None listed
Conditions
Interventions
V114 Type of group
Single dose of V114 (day 1) followed by single dose of Pneumovax™ 23, 8 weeks later
Group name:Prevenar 13 Type of group
Single dose of Prevenar 13™ (day 1) followed by single dose of Pneumovax™ 23, 8 weeks later
Sponsors
Merck Sharp & Dohme Corp., una subsidiaria de Mer·ck & Co. Inc.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women and men of at least 18 years of age 2. Infected with HIV and CD4+ T-cell count ≥50 cells/μL and plasma HIV RNA <50,000 copies/mL tested at Screening 3. Receiving combination ART for at least 6 weeks prior to study entry with no intended changes to combination ART therapy for 3 months after randomization. 4. If participant is female, she is not pregnant or breastfeeding, and is either not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow the contraceptive guidance in protocol. 5. The participant provides written informed consent for the study.
Exclusion criteria
Exclusion criteria: 1. History of opportunistic infections 12 months before the first vaccination 2. History of non-infectious AIDS-related illness such as Kaposi´s sarcoma, wasting syndrome, or HIV-associated nephropathy. 3. History of active hepatitis with elevation in pretreatment ALT or AST values >5 times the upper limit of normal within 6 months before the first vaccination 4. History of IPD or known history of other culture-positive pneumococcal disease within 3 years of Visit 2 5. Known hypersensitivity to any component of pneumococcal polysaccharide vaccine, pneumococcal conjugate vaccine, or any diphtheria toxoid-containing vaccine or known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease. 6. Coagulation disorder contraindicating intramuscular vaccinations. 7. Recent febrile illness 8. History of malignancy ≤5 years prior to signing informed consent. 9. A WOCBP who has a positive urine or serum pregnancy test before the first vaccination at Visit 2 or Is breastfeeding. 10. Prior administration of any pneumococcal vaccine or expected to receive any pneumococcal vaccine during the study outside of the protocol. 11. Received systemic corticosteroids (prednisone equivalent of ≥20 mg/day) for ≥14 consecutive days and has not completed treatment at least 30 days before study entry. 12. Received any licensed, non-live vaccine within the 14 days before receipt of any study vaccine or any live vaccine within 30 days before receipt of any study vaccine or is scheduled to receive any of the above within 30 days following receipt of any study vaccine. 13. Is participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study. 14. Has history or current evidence of any condition, therapy, lab abnormality, or other circumstance that might expose the participant to risk by participating in the study, confound the results of the study, or interfere with the participant’s participation for the full duration of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Evaluation and quantification of adverse events, notified and registered through the electronic vaccination booklet (eVRC) Measure:Adverse event / Serious adverse event at the site of injection, systemic and vaccine-related. Timepoints:From Day 1 through Day 5 postvaccination ; Outcome name:Safety parameters will be summarized via descriptive statistics. In addition, for select safety parameters, 95% within-group CIs will be provided. Measure:Proportion of solicited systemic AEs postvaccination with V114 or Prevenar 13. Timepoints:From Day 1 through Day 14 postvaccination ; Outcome name:Safety parameters will be summarized via descriptive statistics. In addition, for select safety parameters, 95% within-group CIs will be provided. Measure:Proportion of vaccine-related (V114 or Prevenar 13) serious adverse events (SAEs) Timepoints:From Day 1 to Week 8 postvaccination ; Outcome name:Descriptive summaries and within-group 95% CIs to be calculated for each vaccination group. Measure:Serotype-specific OPA and IgG responses for the 15 serotypes in V114 (serotype-specific OPA GMTs and IgG GMCs after vaccination with V114 or Prevnar 13™) Timepoints:Day 30 postvaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Safety parameters will be summarized via descriptive statistics. In addition, for select safety parameters, 95% within-group CIs will be provided. Measure:Proportion of solicited injection-site AEs postvaccination with Pneumovax 23. Timepoints:From Day 1 through Day 5 postvaccination ; Outcome name:Safety parameters will be summarized via descriptive statistics. In addition, for select safety parameters, 95% within-group CIs will be provided. Measure:Proportion of solicited systemic AEs postvaccination with Pneumovax 23 Timepoints:From Day 1 through Day 14 postvaccination ; Outcome name:Safety parameters will be summarized via descriptive statistics. In addition, for select safety parameters, 95% within-group CIs will be provided. Measure:Proportion of vaccine-related (Pneumovax 23) SAEs Timepoints:From Week 8 to Month 6 postvaccination ; Outcome name:Descriptive summaries and within-group 95% CIs to be calculated for each vaccination group. Measure:Serotype-specific OPA and IgG responses for the 15 serotypes in V114 (serotype-specific OPA GMTs and IgG GMCs after vaccination with PNEUMOVAX™23) Timepoints:Week 12 postvaccination | — |
Countries
France, Peru, Russian Federation, South Africa, Thailand, United States
Contacts
Public ContactAngela Chavez
MERCK SHARP & DOHME PERU S.R.L
Outcome results
None listed