 1 (P1): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: 3M-052-AF, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 5 mcg of 3M-052-AF and 500 mcg of Alum, as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part A, Group 2 (P2): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0 and 2, with optional second boost at Month 6. |
| Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: CpG 1018, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 300 mcg of CpG 1018 and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. |
| Part B, Group 3 (P3): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: 3M-052-AF, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with either 1 mcg or 5 mcg of 3M-052-AF (the highest tolerated dose from Part A), and 500 mcg of Alum, as one IM injection at Months 0, 2, and 6. |
| Group 4 (P4): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: GLA-LSQParticipants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with GLA-LSQ (GLA 5 mcg, and QS-21 2 mcg), as one IM injection at Months 0, 2, and 6. |
| Part B, Group 5 (P5): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive 100 mcg of BG505 SOSIP.664 gp140, admixed with 500 mcg of Alum, administered as one IM injection at Months 0, 2, and 6. |
| Part B, Group 6 (P6): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum | Experimental | Biological: BG505 SOSIP.664 gp140, Biological: 3M-052-AF, Biological: Alum (Aluminum Hydroxide Suspension)Participants will receive BG505 SOSIP.664 gp140, 100 mcg admixed with 3M-052-AF, 3 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose intramuscularly (IM) at months 0, 2, and 6. |
| Part C, Group 7 (P7): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
| Part C, Group 8 (T8): Trimer 4571 + Alum | Experimental | Biological: 3M-052-AF, Biological: Alum (Aluminum Hydroxide Suspension), Biological: Trimer 4571Participants will receive Trimer 4571, 100 mcg admixed with 3M-052-AF, 5 mcg and Alum, 500 mcg to be administered as one 0.5-mL dose IM at months 0, 2, and 6. |
| Part C, Group 8 (P8): Placebo | Placebo comparator | Biological: PlaceboParticipants will receive placebo as one IM injection at Months 0, 2, and 6. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (47 listed)
- General and Demographic Criteria
- Age of 18 through 50 years, inclusive
- 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; completes a questionnaire prior to first vaccination with verbal demonstration of understanding of all questionnaire items answered incorrectly
Key exclusion criteria (49 listed)
- General
- Blood products received within 120 days before first vaccination
- Investigational research agents received within 30 days before first vaccination
- Body mass index (BMI) ≥ 40; or BMI ≥ 35 with 2 or more of the following: age > 45, systolic blood pressure > 140 mm Hg, diastolic blood pressure > 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 137 study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BG505 SOSIP.664 gp140Administered by IM injection | Biological | Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum, Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ, Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum, Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum |
| PlaceboAdministered by IM injection | Biological | Group 4 (P4): Placebo, Part A, Group 1 (P1): Placebo, Part A, Group 2 (P2): Placebo, Part B, Group 3 (P3): Placebo, Part B, Group 5 (P5): Placebo, Part B, Group 6 (P6): Placebo, Part C, Group 7 (P7): Placebo, Part C, Group 8 (P8): Placebo |
| 3M-052-AFAdministered by IM injection | Biological | Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum, Part C, Group 8 (T8): Trimer 4571 + Alum |
| CpG 1018Administered by IM injection | Biological | Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum |
| GLA-LSQAdministered by IM injection | Biological | Part B, Group 5 (T5): BG505 SOSIP.664 gp140 + GLA-LSQ |
| Alum (Aluminum Hydroxide Suspension)Administered by IM injection | Biological | Part A, Group 1 (T1): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part A, Group 2 (T2): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 3 (T3): BG505 SOSIP.664 gp140 + CpG 1018 + Alum, Part B, Group 4 (T4): BG505 SOSIP.664 gp140 + 3M-052-AF + Alum, Part B, Group 6 (T6): BG505 SOSIP.664 gp140 + Alum, Part C, Group 7 (T7): BG505 SOSIP.664 gp140 + Alum, Part C, Group 8 (T8): Trimer 4571 + Alum |
| Trimer 4571Administered by IM injection | Biological | Part C, Group 8 (T8): Trimer 4571 + Alum |
Primary outcome
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants Reporting Systemic Solicited Adverse Events Signs and Symptoms
Time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 [July 2017]. The maximum grade observed for each symptom over the time frame is presented
Number of Participants With Local Laboratory Values Meeting Grade 1 AE Criteria or Above
Time frame: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
For each local laboratory measure meeting Grade 1 AE criteria (Mild) or above as specified in the DAIDS AE Grading Table, counts of severity were presented by treatment group and timepoint for the overall population
Number of Participants Reporting Unsolicited Adverse Events (AEs)
Time frame: Measured through Month 14 (Part A without second boost) or Month 18 (Part A with second boost, Part B, Part C)
The number (percentage) of Participants Reporting Unsolicited Adverse Events (AEs) was summarized by arm
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Time frame: Measured through Month 2 (Part A without second boost) or Month 6 (Part A with second boost, Part B, Part C)
The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Number of Participants With Early Study Termination and Reason for Early Study Termination
Time frame: Measured through Month 8 (Part A without second boost) or Month 12 (Part A with second boost, Part B, Part C)
The number (percentage) of participants with early study termination and reason for early study termination was summarized by arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 39235529Hahn WO, Parks KR, Shen M, Ozorowski G, Janes H, Ballweber-Fleming L, Woodward Davis AS, Duplessis C, Tomai M, Dey AK, Sagawa ZK, De Rosa SC, Seese A, Kallur Siddaramaiah L, Stamatatos L, Lee WH, Sewall LM, Karlinsey D, Turner HL, Rubin V, Furth S, MacPhee K, Duff M, Corey L, Keefer MC, Edupuganti S, Frank I, Maenza J, Baden LR, Hyrien O, Sanders RW, Moore JP, Ward AB, Tomaras GD, Montefiori DC, Rouphael N, McElrath MJ. Use of 3M-052-AF with Alum adjuvant in HIV trimer vaccine induces human autologous neutralizing antibodies. J Exp Med. 2024 Oct 7;221(10):e20240604. doi: 10.1084/jem.20240604. Epub 2024 Sep 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Juliana McElrath study chair
Seattle Vaccine Trials Unit
Nadine Rouphael study chair
Emory University
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BG505 SOSIP.664 gp140, 3M-052-AF and CpG 1018 in people with HIV Infections, run by National Institute of Allergy and Infectious Diseases (NIAID) at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 47 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness (time frame: Measured for 7 days after each injection in Parts A and B and 14 days after each injection in Part C, up to Month 6). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04177355, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.