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New 21-Valent vaccine aims to shield HIV patients from pneumococcal disease

NCT ID NCT05393037

Prevention Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a new vaccine called V116 in 313 adults with HIV to see if it safely prevents pneumococcal disease (a serious infection that can cause pneumonia and meningitis). Participants received either V116, a placebo, or an existing vaccine. The trial is complete, and researchers are checking for side effects and immune response.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pneumococcal 21-valent conjugate vaccine (V116)
What this could lead to
If successful, V116 could provide better protection against pneumococcal disease for people with HIV, who are at higher risk.
What could go wrong
This is a completed phase 3 trial, but results are not yet published. The vaccine may not prove superior to existing vaccines, and side effects like injection-site pain or fatigue are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

313 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Is infected with HIV * Is receiving combination anti-retroviral therapy (ART) for ≥6 weeks before study entry with no intended changes to combination ART therapy for 3 months after randomization. * Is vaccine-naïve Exclusion Criteria: * Has a history of opportunistic infections ≤12 months before the first vaccination * Has a history of noninfectious acquired immune deficiency syndrome-related illness * Has a history of active hepatitis * Has a history of invasive pneumococcal disease (IPD) or other culture-positive pneumococcal disease ≤3 years before Visit 2 (Day 1) * Has a known hypersensitivity to any component of V116, PCV15, or PPSV23, including diphtheria toxoid * Has a known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease * Has a coagulation disorder contraindicating intramuscular vaccinations. * Has a recent illness with fever * Has a known cancer malignancy that is progressing or has required active treatment \<3 years before enrollment * Had prior administration of PCV15 or PCV20. * Is expected to receive any pneumococcal vaccine during the study outside of the protocol * Has received systemic corticosteroids for ≥14 consecutive days and has not completed treatment ≥14 days before receipt of study vaccine * Is currently receiving immunosuppressive therapy, including chemotherapeutic agents or other immunotherapies/immunomodulators used to treat cancer or other conditions, and interventions associated with organ or bone marrow transplantation, or autoimmune disease * Has received any non-live vaccine ≤14 days before receipt of any study vaccine or is scheduled to receive any non-live vaccine ≤30 days after receipt of any study vaccine * Has received any live virus vaccine ≤30 days before receipt of any study vaccine or is scheduled to receive any live virus vaccine ≤30 days after receipt of any study vaccine * Has received a blood transfusion or blood products, including immunoglobulins ≤6 months before receipt of study vaccine or is scheduled to receive a blood transfusion or blood product ≤30 days after receipt of study vaccine * Is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 2 months of participating in this current study.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease pneumococcal infection prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pneumococcal disease

Contacts and locations

Locations

  • Be Part Yoluntu Centre ( Site 0902)

    Paarl, Western Cape, 7646, South Africa

  • CHU Saint-Pierre ( Site 0500)

    Brussels, Bruxelles-Capitale, Region de, 1000, Belgium

  • Faculty of Medicine Siriraj Hospital-Preventive and social ( Site 1100)

    Bangkok, Bangkok, 10700, Thailand

  • Hopitaux Universitaires Paris Centre-Hopital Cochin ( Site 0601)

    Paris, 75014, France

  • Hospital hernan henriquez aravena de temuco-Unidad de Investigación Clínica ( Site 0101)

    Temuco, Araucania, 4781151, Chile

  • Hôpital Saint-Louis ( Site 0600)

    Paris, Île-de-France Region, 75010, France

  • Insituut voor tropische Geneeskunde ( Site 0501)

    Antwerp, 2000, Belgium

  • Josha Research ( Site 0900)

    Bloemfontein, Free State, 9300, South Africa

  • KC CARE Health Center ( Site 0013)

    Kansas City, Missouri, 64111, United States

  • Midway Immunology and Research Center ( Site 0003)

    Ft. Pierce, Florida, 34982, United States

  • North Texas Infectious Diseases Consultants, P.A ( Site 0001)

    Dallas, Texas, 75246, United States

  • Orlando Immunology Center ( Site 0004)

    Orlando, Florida, 32803, United States

  • Perinatal HIV Research Unit (PHRU)-Adult Treatment and Research ( Site 0906)

    Johannesburg, Gauteng, 1862, South Africa

  • Pueblo Family Physicians ( Site 0014)

    Phoenix, Arizona, 85015, United States

  • Research Institute for Health Sciences-Research Institute for Health Sciences Building 1 ( Site 1101

    Chiang Mai, 50200, Thailand

  • Right To Care Research - Esizayo ( Site 0904)

    Johannesburg, Gauteng, 2087, South Africa

  • Texas Center for Infectious Disease Associates ( Site 0011)

    Fort Worth, Texas, 76104, United States

  • Universidad San Sebastian - Providencia ( Site 0111)

    Providencia, Region M. de Santiago, 7500000, Chile

  • Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0107)

    Santiago, Region M. de Santiago, 8380420, Chile

  • Whitman-Walker Institute ( Site 0009)

    Washington D.C., District of Columbia, 20005, United States

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