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

NCT03921424 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: V114-0302019-000341-12
• Study Type: interventional
• Target: 407
• Locations: 3 countries
• Sites: 13

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.

Conditions

Pneumococcal Infections

Keywords

Pneumococcal conjugate vaccine (PCV), 15-valent, 22F, 33F

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (5)

• 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)

• Percentage of Participants With a Solicited Systemic Adverse Event Following Vaccination With PNEUMOVAX™23

  Through 14 Days after Vaccination 2 (Up to Day 84)

• Anti-PnPs Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 30 Days Following Vaccination With V114 or Prevnar 13™

  Day 30

• Anti-PnPs Serotype-specific OPA GMTs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)

  Week 12

• Anti-PnPs Serotype-specific IgG GMCs at 30 Days Following Vaccination With PNEUMOVAX™23 (Week 12)

  Week 12

Study Arms (2)

V114

EXPERIMENTAL

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)

Biological: V114; Biological: PNEUMOVAX™23

Prevnar 13™

ACTIVE COMPARATOR

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)

Biological: Prevnar 13™; Biological: PNEUMOVAX™23

Interventions

V114 BIOLOGICAL

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.

Also known as: VAXNEUVANCE™, Pneumococcal 15-Valent Conjugate Vaccine

V114

Prevnar 13™ BIOLOGICAL

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.

Prevnar 13™

PNEUMOVAX™23 BIOLOGICAL

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

Prevnar 13™; V114

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (13)

Perinatal HIV Research Unit ( Site 0042)

Johannesburg, Gauteng, 1864, South Africa

Location

Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)

Johannesburg, Gauteng, 2001, South Africa

Location

Family Clinic Research With UBUNTU ( Site 0045)

Cape Town, Western Cape, 7505, South Africa

Location

Be Part Yoluntu Centre ( Site 0041)

Paarl, Western Cape, 7626, South Africa

Location

Chulalongkorn University-Pediatrics ( Site 0062)

Bangkok, Bangkok, 10330, Thailand

Location

Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)

Bangkok, Bangkok, 10700, Thailand

Location

Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)

Amphoe Mueang, Changwat Khon Kaen, 40002, Thailand

Location

CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)

Chiang Mai, 50200, Thailand

Location

Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)

Dnipro, Dnipropetrovsk Oblast, 49006, Ukraine

Location

Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)

Dnipro, Dnipropetrovsk Oblast, 49115, Ukraine

Location

Odesa Regional Center of Socially Significant Diseases ( Site 0083)

Odesa, Odesa Oblast, 65014, Ukraine

Location

Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)

Vinnytsia, Vinnytsia Oblast, 21000, Ukraine

Location

Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)

Zaporizhzhya, Zaporizhzhia Oblast, 69063, Ukraine

Location

Related 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 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.

  PMID: 36939067 RESULT

MeSH Terms

Conditions

Pneumococcal Infections

Interventions

13-valent pneumococcal vaccine

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 19, 2019
• Study Start: November 5, 2019
• Primary Completion: May 3, 2021
• Study Completion: May 3, 2021
• Last Updated: June 7, 2023
• Results First Posted: December 9, 2021

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

ZA (4); UA (5); TH (4)