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)
Completed · Phase 3
Conditions studied: Pneumococcal Infections
In brief
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™.
Key facts
- Study ID
- NCT03480802
- Run by
- Merck Sharp & Dohme LLC
- People needed
- 302
- Starts
- 2018-07-06
- Expected to finish
- 2020-01-17
- Last updated by the study team
- 2022-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Bliss Healthcare Services ( Site 0010) — Orlando, Florida, United States
- Triple O Research Institute, P.A. ( Site 0011) — West Palm Beach, Florida, United States
- Saint Hope Foundation, Inc. ( Site 0009) — Houston, Texas, United States
- The Crofoot Research Center, Inc. ( Site 0002) — Houston, Texas, United States
- Hopital Gabriel Montpied ( Site 0084) — Clemont Ferrand, France
- Hopital Saint Louis ( Site 0094) — Paris, France
- Hopital Cochin du Paris ( Site 0089) — Paris, France
- Via Libre ( Site 0043) — Lima, Peru
- Investigaciones Medicas en Salud - INMENSA ( Site 0041) — Lima, Peru
- Chris Hani Baragwanath Hospital ( Site 0122) — Johannesburg, Soweto, South Africa
- Be Part Yoluntu Centre ( Site 0123) — Paarl, Western Cape, South Africa
- Siriraj Hosp (Prev&Social Med). ( Site 0183) — Bangkok, Thailand
- Research Institute for Health. ( Site 0182) — Chiang Mai, Thailand
Full record on ClinicalTrials.gov
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