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CompletedNCT05112848COVID-19Updated Mar 16, 2023

A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19)

A Phase 2 interventional study of NVX-CoV2373 in SARS-CoV-2 Infection, sponsored by Novavax. Completed at 7 sites in South Africa. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-03-16.

Sponsored by Novavax · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
384
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

This is a Phase 2, randomized, observer-blinded study evaluating the safety and immunogenicity of SARS-CoV-2 with Matrix-M™ Adjuvant in people living with human immunodeficiency virus (HIV) (PLWH) and HIV- negative adults, seronegative to SARS-CoV-2 at baseline.

Read the detailed description

The investigational product will be a monovalent Serum Institute of India (SII) SARS CoV-2 vaccine at a dose of 5 µg antigen adjuvanted with 50 µg Matrix-M (referred hereafter as NVX-CoV2373).

Approximately 270 PLWH, 18 to 65 years of age inclusive, will be enrolled into 3 groups and stratified at presentation based on the level of control of HIV infection. All PLWH will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. PLWH will be randomly assigned 1:1:1 to receive NVX-CoV2373 in either a two dose regimen on Days 0 and 21 or Days 0 and 70 or a three-dose regimen on Days 0, 21, and 70. Randomization of PLWH will be stratified by level of control of HIV infection to distribute well controlled and less well controlled participants approximately evenly among the 3 PLWH treatment groups. Approximately 90 HIV negative participants, 18 to 65 years of age inclusive, will be randomly assigned 1:1 to receive NVX-CoV2373 in a two dose regimen on Days 0 and 21 or Days 0 and 70. All HIV negative participants will be baseline seronegative (for SARS-CoV-2) and have not received any authorized SARS-CoV-2 vaccines. Placebo (normal saline solution) will be administered to participants who receive a two-dose regimen of NVX-CoV2373 to maintain overall blinding.

02

Conditions studied

  • SARS-CoV-2 Infection

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Keywords

  • Coronavirus disease 2019 (COVID-19)
  • HIV
03

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's enrollment of 384 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Novavax is the lead sponsor of 47 studies on the registry; none are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults 18 to 65 years of age, inclusive, at screening.
  2. Willing and able to give informed consent prior to study enrollment and to comply with study procedures.

  3. Participants of childbearing potential (defined as any participant who has experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days prior to enrollment and through the end of the study OR agree to consistently use a medically acceptable method of contraception listed below from at least 28 days prior to enrollment and through the end of the study.

    1. Condoms (male or female) with spermicide (if acceptable in-country)
    2. Diaphragm with spermicide
    3. Cervical cap with spermicide
    4. Intrauterine device
    5. Oral or patch contraceptives
    6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive method that is designed to protect against pregnancy.
    7. Abstinence as a form of contraception is acceptable if in line with the participant's lifestyle.
  4. Vital signs must be within medically acceptable ranges prior to the first vaccination

  5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for the duration of the study.

    For well-controlled PLWH

  6. PLWH with a cluster of differentiation 4 (CD4) + T-cell count of ≥ 350 cells/μL at screening or viral load of ≤ 1,000 copies/mL.
  7. PLWH being managed on a stable/unchanged antiretroviral therapy (ART) regimen for at least 2 months prior to enrollment.

  8. No opportunistic infections in the past year.

    For less-well-controlled PLWH

  9. PLWH with a CD4+ T-cell count of ≥ 200 and \< 350 cells/μL at screening or viral load of 1,000 to 10,000 copies/mL.
  10. PLWH being managed on a stable/unchanged (ART) regimen for at least 1 month prior to enrollment.

Exclusion criteria

Exclusion Criteria:

  1. Laboratory-confirmed SARS-CoV-2 infection (PCR+ within 5 days prior to first study vaccination with results available before randomization) or positive anti-S protein antibody to SARS-CoV-2 at screening.
  2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic or therapeutic agent for the prevention or treatment of COVID-19.
  3. Participation in research involving receipt of an investigational product (drug/biologic/device) within 90 days prior to the first study vaccination.
  4. Received influenza vaccination within 14 days prior to first study vaccination, or any other vaccine within 30 days prior to first study vaccination.
  5. Any known allergies to products contained in the investigational product.
  6. Any history of anaphylaxis to any prior vaccine.
  7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring ongoing immunomodulatory therapy.
  8. Chronic administration (defined as > 14 continuous days) of immunosuppressant, systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to first study vaccination.
  9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90 days prior to first study vaccination.
  10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo maligna and uterine cervical carcinoma in situ without evidence of disease, at the discretion of the investigator).
  11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to the end of study.
  12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to the first study vaccine dose that, in the opinion of the investigator, might interfere with protocol compliance.
  13. Any other condition that, in the opinion of the investigator, would pose a health risk to the participant if enrolled or could interfere with evaluation of the trial vaccine or interpretation of study results (including neurologic or psychiatric conditions likely to impair the quality of safety reporting).
  14. Study team member or immediate family member of any study team member (inclusive of Sponsor, Contract Research Organization, and study site personnel involved in the conduct or planning of the study).
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
384 participants (actual)

Study arms

  • Experimental
    Group 1 PLWH

    Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70.

    Biological: NVX-CoV2373

  • Experimental
    Group 2 PLWH

    Three doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0, Day 21, and Day 70.

    Biological: NVX-CoV2373

  • Experimental
    Group 3 PLWH

    Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21.

    Biological: NVX-CoV2373

  • Experimental
    Group 4 HIV-Negative Participants

    2 doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 21. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 70.

    Biological: NVX-CoV2373

  • Experimental
    Group 5 HIV-Negative Participants

    Two doses of 5μg monovalent prototype vaccine+50µg Matrix-M adjuvant, given on Day 0 and Day 70. Alternating IM (deltoid) injection of placebo (0.5mL) given on Day 21.

    Biological: NVX-CoV2373

Interventions

  • BiologicalNVX-CoV2373

    Alternating intramuscular (IM) (deltoid) injections of monovalent prototype vaccine premixed with Matrix-M™ adjuvant (0.5 mL) given either as 2 doses (one on Day 0 and one on Day 21 or Day 70) and an injection of placebo (0.5mL) on Day 21 or Day 70, or 3 doses (Day 0, Day 21, and Day 70).

    Also known as: Monovalent SARS-CoV-2 rS vaccine premixed with Matrix-M adjuvant

06

What researchers measure

Primary outcomes

  1. Number of PLWH with unsolicited adverse events (AEs)

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

    Time frame: Day 84

  2. Number of HIV-Negative participants with unsolicited AEs

    Number of HIV-Negative participants with unsolicited AEs.

    Time frame: Day 84

  3. Number of PLWH with unsolicited AEs

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

    Time frame: Day 120

  4. Number of PLWH with unsolicited AEs

    Number of PLWH with unsolicited AEs stratified by level of control of HIV infection.

    Time frame: Day 180

  5. Number of HIV-Negative participants with unsolicited AEs

    Number of HIV-Negative participants with unsolicited AEs.

    Time frame: Day 120

  6. Number of HIV-Negative participants with unsolicited AEs

    Number of HIV-Negative participants with unsolicited AEs.

    Time frame: Day 180

  7. Number of PLWH with solicited systemic AEs

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 0

  8. Number of PLWH with solicited systemic AEs

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 21

  9. Number of PLWH with solicited systemic AEs

    Number of PLWH with solicited systemic AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 70

  10. Number of HIV-Negative participants with solicited systemic AEs

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

    Time frame: Day 0

  11. Number of HIV-Negative participants with solicited systemic AEs

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

    Time frame: Day 21

  12. Number of HIV-Negative participants with solicited systemic AEs

    Number of HIV-Negative participants with solicited systemic AEs for 7 days following each vaccination.

    Time frame: Day 70

  13. Number of PLWH with solicited local AEs

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 0

  14. Number of PLWH with solicited local AEs

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 21

  15. Number of PLWH with solicited local AEs

    Number of PLWH with solicited local AEs for 7 days following each vaccination stratified by baseline severity of disease as determined by the level of control of HIV infection into well-controlled and less-well-controlled treatment groups.

    Time frame: Day 70

  16. Number of HIV-Negative participants with solicited local AEs

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

    Time frame: Day 0

  17. Number of HIV-Negative participants with solicited local AEs

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

    Time frame: Day 21

  18. Number of HIV-Negative participants with solicited local AEs

    Number of HIV-Negative participants with solicited local AEs for 7 days following each vaccination.

    Time frame: Day 70

  19. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  20. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  21. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  22. Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMEUs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  23. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  24. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  25. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  26. Serum IgG antibody levels expressed as geometric mean fold rise (GMFR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as GMFRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  27. Serum IgG antibody levels expressed as seroconversion rate (SCR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  28. Serum IgG antibody levels expressed as seroconversion rate (SCR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  29. Serum IgG antibody levels expressed as seroconversion rate (SCR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  30. Serum IgG antibody levels expressed as seroconversion rate (SCR)

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein antigen expressed as SCRs in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  31. Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  32. Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  33. Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  34. Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT)

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  35. hACE2 receptor binding inhibition assay expressed as GMFR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  36. hACE2 receptor binding inhibition assay expressed as GMFR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  37. hACE2 receptor binding inhibition assay expressed as GMFR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  38. hACE2 receptor binding inhibition assay expressed as GMFR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  39. hACE2 receptor binding inhibition assay expressed as SCR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 21

  40. hACE2 receptor binding inhibition assay expressed as SCR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  41. hACE2 receptor binding inhibition assay expressed as SCR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 70

  42. hACE2 receptor binding inhibition assay expressed as SCR

    Epitope-specific immune responses assayed with the SARS-CoV-2 rS protein receptor-binding domain measured by serum titers in an hACE2 receptor binding inhibition assay expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  43. Neutralizing antibody activity expressed as GMT

    Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  44. Neutralizing antibody activity expressed as GMT

    Titers of neutralizing antibody to the prototype virus expressed as GMT in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  45. Neutralizing antibody activity expressed as SCR

    Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  46. Neutralizing antibody activity expressed as SCR

    Titers of neutralizing antibody to the prototype virus expressed as SCR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

  47. Neutralizing antibody activity expressed as GMFR

    Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 35

  48. Neutralizing antibody activity expressed as GMFR

    Titers of neutralizing antibodies to the prototype virus expressed as GMFR in PLWH stratified by level of control of HIV infection.

    Time frame: Day 84

Secondary outcomes

  1. Serum IgG antibody levels expressed as GMEU

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

    Time frame: Day 21

  2. Serum IgG antibody levels expressed as GMEU

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

    Time frame: Day 35

  3. Serum IgG antibody levels expressed as GMEU

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

    Time frame: Day 70

  4. Serum IgG antibody levels expressed as GMEU

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMEUs in HIV-negative participants.

    Time frame: Day 84

  5. Serum IgG antibody levels expressed as GMFR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

    Time frame: Day 21

  6. Serum IgG antibody levels expressed as GMFR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

    Time frame: Day 35

  7. Serum IgG antibody levels expressed as GMFR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

    Time frame: Day 70

  8. Serum IgG antibody levels expressed as GMFR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as GMFR in HIV-negative participants.

    Time frame: Day 84

  9. Serum IgG antibody levels expressed as SCR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

    Time frame: Day 21

  10. Serum IgG antibody levels expressed as SCR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

    Time frame: Day 35

  11. Serum IgG antibody levels expressed as SCR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

    Time frame: Day 70

  12. Serum IgG antibody levels expressed as SCR

    Serum IgG antibody levels assayed with the SARS-CoV-2 rS protein expressed as SCR in HIV-negative participants.

    Time frame: Day 84

07

Study locations

7 sites
  • KwaPhila Health Solutions (Enhancing Care)
    Westridge, Durban 4091, South Africa
  • Josha Research
    Bloemfontein, Free State 9301, South Africa
  • The Aurum Institute Pretoria Clinical Research Services
    Pretoria, Gauteng 0087, South Africa
  • Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
    Diepkloof, Johannesburg 1862, South Africa
  • Wits RHI Shandukani Research Centre
    Hillbrow, Johannesburg 2001, South Africa
  • MERC Research (Pty) Ltd - Middelburg
    Middelburg, Mpumalanga 1055, South Africa
  • Madibeng Centre for Research
    Brits, North-West 250, South Africa
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05112848
Lead sponsor
Novavax
Responsible party
Sponsor
First posted
Nov 9, 2021
Start date
Feb 28, 2022
Primary completion
May 23, 2022
Completion
Nov 30, 2022
Last update
Mar 16, 2023

Study contacts

Clinical Development
study director · Novavax

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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