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Conjugate Vaccine
V116 Vaccine for Pneumococcal Infections in HIV Patients (STRIDE-7 Trial)
Phase 3
Waitlist Available
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 194 days in part a
Awards & highlights
STRIDE-7 Trial Summary
This trial will test a new pneumonia vaccine in people with HIV to see if it is safe and effective.
Who is the study for?
This trial is for adults living with HIV who haven't had pneumococcal vaccines before and are on stable anti-retroviral therapy. They can't join if they've had certain AIDS-related illnesses, active hepatitis, recent cancer treatments, prior PCV15 or PCV20 vaccines, heavy steroid use, immunosuppressive therapies, recent live virus vaccines, a history of severe pneumococcal disease or allergies to vaccine components.Check my eligibility
What is being tested?
The study tests the safety and immune response to V116—a new pneumococcal vaccine—compared to PPSV23 (an existing vaccine), PCV15 (another type of vaccine), and placebo in people with HIV. It aims to prevent diseases caused by specific bacteria that the vaccines target.See study design
What are the potential side effects?
Possible side effects from these vaccines may include pain at the injection site, fatigue, headache, muscle pain, joint pain and possibly allergic reactions. The full range of side effects will be monitored throughout the trial.
STRIDE-7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 194 days in part a
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 194 days in part a
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants with solicited injection-site AEs from Day 1 through Day 5 postvaccination in Part A
Percentage of participants with solicited systemic AEs from Day 1 through Day 5 postvaccination in Part A
Percentage of participants with vaccine-related serious adverse events (SAEs) from Day 1 through the duration of participation in Part A
+1 moreSecondary outcome measures
Percentage of participants with a >=4-fold rise in IgG responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
Percentage of participants with a >=4-fold rise in OPA responses from baseline (Day 1) to postvaccination in Part A for 13 serotypes common between V116 and PCV15 + PPSV23 and 8 serotypes unique to V116
Percentage of participants with solicited injection-site AEs from Day 1 of Part B through Day 5 postvaccination in Part B
+5 moreSide effects data
From 2021 Phase 1 & 2 trial • 600 Patients • NCT0416819038%
Injection site pain
16%
Headache
13%
Fatigue
10%
Myalgia
8%
Injection site swelling
7%
Injection site erythema
5%
Arthralgia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 2: PPSV23
Phase 2: V116
Phase 1: V116 0.5 mL
Phase 1: V116 1.0 mL
Phase 1: PPSV23
STRIDE-7 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: V116Experimental Treatment3 Interventions
Participants will receive a single intramuscular (IM) dose of V116 on Day 1, a single IM dose of placebo for PPSV23 on Week 8, and a single IM dose of PCV15 between 10 to 18 months after V116.
Group II: PCV15 + PPSV23Active Control2 Interventions
Participants will receive a single IM dose of PCV15 on Day 1, and a single IM dose of PPSV23 on Week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
V116
2022
Completed Phase 3
~8610
Placebo
1995
Completed Phase 3
~2670
PCV15
2022
Completed Phase 3
~1950
Find a Location
Who is running the clinical trial?
Merck Sharp & Dohme LLCLead Sponsor
3,886 Previous Clinical Trials
5,054,240 Total Patients Enrolled
5 Trials studying Pneumococcal Diseases
4,256 Patients Enrolled for Pneumococcal Diseases
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,777 Previous Clinical Trials
8,063,173 Total Patients Enrolled
7 Trials studying Pneumococcal Diseases
4,961 Patients Enrolled for Pneumococcal Diseases
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of non-infectious illness related to a weakened immune system.You have a bleeding disorder that makes it unsafe to receive vaccinations in the muscle.You have a condition that weakens your immune system from birth, have had your spleen removed, or have a history of autoimmune disease.You have recently been sick with a fever.
Research Study Groups:
This trial has the following groups:- Group 1: V116
- Group 2: PCV15 + PPSV23
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are volunteers needed for this experiment currently?
"This trial, as reported on clinicaltrials.gov, is looking for participants right now. The listing was first posted on 7/13/2022 and updated most recently on 10/21/2022."
Answered by AI
What is the V116's FDA classification?
"V116's safety is estimated to be a 3. This is based off of the fact that it is a Phase 3 trial, so while there is data supporting efficacy, there is also multiple rounds of data supporting safety."
Answered by AI
Is this trial taking place in more than one state in the US?
"The six different centres conducting this study are Pueblo Family Physicians ( Site 0014) in Phoenix, Whitman-Walker Institute ( Site 0009) in Washington, and KC CARE Health Center ( Site 0013) in Kansas City. The other three locations have not been specified."
Answered by AI
How many subjects are under investigation in this clinical trial?
"The sponsor, Merck Sharp & Dohme LLC, needs to recruit 300 individuals that meet the study's inclusion criteria from multiple locations in order to proceed. For example, Pueblo Family Physicians ( Site 0014) in Phoenix, Arizona and Whitman-Walker Institute ( Site 0009) in Washington, District of Columbia are both participating locations."
Answered by AI
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