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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 : April 17, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.Mos.HIV Biological: Ad26.Mos4.HIV Biological: Clade C gp140 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : July 8, 2016
Actual Primary Completion Date : August 27, 2018
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arms and Interventions
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Arm Intervention/treatment
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.
 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: 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.
Placebo Comparator: Group 1B: Placebo
Participants will receive placebo at Weeks 0, 12, 24 and 48.
 Drug: Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
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 year Follow-up after Week 72, every 6 months visit) to assess immunogenicity and safety (serious adverse events [SAEs]).
 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.
Placebo Comparator: Group 2B: Placebo
Participants will receive placebo at Weeks 0, 12, 24 and 48.
 Drug: Placebo
Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. AEs for 28 Days After Each Vaccination [ Time Frame: Baseline up to 28 days after each vaccination ]
  3. Discontinuations From Vaccination/From Study Due to AEs [ Time Frame: Baseline up to Week 72 ]
  4. 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 216 ]
  5. Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [ Time Frame: Baseline up to Week 216 ]

Secondary Outcome Measures :
  1. Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses) [ Time Frame: Baseline up to Week 216 ]
  2. Env-specific Functional Abs (Phagocytosis Score and Breadth) [ Time Frame: Baseline up to Week 216 ]
  3. Env-specific Binding Ab Isotypes (Immunoglobulin A [Iga], Igg1-4) (Titers and Breadth) [ Time Frame: Baseline up to Week 216 ]
  4. 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 216 ]
  5. 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 216 ]
  6. T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [ Time Frame: Baseline up to Week 72 ]
  7. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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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): NCT02788045


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
San Francisco, California, United States
United States, Georgia
Decatur, Georgia, United States
United States, Maryland
Silver Spring, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New York
New York, New York, United States
Rochester, New York, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Washington
Seattle, Washington, United States
Rwanda
Kigali, Rwanda
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
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Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.
More Information
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02788045     History of Changes
Other Study ID Numbers: CR108152
VAC89220HPX2004 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: June 2, 2016    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Acquired Immunodeficiency Syndrome
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Vaccines
polysaccharide-K
Aluminum phosphate
 Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Antibiotics, Antineoplastic
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Interferon Inducers
Radiation-Protective Agents
Protective Agents
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents