HIV InfectionsPhase 3NCT00622843

Pneumococcal Conjugate Vaccination in HIV in Comparison to Polysaccharide Vaccine Boosting

A Phase 3 study testing pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine in people with HIV Infections and Streptococcus Pneumoniae, run by Henry M. Jackson Foundation for the Advancement of Military Medicine at 6 sites 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

Purpose: To study the immune response of the newly licensed pneumococcal conjugate vaccine (PCV) in comparison to the pneumococcal polysaccharide vaccine (PPV) to determine if a significantly better immunologic response to boosting can be elicited in patients previously vaccinated with PPV. Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: HIV Infections, Streptococcus Pneumoniae
What is being tested?: pneumococcal conjugate vaccine and pneumococcal polysaccharide vaccine
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 275 participants
Where: 6 sitesUnited States
Study dates: Dec 2002to Jul 2013
Phase: Phase 3
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 to 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

At least one prior PPV ≥ 3 and < 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs.
HIV-positive (except 25 HIV-negative persons as control group).
Age between 18 and 60 years of age.
Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
HIV-negative by HIV ELISA within the last 12 months
Age between 18 and 60 years of age.
Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.

Who cannot join

Prior allergic reaction to the PPV
Allergic to components of PCV, including diphtheria toxin.
Pregnant or lactating females as defined by history or positive HCG urine test.
History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
History of splenectomy
Temperature of >38C

Show all 24Show fewer

Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
Patients diagnosed with HIV wasting disease
Viral load over 50,000 copies/ml.
History or evidence of recent illicit drug or alcohol abuse.
Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
Prior PCV and/or PPV vaccination.
Prior allergic reaction to the PPV
Allergic to components of PCV, including diphtheria toxin.
Pregnant or lactating females as defined by history or positive HCG urine test.
History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
History of splenectomy
Temperature of >38C
Inability to ambulate for more than 1000 meters secondary to fatigue, pain or weakness.
Patients in whom IM vaccination is not possible because of disease or medication. (e.g. hemophilia, coumadin therapy).
History or evidence of recent illicit drug or alcohol abuse.
Use of immunosuppressive agents, to include corticosteroids and cancer chemotherapeutic agents.
Works in chain of command of primary/associate investigators.

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

United States6 sites

National Naval Medical Center
Bethesda, Maryland, 20814
San Antonio Military Medical Center
Lackland Air Force Base, Texas, 78236
Naval Medical Center Portsmouth
Portsmouth, Virginia, 23708
Naval Medical Center San Diego
San Diego, California, 92134
Tripler Army Medical Center
Tripler AMC, Hawaii, 96859
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307

Other trials in United States

About this study

Official title: An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients

Conditions: HIV Infections, Streptococcus Pneumoniae
Being tested: pneumococcal conjugate vaccine, pneumococcal polysaccharide vaccine
Keywords: pneumococcal conjugate vaccine, polysaccharide vaccine, PPV, PCV, Streptococcus pneumoniae, Prevnar, Pneumovax, HIV
Medical subject headings: HIV Infections

What participants receive

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

pneumococcal conjugate vaccineBiological
Also called PCV
Prevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain:
2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.
pneumococcal polysaccharide vaccineBiological
Also called PPV
PNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.

Study groups in NCT00622843
Study group	Role	What they receive
Group 1	Experimental	PCV, 210 patients Receives: Biological: pneumococcal conjugate vaccine
Group 2	Active comparator	PPV, 110 patients Receives: Biological: pneumococcal polysaccharide vaccine
Group 3	Active comparator	PCV, HIV-negative, 25 patients Receives: Biological: pneumococcal conjugate vaccine

What is being measured

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

Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.
Measured: Day 14, 60, and 180 after vaccination
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Measured: Day 7 after vaccination

Secondary outcomes (3)

Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.
The pairwise change in CD4+ cell count from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination) (CD4+ cell count at day 14/60/180 [minus] CD4+ cell count at screening).
Analysis Population Description (further details): not all participants completed each follow-up visit. Therefore, a different number of participants analyzed is noted for each visit day. For example, in Group 1, 131 participants completed the screening visit but only 129 completed Day 14, and only 123 completed Day 60, etc.
Measured: Day 14, 60, and 180 after vaccination
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
Number with ≥ Successes, which is defined as: Success = 2-fold increase on Log10 scale -- if log10(Day 60) - log10(Screening) > log10(2)
Measured: Day 60 after vaccination
Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.
The pairwise change in viral load from the time of screening to each time frame (day 14, day 60 and day 180 post-vaccination), similar to CD4 change above.
Measured: Day 14, 60, and 180 after vaccination

Timeline

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

Dec 2002Jul 2013

First posted25 Feb 2008 (estimated)
Study startDec 2002
Primary completionJul 2013
Study completionJul 2013

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.
Publications (2)Papers the sponsor has linked to this study.
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 3
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 275 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00622843
Sponsor's protocol ID: RV150 Prevnar
Status last verified: May 2025
First submitted: 13 Feb 2008
Last updated: 8 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Agan B, Medina S, Rahkola J, Hale B, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine. 2010 Nov 10;28(48):7583-8. doi: 10.1016/j.vaccine.2010.09.056. Epub 2010 Sep 29.
PubMed 20887830
Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147.
PubMed 20795819

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 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label, Phase III, Randomized Study of Pneumococcal Conjugate Vaccination in HIV, in Comparison to Polysaccharide Vaccine Boosting in Previously Vaccinated Patients
ClinicalTrials.gov ID: NCT00622843
Acronym / sponsor ID: RV150 Prevnar
Conditions: HIV Infections, Streptococcus Pneumoniae
Keywords: pneumococcal conjugate vaccine, polysaccharide vaccine, PPV, PCV, Streptococcus pneumoniae, Prevnar, Pneumovax, HIV
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 275 participants (actual)
Lead sponsor: Henry M. Jackson Foundation for the Advancement of Military MedicineUniversity, hospital or other
Collaborators: Infectious Diseases Clinical Research Program, National Institute of Allergy and Infectious Diseases (NIAID), US Military HIV Research Program, Uniformed Services University of the Health Sciences
Study start: Dec 2002
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 25 Feb 2008 (estimated)
Results: Posted 8 Jun 2025

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Group 1	Experimental	Biological: pneumococcal conjugate vaccinePCV, 210 patients
Group 2	Active comparator	Biological: pneumococcal polysaccharide vaccinePPV, 110 patients
Group 3	Active comparator	Biological: pneumococcal conjugate vaccinePCV, HIV-negative, 25 patients

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (7 listed)

At least one prior PPV ≥ 3 and < 8 years ago, while HIV positive. There is no upper limit to the number of previously received PPVs.
HIV-positive (except 25 HIV-negative persons as control group).
Age between 18 and 60 years of age.
Availability of patient to remain within the immediate area for the period of the study and be able to comply with protocol requirements.
HIV-negative by HIV ELISA within the last 12 months

Key exclusion criteria (24 listed)

Prior allergic reaction to the PPV
Allergic to components of PCV, including diphtheria toxin.
Pregnant or lactating females as defined by history or positive HCG urine test.
History of chronic viral hepatitis or biochemical evidence to include pretreatment AST or ALT values greater than 3 fold higher than upper limit of normal, or a creatinine of greater than 1.8 mg/dl
History of splenectomy

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
pneumococcal conjugate vaccineAlso: PCVPrevnar is manufactured as a liquid preparation. Each 0.5 mL dose is formulated to contain: 2 μg of each saccharide for serotypes 4, 9V, 14, 18C, 19F, and 23F, and 4 μg of serotype 6B per dose (16 μg total saccharide); approximately 20 μg of CRM197 carrier protein; and 0.125 mg of aluminum per 0.5 mL dose as aluminum phosphate adjuvant. After shaking, the vaccine is a homogeneous, white suspension.	Biological	Group 1, Group 3
pneumococcal polysaccharide vaccineAlso: PPVPNEUMOVAX 23 is manufactured according to methods developed by the Merck Research Laboratories. Each 0.5 mL dose of vaccine contains 25 μg of each polysaccharide type in isotonic saline solution containing 0.25% phenol as a preservative.	Biological	Group 2

Primary outcome

Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms
Time frame: Day 14, 60, and 180 after vaccination
The primary end point is greater than or equal to a 2-fold increase in the IgG level for at least 2 of the 4 serotypes on day 60, with levels greater than or equal to 1000 ng/mL.
Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination
Time frame: Day 7 after vaccination

3 secondary outcomes

Assessment of CD4+ Cell Count Changes Caused by Vaccination With PCV and PPV.
Time frame: Day 14, 60, and 180 after vaccination
Assessment of the Importance of the Host Immune Status (CD4+ Count) on the PCV and PPV Immunologic Response.
Time frame: Day 60 after vaccination
Assessment of Viral Load Changes Caused by Vaccination With PCV and PPV.
Time frame: Day 14, 60, and 180 after vaccination

Results and safety

Results posted to the registry on 8 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 - PCV	131	131
Group 2 - PPV	73	73
Group 3 - HIV-negative	25	25

Primary outcome: Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms

Time frame: Day 14, 60, and 180 after vaccination. Count of participants. Unit: Participants

Measure	Group 1 - PCV n = 131	Group 2 - PPV n = 73	Group 3 - HIV-negative n = 25
Day 14 : At least 2 of 4 serotypes	67	23	22
Day 14 : At least 3 of 4 serotypes	37	11	16
Day 14 : Serotype 4	54	17	17
Day 14 : Serotype 9V	68	22	22
Day 14 : Serotype 14	57	27	18
Day 14 : Serotype 419F	37	12	14
Day 60 : At least 2 of 4 serotypes	68	23	22
Day 60 : At least 3 of 4 serotypes	37	9	16

Population analysed: The number of participants analyzed represents the number of participants who were actually vaccinated from those who consented to participate.

Primary outcome: Adverse Events (AEs) Occurring Temporally (Within 7 Days) in Association With Pneumococcal Vaccination

Time frame: Day 7 after vaccination. Count of participants. Unit: Participants

Measure	Group 1 - PCV n = 131	Group 2 - PPV n = 73	Group 3 - HIV-negative n = 25
Number of AEs = 0	80	50	1
Number of AEs =1	36	17	13
Number of AEs >/= 2	15	6	11

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 180 days post vaccination.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1 - PCV	0 of 131 (0%)	51 of 131 (38.9%)	0 of 131
Group 2 - PPV	0 of 73 (0%)	23 of 73 (31.5%)	0 of 73
Group 3 - HIV-negative	0 of 25 (0%)	24 of 25 (96%)	0 of 25

Limitations and caveats (from the sponsor): Limitations include: enrollment halted before full recruitment, no defined correlate of protective pneumococcal immunity in adults, prior pneumococcal vaccination may result in blunted responses to subsequent vaccination, and limiting to 4 serotypes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20887830Crum-Cianflone NF, Roediger M, Huppler Hullsiek K, Ganesan A, Landrum M, Weintrob A, Agan B, Medina S, Rahkola J, Hale B, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. The association of ethnicity with antibody responses to pneumococcal vaccination among adults with HIV infection. Vaccine. 2010 Nov 10;28(48):7583-8. doi: 10.1016/j.vaccine.2010.09.056. Epub 2010 Sep 29.
Results publication: PubMed 20795819Crum-Cianflone NF, Huppler Hullsiek K, Roediger M, Ganesan A, Patel S, Landrum ML, Weintrob A, Agan BK, Medina S, Rahkola J, Hale BR, Janoff EN; Infectious Disease Clinical Research Program HIV Working Group. A randomized clinical trial comparing revaccination with pneumococcal conjugate vaccine to polysaccharide vaccine among HIV-infected adults. J Infect Dis. 2010 Oct 1;202(7):1114-25. doi: 10.1086/656147.

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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.

Brian Agan, MD principal investigator

Uniformed Services University of the Health Sciences

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

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 24 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 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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.

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?

Yes. Results are posted in the registry (first posted 8 Jun 2025). 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?

Positive Immune Responses in the Human Immunodeficiency Virus (HIV)-Infected Pneumococcal Conjugate Vaccine (PCV) and Pneumococcal Polysaccharide Vaccine (PPV) Arms (time frame: Day 14, 60, and 180 after vaccination). The study lists 2 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 NCT00622843, which also lists 2 linked publications.

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 Jun 2025.