V116 for Pneumococcal Diseases

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Pneumococcal Diseases+1 More
V116 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new pneumococcal vaccine (V116) to see if it is safe, effective, and tolerable. The study will compare V116 to another pneumococcal vaccine (PCV20) in people who have not received a pneumococcal vaccine before. It is expected that V116 will be at least as good as PCV20 for the common serotypes and better than PCV20 for the unique serotypes.

Eligible Conditions
  • Pneumococcal Diseases

Treatment Effectiveness

Effectiveness Progress

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

Study Objectives

5 Primary · 8 Secondary · Reporting Duration: Up to 194 days postvaccination

Day 30
GMFR from baseline in serotype-specific IgG GMCs in Cohort 1
Geometric mean fold rise (GMFR) from baseline in serotype-specific OPA GMTs in Cohort 1
Percentage of participants with ≥4-fold rise from baseline in serotype-specific IgG GMCs in Cohort 1
Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPA GMTs in Cohort 1
Percentage of participants with ≥4-fold rise from baseline in serotype-specific OPAs in Cohort 1 for for the 21 serotypes contained in V116
Day 30 postvaccination
Percentage of participants with ≥4-fold rise in serotype-specific cross-reactive OPA responses in Cohorts 1 and 2
Serotype-specific Immunoglobulin G (IgG) geometric mean concentrations (GMCs) in Cohort 1
Serotype-specific OPA GMTs in Cohorts 1 and 2
Serotype-specific cross-reactive OPA GMTs in Cohorts 1 and 2
Serotype-specific opsonophagocytic (OPA) geometric mean titers (GMTs) in Cohort 1 for the 21 serotypes contained in V116
Day 194
Percentage of participants with vaccine-related serious AE (SAE)
Day 5
Percentage of participants with solicited injection-site AEs
Percentage of participants with solicited systemic AEs

Trial Safety

Safety Progress

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

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
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

4 Treatment Groups

Cohort 1 PCV20
1 of 4
Cohort 2 PCV20
1 of 4
Cohort 2 V116
1 of 4
Cohort 1 V116
1 of 4

Active Control

Experimental Treatment

2600 Total Participants · 4 Treatment Groups

Primary Treatment: V116 · No Placebo Group · Phase 3

Cohort 2 V116
Biological
Experimental Group · 1 Intervention: V116 · Intervention Types: Biological
Cohort 1 V116
Biological
Experimental Group · 1 Intervention: V116 · Intervention Types: Biological
Cohort 1 PCV20
Biological
ActiveComparator Group · 1 Intervention: PCV20 · Intervention Types: Biological
Cohort 2 PCV20
Biological
ActiveComparator Group · 1 Intervention: PCV20 · 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

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 194 days postvaccination

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,658 Previous Clinical Trials
4,952,542 Total Patients Enrolled
6 Trials studying Pneumococcal Diseases
4,340 Patients Enrolled for Pneumococcal Diseases
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,623 Previous Clinical Trials
7,935,807 Total Patients Enrolled
8 Trials studying Pneumococcal Diseases
5,045 Patients Enrolled for Pneumococcal Diseases

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 2nd, 2021

Last Reviewed: November 27th, 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.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Elixir Research Group - W Houston ( Site 0068)100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%