Phase 2
Completed N=600
A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)
Pneumonia, Pneumococcal
Source: ClinicalTrials.gov NCT04168190 ↗
Enrolled (actual)
600
Serious AEs
1.2%
Results posted
Aug 2022
Primary outcomePrimary: Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) — 10.0; 23.3; 20.0; 73.3 Percentage of participants
Summary
This Phase 1 and Phase 2 study will evaluate the safety, tolerability and immunogenicity of V116 when administered to adults. Phase 1 has no formal hypothesis. The primary hypotheses for Phase 2 are: V116 is noninferior to Pneumovax™23 as measured by the serotype-specific opsonophagocytic activity (OPA) geometric mean titers (GMTs) for the common serotypes at 30 days postvaccination and that the serotype-specific OPA GMTs for the unique serotypes in V116 at 30 days postvaccination are statistically significantly greater following vaccination with V116 than those following vaccination with Pneumovax™23.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) |
10.0; 23.3; 20.0; 73.3; 76.7; 56.7 | — |
| PRIMARY Phase 1: Percentage of Participants With a Solicited Systemic AE |
26.7; 26.7; 16.7; 16.7; 10.0; 6.7 | — |
| PRIMARY Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs) |
0.0; 0.0; 0.0 | — |
| PRIMARY Phase 2: Percentage of Participants With a Solicited Injection-site AE |
8.7; 6.7; 46.5; 37.8; 11.0; 7.9 | — |
| PRIMARY Phase 2: Percentage of Participants With a Solicited Systemic AE |
19.3; 12.2; 4.3; 4.3; 11.0; 9.4 | — |
| PRIMARY Phase 2: Percentage of Participants With Vaccine-related SAEs |
0.0; 0.0 | — |
| PRIMARY Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 |
226.26; 226.21; 3535.44; 2906.76; 2388.12; 2116.13 | <0.001 sig |
| PRIMARY Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116 |
2757.55; 456.97; 11640.00; 1711.40; 12611.76; 4200.74 | <0.001 sig |
| SECONDARY Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23 |
0.78; 0.97; 0.86; 3.33; 6.39; 2.98 | — |
| SECONDARY Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116 |
6.32; 8.08; 1.47; 8.87; 15.66; 1.76 | — |
| SECONDARY Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23 |
242.35; 259.17; 243.66; 4503.32; 5672.08; 5122.36 | — |
| SECONDARY Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23 |
7182.41; 7407.66; 513.88; 19337.39; 24580.49; 2615.98 | — |
| SECONDARY Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA |
12.90; 10.68; 10.01; 15.64; 19.68; 34.18 | — |
| SECONDARY Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG |
5.36; 5.94; 4.97; 8.38; 16.00; 7.44 | — |
| SECONDARY Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23 |
0.78; 0.72; 4.98; 4.07; 7.77; 6.26 | <0.001 sig |
| SECONDARY Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116 |
4.06; 1.07; 13.14; 1.71; 11.91; 3.62 | <0.001 sig |
| SECONDARY Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA |
12.03; 10.96; 31.07; 22.52; 13.05; 10.26 | — |
| SECONDARY Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG |
5.23; 4.56; 9.96; 8.28; 5.29; 4.12 | — |
| SECONDARY Phase 2: Percentage of Participants Who Achieve a ≥4-fold Increase in Serotype-specific OPA Responses From Prevaccination (Baseline [Day 1]) to 30 Days Post Vaccination |
74.8; 75.7; 74.2; 77.0; 66.9; 67.1 | — |
Eligibility Criteria
Inclusion Criteria
- Phase 1:
- Male or female, from 18 years to 49 years of age inclusive
- Phase 2:
- Male or female ≥50 years of age Phase 1 and Phase 2
- Males: refrain from donating sperm, remain abstinent during study or agree to use condom
- Females: Not pregnant. If a woman of childbearing potential, agree to use contraception or remain abstinent
Exclusion Criteria
- History of invasive pneumococcal disease or known history of other culture-positive pneumococcal disease within 3 years of screening
- Known hypersensitivity to any component of the pPCV, or any diphtheria toxoid-containing vaccine
- Known or suspected impairment of immunological function including, but not limited to, a history of congenital or acquired immunodeficiency, documented human immunodeficiency virus (HIV) infection, functional or anatomic asplenia, or history of autoimmune disease
- Coagulation disorder contraindicating IM vaccination
- Recent febrile illness (defined as oral or tympanic temperature ≥100.4°F [≥38.0°C] or axillary or temporal temperature ≥99.4°F [≥37.4°C]) or received antibiotic therapy for any acute illness occurring within 72 hours of screening
- Known malignancy that is progressing or has required active treatment within 3 years.(Note: participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ [eg, breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded)
- Pregnant
- Received any pneumococcal vaccine or is expected to receive any pneumococcal vaccine during the study, outside of the protocol.
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease
- Received a blood transfusion or blood products, including immunoglobulin, 6 months before study vaccination or is scheduled to receive a blood transfusion or blood product
Data sourced from ClinicalTrials.gov (NCT04168190). 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.