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

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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™.


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
4728 West Alabama Street
Houston, Texas 77098
Phone: 713-526-0005
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Clemont Ferrand, 63000
Phone: +33473178417
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Houston, Texas 77060
Phone: 832-300-8040
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Orlando, Florida 32806
Phone: 407-203-5984
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Orlando, FL
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West Palm Beach, Florida 33401
Phone: 561-855-7871
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West Palm Beach, FL
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