Clinical trial NCT03480802: A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by PNEUMOVAX™23 in Adults Infected With Human Immunodeficiency Virus (HIV) (V114-018)
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 Adults Infected With HIV (PNEU-WAY)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pneumococcal Infections
Keywords: Conjugate pneumococcal vaccine, 15-valent, 22F, 33F
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-03-29
Enrollment: 302
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is designed to 1) describe the safety, tolerability, and immunogenicity of V114 and Prevnar 13™ in pneumococcal vaccine-naïve adults infected with HIV and to 2) describe the safety, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.


Eligibility criteria: Inclusion Criteria:

* Male or female infected with human immunodeficiency virus (HIV) and Cluster of Differentiation 4+ (CD4+) cell count ≥50 cells/µL and plasma HIV ribonucleic acid (RNA) \<50,000 copies/mL
* Receiving combination anti-retroviral therapy (ART) for at least 6 weeks before enrollment with no intention of changing therapy for 3 months after randomization
* 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 study vaccine.

Exclusion Criteria:

* History of opportunistic infections within 12 months before the first study vaccination
* History of non-infectious acquired immune deficiency syndrome-related illness such as Kaposi's sarcoma, wasting syndrome, or HIV-associated nephropathy
* History of invasive pneumococcal disease
* Known hypersensitivity to any vaccine component
* Known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease
* Coagulation disorder contraindicating intramuscular vaccination
* History of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
* Female participant: positive urine or serum pregnancy test
* Prior administration of any pneumococcal vaccine
* Received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment
* Received immunosuppressive therapy
* 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 recent history of drug or alcohol abuse or dependence.

Primary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
timeFrame: Up to 5 days after Vaccination 1 (Up to Day 5)
measure: Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
timeFrame: Up to 14 days after Vaccination 1 (Up to Day 14)
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1
timeFrame: Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)
measure: Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
timeFrame: Day 30
measure: Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
timeFrame: Up to 5 days after Vaccination 2 (Up to Day 61)
measure: Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
timeFrame: Up to 14 days after Vaccination 2 (Up to Day 70)
measure: Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2
timeFrame: From Week 8 up to Month 6
measure: Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
timeFrame: Week 12
measure: Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
timeFrame: Week 12
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Bliss Healthcare Services ( Site 0010)
state: Florida
city: West Palm Beach
country: United States
facility: Triple O Research Institute, P.A. ( Site 0011)
state: Florida
city: Houston
country: United States
facility: Saint Hope Foundation, Inc. ( Site 0009)
state: Texas
city: Houston
country: United States
facility: The Crofoot Research Center, Inc. ( Site 0002)
state: Texas
city: Clemont Ferrand
country: France
facility: Hopital Gabriel Montpied ( Site 0084)
city: Paris Cedex 10
country: France
facility: Hopital Saint Louis ( Site 0094)
city: Paris
country: France
facility: Hopital Cochin du Paris ( Site 0089)
city: Lima
country: Peru
facility: Via Libre ( Site 0043)
city: Lima
country: Peru
facility: Investigaciones Medicas en Salud - INMENSA ( Site 0041)
city: Johannesburg
country: South Africa
facility: Chris Hani Baragwanath Hospital ( Site 0122)
state: Soweto
city: Paarl
country: South Africa
facility: Be Part Yoluntu Centre ( Site 0123)
state: Western Cape
city: Bangkok
country: Thailand
facility: Siriraj Hosp (Prev&Social Med). ( Site 0183)
city: Chiang Mai
country: Thailand
facility: Research Institute for Health. ( Site 0182)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Mohapi L, Pinedo Y, Osiyemi O, Supparatpinyo K, Ratanasuwan W, Molina JM, Dagan R, Tamms G, Sterling T, Zhang Y, Pedley A, Hartzel J, Kan Y, Hurtado K, Musey L, Simon JK, Buchwald UK; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. AIDS. 2022 Mar 1;36(3):373-382. doi: 10.1097/QAD.0000000000003126.