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

Last updated: May 11, 2023
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Completed

Phase

3

Condition

Hiv Infections

Aids And Aids Related Infections

Hiv/aids

Treatment

Prevnar 13™

V114

PNEUMOVAX™23

Clinical Study ID

NCT03921424
V114-030
V114-030
2019-000341-12
  • Ages 6-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female between the ages of 6 and 17 years (inclusive) infected with HIV andhas a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIVribonucleic acid (RNA) <50,000 copies/mL
  • Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valentPCV, 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 beforeVisit 2 (Day 1)
  • Female participant: not pregnant, not breastfeeding and 1) not of childbearingpotential, or 2) of childbearing potential and agrees to practice contraceptionthrough 6 weeks after administration of last dose of the study vaccine.

Exclusion

Exclusion Criteria:

  • History of World Health Organization (WHO) HIV classification of clinical Stage 4disease 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), functionalor anatomic asplenia, or history of autoimmune disease
  • Bleeding disorder contraindicating intramuscular vaccinations
  • History of malignancy ≤5 years prior to signing informed consent/assent, except foradequately 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 treatcancer or other conditions, and interventions associated with organ or bone marrowtransplantation, 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 monthsof enrollment
  • Current user of recreational or illicit drugs or history of drug or alcohol abuse ordependence

Study Design

Total Participants: 407
Treatment Group(s): 3
Primary Treatment: Prevnar 13™
Phase: 3
Study Start date:
November 05, 2019
Estimated Completion Date:
May 03, 2021

Connect with a study center

  • Perinatal HIV Research Unit ( Site 0042)

    Johannesburg, Gauteng 1864
    South Africa

    Site Not Available

  • Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)

    Johannesburg, Gauteng 2001
    South Africa

    Site Not Available

  • Family Clinic Research With UBUNTU ( Site 0045)

    Cape Town, Western Cape 7505
    South Africa

    Site Not Available

  • Be Part Yoluntu Centre ( Site 0041)

    Paarl, Western Cape 7626
    South Africa

    Site Not Available

  • Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)

    Amphoe Mueang, Khon Kaen 40002
    Thailand

    Site Not Available

  • Chulalongkorn University-Pediatrics ( Site 0062)

    Bangkok, Krung Thep Maha Nakhon 10330
    Thailand

    Site Not Available

  • Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)

    Bangkok, Krung Thep Maha Nakhon 10700
    Thailand

    Site Not Available

  • CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)

    Chiang Mai, 50200
    Thailand

    Site Not Available

  • Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)

    Dnipro, Dnipropetrovska Oblast 49006
    Ukraine

    Site Not Available

  • Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)

    Dnipro, Dnipropetrovska Oblast 49115
    Ukraine

    Site Not Available

  • Odesa Regional Center of Socially Significant Diseases ( Site 0083)

    Odesa, Odeska Oblast 65014
    Ukraine

    Site Not Available

  • Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)

    Vinnytsia, Vinnytska Oblast 21000
    Ukraine

    Site Not Available

  • Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)

    Zaporizhzhya, Zaporizka Oblast 69063
    Ukraine

    Site Not Available

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