Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
- Conditions
- Pneumococcal Infections
- Interventions
- Biological: V114Biological: Prevnar 13™Biological: PNEUMOVAX™23
- Registration Number
- NCT03921424
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 407
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description V114 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) Prevnar 13™ 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) Prevnar 13™ PNEUMOVAX™23 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) V114 PNEUMOVAX™23 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)
- Primary Outcome Measures
Name Time Method 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 Through 6 Months after Vaccination 1 (Up to Day 194) 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.
Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ Through 14 Days after Vaccination 1 (Up to Day 14) 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.
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ Through 14 Days after Vaccination 1 (Up to Day 14) 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.
Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ Day 30 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.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 Through 14 Days after Vaccination 2 (Up to Day 84) 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.
Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 Through 14 Days after Vaccination 2 (Up to Day 84) 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.
Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ Day 30 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.
Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) 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.
Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) 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.
Trial Locations
- Locations (13)
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)
🇹🇭Amphoe Mueang, Khon Kaen, Thailand
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)
🇿🇦Johannesburg, Gauteng, South Africa
Perinatal HIV Research Unit ( Site 0042)
🇿🇦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
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)
🇹🇭Chiang Mai, Thailand
Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine
Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)
🇺🇦Vinnytsia, Vinnytska Oblast, Ukraine
Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)
🇺🇦Zaporizhzhya, Zaporizka Oblast, Ukraine
Odesa Regional Center of Socially Significant Diseases ( Site 0083)
🇺🇦Odesa, Odeska Oblast, Ukraine
Chulalongkorn University-Pediatrics ( Site 0062)
🇹🇭Bangkok, Krung Thep Maha Nakhon, Thailand
Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)
🇺🇦Dnipro, Dnipropetrovska Oblast, Ukraine