Status:
COMPLETED
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)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Pneumococcal Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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, tolerab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2020
Estimated Enrollment :
302 Patients enrolled
Trial Details
Trial ID
NCT03480802
Start Date
July 6 2018
End Date
January 17 2020
Last Update
May 5 2022
Active Locations (13)
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1
Bliss Healthcare Services ( Site 0010)
Orlando, Florida, United States, 32806
2
Triple O Research Institute, P.A. ( Site 0011)
West Palm Beach, Florida, United States, 33407
3
Saint Hope Foundation, Inc. ( Site 0009)
Houston, Texas, United States, 77060
4
The Crofoot Research Center, Inc. ( Site 0002)
Houston, Texas, United States, 77098