- ICH GCP
- US Clinical Trials Registry
- 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) (PNEU-WAY)
April 13, 2022 updated by: Merck Sharp & Dohme LLC
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™.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
302
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clemont Ferrand, France, 63000
- Hopital Gabriel Montpied ( Site 0084)
-
Paris, France, 75679
- Hopital Cochin du Paris ( Site 0089)
-
Paris Cedex 10, France, 75475
- Hopital Saint Louis ( Site 0094)
-
-
-
-
-
Lima, Peru, 15001
- Via Libre ( Site 0043)
-
Lima, Peru, 15046
- Investigaciones Medicas en Salud - INMENSA ( Site 0041)
-
-
-
-
Soweto
-
Johannesburg, Soweto, South Africa, 1862
- Chris Hani Baragwanath Hospital ( Site 0122)
-
-
Western Cape
-
Paarl, Western Cape, South Africa, 7626
- Be Part Yoluntu Centre ( Site 0123)
-
-
-
-
-
Bangkok, Thailand, 10700
- Siriraj Hosp (Prev&Social Med). ( Site 0183)
-
Chiang Mai, Thailand, 50200
- Research Institute for Health. ( Site 0182)
-
-
-
-
Florida
-
Orlando, Florida, United States, 32806
- Bliss Healthcare Services ( Site 0010)
-
West Palm Beach, Florida, United States, 33407
- Triple O Research Institute, P.A. ( Site 0011)
-
-
Texas
-
Houston, Texas, United States, 77060
- Saint Hope Foundation, Inc. ( Site 0009)
-
Houston, Texas, United States, 77098
- The Crofoot Research Center, Inc. ( Site 0002)
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: V114
Participants will receive a single 0.5 mL intramuscular (IM) injection of V114 on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
|
Active Comparator: Prevnar 13™
Participants will receive a single 0.5 mL IM injection of Prevnar 13™ on Day 1 (Vaccination 1) and a single 0.5 mL IM injection of PNEUMOVAX™23 at Week 8 (Vaccination 2)
|
23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1
Time Frame: Up to 5 days after Vaccination 1 (Up to Day 5)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
The 95% confidence interval (CI) were based on the exact binomial method proposed by Clopper and Pearson.
|
Up to 5 days after Vaccination 1 (Up to Day 5)
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1
Time Frame: Up to 14 days after Vaccination 1 (Up to Day 14)
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue).
The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
|
Up to 14 days after Vaccination 1 (Up to Day 14)
|
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1
Time Frame: Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)
|
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Relatedness of an SAE to the study vaccine is determined by the investigator.
The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
|
Day 1 up to 8 weeks after Vaccination 1 (Up to Week 8)
|
Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1
Time Frame: Day 30
|
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo.
Sera from participants was used to measure geometric mean titer (GMT) of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the Multiplexed Opsonophagocytic Assay (MOPA).
This assay reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls.
The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
|
Day 30
|
Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1
Time Frame: Day 30
|
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex electrochemiluminescence (ECL) using the pneumococcal electrochemiluminescence (PnECL) v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates.
The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
|
Day 30
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2
Time Frame: Up to 5 days after Vaccination 2 (Up to Day 61)
|
An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited injection-site AEs consist of redness/erythema, swelling, and tenderness/pain.
The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
|
Up to 5 days after Vaccination 2 (Up to Day 61)
|
Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2
Time Frame: Up to 14 days after Vaccination 2 (Up to Day 70)
|
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment.
Solicited systemic AEs consist of muscle pain (myalgia), joint pain (arthralgia), headache, and tiredness (fatigue).
The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
|
Up to 14 days after Vaccination 2 (Up to Day 70)
|
Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2
Time Frame: From Week 8 up to Month 6
|
A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment.
Relatedness of an SAE to the study vaccine is determined by the investigator.
The 95% CI were based on the exact binomial method proposed by Clopper and Pearson.
|
From Week 8 up to Month 6
|
Geometric Mean Titer of Serotype-specific OPA After Vaccination 2
Time Frame: Week 12
|
Opsonization of pneumococci for phagocytosis is an important mechanism by which antibodies to polysaccharides protect against disease in vivo.
Sera from participants was used to measure GMT of 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) included in V114 and Prevnar 13™; and two serotypes (22F and 33F) which are unique to V114, using the MOPA.
The MOPA reads the reciprocal of the highest dilution (1/dil) that gives ≥50% bacterial killing, as determined by comparison to assay background controls.
The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
|
Week 12
|
Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2
Time Frame: Week 12
|
The geometric mean concentration of IgG serotype-specific antibodies to the 13 pneumococcal polysaccharide serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) contained in V114 and Prevnar 13™ ; and two serotypes (22F and 33F) which are unique to V114, were quantitated from participants' sera by multiplex ECL using the PnECL v2.0 assay, based on the Meso-Scale Discovery technology, which employs disposable multi-spot microtiter plates.
The 95% CIs were derived by exponentiating the CIs of the mean of the natural log values based on the t-distribution.
|
Week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 6, 2018
Primary Completion (Actual)
September 16, 2019
Study Completion (Actual)
January 17, 2020
Study Registration Dates
First Submitted
March 22, 2018
First Submitted That Met QC Criteria
March 22, 2018
First Posted (Actual)
March 29, 2018
Study Record Updates
Last Update Posted (Actual)
May 5, 2022
Last Update Submitted That Met QC Criteria
April 13, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- V114-018 (Other Identifier: Merck Protocol Number)
- 2017-001909-32 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pneumococcal Infections
-
Johns Hopkins Bloomberg School of Public HealthPfizer; National Institutes of Health (NIH); Centers for Disease Control and...CompletedInvasive Pneumococcal Disease | Pneumococcal Nasopharyngeal ColonizationUnited States
-
Institut National de la Santé Et de la Recherche...CompletedPneumococcal DiseasesFrance
-
Wyeth is now a wholly owned subsidiary of PfizerPfizerCompletedInvasive Pneumococcal DiseaseIceland
-
GlaxoSmithKlineCompletedProphylactic Pneumococcal DiseasesBelgium
-
Centers for Disease Control and PreventionKaiser PermanenteCompletedPneumococcal Disease PreventionUnited States
-
PfizerCompletedPneumococcal Disease | 13-valent Pneumococcal VaccineUnited States
-
Walvax Biotechnology Co., Ltd.Enrolling by invitationPneumococcal Disease, InvasiveIndonesia
-
PfizerCompletedInvasive Pneumococcal DiseaseSpain
-
PfizerCompletedPneumococcal DiseasesTurkey
-
PfizerKaiser PermanenteCompletedInvasive Pneumococcal DiseaseUnited States
Clinical Trials on V114
-
Merck Sharp & Dohme LLCCompletedPneumococcal InfectionsUnited States, Canada, Denmark, Finland, Israel, Spain
-
Merck Sharp & Dohme LLCCompletedPneumococcal Infections | Streptococcus Pneumoniae Infection
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedPneumococcal Infections
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompleted
-
Merck Sharp & Dohme LLCCompletedPneumococcal InfectionsUnited States, Brazil, Colombia, Dominican Republic, Greece, Italy, Panama
-
Merck Sharp & Dohme LLCCompletedPneumococcal InfectionsTaiwan, United States, Canada, Japan, Spain
-
Merck Sharp & Dohme LLCCompletedPneumococcal Infections | Pneumonia, PneumococcalUnited States, Australia, Chile, Denmark, Finland, United Kingdom