Clinical trial NCT03921424: Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-04-19
Enrollment: 407
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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 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

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™
timeFrame: Through 14 Days after Vaccination 1 (Up to Day 14)
measure: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™
timeFrame: Through 14 Days after Vaccination 1 (Up to Day 14)
measure: 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
timeFrame: Through 6 Months after Vaccination 1 (Up to Day 194)
measure: Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23
timeFrame: Through 14 Days after Vaccination 2 (Up to Day 84)
measure: Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23
timeFrame: Through 14 Days after Vaccination 2 (Up to Day 84)
measure: Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™
timeFrame: Day 30
measure: Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
timeFrame: Week 12
measure: Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)
timeFrame: Week 12
Other outcomes:
Locations:
city: Johannesburg
country: South Africa
facility: Perinatal HIV Research Unit ( Site 0042)
state: Gauteng
city: Johannesburg
country: South Africa
facility: Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)
state: Gauteng
city: Cape Town
country: South Africa
facility: Family Clinic Research With UBUNTU ( Site 0045)
state: Western Cape
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 0041)
state: Western Cape
city: Amphoe Mueang
country: Thailand
facility: Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)
state: Khon Kaen
city: Bangkok
country: Thailand
facility: Chulalongkorn University-Pediatrics ( Site 0062)
state: Krung Thep Maha Nakhon
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)
state: Krung Thep Maha Nakhon
city: Chiang Mai
country: Thailand
facility: CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)
city: Dnipro
country: Ukraine
facility: Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)
state: Dnipropetrovska Oblast
city: Odesa
country: Ukraine
facility: Odesa Regional Center of Socially Significant Diseases ( Site 0083)
state: Odeska Oblast
city: Vinnytsia
country: Ukraine
facility: Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)
state: Vinnytska Oblast
city: Zaporizhzhya
country: Ukraine
facility: Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)
state: Zaporizka Oblast
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Wilck M, Barnabas S, Chokephaibulkit K, Violari A, Kosalaraksa P, Yesypenko S, Chukhalova I, Dagan R, Richmond P, Mikviman E, Morgan L, Feemster K, Lupinacci R, Chiarappa J, Madhi SA, Bickham K, Musey L; V114-030 Study Group. A phase 3 study of safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by 23-valent pneumococcal polysaccharide vaccine, in children with HIV. AIDS. 2023 Jul 1;37(8):1227-1237. doi: 10.1097/QAD.0000000000003551. Epub 2023 Mar 17.