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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

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ClinicalTrials.gov Identifier: NCT03307915
Recruitment Status : Recruiting
First Posted : October 12, 2017
Last Update Posted : November 7, 2018
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.

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).

Condition or disease Intervention/treatment Phase
Human Immunodeficiency Virus Biological: Ad26.Mos4.HIV Biological: MVA-Mosaic Biological: Clade C gp140 + Mosaic gp140 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: 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
Actual Study Start Date : March 5, 2018
Estimated Primary Completion Date : February 19, 2020
Estimated Study Completion Date : February 12, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
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).
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.

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.

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) IM injection at Weeks 24 and 36 (2 injections).
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: Clade C gp140 + Mosaic gp140
Participants will receive both Clade C gp140 125 mcg plus Mosaic gp140 125 mcg (250 mcg co-formulated with Aluminum phosphate adjuvant) IM at Weeks 24 and 36.

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).
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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 24 weeks prior to randomization. Changes in antiretrovirals (ARVs) can be made for safety/tolerability reasons only until 24 weeks prior to randomization
  • 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 is acceptable, provided that the most recent (before screening) HIV RNA is <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

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): NCT03307915


Contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Beth Israel Deaconess Medical Center
Ragon Institute of MGH, MIT and Harvard
US Military HIV Research Program
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Additional Information:
Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT03307915     History of Changes
Other Study ID Numbers: CR108372
VAC89220HTX1002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
IPCAVD-013 ( Other Identifier: National Institute of Allergy and Infectious Diseases )
First Posted: October 12, 2017    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018

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

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