A Phase 1/Phase 2 Study of Polyvalent Pneumococcal Conjugate Vaccine (V116) in Adults (V116-001)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Pneumonia, Pneumococcal

Treatments: Biological: Pneumovax™23; Biological: V116

Study type: Interventional

Funder types: Industry

Identifiers

NCT04168190

V116-001 (Other Identifier)

pPCV-001 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 600 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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600 participants in 5 patient groups

Phase 1: V116 0.5 mL

Experimental group

Description:

Participants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1

Treatment:

Biological: V116

Phase 1: V116 1.0 mL

Experimental group

Description:

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1

Treatment:

Biological: V116

Phase 1: Pneumovax™23

Active Comparator group

Description:

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1

Treatment:

Biological: Pneumovax™23

Phase 2: V116

Experimental group

Description:

Participants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2

Treatment:

Biological: V116

Phase 2: Pneumovax™23

Active Comparator group

Description:

Participants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2

Treatment:

Biological: Pneumovax™23