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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)

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ClinicalTrials.gov Identifier: NCT03480802
Recruitment Status : Completed
First Posted : March 29, 2018
Results First Posted : November 25, 2020
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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, tolerability, and immunogenicity of PNEUMOVAX™23 when administered 8 weeks after receipt of either V114 or Prevnar 13™.

Condition or disease Intervention/treatment Phase
Pneumococcal Infections Biological: V114 Biological: Prevnar 13™ Biological: PNEUMOVAX™23 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 302 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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)
Actual Study Start Date : July 6, 2018
Actual Primary Completion Date : September 16, 2019
Actual Study Completion Date : January 17, 2020

Resource links provided by the National Library of Medicine


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)
Biological: V114
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

Biological: PNEUMOVAX™23
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)
Biological: Prevnar 13™
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

Biological: PNEUMOVAX™23
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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480802


Locations
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United States, Florida
Bliss Healthcare Services ( Site 0010)
Orlando, Florida, United States, 32806
Triple O Research Institute, P.A. ( Site 0011)
West Palm Beach, Florida, United States, 33407
United States, Texas
Saint Hope Foundation, Inc. ( Site 0009)
Houston, Texas, United States, 77060
The Crofoot Research Center, Inc. ( Site 0002)
Houston, Texas, United States, 77098
France
Hopital Gabriel Montpied ( Site 0084)
Clemont Ferrand, France, 63000
Hopital Saint Louis ( Site 0094)
Paris Cedex 10, France, 75475
Hopital Cochin du Paris ( Site 0089)
Paris, France, 75679
Peru
Via Libre ( Site 0043)
Lima, Peru, 15001
Investigaciones Medicas en Salud - INMENSA ( Site 0041)
Lima, Peru, 15046
South Africa
Chris Hani Baragwanath Hospital ( Site 0122)
Johannesburg, Soweto, South Africa, 1862
Be Part Yoluntu Centre ( Site 0123)
Paarl, Western Cape, South Africa, 7626
Thailand
Siriraj Hosp (Prev&Social Med). ( Site 0183)
Bangkok, Thailand, 10700
Research Institute for Health. ( Site 0182)
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Director Merck Sharp & Dohme Corp.
  Study Documents (Full-Text)

Documents provided by Merck Sharp & Dohme Corp.:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT03480802    
Other Study ID Numbers: V114-018
V114-018 ( Other Identifier: Merck Protocol Number )
2017-001909-32 ( EudraCT Number )
First Posted: March 29, 2018    Key Record Dates
Results First Posted: November 25, 2020
Last Update Posted: November 25, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Merck Sharp & Dohme Corp.:
Conjugate pneumococcal vaccine, 15-valent, 22F, 33F
Additional relevant MeSH terms:
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Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs