Cohort 1: V116 for Pneumonia, Pneumococcal

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Hadassah Medical Center-Clinical Reaserch Unit ( Site 0300), Jerusalem, Israel
Pneumonia, Pneumococcal
V116 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This a study of V116 in adults ≥50 years of age who previously received a pneumococcal vaccination ≥1 year before enrollment. The primary objectives of this study are to evaluate the safety, tolerability, and immunogenicity of V116.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Other trials for Pneumonia, Pneumococcal

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: Up to ~180 days

30 Days post-vaccination
Geometric Mean Concentration (GMC) of Serotype-specific Immunoglobulin G (IgG)
Geometric Mean Titer of Serotype-specific Opsonophagocytic Activity (OPA) Responses
Day 30
Geometric Mean Fold Rise (GMFR) of Serotype-specific IgG
Day 30
Geometric Mean Fold Rise (GMFR) of Serotype-specific OPA
Day 5
Percentage of Participants with Solicited Injection-site Adverse Events (AEs)
Percentage of Participants with Solicited Systemic AEs
Up to ~180 days
Percentage of Participants with Vaccine-related Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Other trials for Pneumonia, Pneumococcal

Side Effects for

Phase 1: V116 0.5 mL
73%Injection site pain
33%Headache
27%Fatigue
27%Myalgia
20%Injection site swelling
17%Arthralgia
10%Injection site erythema
3%Upper respiratory tract infection
0%Acute coronary syndrome
0%Rotator cuff syndrome
0%Atrial fibrillation
0%Cervical radiculopathy
0%Acute kidney injury
0%Gastrointestinal haemorrhage
0%Injection site bruising
0%COVID-19
0%Pyrexia
0%Staphylococcal bacteraemia
0%Urinary tract infection
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT04168190) in the Phase 1: V116 0.5 mL ARM group. Side effects include: Injection site pain with 73%, Headache with 33%, Fatigue with 27%, Myalgia with 27%, Injection site swelling with 20%.

Trial Design

5 Treatment Groups

Cohort 1: PCV15
1 of 5
Cohort 2: PPSV23
1 of 5
Cohort 1: V116
1 of 5
Cohort 2: V116
1 of 5
Cohort 3: V116
1 of 5
Active Control
Experimental Treatment

700 Total Participants · 5 Treatment Groups

Primary Treatment: Cohort 1: V116 · No Placebo Group · Phase 3

Cohort 1: V116
Biological
Experimental Group · 1 Intervention: V116 · Intervention Types: Biological
Cohort 2: V116
Biological
Experimental Group · 1 Intervention: V116 · Intervention Types: Biological
Cohort 3: V116
Biological
Experimental Group · 1 Intervention: V116 · Intervention Types: Biological
Cohort 1: PCV15
Biological
ActiveComparator Group · 1 Intervention: PCV15 · Intervention Types: Biological
Cohort 2: PPSV23
Biological
ActiveComparator Group · 1 Intervention: PPSV23 · Intervention Types: Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V116
2019
Completed Phase 2
~600

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to ~180 days
Closest Location: Diex Recherche Sherbrooke Inc. ( Site 0101) · Sherbrooke, Canada
N/AFirst Recorded Clinical Trial
1 TrialsResearching Pneumonia, Pneumococcal
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 1 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.