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Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
San Francisco, California, 94115 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
HIV Infections, Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects aged 18 years or older at the time of enrollment.

- All female and male subjects who are biologically capable of having children must
agree and commit to the use of a reliable method of birth control from the signing of
the informed consent form (ICF) until 3 months after the last dose of investigational
product.

- Documented vaccination with 1 or more doses of 23vPS at least 6 months before study
enrollment.

- CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6
months before the first investigational product vaccination.

- HIV-infected subjects with viral load occasions within 6 months before the first investigational product vaccination.

- Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first
investigational product vaccination, or not currently receiving antiretroviral
therapy.

- Subject is expected to be available for the entire study period (approximately 18
months) and can be contacted by telephone.

- Subject must be able to complete an electronic diary (e-diary) and complete all
relevant study procedures during study participation.

- Subject is deemed to be eligible for the study on the basis of medical history,
physical examination, and clinical judgment. (Note: Subjects with preexisting stable
disease, defined as disease not requiring significant change in therapy or
hospitalization for worsening disease 6 weeks before investigational product
vaccination, are eligible.)

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects with active AIDS related illness, including opportunistic infections or
malignancy.

- Evidence of current illicit substance and/or alcohol abuse, that in the investigator's
opinion, precludes the subject from participating in the study or interferes with the
evaluation of the study objectives..

- Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to
enrollment.

- Contraindication to vaccination with pneumococcal conjugate vaccine.

- Previous anaphylactic reaction to any vaccine or vaccine-related component.

- History of culture-proven invasive disease caused by Streptococcus pneumoniae within
the last year.

- Current anticoagulant therapy or a history of bleeding diathesis or any condition
associated with prolonged bleeding time that would contraindicate intramuscular
injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is
permitted.)

- Pregnant or breastfeeding women, as defined by history or positive human chorionic
gonadotropin (hCG) urine test. All women of childbearing potential must have a urine
pregnancy test.

- History of active hepatitis with elevation in pretreatment aspartate aminotransferase
(AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal
within the last 6 months.

- Serious chronic disorder or any other disorder that, in the investigator's opinion,
precludes the subject from participating in the study or interferes with the
evaluation of the study objectives. (Note: Serious chronic disorders include
metastatic malignancy, severe chronic obstructive pulmonary disease requiring
supplemental oxygen, end-stage renal disease with or without dialysis, and clinically
unstable cardiac disease).

- Any major illness/condition that, in the investigator's judgment, will substantially
increase the risk associated with the subject's participation in and completion of,
the study, or could preclude the evaluation of the subject's response.

- History of splenectomy.

- Receipt of any blood products, including immunoglobulin, within 42 days before
investigational product vaccination until the last blood draw for the study
(approximately 13 months after the first investigational product vaccination).

- Evidence of dementia or other severe cognitive impairment.

- Subject who is, in the opinion of the investigator, unable to receive a vaccination in
the deltoid muscle of either arm because of insufficient muscle mass.

- Participation in another study using investigational product from 28 days before study
enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the
6 month follow-up telephone call (visit 7), use of investigational product must be
discussed with the Medical Monitor. (Note: Participation in purely observational
studies is acceptable.)

- Residence in a nursing home, long-term care facility, or other institution or
requirement of semi-skilled nursing care. An ambulatory resident of a retirement home
or village is eligible for the trial.

- Subject who is a direct relative (child, grandchild, parent, or grandparent) of study
personnel, or who is study personnel.

Temporary Delay Criteria:

- Current febrile illness (oral temperature of =38.0°C [100.4°F]) or other acute illness
within 48 hours before study vaccine administration.

- Currently receiving antibiotic therapy, or has completed a course of antibiotic
therapy within 10 days before study vaccine administration.

- Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational
product vaccination (seasonal influenza vaccine can be given at any time at the
discretion of the investigator).

NCT00963235
Pfizer
Completed
Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS

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Safety & Immunogenicity of 13vPnC in HIV-Infected Subjects Aged 18 or Older Who Were Previously Immunized With 23vPS
A Phase 3, Open-label, Single-Arm Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 3 Doses of 13vPnC Vaccine in HIV-Infected Subjects 18 Years of Age or Older Who Have Been Previously Immunized With 23vPS Vaccine
The study will evaluate the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC) in HIV-infected subjects 18 years of age or older who have been previously immunized with at least one dose of 23-valent pneumococcal polysaccharide vaccine (23vPS). All subjects will receive 3 doses of 13vPnC, with each study vaccine dose given approximately 6 months apart.
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • HIV Infections
  • Pneumococcal Infections
  • Biological: 13-valent pneumococcal conjugate vaccine
    Three doses of 13vPnC given 6 months apart.
    Other Name: 13vPnC
  • Procedure: Blood draw
    Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.
Experimental: 1
Interventions:
  • Biological: 13-valent pneumococcal conjugate vaccine
  • Procedure: Blood draw
Glesby MJ, Watson W, Brinson C, Greenberg RN, Lalezari JP, Skiest D, Sundaraiyer V, Natuk R, Gurtman A, Scott DA, Emini EA, Gruber WC, Schmoele-Thoma B. Immunogenicity and Safety of 13-Valent Pneumococcal Conjugate Vaccine in HIV-Infected Adults Previously Vaccinated With Pneumococcal Polysaccharide Vaccine. J Infect Dis. 2015 Jul 1;212(1):18-27. doi: 10.1093/infdis/jiu631. Epub 2014 Nov 13.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
331
May 2012
May 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female subjects aged 18 years or older at the time of enrollment.
  • All female and male subjects who are biologically capable of having children must agree and commit to the use of a reliable method of birth control from the signing of the informed consent form (ICF) until 3 months after the last dose of investigational product.
  • Documented vaccination with 1 or more doses of 23vPS at least 6 months before study enrollment.
  • CD4+ T-cell count >= 200 cells/µ, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
  • HIV-infected subjects with viral load <50,000 copies/mL, obtained on the most recent 2 occasions within 6 months before the first investigational product vaccination.
  • Subject is receiving a stable dose of HAART for at least 6 weeks prior to the first investigational product vaccination, or not currently receiving antiretroviral therapy.
  • Subject is expected to be available for the entire study period (approximately 18 months) and can be contacted by telephone.
  • Subject must be able to complete an electronic diary (e-diary) and complete all relevant study procedures during study participation.
  • Subject is deemed to be eligible for the study on the basis of medical history, physical examination, and clinical judgment. (Note: Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 6 weeks before investigational product vaccination, are eligible.)

Exclusion Criteria:

  • Subjects with active AIDS related illness, including opportunistic infections or malignancy.
  • Evidence of current illicit substance and/or alcohol abuse, that in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives..
  • Receipt of any licensed or experimental pneumococcal conjugate vaccine prior to enrollment.
  • Contraindication to vaccination with pneumococcal conjugate vaccine.
  • Previous anaphylactic reaction to any vaccine or vaccine-related component.
  • History of culture-proven invasive disease caused by Streptococcus pneumoniae within the last year.
  • Current anticoagulant therapy or a history of bleeding diathesis or any condition associated with prolonged bleeding time that would contraindicate intramuscular injection. (Note: Use of antiplatelet drugs, such as aspirin and clopidogrel, is permitted.)
  • Pregnant or breastfeeding women, as defined by history or positive human chorionic gonadotropin (hCG) urine test. All women of childbearing potential must have a urine pregnancy test.
  • History of active hepatitis with elevation in pretreatment aspartate aminotransferase (AST) or alanine aminotransferase (ALT) values >5 times the upper limit of normal within the last 6 months.
  • Serious chronic disorder or any other disorder that, in the investigator's opinion, precludes the subject from participating in the study or interferes with the evaluation of the study objectives. (Note: Serious chronic disorders include metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, and clinically unstable cardiac disease).
  • Any major illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and completion of, the study, or could preclude the evaluation of the subject's response.
  • History of splenectomy.
  • Receipt of any blood products, including immunoglobulin, within 42 days before investigational product vaccination until the last blood draw for the study (approximately 13 months after the first investigational product vaccination).
  • Evidence of dementia or other severe cognitive impairment.
  • Subject who is, in the opinion of the investigator, unable to receive a vaccination in the deltoid muscle of either arm because of insufficient muscle mass.
  • Participation in another study using investigational product from 28 days before study enrollment until the blood draw at visit 6. Between the blood draw at visit 6 and the 6 month follow-up telephone call (visit 7), use of investigational product must be discussed with the Medical Monitor. (Note: Participation in purely observational studies is acceptable.)
  • Residence in a nursing home, long-term care facility, or other institution or requirement of semi-skilled nursing care. An ambulatory resident of a retirement home or village is eligible for the trial.
  • Subject who is a direct relative (child, grandchild, parent, or grandparent) of study personnel, or who is study personnel.

Temporary Delay Criteria:

  • Current febrile illness (oral temperature of =38.0°C [100.4°F]) or other acute illness within 48 hours before study vaccine administration.
  • Currently receiving antibiotic therapy, or has completed a course of antibiotic therapy within 10 days before study vaccine administration.
  • Receipt of novel influenza A (H1N1) vaccine within 14 days before investigational product vaccination (seasonal influenza vaccine can be given at any time at the discretion of the investigator).
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00963235
6115A1-3017
B1851028
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
April 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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