Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03480802
Other study ID # V114-018
Secondary ID V114-0182017-001
Status Completed
Phase Phase 3
First received
Last updated
Start date July 6, 2018
Est. completion date January 17, 2020

Study information

Verified date April 2022
Source Merck Sharp & Dohme LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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™.


Recruitment information / eligibility

Status Completed
Enrollment 302
Est. completion date January 17, 2020
Est. primary completion date September 16, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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
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
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

Locations

Country Name City State
France Hopital Gabriel Montpied ( Site 0084) Clemont Ferrand
France Hopital Cochin du Paris ( Site 0089) Paris
France Hopital Saint Louis ( Site 0094) Paris Cedex 10
Peru Investigaciones Medicas en Salud - INMENSA ( Site 0041) Lima
Peru Via Libre ( Site 0043) Lima
South Africa Chris Hani Baragwanath Hospital ( Site 0122) Johannesburg Soweto
South Africa Be Part Yoluntu Centre ( Site 0123) Paarl Western Cape
Thailand Siriraj Hosp (Prev&Social Med). ( Site 0183) Bangkok
Thailand Research Institute for Health. ( Site 0182) Chiang Mai
United States Saint Hope Foundation, Inc. ( Site 0009) Houston Texas
United States The Crofoot Research Center, Inc. ( Site 0002) Houston Texas
United States Bliss Healthcare Services ( Site 0010) Orlando Florida
United States Triple O Research Institute, P.A. ( Site 0011) West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Merck Sharp & Dohme LLC

Countries where clinical trial is conducted

United States,  France,  Peru,  South Africa,  Thailand, 

References & Publications (1)

Mohapi L, Pinedo Y, Osiyemi O, Supparatpinyo K, Ratanasuwan W, Molina JM, Dagan R, Tamms G, Sterling T, Zhang Y, Pedley A, Hartzel J, Kan Y, Hurtado K, Musey L, Simon JK, Buchwald UK; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 1 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1 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)
Primary Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1 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)
Primary Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1 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)
Primary Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1 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
Primary Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1 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 Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2 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)
Secondary Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2 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)
Secondary Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2 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
Secondary Geometric Mean Titer of Serotype-specific OPA After Vaccination 2 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
Secondary Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2 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
See also
  Status Clinical Trial Phase
Completed NCT02201030 - Immunogenicity and Safety Study of NBP606 in Healthy Infants Phase 3
Completed NCT02787863 - Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology Phase 4
Completed NCT04031846 - Safety, Tolerability, and Immunogenicity of V114 in Healthy Infants (V114-025) Phase 3
Recruiting NCT05920499 - The Effect of AUDIT and Feedback on Pneumococcal Vaccination Coverage N/A
Completed NCT01215175 - Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001) Phase 1
Completed NCT02892812 - A Phase I Clinical Trial of a 13-valent Pneumococcal Conjugate Vaccine and 14-valent Pneumococcal Conjugate Vaccine in Adults Phase 1
Completed NCT02116998 - Safety, Tolerability, and Efficacy Study of Prophylactic S. Pneumoniae Vaccine Following Challenge With S. Pneumoniae Phase 2
Completed NCT01446926 - Study of Investigational Pneumococcal Vaccine in Healthy Adults, Toddlers and Infants Phase 1
Completed NCT01193582 - A Study To Assess The Safety And Effectiveness Of Prevenar In Chinese Children Who Have Not Previously Received A Vaccine Against Pneumococcal Bacteria Phase 4
Completed NCT00744263 - Study Evaluating the Effiacy of a 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) in Adults Phase 4
Completed NCT00492557 - Study Evaluating Safety and Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine With Influenza Vaccine in Adults Phase 3
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Completed NCT00137605 - Early Versus Delayed Pneumococcal Vaccination in HIV Phase 1/Phase 2
Completed NCT00205803 - Study Evaluating Pneumococcal Vaccine in Healthy Infants Phase 1/Phase 2
Completed NCT02531373 - A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-005) Phase 1/Phase 2
Completed NCT03615482 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 When Administered Concomitantly With Influenza Vaccine in Healthy Adults 50 Years of Age or Older (V114-021/PNEU-FLU) Phase 3
Completed NCT03565900 - A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Allogeneic Hematopoietic Stem Cell Transplant Recipients (V114-022/PNEU-STEM) Phase 3
Completed NCT04989465 - A Clinical Trial of 23-valent Pneumococcal Polysaccharide Vaccine Phase 4
Completed NCT02547649 - Safety, Tolerability, and Immunogenicity of Two Formulations of V114 in Healthy Adults 50 Years of Age or Older (V114-006) Phase 2
Completed NCT02573181 - Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in PPSV23-vaccinated Healthy Adults ≥65 Years of Age (V114-007) Phase 2