Pneumococcal VaccinesPhase 3NCT00999739
Conjugate And Polysaccharide Vaccines Compared With Polysaccharide Vaccine In Hiv-Infected Adults
A Phase 3 study testing Prevenar and Pneumo23 in people with Pneumococcal Vaccines and HIV, run by Hospital Universitari Son Dureta at 2 sites in Spain.
Trial summary
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur)… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumococcal Vaccines, HIV, HIV Infections
- What is being tested?
- Prevenar and Pneumo23
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 2 sitesSpain
- Study dates
- Dec 2007to Apr 2010
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-infected adults with CD4 between 200 and 500 cels/ul and viral load under 5 logarithm
Who cannot join
- previous pneumococcal vaccine, pregnancy, advanced renal or liver disease, other vaccine or antibiotics 6 weeks before, other immunosuppression, immunoglobulins or investigation drugs
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Hospital Son Dureta
Palma de Mallorca, Balearic Islands, 07014
Maria Penaranda, physician, 0034971175371, maria.penaranda@ssib.es
maria penaranda, physician
- Recruiting
Hospital Son Llatzer
Palma de Mallorca, Balearic Islands, 07014
antonio payeras, physician, 0037971175371, a.payeras@hsll.es
antonio payeras, physician
About this study
Official title: A Sequential Vaccination Strategy With Conjugated and Polysaccharide Pneumococcal Vaccines Compared With Polysaccharide Vaccine in HIV- Infected Adults.
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. Determination of secondary effects related to both vaccines and determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and opsonophagocytosis killing activity against the seven serotypes included in the heptavalent vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220 HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the one after polysaccharide vaccine alone, both vaccinations are safe.
Read the detailed description
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. A sample of 220 HIV-infected adults will be randomised to receive twe strategy one(110 patients) one dose of heptavalent conjugated vaccine at day 0 and one dose of polysaccharide vaccine at week 4 (in deltoid muscle); or strategy two (110 patients) one dose of polysaccharide vaccine at day 0. Secondary effects to the vaccines will be evaluated by phone interview 3 days after vaccinations.
Blood samples will be taken at day 0(before the first vaccine), at week 4 before the polysaccharide in the group one, and 4 weeks after the polysaccharide in the group two) and at week 8 in the group one, and at weeks 48 and 96 in both groups Antibody concentration , avidity, and opsonophagocytic killing activity will be measured in all the samples for serotypes 4,14,19F,23F,6B,18C,9V.
Antibody concentration , avidity, and opsonophagocytic killing activity will be compared between both vaccine groups, and between prevaccination and at 4,8, 48 and 96 weeks of vaccination. Risk factors associated to good antibody response (antibody duplication and antibody duplication plus achieve a level above 1ug/ml)will be measured at 8, 48 and96 weeks.
- Conditions
- Pneumococcal Vaccines, HIV, HIV Infections
- Being tested
- Prevenar and Pneumo23
- Keywords
- pneumococcal vaccines, HIV, antibody response, antibody affinity, Antibody formation, Phagocytosis
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevenar and Pneumo23Biological
Also called Prevenar (heptavalent conjugated pneumococcal vaccine), Pneumo23 (23valent polysaccharide pneumococcal vaccine)
Two vaccines: participants will receive via intramuscular in deltoid one dose of conjugated heptavalent vaccine at day 0 (Prevenar, Wyeth-lederle)and one dose of 23valent polysaccharide vaccine (Pneumo23, AventisPasteur)at week4 One vaccine:participants will receive only one dose of 23valent polysaccharide vaccine at day 0.
| Study group | Role | What they receive |
|---|---|---|
| two vaccines | Experimental | people allocated to arm two vaccines will receive one dose of heptavalent pneumococcal conjugate vaccine at day 0 and 23-valent polysaccharide vaccine at week4 , 110 HIV-infected people will be included Intervention: administration of two vaccines Receives: Biological: Prevenar and Pneumo23 |
| One vaccine | Experimental | people allocated to arm one will receive only one doses of pneumococcal polysaccharide 23-valent vaccine. 110 HIV-infected adults will be included in this arm Intervention: administration of one vaccine Receives: Biological: Prevenar and Pneumo23 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response in terms of antibody concentration at 4,8,48 and 69 weeks of vaccination
Measured: 4, 8, 48 and 96 weeks of vaccination
Secondary outcomes (4)
Avidity of the antibodies induced in the two vaccination groups before and at 4 ,8 , 48 and 96 weeks of vaccination
Measured: 4 , 8 ,48 and 96 weeks after vaccintation
safety of both vaccines
Measured: 3 days
risk factors associated to a good vaccine response
Measured: 8 weeks, 48 weeks, 96 weeks
opsonophagocytic activity against the seven polysaccharides before, and after 4,8,48 and 96 weeks of vaccination
Measured: 4,8,48 and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startDec 2007
- Primary completionApr 2008 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal VaccinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Son Dureta
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Son Llatzer, Fondo de Investigacion Sanitaria
- Investigators
- maria penaranda, physician, Principal investigator, Hospital Son Duretaantonio payeras, physician, Principal investigator, Hospital Son Llatzer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00999739
- Sponsor's protocol ID
- Maria Penaranda
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 9 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Penaranda M, Payeras A, Cambra A, Mila J, Riera M; Majorcan Pneumococcal Study Group. Conjugate and polysaccharide pneumococcal vaccines do not improve initial response of the polysaccharide vaccine in HIV-infected adults. AIDS. 2010 May 15;24(8):1226-8. doi: 10.1097/QAD.0b013e3283389de5.
PubMed 20299956
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Sequential Vaccination Strategy With Conjugated and Polysaccharide Pneumococcal Vaccines Compared With Polysaccharide Vaccine in HIV- Infected Adults.
- ClinicalTrials.gov ID
- NCT00999739
- Acronym / sponsor ID
- Maria Penaranda
- Conditions
- Pneumococcal Vaccines, HIV, HIV Infections
- Keywords
- pneumococcal vaccines, HIV, antibody response, antibody affinity, Antibody formation, Phagocytosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Hospital Universitari Son DuretaUniversity, hospital or other
- Collaborators
- Hospital Son Llatzer, Fondo de Investigacion Sanitaria
- Study start
- Dec 2007
- Primary completion
- Apr 2008 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. Determination of secondary effects related to both vaccines and determination of antibody concentration (ELISA) and avidity (ELISA with thiocyanate) and opsonophagocytosis killing activity against the seven serotypes included in the heptavalent vaccine before vaccination, at 4 weeks, at 8 weeks, at48 weeks and 96 weeks. A sample of 220 HIV-infected adults (110 in each group) will be needed to detect differences of 10% for a type I error o 5% for a limited population of 2500 HIV-infected adults. The main hypothesis are :the immunogenicity of pneumococcal vaccination with conjugate and polysaccharide vaccines is superior to immunogenicity induced by polysaccharide vaccination alone(antibody concentration), the avidity and opsonophagocytosis induced by two vaccines is better than the one after polysaccharide vaccine alone, both vaccinations are safe.
Detailed description
Randomised study comparing two pneumococcal vaccination strategies in HIV-infected adults with moderate immunossupression (CD4 between 200 and 500 cells/uL and viral load under 5logs), one with conjugated heptavalent vaccine(Prevenar, Wyeth-Lederle) followed by polysaccharide vaccine 4 weeks after (Aventis-Pasteur), and two with one dose of polysaccharide vaccine. A sample of 220 HIV-infected adults will be randomised to receive twe strategy one(110 patients) one dose of heptavalent conjugated vaccine at day 0 and one dose of polysaccharide vaccine at week 4 (in deltoid muscle); or strategy two (110 patients) one dose of polysaccharide vaccine at day 0. Secondary effects to the vaccines will be evaluated by phone interview 3 days after vaccinations.
Blood samples will be taken at day 0(before the first vaccine), at week 4 before the polysaccharide in the group one, and 4 weeks after the polysaccharide in the group two) and at week 8 in the group one, and at weeks 48 and 96 in both groups Antibody concentration , avidity, and opsonophagocytic killing activity will be measured in all the samples for serotypes 4,14,19F,23F,6B,18C,9V.
Antibody concentration , avidity, and opsonophagocytic killing activity will be compared between both vaccine groups, and between prevaccination and at 4,8, 48 and 96 weeks of vaccination. Risk factors associated to good antibody response (antibody duplication and antibody duplication plus achieve a level above 1ug/ml)will be measured at 8, 48 and96 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| two vaccines | Experimental | Biological: Prevenar and Pneumo23people allocated to arm two vaccines will receive one dose of heptavalent pneumococcal conjugate vaccine at day 0 and 23-valent polysaccharide vaccine at week4 , 110 HIV-infected people will be included Intervention: administration of two vaccines |
| One vaccine | Experimental | Biological: Prevenar and Pneumo23people allocated to arm one will receive only one doses of pneumococcal polysaccharide 23-valent vaccine. 110 HIV-infected adults will be included in this arm Intervention: administration of one vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV-infected adults with CD4 between 200 and 500 cels/ul and viral load under 5 logarithm
Key exclusion criteria (1 listed)
- previous pneumococcal vaccine, pregnancy, advanced renal or liver disease, other vaccine or antibiotics 6 weeks before, other immunosuppression, immunoglobulins or investigation drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevenar and Pneumo23Also: Prevenar (heptavalent conjugated pneumococcal vaccine), Pneumo23 (23valent polysaccharide pneumococcal vaccine)Two vaccines: participants will receive via intramuscular in deltoid one dose of conjugated heptavalent vaccine at day 0 (Prevenar, Wyeth-lederle)and one dose of 23valent polysaccharide vaccine (Pneumo23, AventisPasteur)at week4 One vaccine:participants will receive only one dose of 23valent polysaccharide vaccine at day 0. | Biological | One vaccine, two vaccines |
Primary outcome
Antibody response in terms of antibody concentration at 4,8,48 and 69 weeks of vaccination
Time frame: 4, 8, 48 and 96 weeks of vaccination
4 secondary outcomes
Avidity of the antibodies induced in the two vaccination groups before and at 4 ,8 , 48 and 96 weeks of vaccination
Time frame: 4 , 8 ,48 and 96 weeks after vaccintation
safety of both vaccines
Time frame: 3 days
risk factors associated to a good vaccine response
Time frame: 8 weeks, 48 weeks, 96 weeks
opsonophagocytic activity against the seven polysaccharides before, and after 4,8,48 and 96 weeks of vaccination
Time frame: 4,8,48 and 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2009.
- Derived from this study: PubMed 20299956Penaranda M, Payeras A, Cambra A, Mila J, Riera M; Majorcan Pneumococcal Study Group. Conjugate and polysaccharide pneumococcal vaccines do not improve initial response of the polysaccharide vaccine in HIV-infected adults. AIDS. 2010 May 15;24(8):1226-8. doi: 10.1097/QAD.0b013e3283389de5.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
maria penaranda, physician principal investigator
Hospital Son Dureta
antonio payeras, physician principal investigator
Hospital Son Llatzer
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prevenar and Pneumo23 in people with Pneumococcal Vaccines and HIV, run by Hospital Universitari Son Dureta at 2 sites in Spain.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Nov 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact maria penaranda, physician (0034971175371, maria.penaranda@ssib.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibody response in terms of antibody concentration at 4,8,48 and 69 weeks of vaccination (time frame: 4, 8, 48 and 96 weeks of vaccination). 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 NCT00999739, 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 9 Nov 2009.