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

Pneumococcal Infections Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921424
• Other study ID #: V114-030
• Secondary ID: V114-0302019-000
• Status: Completed
• Phase: Phase 3
• Start date: November 5, 2019
• Est. completion date: May 3, 2021

Study information

• Verified date: May 2023
• Source: Merck Sharp & Dohme LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 407
• Est. completion date: May 3, 2021
• Est. primary completion date: May 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Pneumococcal Infections

Intervention

Biological:
• V114
15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.
• Prevnar 13™
13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 mL dose.
• PNEUMOVAX™23
23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose

Locations

Country	Name	City	State
South Africa	Family Clinic Research With UBUNTU ( Site 0045)	Cape Town	Western Cape
South Africa	Perinatal HIV Research Unit ( Site 0042)	Johannesburg	Gauteng
South Africa	Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)	Johannesburg	Gauteng
South Africa	Be Part Yoluntu Centre ( Site 0041)	Paarl	Western Cape
Thailand	Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)	Amphoe Mueang	Khon Kaen
Thailand	Chulalongkorn University-Pediatrics ( Site 0062)	Bangkok	Krung Thep Maha Nakhon
Thailand	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
Ukraine	Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)	Dnipro	Dnipropetrovska Oblast
Ukraine	Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)	Dnipro	Dnipropetrovska Oblast
Ukraine	Odesa Regional Center of Socially Significant Diseases ( Site 0083)	Odesa	Odeska 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

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

South Africa,  Thailand,  Ukraine, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through 14 Days after Vaccination 1 (Up to Day 14)
Primary	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.	Through 14 Days after Vaccination 1 (Up to Day 14)
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	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.	Through 6 Months after Vaccination 1 (Up to Day 194)
Primary	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.	Day 30
Secondary	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.	Through 14 Days after Vaccination 2 (Up to Day 84)
Secondary	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.	Through 14 Days after Vaccination 2 (Up to Day 84)
Secondary	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.	Day 30
Secondary	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.	Week 12
Secondary	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.	Week 12