Phase 3
Completed N=302
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)
Pneumococcal Infections
Source: ClinicalTrials.gov NCT03480802 ↗
Enrolled (actual)
302
Serious AEs
1.8%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1 — 4.6; 3.3; 57.2; 51.3 Percentage of Participants
◆ Published Evidence
Established
28citations · ~7 / year
Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV.
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™.
Linked Publications
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Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 1 |
4.6; 3.3; 57.2; 51.3; 11.8; 4.0 | — |
| PRIMARY Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 1 |
3.3; 4.0; 20.4; 13.3; 13.2; 9.3 | — |
| PRIMARY Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 1 |
0; 0 | — |
| PRIMARY Geometric Mean Titer (GMT) of Serotype-specific Opsonophagocytic Activity (OPA) After Vaccination 1 |
238.8; 200.9; 116.8; 72.3; 824.0; 1465.5 | — |
| PRIMARY Geometric Mean Concentration of Serotype-specific Immunoglobulin G (IgG) After Vaccination 1 |
3.16; 4.27; 0.57; 0.50; 1.14; 2.00 | — |
| SECONDARY Percentage of Participants With a Solicited Injection-site Adverse Event After Vaccination 2 |
10.0; 12.2; 53.3; 61.5; 20.0; 29.1 | — |
| SECONDARY Percentage of Participants With a Solicited Systemic Adverse Event After Vaccination 2 |
2.7; 1.4; 12.7; 10.8; 8.7; 8.8 | — |
| SECONDARY Percentage of Participants With a Vaccine-related Serious Adverse Event After Vaccination 2 |
0; 0 | — |
| SECONDARY Geometric Mean Titer of Serotype-specific OPA After Vaccination 2 |
212.0; 154.0; 102.8; 96.6; 915.4; 984.7 | — |
| SECONDARY Geometric Mean Concentration of Serotype-specific IgG After Vaccination 2 |
2.80; 4.04; 0.51; 0.59; 1.26; 1.61 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT03480802) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.