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Safety, Tolerability and Immunogenicity Study of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults

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ClinicalTrials.gov Identifier: NCT02685020
Recruitment Status : Completed
First Posted : February 18, 2016
Last Update Posted : January 23, 2019
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 schedules (different regimen durations and different number of dose administrations) with Ad26.Mos.HIV and Clade C Glycoprotein (gp) 140 and to assess Envelope (Env)-binding Antibody (Ab) responses of the different vaccine schedules.

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

Detailed Description:
This is a phase 1 single-center, randomized (the study drug is assigned by chance), parallel group (each group of participants will be treated at the same time), placebo-controlled (study in which the experimental treatment or procedure is compared to a pretend treatment with no drug in it to test if the drug has a real effect), and double-blind (neither physician nor participant knows the treatment that the participant receives) study. Participants will be randomized in to 3 groups and will receive study vaccines or placebo. Group 1 will have 4 vaccination time points during 48 weeks, Groups 2 and 3 will have 3 vaccination time points during 24 weeks. The study comprises a Screening Period (up to 4 weeks), a Vaccination Period (maximum 48 weeks), and a Follow-up Period (up to 72 weeks). Participants' safety will be monitored throughout the study. An optional Long-term Extension (LTE) phase (approximately 1 year after Week 72) will be performed for participants randomized to receive study vaccine, who have received all planned vaccinations and are negative for HIV infection at Week 72. The duration of the participation will be approximately 124 weeks for participants participating to the optional LTE phase.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 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 Study in Healthy HIV-uninfected Adults to Evaluate Safety/Tolerability and Immunogenicity of Different Vaccine Schedules With Ad26.Mos.HIV and Clade C gp140
Actual Study Start Date : March 28, 2016
Actual Primary Completion Date : January 5, 2018
Actual Study Completion Date : January 3, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

Arm Intervention/treatment
Experimental: Group 1A
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
The 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
Participants will receive placebo at weeks 0, 12, 24 and 48.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.

Experimental: Group 2A
Participants will receive Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 0, 12 and 24.
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
The 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
Participants will receive placebo at weeks 0, 12 and 24.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.

Experimental: Group 3A
Participants will receive Ad26.Mos.HIV vaccine at Week 0; followed by Ad26.Mos.HIV vaccine + Clade C glycoprotein 140 vaccine containing 250 mcg of total protein mixed with adjuvant (aluminum phosphate) at Week 8 and 24.
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
The 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 3B
Participants will receive placebo at weeks 0, 8 and 24.
Drug: Placebo
Normal saline, 0.5 mL injection administered intramuscularly.




Primary Outcome Measures :
  1. Titer to HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay [ Time Frame: Up to Week 72 ]
  2. Breadth of HIV-Envelope Specific Binding Antibodies Assessed by Env-Ab-binding Assay [ Time Frame: Up to Week 72 ]
  3. Number of Participants With Local and Systemic Reactogenicity for 8 Days After Each Vaccination [ Time Frame: Up to 8 days after each vaccination ]
    Participants will be asked to note occurrences of local reactions: pain/tenderness, erythema or swelling/induration at the injection site, and systemic events: fever (temperature measurement), fatigue, headache, nausea, myalgia and chills daily for 8 days post-vaccination. These occurrences will be recorded through the diary card provided to serve as a reminder to the participants for the next clinic visit.

  4. Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to Week 72 ]
  5. Serious Adverse Events (SAEs) and AEs of Special Interest (AESI) [ Time Frame: Up to Week 124 ]
  6. Discontinuations From Vaccination or From Study due to AEs [ Time Frame: At the time of discontinuation from vaccination or from study (Up to Week 72) ]
  7. Number of Participants With AEs or SAEs [ Time Frame: Up to 28 days after each vaccination ]

Secondary Outcome Measures :
  1. Env-Specific Functional Antibodies: Phagocytosis Score [ Time Frame: Up to Week 72 ]
  2. Env-Specific Functional Antibodies: Breadths [ Time Frame: Up to Week 72 ]
  3. Env-Specific Binding Antibody Isotypes: Titers [ Time Frame: Up to Week 72 ]
    The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody titers will be assessed using ELISA.

  4. Env-Specific Binding Antibody Isotypes: Breadths [ Time Frame: Up to Week 72 ]
    The Isotyping (Clade C) (IgA, IgG1-4)- Env binding antibody breadths will be assessed using ELISA.

  5. Env-Specific Neutralizing Antibodies (nAbs): Titers [ Time Frame: Up to Week 72 ]
  6. Env-Specific Neutralizing Antibodies (nAbs): Breadths [ Time Frame: Up to Week 72 ]
  7. Induction of New T-cell Immune Response by the Vaccine [ Time Frame: Up to Week 72 ]
    Induction of new T-cell immune response against one or more of the vaccine epitopes using Interferon gamma Enzyme Linked Immuno spot assay (IFNg-ELISPOT assay) measuring Spot forming Units per 1 million peripheral blood mononuclear cells (SFU/1 mio PBMCs) above threshold (> 50 sfu/mio PBMC).

  8. Change From Baseline of the Frequency of HIV-Specific PBMC and/or CD4 and/or CD8 T cells as Measured by ELISpot Interferon (IFN) Gamma [ Time Frame: Up to Week 72 ]

Other Outcome Measures:
  1. Mucosal Immunogenicity [ Time Frame: Up to week 72 ]
    Immune Responses to the Different Vaccine Schedules in Mucosal Secretions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and is voluntarily willing to participate in the study
  • Participant must be healthy on the basis of physical examination, medical history, electrocardiogram (ECG), and vital signs measurement performed at Screening
  • Participants are negative for Human Immunodeficiency Virus (HIV) infection at Screening
  • All 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
  • Participants are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

Exclusion Criteria:

  • Participant has chronic hepatitis B or active hepatitis C, active syphilis infection, chlamydia, gonorrhea, or trichomonas . Active syphilis documented by serology unless positive serology is due to past treated infection
  • In the 12 months prior to randomization, participant has a history of newly acquired herpes simplex virus type 2, syphilis, gonorrhea, non-gonococcal urethritis, chlamydia, pelvic inflammatory disease, trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranuloma venereum, chancroid, or hepatitis B
  • Participant has any condition 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
  • Participant has had major surgery within 4 weeks prior to Screening or planned major surgery through the course of the study
  • Participant has had a thyroidectomy or active thyroid disease requiring medication during the last 12 months

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): NCT02685020


Locations
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United States, Massachusetts
Boston, Massachusetts, United States
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen Vaccines & Prevention B.V.
ClinicalTrials.gov Identifier: NCT02685020    
Other Study ID Numbers: CR108068
VAC89220HPX1002 ( Other Identifier: Janssen Vaccines & Prevention B.V. )
First Posted: February 18, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Vaccines & Prevention B.V.:
Healthy
Human Immunodeficiency Virus
adenovirus serotype 26
Ad26.Mos.HIV
Vaccine
Placebo
Glycoprotein
IPCAVD010
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