HIV InfectionsNCT00706550

Immune Responses to Pneumococcal Vaccination Among HIV-infected Subjects

A study testing (PV) 23-valent pneumococcal polysaccharide vaccine in people with HIV Infections, run by US Department of Veterans Affairs at 1 site in United States.

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

Who is it for?: Ages 18 years and older
Conditions the study is for: HIV Infections
What is being tested?: (PV) 23-valent pneumococcal polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 107 participants
Where: 1 siteUnited States
Study dates: Oct 2008to Sep 2012
Phase: Interventional
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
No healthy volunteers
Adult, Older adult

Who may be able to join

HIV infected
CD4 count >200
no acute illness
no pneumococcal vaccination within 3 years
naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months
willingness to start antiretroviral treatment as recommended by current guidelines

Who cannot join

prior pneumococcal vaccination within 3 years
prior AIDS diagnosis based on opportunistic disease
acute illness

Trial locations and contacts

1 site in 1 country.

United States1 site

Michael E DeBakey VA Medical Center
Houston, Texas, 77030

Other trials in United States

About this study

Official title: Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects

The purpose of this study is to evaluate the best timing for administering pneumococcal vaccine (PV) to HIV-infected adults that have CD4 cell counts of more than 200 and are not yet receiving combination antiretroviral treatment (ART). Participants in this study will be assigned by chance to receive vaccination with PV prior to starting ART or after at least 6 months of ART. Antibody levels to components of the PV will be measured at 6 months and 12 months after vaccination. The results will tell us if patients that receive PV after 6 months of ART have better response to the vaccine than those that get vaccinated prior to treatment.

Conditions: HIV Infections
Being tested: (PV) 23-valent pneumococcal polysaccharide vaccine, Placebo
Keywords: pneumococcal polysaccharide vaccine
Medical subject headings: HIV Infections

What participants receive

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

(PV) 23-valent pneumococcal polysaccharide vaccineBiological
Also called Pneumovax 23
Currently commercially available pneumococcal polysaccharide vaccine
PlaceboBiological
Placebo

Study groups in NCT00706550
Study group	Role	What they receive
Immediate	Other	Arm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine Receives: Biological: (PV) 23-valent pneumococcal polysaccharide vaccine; Biological: Placebo
Delayed	Other	Arm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine Receives: Biological: (PV) 23-valent pneumococcal polysaccharide vaccine; Biological: Placebo

What is being measured

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

Immunoglobulin G (IgG) Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Measured: Baseline
IgG Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Measured: One-month post-vaccine
Immunoglobulin M (IgM) Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
Measured: Baseline
IgM Levels
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Measured: One-month post-vaccine
Opsonophagocytic Killing Activity (OPA)
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.
Measured: Baseline
Opsonophagocytic Killing Activity (OPA)
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.
Measured: One-month post-vaccine

Timeline

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

Oct 2008Sep 2012

First posted27 Jun 2008 (estimated)
Study startOct 2008
Primary completionSep 2011
Study completionSep 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HIV InfectionsStudies 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 N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 107 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706550
Sponsor's protocol ID: INDA-002-08S
Status last verified: Mar 2014
First submitted: 24 Jun 2008
Last updated: 24 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immune Responses to Pneumococcal Vaccination Among HIV-Infected Subjects
ClinicalTrials.gov ID: NCT00706550
Acronym / sponsor ID: INDA-002-08S
Conditions: HIV Infections
Keywords: pneumococcal polysaccharide vaccine
Study type: Interventional
Recruitment status: Completed
Enrolment: 107 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Collaborators: Albert Einstein College of Medicine, Montefiore Medical Center
Study start: Oct 2008
Primary completion: Sep 2011 (actual)
Study completion: Sep 2012 (actual)
First posted: 27 Jun 2008 (estimated)
Results: Posted 12 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
Immediate	Other	Biological: (PV) 23-valent pneumococcal polysaccharide vaccine, Biological: PlaceboArm 1 will receive PV (23-valent pneumococcal polysaccharide vaccine) prior to starting antiretroviral treatment and will receive PLACEBO after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine
Delayed	Other	Biological: (PV) 23-valent pneumococcal polysaccharide vaccine, Biological: PlaceboArm 2 will receive PLACEBO prior to starting antiretroviral treatment and will receive PV (23-valent pneumococcal polysaccharide vaccine) after at least 6 months of starting antiretroviral treatment. PV (23-valent pneumococcal polysaccharide vaccine): Currently commercially available pneumococcal polysaccharide vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

HIV infected
CD4 count >200
no acute illness
no pneumococcal vaccination within 3 years
naive to treatment or if previously on treatment, no antiretroviral treatment for at least 6 months

Key exclusion criteria (3 listed)

prior pneumococcal vaccination within 3 years
prior AIDS diagnosis based on opportunistic disease
acute illness

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
(PV) 23-valent pneumococcal polysaccharide vaccineAlso: Pneumovax 23Currently commercially available pneumococcal polysaccharide vaccine	Biological	Delayed, Immediate
PlaceboPlacebo	Biological	Delayed, Immediate

Primary outcome

Immunoglobulin G (IgG) Levels
Time frame: Baseline
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgG Levels
Time frame: One-month post-vaccine
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgG is the most common antibody. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Immunoglobulin M (IgM) Levels
Time frame: Baseline
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. We measure baseline levels (before the vaccine is administered) to know how much antibody the subject has at the start point to be able to evaluate how much antibody is produced after the vaccine is administered.
IgM Levels
Time frame: One-month post-vaccine
Immunoglobulins are antibodies or special proteins that the immune system produces to protect the body against infections. IgM is the first antibody produced by the immune system to fight a new infection. This point of time (one-month after vaccine), gives the information about how much antibody was produced by the participant's immune system in response to the vaccine.
Opsonophagocytic Killing Activity (OPA)
Time frame: Baseline
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. As explained previously for the immunoglobulins' assays, we measure the baseline point to be able to determine the increase after the vaccine is administered.
Opsonophagocytic Killing Activity (OPA)
Time frame: One-month post-vaccine
This assay helps us to know how the antibody produced by the body are working to kill the bacteria against which the antibody is produced. This point of time (one-month after vaccine), gives the information about how much the killing activity increased 1 month after the vaccine was administered.

Results and safety

Results posted to the registry on 12 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Immediate: PV Before Starting Antiretroviral Therapy	43	36
Delayed: PV After >6 Months of Antiretroviral Therapy	64	36

Primary outcome: Immunoglobulin G (IgG) Levels

Time frame: Baseline. Geometric mean (Full Range). Unit: Micrograms/ml

Measure	Immediate: PV Before Starting Antiretroviral Therapy n = 36	Delayed: PV After >6 Months of Antiretroviral Therapy n = 36
IgG levels against CPS 6B	5.12 (1.0)	5.17 (1.0)
IgG levels against CPS 23F	1.80 (1.0)	1.83 (1.0)

Primary outcome: IgG Levels

Time frame: One-month post-vaccine. Geometric mean (Full Range). Unit: Micrograms/ml

Measure	Immediate: PV Before Starting Antiretroviral Therapy n = 36	Delayed: PV After >6 Months of Antiretroviral Therapy n = 36
IgG levels against CPS 6B	7.85 (1.0)	5.79 (1.0)
IgG levels against CPS 23F	2.50 (1.0)	2.41 (1.0)

Primary outcome: Immunoglobulin M (IgM) Levels

Time frame: Baseline. Geometric mean (Full Range). Unit: Micrograms/ml

Measure	Immediate: PV Before Starting Antiretroviral Therapy n = 36	Delayed: PV After >6 Months of Antiretroviral Therapy n = 36
IgM levels against CPS 6B	1.89 (0.40 to 7.56)	1.85 (0.39 to 4.86)
IgM levels against CPS 23F	0.59 (0.01 to 4.29)	0.78 (0.09 to 3.18)

Primary outcome: IgM Levels

Time frame: One-month post-vaccine. Geometric mean (Full Range). Unit: Micrograms/ml

Measure	Immediate: PV Before Starting Antiretroviral Therapy n = 36	Delayed: PV After >6 Months of Antiretroviral Therapy n = 36
IgM levels against CPS 6B	2.18 (0.42 to 9.00)	2.26 (0.59 to 6.29)
IgM levels against CPS 23F	0.65 (0.02 to 3.20)	0.84 (0.23 to 2.86)

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm 1: PV Before Starting Antiretroviral Therapy	6 of 43 (14%)	2 of 43 (4.7%)	Not reported
Arm 2: PV After >6 Months of Antiretroviral Therapy	8 of 64 (12.5%)	1 of 64 (1.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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 Rodriguez-Barradas, MD principal investigator

Michael E. DeBakey VA Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing (PV) 23-valent pneumococcal polysaccharide vaccine in people with HIV Infections, run by US Department of Veterans Affairs at 1 site 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 3 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 24 Apr 2014. 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 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Dec 2013). 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?

Immunoglobulin G (IgG) Levels (time frame: Baseline). The study lists 6 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 NCT00706550.

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 24 Apr 2014.