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

Merck Sharp & Dohme LLC407 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

407

Conditions

Pneumococcal Infections

Interventions

Eligibility

Sex: ALLMin age: 6 YearsMax age: 17 Years

Medical Language ↔ Plain English

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 last dose of the 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

Locations (13)

Perinatal HIV Research Unit ( Site 0042)

Johannesburg, Gauteng, South Africa

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

Johannesburg, Gauteng, South Africa

Family Clinic Research With UBUNTU ( Site 0045)

Cape Town, Western Cape, South Africa

Be Part Yoluntu Centre ( Site 0041)

Paarl, Western Cape, South Africa

Chulalongkorn University-Pediatrics ( Site 0062)

Bangkok, Bangkok, Thailand

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

Bangkok, Bangkok, Thailand

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

Amphoe Mueang, Changwat Khon Kaen, Thailand

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

Chiang Mai, Thailand

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

Dnipro, Dnipropetrovsk Oblast, Ukraine

Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)

Dnipro, Dnipropetrovsk Oblast, Ukraine

...and 3 more locations

Outcomes

Primary Outcomes

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.

Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)

Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 1 with either V114 or Prevnar 13™, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.

Time frame: Through 14 Days after Vaccination 1 (Up to Day 14)

Percentage of Participants With a Vaccine-related Serious Adverse Event (SAE) Following Vaccination 1 (V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) Through Completion of Study

An SAE is an AE that results in death, 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 an other important medical event deemed such by medical or scientific judgment. The percentage of participants with a vaccine-related SAE following Vaccination 1 (with either V114 or Prevnar 13™) or Vaccination 2 (PNEUMOVAX™23) through completion of study participation was reported.

Time frame: Through 6 Months after Vaccination 1 (Up to Day 194)

Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™

The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.

Time frame: Day 30

Secondary Outcomes

Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23 (PPV23), the percentage of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, hard lump/induration, tenderness/pain, and swelling.

Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)

Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Following Vaccination 2 with PNEUMOVAX™23, the percentage of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were joint pain/arthralgia, tiredness/fatigue, headache, muscle pain/myalgia, and hives or welts/urticaria.

Time frame: Through 14 Days after Vaccination 2 (Up to Day 84)

Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™

The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.

Time frame: Day 30

Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)

The GMT of serotype-specific OPA for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using a multiplexed opsonophagocytic assay.

Time frame: Week 12

Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)

The GMC of serotype-specific IgG for the serotypes contained in V114 (13 serotypes shared with Prevnar 13™ and 2 serotypes unique to V114) was determined using an electrochemiluminescence assay.