Phase 3
N=407
Safety and Immunogenicity of V114 in Children Infected With Human Immunodeficiency Virus (HIV) (V114-030/PNEU-WAY PED)
Pneumococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03921424 ↗Enrolled (actual)
407
Serious AEs
0.7%
Results posted
Dec 2021
Primary outcome: Primary: Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ — 9.4; 5.9; 10.3; 6.4 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- V114 (Biological); Prevnar 13™ (Biological); PNEUMOVAX™23 (Biological)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With V114 or Prevnar 13™ |
9.4; 5.9; 10.3; 6.4; 55.2; 53.9 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With V114 or Prevnar 13™ |
9.4; 10.3; 7.9; 8.3; 14.8; 10.8 | — |
| PRIMARY 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 |
0.0; 0.0; 0.0; 0.0 | — |
| PRIMARY Anti-PnPs Serotype-specific IgG Geometric Mean Concentrations (GMCs) at 30 Days Following Vaccination With V114 or Prevnar 13™ |
2.17; 3.26; 1.05; 0.84; 2.59; 4.27 | — |
| SECONDARY Percentage of Participants With a Solicited Injection-Site Adverse Event Following Vaccination With PNEUMOVAX™23 |
10.3; 12.4; 18.2; 13.4; 51.7; 55.0 | — |
| SECONDARY Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23 |
12.8; 8.4; 12.3; 11.4; 10.3; 9.4 | — |
| SECONDARY Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™ |
353.4; 398.3; 330.0; 301.5; 6078.3; 9172.8 | — |
| SECONDARY Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) |
326.4; 337.0; 327.2; 384.8; 5445.7; 7526.8 | — |
| SECONDARY Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12) |
2.58; 3.33; 1.10; 1.08; 2.36; 3.61 | — |
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
Data sourced from ClinicalTrials.gov (NCT03921424). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.