AzTrials
AzTrials

Pneumonia, PneumococcalPhase 1/2NCT04168190

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

A Phase 1/2 study testing V116 and Pneumovax™23 in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Pneumonia, Pneumococcal
What is being tested?
V116 and Pneumovax™23
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
20 sitesUnited States
Study dates
6 Dec 2019to 12 Jul 2021
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 10Show fewer
  • 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 locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Simon Williamson Clinic ( Site 0004)

    Birmingham, Alabama, 35211

  • Clinical Research of South Florida ( Site 0008)

    Coral Gables, Florida, 33134

  • PriMED Clinical Research ( Site 0021)

    Dayton, Ohio, 45419

  • Meridian Clinical Research, LLC ( Site 0025)

    Endwell, New York, 13760

  • Indago Research & Health Center, Inc ( Site 0011)

    Hialeah, Florida, 33012

  • Research Centers of America, LLC ( Site 0001)

    Hollywood, Florida, 33024

  • Wake Research Clinical Research Center of Nevada, LLC ( Site 0014)

    Las Vegas, Nevada, 89104

  • Advanced Medical Research ( Site 0017)

    Maumee, Ohio, 43537

  • Central Arizona Medical Associates ( Site 0003)

    Mesa, Arizona, 85206

  • Benchmark Research ( Site 0012)

    Metairie, Louisiana, 70006

  • QPS Miami Research Associates ( Site 0016)

    Miami, Florida, 33143

  • L&C Professional Medical Research Institute ( Site 0009)

    Miami, Florida, 33144

  • Advanced Medical Research Institute ( Site 0010)

    Miami, Florida, 33174

  • Meridian Clinical Research, LLC ( Site 0024)

    Norfolk, Nebraska, 68701

  • Optimal Research ( Site 0006)

    Peoria, Illinois, 61614

  • Kaiser Permanente Center for Health Research ( Site 0015)

    Portland, Oregon, 97227

  • Rochester Clinical Research, Inc. ( Site 0002)

    Rochester, New York, 14609

  • Diagnostics Research Group ( Site 0013)

    San Antonio, Texas, 78229

  • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0018)

    Troy, Michigan, 48098

  • Advanced Clinical Research ( Site 0022)

    West Jordan, Utah, 84088

Other trials in United States

About this study

Official title: A Phase 1/Phase 2, Randomized, Double-blind Study to Evaluate the Safety, Tolerability, and Immunogenicity of a Polyvalent Pneumococcal Conjugate Vaccine in Adults.

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.

Being tested
V116, Pneumovax™23
Medical subject headings
Pneumonia, Pneumococcal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V116Biological

    Also called Polyvalent pneumococcal conjugate vaccine (pPCV), Pneumococcal 21-valent Conjugate Vaccine

    Pneumococcal 21-valent conjugate vaccine with 2 μg of each of the following pneumococcal polysaccharides (PnPs) antigen: 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B in each 0.5 mL sterile solution

  • Pneumovax™23Biological

    Also called PPSV23

    Pneumococcal 23-valent polyvalent vaccine with 25 μg of each of the following PnPs antigen: 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in each 0.5 mL sterile solution

Study groups in NCT04168190
Study groupRoleWhat they receive
Phase 1: V116 0.5 mLExperimentalParticipants will receive a single intramuscular (IM) 0.5 mL vaccination on Day 1 of Phase 1
Receives: Biological: V116
Phase 1: V116 1.0 mLExperimentalParticipants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 1
Receives: Biological: V116
Phase 1: Pneumovax™23Active comparatorParticipants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 1
Receives: Biological: Pneumovax™23
Phase 2: V116ExperimentalParticipants will receive a single IM 1.0 mL vaccination on Day 1 of Phase 2
Receives: Biological: V116
Phase 2: Pneumovax™23Active comparatorParticipants will receive a single IM 0.5 mL vaccination on Day 1 of Phase 2
Receives: Biological: Pneumovax™23

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE)

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

    Measured: Up to 5 days post-vaccination

  2. Phase 1: Percentage of Participants With a Solicited Systemic AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with one or more solicited systemic AE was assessed.

    Measured: Up to 5 days post-vaccination

  3. Phase 1: Percentage of Participants With Vaccine-related Serious Adverse Events (SAEs)

    A serious adverse event (SAE) is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants with one or more SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.

    Measured: Up to Day 195

  4. Phase 2: Percentage of Participants With a Solicited Injection-site AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Injection-site AEs solicited on the Vaccine Report Card (VRC) were redness/erythema, swelling, and tenderness/pain. The percentage of participants with one or more solicited injection-site AE was assessed.

    Measured: Up to 5 days post-vaccination

  5. Phase 2: Percentage of Participants With a Solicited Systemic AE

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Systemic AEs solicited on the VRC were muscle pain/myalgia, joint pain/arthralgia, headache, and tiredness/fatigue. The percentage of participants with 1 or more solicited systemic AE was assessed.

    Measured: Up to 5 days post-vaccination

  6. Phase 2: Percentage of Participants With Vaccine-related SAEs

    An SAE is an AE that results in death, is life threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. The percentage of participants who experienced at least one SAE that were assessed by the investigator to be at least possibly related to the study vaccination were reported.

    Measured: Up to Day 293

  7. Phase 2: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23

    GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the muliplex opsonophagocytic assay (MOPA). Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals (CIs) were calculated using a constrained longitudinal data analysis (cLDA) model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  8. Phase 2: Serotype-specific OPA GMTs for the Unique Serotypes in V116

    GMTs for the serotypes unique to V116 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% CIs were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

Secondary outcomes (11)

  1. Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Common Serotypes in V116 and Pneumovax™23

    Serotype-specific pneumococcal IgG antibodies were measured using pneumococcal electrochemiluminescence (PnECL). Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  2. Phase 1: Serotype-specific Immunoglobin G (IgG) Geometric Mean Concentrations (GMCs) for the Serotypes Unique to V116

    Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  3. Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Common Serotypes in V116 and Pneumovax™23

    GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  4. Phase 1: Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for the Unique Serotypes in V116 and Pneumovax™23

    GMTs for the serotypes common to V116 and Pneumovax™23 were determined using the MOPA. Serotype-specific OPA GMTs and GMT ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  5. Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

    GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMT/Day 1 GMT) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.

    Measured: Baseline (Day 1) and 30 days postvaccination

  6. Phase 1: Geometric Mean Fold Rise (GMFR) From Baseline in GMCs of Serotype-specific IgG

    GMCs for the serotypes in V116 and Pneumovax™23 were measured by PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR (Day 30 GMC/Day 1 GMC) from baseline (Day 1) to Day 30 of each pneumococcal IgG serotype was calculated.

    Measured: Baseline (Day 1) and 30 days post vaccination

  7. Phase 2: Serotype-specific IgG GMCs for the Common Serotypes in V116 and Pneumovax™23

    Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  8. Phase 2: Serotype-specific IgG GMCs for the Serotypes Unique to V116

    Serotype-specific pneumococcal IgG antibodies were measured using PnECL. Serotype-specific pneumococcal IgG GMCs and GMC ratios with 95% confidence intervals were calculated using a cLDA model. Per protocol, within-group CIs were not calculated.

    Measured: 30 days post vaccination

  9. Phase 2: Geometric Mean Fold Rise (GMFR) From Baseline in GMTs of Serotype-specific OPA

    GMTs for the serotypes in V116 and Pneumovax™23 were determined using the MOPA at baseline and at 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMT/Day 1 GMT.

    Measured: Baseline (Day 1) and 30 days post vaccination

  10. Phase 2: GMFR From Baseline in GMCs of Serotype-specific IgG

    GMCs for each serotype common in V116 and Pneumovax™23 were measured using PnECL at baseline and 30 days post vaccination and derived from a cLDA model. The GMFR for each pneumococcal IgG serotype was calculated as Day 30 GMC/Day 1 GMC.

    Measured: Baseline (Day 1) and 30 days post vaccination

  11. 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

    The percentage of participants with ≥4-fold rise from baseline (Day 1) to Day 30 in GMTs of each pneumococcal serotype was calculated. Titer levels were determined by the MOPA and derived from a cLDA model.

    Measured: Baseline (Day 1) and 30 days post vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2019
  2. Study start6 Dec 2019
  3. Primary completion12 Jul 2021
  4. Study completion12 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04168190
Sponsor's protocol ID
pPCV-001
Other IDs
pPCV-001, V116-001
Status last verified
Sep 2022
First submitted
18 Nov 2019
Last updated
16 Sep 2022
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Publications

  • Platt H, Omole T, Cardona J, Fraser NJ, Mularski RA, Andrews C, Daboul N, Gallagher N, Sapre A, Li J, Polis A, Fernsler D, Tamms G, Xu W, Murphy R, Skinner J, Joyce J, Musey L. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial. Lancet Infect Dis. 2023 Feb;23(2):233-246. doi: 10.1016/S1473-3099(22)00526-6. Epub 2022 Sep 15.

    PubMed 36116461

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing V116 and Pneumovax™23 in people with Pneumonia, Pneumococcal, run by Merck Sharp & Dohme LLC at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: Percentage of Participants With a Solicited Injection-site Adverse Event (AE) (time frame: Up to 5 days post-vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04168190, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in