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Trial record 1 of 1 for:    HPX2004
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Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

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ClinicalTrials.gov Identifier: NCT02788045
Recruitment Status : Active, not recruiting
First Posted : June 2, 2016
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE June 2, 2016
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE July 8, 2016
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • Local And Systemic Solicited Adverse Events (Aes) for 7 Days Post-Vaccination [ Time Frame: Baseline up to 7 days after each vaccination ]
    Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema, swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 7 days post-vaccination.
  • AEs for 28 Days After Each Vaccination [ Time Frame: Baseline up to 28 days after each vaccination ]
  • Discontinuations From Vaccination/From Study Due to AEs [ Time Frame: Baseline up to Week 72 ]
  • Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) During the Course of the Study, Including the Optional LTE Phase [ Time Frame: Baseline up to Week 312 ]
  • Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [ Time Frame: Baseline up to Week 312 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Local And Systemic Solicited Adverse Events (Aes) for 7 Days Post-Vaccination [ Time Frame: Baseline up to 7 days after each vaccination ]
    Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema, swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 7 days post-vaccination.
  • AEs for 28 Days After Each Vaccination [ Time Frame: Baseline up to 28 days after each vaccination ]
  • Discontinuations From Vaccination/From Study Due to AEs [ Time Frame: Baseline up to Week 72 ]
  • Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) During the Course of the Study [ Time Frame: Baseline up to Week 72 ]
  • Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [ Time Frame: Baseline up to Week 72 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2020)
  • Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [ Time Frame: Baseline up to Week 312 ]
  • Env-specific Functional Abs (Phagocytosis Score and Breadth) [ Time Frame: Baseline up to Week 312 ]
  • Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth) [ Time Frame: Baseline up to Week 312 ]
  • Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic Peptide Pools of Env/Group-specific Antigen (Gag)/Polymerase (Pol) and Potential T-cell Epitope (PTE) [ Time Frame: Baseline up to Week 312 ]
  • Cluster of Differentiation (Cd)4+ and Cd8+ T-Cell Functionality (Percentage [%] Cells Producing I-alpha, Ifn-gamma, Interleukin [Il-2], Il-4, Tumor Necrosis Factor [Tnf]-alpha) [ Time Frame: Baseline up to Week 312 ]
  • T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [ Time Frame: Baseline up to Week 72 ]
  • Available Samples From Time Points After Last Vaccination Until the Final Main Study Visit at Week 72 Will be Used for Determination of Durability of the Immune Responses [ Time Frame: Baseline up to Week 72 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 27, 2016)
  • Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [ Time Frame: Baseline up to Week 72 ]
  • Env-specific Functional Abs (Phagocytosis Score and Breadth) [ Time Frame: Baseline up to Week 72 ]
  • Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth) [ Time Frame: Baseline up to Week 72 ]
  • Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic Peptide Pools of Env/Group-specific Antigen (Gag)/Polymerase (Pol) and Potential T-cell Epitope (PTE) [ Time Frame: Baseline up to Week 72 ]
  • Cluster of Differentiation (Cd)4+ and Cd8+ T-Cell Functionality (Percentage [%] Cells Producing I-alpha, Ifn-gamma, Interleukin [Il-2], Il-4, Tumor Necrosis Factor [Tnf]-alpha) [ Time Frame: Baseline up to Week 72 ]
  • T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [ Time Frame: Baseline up to Week 72 ]
  • Available Samples From Time Points After Last Vaccination Will be Used for Determination Of Durability [ Time Frame: Baseline up to Week 72 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Official Title  ICMJE A Randomized, Parallel-Group, Placebo-Controlled, Double-Blind Phase 1/2a Study in Healthy HIV Uninfected Adults to Assess the Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens; Priming With Trivalent Ad26.Mos.HIV and Boosting With Trivalent Ad26.Mos.HIV And Clade C Gp140 Plus Adjuvant or Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Clade C Gp140 Plus Adjuvant
Brief Summary The purpose of this study is to assess the safety/tolerability of the 2 different vaccine regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the different vaccine schedules will be assessed.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE
  • Biological: Ad26.Mos.HIV
    Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
  • Biological: Ad26.Mos4.HIV
    Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5mL injection administered intramuscularly.
  • Biological: Clade C gp140
    Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
  • Drug: Placebo
    Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Study Arms  ICMJE
  • Experimental: Group 1A: Ad26.Mos.HIV
    Participants will receive Ad26.Mos.HIV vaccine at Week 0 and 12, followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48.
    Interventions:
    • Biological: Ad26.Mos.HIV
    • Biological: Clade C gp140
  • Placebo Comparator: Group 1B: Placebo
    Participants will receive placebo at Weeks 0, 12, 24 and 48.
    Intervention: Drug: Placebo
  • Experimental: Group 2A: Ad26.Mos4.HIV
    Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 microgram (mcg) of total protein mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants will be included in an optional Long-term Extension (LTE) phase (3 years or 5 years Follow-up after Week 72, every 6 months visit) to assess immunogenicity and safety (serious adverse events [SAEs]).
    Interventions:
    • Biological: Ad26.Mos4.HIV
    • Biological: Clade C gp140
  • Placebo Comparator: Group 2B: Placebo
    Participants will receive placebo at Weeks 0, 12, 24 and 48.
    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: April 5, 2018)
201
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2016)
198
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Are negative for human immunodeficiency virus (HIV) infection at screening
  • Is healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at screening
  • Are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures
  • Female participants of childbearing potential must have a negative serum pregnancy test (beta human chorionic gonadotropin [beta hCG]) at the Screening visit, and a negative urine pregnancy test pre-dose on Day 1
  • Are assessed by the clinic staff as being at low risk for HIV infection

Exclusion Criteria:

  • Has chronic hepatitis B (measured by hepatitis B surface antigen test) or active hepatitis C (measured by hepatitis C virus [HCV] Ab test; if positive, HCV ribonucleic acid [RNA] PCR test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection
  • Has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
  • Has had major psychiatric illness and/or substance abuse problems during the past 12 months (including hospitalization or periods of work disability) that in the opinion of the investigator would preclude participation
  • Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine/placebo, plans to receive within 14 days after the first study vaccination, or plans to receive within 14 days before or after the second, third or fourth vaccination
  • Is a recipient of a prophylactic or therapeutic HIV vaccine candidate at any time, or a recipient of other experimental vaccine(s) within the last 12 months prior to the Day 1 visit (Vaccination 1). For participants who received an experimental vaccine (except HIV vaccine) more than 12 months prior to the Day 1 visit (Vaccination 1), documentation of the identity of the experimental vaccine must be provided to the sponsor, who will determine eligibility on a case-by-case basis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Rwanda,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02788045
Other Study ID Numbers  ICMJE CR108152
VAC89220HPX2004 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Janssen Vaccines & Prevention B.V.
Study Sponsor  ICMJE Janssen Vaccines & Prevention B.V.
Collaborators  ICMJE Not Provided
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 June 2020

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