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Lupus vaccine study: which shot schedule protects best?

NCT ID NCT00611663

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two ways to give pneumococcal vaccines to people with lupus, a disease where the immune system attacks the body. One group got a prime-boost strategy (two different vaccines six months apart), while the other got the standard single vaccine. The goal was to see which approach produced a stronger immune response without worsening lupus. The trial involved 47 adults with stable lupus.

What this could mean

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

Active substance
pneumococcal vaccines (Prevenar and Pneumo23)
What this could lead to
If successful, this could identify a safer, more effective vaccination schedule for lupus patients to prevent pneumonia.
What could go wrong
This is a small, completed Phase 2/3 trial with only 47 participants, so results may not apply to all lupus patients. The vaccines might not boost immunity enough or could trigger lupus flares.

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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

47 people

The number who actually took part.

Start date

May 2008

Finished

Apr 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 years

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: * age 18 to 65 years * SLE as defined by the ACR classification * Stable SLE (treatment not modified during the 2 months preceding the inclusion date W0) * SLE treated by immunosuppressant only or systemic corticosteroids at a dose ≥ 5 mg/j or systemic corticosteroids at any dose associated with one or more immunosuppressive drugs * SLE treated by hydroxychloroquine only * 31 months following * females must have an effective method of contraception during the first 7 months of the study and with a negative serum or urinary pregnancy test * females not wishing to have a child during the 7 months following W0 * physical examination * signed written and informed consent Exclusion Criteria: * pregnant females or females wishing to have a child during the 7 months following W0 * subjects infected with HIV and/or HBV( Ag HBs+) and or HVC * medical history of allergy to any vaccine component * receipt of any pneumococcal vaccine less than 5 years * receipt of other vaccine within one month prior to enrolment (inclusion visit W0) * receipt of immunoglobulin within three months prior to enrolment (inclusion visit W0) * splenectomy * hematopoietic disorders which give contra-indications to intramuscular and hypodermic route injections, * active malignancy , cirrhosis * intercurrent illness within one month prior to enrolment (inclusion visit W0) * patients under biotherapy (anti-CD20)must not been included if the interval between vaccination and the end of the biotherapy is less than one year. * participation to another clinical study during the first 7 months of the study * subject not covered by Health Insurance

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Lupus erythematosus, systemic

Contacts and locations

Locations

  • CIC Vaccinologie - Hopital Cochin

    Paris, 75679, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.