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Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED) (PNEU-WAY PED)

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ClinicalTrials.gov Identifier: NCT03921424
Recruitment Status : Not yet recruiting
First Posted : April 19, 2019
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
This is a study of V114 in children infected with HIV. Participants will be randomly assigned in a 1:1 ratio to receive either V114 or Prevnar 13™ followed 8 weeks later by a single dose of Pneumovax™23. The primary objectives of this study are to evaluate the safety and tolerability of V114 in children 6 to 17 years of age inclusive infected with HIV and to evaluate the anti-pneumococcal polysaccharide (PnPs) serotype-specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 30 days following vaccination with V114 or Prevnar 13™ by each vaccination group. There are no formal hypotheses.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Biological: Pneumovax™23 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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 Children Infected With Human Immunodeficiency Virus (HIV) (PNEU-WAY PED)
Estimated Study Start Date : November 6, 2019
Estimated Primary Completion Date : February 17, 2021
Estimated Study Completion Date : February 17, 2021


Arm Intervention/treatment
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)
Biological: V114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.

Biological: Pneumovax™23
23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

Experimental: 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)
Biological: Prevnar 13™
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 ml dose.

Biological: Pneumovax™23
23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose




Primary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-Site Adverse Event after Vaccination 1 [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs will consist of redness/erythema, swelling, tenderness/pain, and hard lump/induration.

  2. Percentage of Participants with a Solicited Systemic Adverse Event after Vaccination 1 [ Time Frame: Up to Day 14 after Vaccination 1 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will consist of muscle pain/myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria.

  3. Percentage of Participants with a Vaccine-related Serious Adverse Event [ Time Frame: Up to Month 6 ]
    A serious adverse event (SAE) is any untoward medical occurrence that, at any dose, results in death, is lifethreatening, requires inpatient hospitalization or prolongs existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an other important medical event. SAEs that are reported to be at least possibly related by the investigator to study vaccination will be summarized.

  4. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PnPs) Serotype-specific Immunoglobulin G (IgG) Antibodies after Vaccination 1 [ Time Frame: Day 30 ]
    IgG antibody levels for the serotypes contained in V114 will be determined using a pneumococcal electrochemiluminescence (PnECL) assay.


Secondary Outcome Measures :
  1. Percentage of Participants with a Solicited Injection-Site Adverse Event after Vaccination 2 [ Time Frame: Up to Day 14 after Vaccination 2 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs will consist of redness/erythema, swelling, tenderness/pain, and hard lump/induration.

  2. Percentage of Participants with a Solicited Systemic Adverse Event after Vaccination 2 [ Time Frame: Up to Day 14 after Vaccination 2 ]
    An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited systemic AEs will consist of muscle pain/myalgia, joint pain/arthralgia, headache, tiredness/fatigue, and hives or welts/urticaria.

  3. Anti-Pneumococcal Polysaccharide (anti-PnPs) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) after Vaccination 1 [ Time Frame: Day 30 ]
    OPA for the serotypes contained in V114 will be determined using the Multiplex Opsonophagocytic Assay (MOPA).

  4. Anti-Pneumococcal Polysaccharide (anti-PnPs) Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) after Vaccination 2 [ Time Frame: Week 12 ]
    OPA for the serotypes contained in V114 will be determined using the MOPA.

  5. Geometric Mean Concentrations (GMCs) of Anti-Pneumococcal Polysaccharide (anti-PnPs) Serotype-specific IgG Antibodies after Vaccination 2 [ Time Frame: Week 12 ]
    IgG antibody levels for the serotypes contained in V114 will be determined using a PnECL assay.



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female between the ages of 6 and 17 years (inclusive) infected with HIV and has a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIV ribonucleic acid (RNA) <50,000 copies/mL
  • Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valent PCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™ vaccination ≥3 years before Visit 2 (Day 1)
  • Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years before Visit 2 (Day 1)
  • 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 World Health Organization (WHO) HIV classification of clinical Stage 4 disease within the past 12 months
  • History of invasive pneumococcal disease
  • Known hypersensitivity to any vaccine component
  • Known or suspected congenital immunodeficiency (other than HIV infection), functional or anatomic asplenia, or history of autoimmune disease
  • Bleeding disorder contraindicating intramuscular vaccinations
  • History of malignancy ≤5 years prior to signing informed consent/assent, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
  • Female participant: positive urine or serum pregnancy test
  • Expect to receive any pneumococcal vaccine during the study outside of the protocol
  • Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
  • 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

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): NCT03921424


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.

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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03921424     History of Changes
Other Study ID Numbers: V114-030
V114-030 ( Other Identifier: Merck )
2019-000341-12 ( EudraCT Number )
First Posted: April 19, 2019    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Additional relevant MeSH terms:
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Pneumococcal Infections
Acquired Immunodeficiency Syndrome
HIV Infections
Immunologic Deficiency Syndromes
Immune System Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Slow Virus Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs