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A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03307915
Recruitment Status : Active, not recruiting
First Posted : October 12, 2017
Last Update Posted : September 30, 2020
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Ragon Institute of MGH, MIT and Harvard
US Military HIV Research Program
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE September 25, 2017
First Posted Date  ICMJE October 12, 2017
Last Update Posted Date September 30, 2020
Actual Study Start Date  ICMJE March 5, 2018
Estimated Primary Completion Date November 16, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Percentage of Participants With Solicited Local Adverse Events (AEs) as a Measure of Safety and Tolerability [ Time Frame: 7 days post-vaccination (approximately up to 37 weeks) ]
    Solicited local AEs: erythema, swelling/induration, and pain/tenderness will be assessed.
  • Percentage of Participants With Solicited Systemic AEs as a Measure of Safety and Tolerability [ Time Frame: 7 days post-vaccination (approximately up to 37 weeks) ]
    Solicited systemic AEs: fever (temperature measurement), fatigue, headache, nausea, myalgia, and chills will be assessed.
  • Percentage of Participants With AEs as a Measure of Safety and Tolerability [ Time Frame: Approximately up to 96 weeks ]
    An AE is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 11, 2017)
  • Total IgG and Subclass Specific Antibody Titer [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    Total immunoglobulin G (IgG) and subclass (IgG1-4) specific antibody titers (binding antibody) to envelope (Env) proteins representing Clades A, B, and C, as well as Mosaic antigens.
  • Antibody Functionality Assessment by Antibody-dependent Cell-mediated Phagocytosis (ADCP) [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    Antibody functionality assessment will be assessed by antibody-dependent cell-mediated phagocytosis (ADCP) assay.
  • Magnitude of T-cell Responses as Measured by Intracellular Cytokine Staining (ICS) Assay [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    Intracellular cytokine staining (ICS) assays with Env, group-specific antigen (Gag), and/or polymerase (Pol)-peptide pools will be used to determine the magnitude of T-cell responses elicited.
  • Functionality of T-cell Responses as Measured by ICS Assay [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the functionality of T-cell responses elicited.
  • Phenotype of T-cell Responses as Measured by ICS Assay [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    ICS assays with Env, Gag, and/or Pol-peptide pools will be used to determine the phenotype of T-cell responses elicited.
  • Frequency of Epitope Recognition by Enzyme-Linked Immunospot (ELISPOT) [ Time Frame: Up to post-vaccination follow-up period until Week 96 ]
    Assays of peptide pool sets covering the Gag, Env or Pol will be evaluated by standard enzyme linked immunospot assay (ELISPOT).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Modified Vaccinia Ankara (MVA)-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in Human Immunodeficiency Virus (HIV) Type 1 Infected Adults on Suppressive Antiretroviral Treatment
Official Title  ICMJE A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With MVA-Mosaic OR Ad26.Mos4.HIV Plus a Combination of Mosaic and Clade C gp140 Protein in HIV-1 Infected Adults on Suppressive ART
Brief Summary The primary purpose of this study is to assess safety/tolerability of 2 different prime/boost regimens containing adenovirus serotype 26 (Ad26).Mos4.HIV, Modified Vaccinia Ankara (MVA) -Mosaic or adjuvanted Mosaic and Clade C gp140 in Human immunodeficiency virus type 1 (HIV-1)-infected participants on suppressive antiretroviral treatment (ART).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Condition  ICMJE Human Immunodeficiency Virus
Intervention  ICMJE
  • Biological: Ad26.Mos4.HIV
    Participants will receive Ad26.Mos4.HIV 5*10^10 vp as 0.5 mL IM injection at Weeks 0, 12 in Group 1 and at Weeks 0, 12, 24, 36 in Group 2.
  • Biological: MVA-Mosaic
    Participants will receive MVA-Mosaic 10^8 pfu as IM injection at Weeks 24 and 36.
  • Biological: Clade C gp140 + Mosaic gp140
    Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg coformulated with Aluminum phosphate adjuvant) OR an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36.
  • Drug: Placebo
    Participants will receive matching placebo as IM injection at Weeks 24, 36 in Group 1 and at Weeks 0, 12, 24, 36 in Group 3.
Study Arms  ICMJE
  • Experimental: Group 1: Ad26.Mos4.HIV + MVA-Mosaic/Placebo
    Participants will receive adenovirus serotype 26-Mosaic 4 -Human Immunodeficiency Virus (Ad26.Mos4.HIV) 5*10^10 virus particles (vp) as intramuscular (IM) injection at Weeks 0 and 12 (1 injection) followed by modified Vaccinia Ankara-Mosaic (MVA-Mosaic) 10^8 Plaque-forming unit (pfu) and placebo as IM injection at Weeks 24 and 36 (2 injections).
    Interventions:
    • Biological: Ad26.Mos4.HIV
    • Biological: MVA-Mosaic
    • Drug: Placebo
  • Experimental: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
    Participants will receive Ad26.Mos4.HIV, 5*10^10 vp as IM injection at Weeks 0 and 12 (1 injection) followed by both Ad26.Mos4.HIV 5*10^10 vp plus Clade C gp140 (125 microgram [mcg]) plus Mosaic gp140 (125 mcg) with aluminum phosphate adjuvant or an equivalent dose of a bivalent vaccine that includes both Clade C gp140 and Mosaic gp140, and aluminum phosphate adjuvant in a single vial, via IM injection at Weeks 24 and 36 (2 injections).
    Interventions:
    • Biological: Ad26.Mos4.HIV
    • Biological: Clade C gp140 + Mosaic gp140
  • Placebo Comparator: Group 3: Placebo
    Participants will receive 0.9 percent (%) saline as IM injection at Weeks 0, 12 (one injection) and at Week 24, 36 (two injections).
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: October 11, 2017)
26
Estimated Study Completion Date  ICMJE December 17, 2021
Estimated Primary Completion Date November 16, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Each participant must have documented Human immunodeficiency virus type1 (HIV-1) infection
  • Each participant must be on suppressive antiretroviral treatment (ART) for at least 48 weeks prior to randomization and on stable suppressive ART for at least 4 weeks prior to screening. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 4 weeks prior to screening
  • Each participant must have started ART outside of the acute or early phase of infection
  • Each participant must have a plasma HIV ribonucleic acid (RNA) less than (<) 50 copies/ milliliter (mL) at screening and at least one documented evidence of plasma HIV RNA <50 copies/mL after the last ART change. In case of ART change within the 48 weeks prior randomization, at least one additional more recent documented plasma HIV RNA <50 copies/mL is required. One blip of HIV RNA greater than (>)50 and <200 copies/mL within 24 weeks prior to screening is acceptable, provided that the 2 most recent (after last ART change, tested before and/or during screening) HIV RNA results are <50 copies/mL
  • Each participant must be medically stable as confirmed by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening

Exclusion Criteria:

  • Anyone who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study, or within 3 months after the last vaccination
  • Anyone with contraindication to intramuscular injections and blood draws example, bleeding disorders
  • Anyone with acute illness (this does not include minor illnesses such as diarrhea or mild upper respiratory tract infection) or temperature greater than or equal to (>=) 38.0ºC (degree centigrade) within 24 hours prior to the first dose of study vaccine; enrollment at a later date is permitted
  • Anyone with a history of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
  • Anyone with a history of an underlying clinically significant acute or uncontrolled chronic medical condition or physical examination findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments
  • Anyone with a history of Acquired Immunodeficiency Syndrome (AIDS)-defining illness according to Centers for Disease Control and prevention (CDC) criteria based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with AIDS-defining illnesses assessed by the investigator as clinically irrelevant must be provided to the sponsor and Protocol Safety Review Team (PSRT), who will determine eligibility on a case-by-case basis prior to randomization
  • Anyone with a history of CD4+ less than (<) 200 cells per millimeter cube (cells/mm^3), based on available medical history and assessed by the investigator as clinically relevant. A case summary for every participant with history of CD4+ <200 cells/mm^3 assessed by the investigator as clinically irrelevant must be provided to the sponsor and PSRT, who will determine eligibility on a case-by-case basis prior to randomization
  • Anyone with chronic active hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] antibody test; if positive, HCV RNA polymerase chain reaction test will be used to confirm active versus past HCV infection) or syphilis infection that has not been effectively treated. Positive syphilis serology due to past effectively treated infection is not exclusionary
  • Anyone who received or plans to receive: a) licensed live attenuated vaccines within 28 days before or after planned administration of any of the study vaccinations; b) other licensed (not live) vaccines - within 14 days before or after planned administration of any of the study vaccinations
  • Anyone who received an investigational drug or used an invasive investigational medical device within 30 days or received an investigational vaccine within 6 months before the planned administration of the first dose of study vaccine. Receipt of prophylactic or therapeutic HIV vaccine candidate at any time is always exclusionary. Exceptions: Participants can be included where the vaccine received was subsequently licensed. Participants with proof of having received only a placebo vaccine can also be included
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03307915
Other Study ID Numbers  ICMJE CR108372
VAC89220HTX1002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
IPCAVD-013 ( Other Identifier: National Institute of Allergy and Infectious Diseases )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE
  • Beth Israel Deaconess Medical Center
  • Ragon Institute of MGH, MIT and Harvard
  • US Military HIV Research Program
Investigators  ICMJE
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
PRS Account Janssen Vaccines & Prevention B.V.
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP