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Lupus Erythematosus, SystemicPhase 2/3VACCILUPNCT00611663

Safety Study of Two Vaccine Strategies in Patients With Systemic Lupus Erythematosus

A Phase 2/3 study testing Prevenar® and Pneumo23® in people with Lupus Erythematosus, Systemic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

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

Official record
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Trial summary

The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Lupus Erythematosus, Systemic
What is being tested?
Prevenar® and Pneumo23®
Type of treatment
Vaccines
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
47 participants
Where
1 siteFrance
Study dates
May 2008to Apr 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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)
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  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CIC Vaccinologie - Hopital Cochin

    Paris, 75679

Other trials in France

About this study

Official title: VACCILUP "A Multicenter, Randomized Double-blind Trial Comparing Two Pneumococcal Vaccination Strategies in Patients With Systemic Lupus Erythematosus"

The aim of this study is to compare the immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) a prime-boost strategy using vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) compared to the standard vaccination with Poly Saccharidic vaccine (Pneumo23®) at W24 after placebo at W0

Read the detailed description

Infections are more frequent and potentially more serious in patients with SLE compared to healthy subjects. This risk increases when patients are treated with corticosteroids and/or immunosuppressive drugs.Among serious infections which can happen in this context, respiratory infections are among the most frequent and Streptococcus pneumoniae is one of the most often responsible germs.Although there are no specific study in SLE, these findings indicate that patients with SLE could benefit from a preventive vaccination against pneumococcal infections.Two pneumococcal vaccines are available: Pneumo23®, a Poly Saccharidic vaccine indicated for adults and children > 2 years at risk of pneumococcal infections; and Prevenar®, a conjugate vaccine, indicated for children < 2 years.Pneumo23® has been found to be safe in SLE but less immunogenic than in general population.Prevenar® has already been studied in immunocompromised patients (HIV-infected patients, patients after renal transplantation). It has been shown that immunological efficacy is better when Prevenar® is administrated prior to Pneumo23®, compared to Pneumo23® administrated alone.To our knowledge, this prime-boost strategy has not been assessed in patients with SLEThe primary objective of the study is to compare immunological efficacy of two pneumococcal vaccination strategies in patients with systemic lupus erythematosus (SLE) treated with corticosteroids associated or not with other immunosuppressive drugs : 1) Vaccination with conjugate vaccine (Prevenar®) at week 0 and Poly Saccharidic vaccine (Pneumo23®) after 6 months (W24)2) Vaccination with placebo at W0 and Poly Saccharidic vaccine (Pneumo23®) at W24Secondary objectives are:

  • To compare the clinical and biological tolerance of the two vaccinal strategies·
  • To evaluate the durability of sero protection at 6 and 24 months after vaccination by Pneumo23®
  • To search predictive factors determinant of the pneumococcal vaccine response
Being tested
Prevenar® and Pneumo23®, Placebo, Pneumo23®
Keywords
Pneumococcal vaccine, SLE, Vaccination, Immunosuppression, SLE as defined by the ACR classification, Stable SLE, SLE treated by systemic corticosteroids
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

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

  • Prevenar® and Pneumo23®Biological

    Vaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE)at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)versus2)

  • Placebo, Pneumo23®Biological

    Vaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24

Study groups in NCT00611663
Study groupRoleWhat they receive
1ExperimentalVaccination with conjugate vaccine Prevenar® (WYETH-LEDERLE) at week 0 and Poly Saccharidic vaccine Pneumo23® (Sanofi Pasteur MSD) after 6 months (W24)
Receives: Biological: Prevenar® and Pneumo23®
2Placebo comparatorVaccination with placebo at W0 and Poly Saccharidic vaccine Pneumo23® at W24
Receives: Biological: Placebo, Pneumo23®

What is being measured

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

  1. Proportion of responders for more than 5 serotypes among the 7 serotypes common between conjugate and Poly Saccharidic vaccines (ie. serotypes 4, 6B, 9V, 14, 18C, 19F and 23F).

    Measured: 31 months

Secondary outcomes (5)

  1. Proportion of patients presenting a disease exacerbation(defined as an increase of ³3 points on the SLEDAI score and/or need to increase treatment with corticosteroids or immunosuppressive drugs) during the 12 months following the first vaccination

    Measured: 13 months

  2. Proportion of patients with local or systemic reactions following vaccination

    Measured: 31 months

  3. Comparison of serum antibodies titers obtained at W28 for each of the tested serotypes

    Measured: 28 weeks

  4. Comparison of ELISA persistent responses six months and 2 years after vaccination with Pneumo23® (M12 and M30)

    Measured: 12 months + 30 months

  5. Research of predictive factors of immunological response disease activity at M0 (defined by SLEDAI), SLE treatment and others variables witch can affect the response.

    Measured: 31 months

Timeline

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

  1. First posted11 Feb 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionDec 2014
  4. Study completionApr 2016

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00611663
Sponsor's protocol ID
P060241
Acronym
VACCILUP
Status last verified
Sep 2025
First submitted
28 Jan 2008
Last updated
8 Sep 2025
Results posted
No
Data monitoring committee
Yes

Publications

  • Grabar S, Groh M, Bahuaud M, Le Guern V, Costedoat-Chalumeau N, Mathian A, Hanslik T, Guillevin L, Batteux F, Launay O; VACCILUP study group. Pneumococcal vaccination in patients with systemic lupus erythematosus: A multicenter placebo-controlled randomized double-blind study. Vaccine. 2017 Sep 5;35(37):4877-4885. doi: 10.1016/j.vaccine.2017.07.094. Epub 2017 Aug 4.

    PubMed 28784280

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Prevenar® and Pneumo23® in people with Lupus Erythematosus, Systemic, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 10 inclusion and 13 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 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Proportion of responders for more than 5 serotypes among the 7 serotypes common between conjugate and Poly Saccharidic vaccines (ie. serotypes 4, 6B, 9V, 14, 18C, 19F and 23F). (time frame: 31 months). 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 NCT00611663, 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 8 Sep 2025.

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