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A Safety, Tolerability and Immunogenicity Study of 2 Different Regimens of Tetravalent Ad26.Mos4.HIV Prime Followed by Boost With Tetravalent Ad26.Mos4.HIV Along With Either Clade C gp140 Plus Adjuvant OR With a Combination of Mosaic and Clade C gp140 Plus Adjuvant in Healthy HIV Uninfected Adults (IPCAVD-012)

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ClinicalTrials.gov Identifier: NCT02935686
Recruitment Status : Active, not recruiting
First Posted : October 17, 2016
Last Update Posted : September 26, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Vaccines & Prevention B.V.

Brief Summary:
The primary purpose of this study is to assess safety/tolerability of the different vaccine regimens and to assess envelope (Env)-binding antibody (Ab) responses of the 2 different vaccine regimens.

Condition or disease Intervention/treatment Phase
Healthy Biological: Ad26.Mos4.HIV Biological: Clade C gp140 plus adjuvant Biological: Clade C gp140/Mosaic gp140 plus adjuvant Other: Placebo Phase 1 Phase 2

Detailed Description:
This is a randomized (study medication assigned by chance), double-blind (neither physician nor participant knows the treatment received), placebo-controlled (placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial), parallel-group (each treatment group will be treated at the same time), multicenter (more than one clinical site) study in healthy human immunodeficiency virus (HIV)-uninfected adults. The main study will be conducted in 3 phases: a 6-week screening period; a 48-week vaccination period; and a follow-up period to the final main study visit at Week 72. A Long-term Extension (LTE) phase (approximately 3 years after Week 72) will be performed for participants randomized to Group 1 or Group 2, who receive all 4 vaccinations and are negative for HIV infection at Week 72. The approximate duration of the study will be approximately 78 weeks for participants not participating in the LTE phase and approximately 222 weeks for participants participating in the LTE phase. Participants safety will be monitored throughout the study.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 155 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 Safety/Tolerability and Immunogenicity of 2 Different Prime/Boost Regimens: Priming With Tetravalent Ad26.Mos4.HIV and Boosting With Tetravalent Ad26.Mos4.HIV and Either Clade C gp140 Plus Adjuvant OR a Combination of Mosaic and Clade C gp140 Plus Adjuvant
Actual Study Start Date : March 31, 2017
Estimated Primary Completion Date : December 26, 2018
Estimated Study Completion Date : January 3, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1: Ad26.Mos4.HIV + Clade C gp140
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 (aluminium phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Biological: Ad26.Mos4.HIV
Ad26.Mos4.HIV at a dose of 5*10^10 viral particles (vp), administered intramuscularly.

Biological: Clade C gp140 plus adjuvant
Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection administered intramuscularly.

Experimental: Group 2: Ad26.Mos4.HIV + Clade C gp140 + Mosaic gp140
Participants will receive Ad26.Mos4.HIV vaccine at Week 0 and 12; followed by Ad26.Mos4.HIV vaccine + combination of 125 mcg Mosaic gp140 and 125 mcg Clade C gp140 mixed with adjuvant (aluminum phosphate) at Week 24 and 48. Participants who receive all 4 vaccinations and are negative for HIV infection at Week 72 can consent to be included in a long-term extension (LTE) phase (approximately 3 years after Week 72).
Biological: Ad26.Mos4.HIV
Ad26.Mos4.HIV at a dose of 5*10^10 viral particles (vp), administered intramuscularly.

Biological: Clade C gp140/Mosaic gp140 plus adjuvant
Clade C gp140 and Mosaic gp140 (each 125 mcg of total protein) mixed with aluminum phosphate adjuvant, per 0.5 milliliter (mL) injection, administered intramuscularly.

Placebo Comparator: Group 3: Placebo
Participants will receive a single placebo injection at Weeks 0 and 12, followed by two placebo injections at Weeks 24 and 48.
Other: Placebo
Placebo Containing 0.9 percent normal saline, administered intramuscularly.




Primary Outcome Measures :
  1. Number of Participants With Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Baseline up to 7 days after each vaccination ]
    Number of Participants With Solicited Local and Systemic Adverse Events (AEs)

  2. Number of Participants With Adverse events (AEs) [ Time Frame: Baseline up to 28 days after each vaccination ]
    Number of Participants With Adverse events (AEs)

  3. Discontinuations From Vaccination/From Study due to AEs [ Time Frame: Baseline up to Week 72 ]
    Discontinuations From Vaccination/From Study due to AEs

  4. Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs) [ Time Frame: Baseline up to Week 216 ]
    Number of Participants With Serious Adverse Events (SAEs) and AEs of Special Interest (AESIs)

  5. Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth) [ Time Frame: Baseline up to Week 216 ]
    Envelope (Env)-specific Binding Antibody (Abs) (Titers and Breadth)


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 ]
    Env-specific Neutralizing Antibody (nAbs) (Titers and Breadth) (for Tier 1 and Tier 2 Viruses)

  2. Env-specific Functional Abs (Phagocytosis Score and Breadth) [ Time Frame: Baseline up to Week 216 ]
    Env-specific Functional Abs (Phagocytosis Score and Breadth)

  3. Env-specific Binding Ab Isotypes (Immunoglobulin A [IgA], IgG1-4) (Titers and Breadth) [ Time Frame: Baseline up to Week 216 ]
    Env-specific Binding Ab Isotypes (Immunoglobulin A [IgA], IgG1-4) (Titers and Breadth)

  4. Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) peptide pools of Env/Group-specific Antigen (Gag)/ Polymerase (Pol) [ Time Frame: Baseline up to Week 216 ]
    Interferon (IFN)-gamma Peripheral Blood Mononuclear Cell (PBMC) Responders to Mosaic and Potential T-cell Epitope (PTE) peptide pools of Env/Group-specific Antigen (Gag)/ Polymerase (Pol)

  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 ]
    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)

  6. T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation [ Time Frame: Baseline up to Week 216 ]
    T-Cell Development With Emphasis on Follicular Helper T-Cells and Memory Differentiation



Information from the National Library of Medicine

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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:

  • Participant must be healthy on the basis of medical history, physical examination, and vital signs measurement performed at screening
  • Participants are negative for human immunodeficiency virus (HIV) infection at screening
  • Participants are amenable to HIV-risk reduction counseling and committed to maintaining behavior consistent with low risk of HIV exposure through the last required protocol clinic visit
  • All female participants of childbearing potential must have a negative serum (beta-human chorionic gonadotropin [beta-hCG]) at the screening visit, and a negative urine pregnancy test pre-dose on Day 1
  • Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

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] polymerase chain reaction (PCR) test will be used to confirm active versus past HCV infection), active syphilis infection, chlamydia, gonorrhea, or trichomonas
  • In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2 (HSV-2), syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
  • Participant has had major surgery (eg, requiring general anesthesia) within the 4 weeks before screening, or will not have fully recovered from surgery, or has surgery planned through the course of the study
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months (not excluded: a stable thyroid supplementation)
  • Current or past drug/alcohol use that investigator assesses poses any more than a remotely increased risk of the ability of the participant to comply with the protocol requirements
  • Has been in receipt of any licensed vaccine within 14 days prior to the first dose of study vaccine or 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

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): NCT02935686


Locations
United States, Alabama
Alabama Vaccine Research Clinic at UAB
Birmingham, Alabama, United States, 35294
United States, California
Bridge HIV
San Francisco, California, United States, 94102-4594
United States, Georgia
The Hope Clinic at Emory University
Decatur, Georgia, United States, 30030-1705
United States, Massachusetts
Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Fenway Health
Boston, Massachusetts, United States, 02215
United States, New York
Columbia University HIV Vaccine Unit
New York, New York, United States, 10032
New York Blood Center
New York, New York, United States, 10065
Strong Memorial Infectious Disease
Rochester, New York, United States, 14642
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Washington
Seattle Vaccine Trials Unit
Seattle, Washington, United States, 98104
Kenya
Walter Reed Project Clinical Research Center
Kericho, Kenya, 20200
Rwanda
Project San Francisco
Kigali, Rwanda, 780
Sponsors and Collaborators
Janssen Vaccines & Prevention B.V.
Investigators
Study Director: Janssen Vaccines & Prevention B.V. Clinical Trial Janssen Vaccines & Prevention B.V.

Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02935686     History of Changes
Other Study ID Numbers: CR108207
VAC89220HPX2003 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: October 17, 2016    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

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

Additional relevant MeSH terms:
Aluminum phosphate
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antacids
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents