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/PNEU-WAY)
Status: | Recruiting |
---|---|
Conditions: | Pneumonia, Infectious Disease, HIV / AIDS, HIV / AIDS |
Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/17/2019 |
Start Date: | July 6, 2018 |
End Date: | February 10, 2020 |
Contact: | Toll Free Number |
Email: | Trialsites@merck.com |
Phone: | 1-888-577-8839 |
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)
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™.
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™.
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 history of drug or alcohol abuse or
dependence.
We found this trial at
5
sites
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4728 West Alabama Street
Houston, Texas 77098
Houston, Texas 77098
Phone: 713-526-0005
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