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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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