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A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY)

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ClinicalTrials.gov Identifier: NCT03480802
Recruitment Status : Active, not recruiting
First Posted : March 29, 2018
Last Update Posted : July 8, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE March 29, 2018
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE July 6, 2018
Estimated Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain, joint pain, headache, and tiredness.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 ]
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
  • Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 30 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
Original Primary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 1 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain, joint pain, headache, and tiredness.
  • Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 ]
    A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine will be determined by the investigator.
  • Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) [ Time Frame: Day 30 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) [ Time Frame: Day 30 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
Change History Complete list of historical versions of study NCT03480802 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 2 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 2 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain, joint pain, headache, and tiredness.
  • Geometric Mean Titer of Serotype-specific OPA [ Time Frame: Week 12 ]
    OPA for the serotypes contained in V114 will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Concentration of Serotype-specific IgG [ Time Frame: Week 12 ]
    IgG for the serotypes contained in V114 will be determined using an electrochemiluminescence assay.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 22, 2018)
  • Percentage of Participants with a Solicited Injection-site Adverse Event [ Time Frame: Up to Day 5 after Vaccination 2 ]
    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited injection-site AEs will be redness, swelling, and pain/tenderness.
  • Percentage of Participants with a Solicited Systemic Adverse Event [ Time Frame: Up to Day 14 after Vaccination 2 ]
    An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. Solicited systemic AEs will be muscle pain, joint pain, headache, and tiredness.
  • Geometric Mean Titer of Serotype-specific OPA [ Time Frame: Week 12 ]
    Serotype-specific OPA will be determined using a Multiplex Opsonophagocytic Assay.
  • Geometric Mean Concentration of Serotype-specific IgG [ Time Frame: Week 12 ]
    Serotype-specific IgG will be determined using an electrochemiluminescence assay.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018/PNEU-WAY)
Official Title  ICMJE A Phase 3, Multicenter, Randomized, Double-Blind, Active Comparator-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected With HIV (PNEU-WAY)
Brief Summary This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Pneumococcal Infections
Intervention  ICMJE
  • Biological: V114
    15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
  • Biological: Prevnar 13™
    13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
  • Biological: PNEUMOVAX™23
    23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
Study Arms  ICMJE
  • Experimental: V114
    Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
    Interventions:
    • Biological: V114
    • Biological: PNEUMOVAX™23
  • Active Comparator: Prevnar 13™
    Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
    Interventions:
    • Biological: Prevnar 13™
    • Biological: PNEUMOVAX™23
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
Estimated Enrollment  ICMJE
 (submitted: March 22, 2018)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 10, 2020
Estimated Primary Completion Date February 10, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female infected with human immunodeficiency virus (HIV) and Cluster of Differentiation 4+ (CD4+) cell count ≥50 cells/µL and plasma HIV ribonucleic acid (RNA) <50,000 copies/mL
  • Receiving combination anti-retroviral therapy (ART) for at least 6 weeks before enrollment with no intention of changing therapy for 3 months after randomization
  • Female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of study vaccine.

Exclusion Criteria:

  • History of opportunistic infections within 12 months before the first study vaccination
  • History of non-infectious acquired immune deficiency syndrome-related illness such as Kaposi's sarcoma, wasting syndrome, or HIV-associated nephropathy
  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
  • Coagulation disorder contraindicating intramuscular vaccination
  • History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Female participant: positive urine or serum pregnancy test
  • Prior administration of any pneumococcal vaccine
  • Received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment
  • Received immunosuppressive therapy
  • Received a blood transfusion or blood products within 6 months of enrollment
  • Participated in another clinical study of an investigational product within 2 months of enrollment
  • Current user of recreational or illicit drugs or history of drug or alcohol abuse or dependence.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Peru,   South Africa,   Thailand,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03480802
Other Study ID Numbers  ICMJE V114-018
V114-018 ( Other Identifier: Merck Protocol Number )
2017-001909-32 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date July 2019

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