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

NCT00963235 | Completed Phase 3 Results DMC

• 2 other identifiers: 6115A1-3017B1851028
• Study Type: interventional
• Target: 331
• Locations: 1 country
• Sites: 15

Brief Summary

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.

Conditions

HIV Infections; Pneumococcal Infections

Keywords

vaccine; 13-valent pneumococcal conjugate vaccine; human immunodeficiency virus

Outcome Measures

Primary Outcomes (1)

• Geometric Mean Fold Rise (GMFR) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC

  Geometric mean fold rises (GMFRs) for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) from 1 month post-dose 2 to 1 month post-dose 3 were computed using the logarithmically transformed assay results. Confidence interval (CI) for the GMFRs were back transformations of a CI based on the Student t distribution for the logarithmically transformed assay results.

  1 month post-dose 2, 1 month post-dose 3

Secondary Outcomes (6)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC

  1 month post-dose 2, 1 month post-dose 3

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC

  1 month post-dose 1, 1 month post-dose 2

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 3 of 13vPnC Relative to 1 Month After Dose 2 of 13vPnC

  1 month post-dose 2, 1 month post-dose 3

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) 1 Month After Dose 2 of 13vPnC Relative to 1 Month After Dose 1 of 13vPnC

  1 month post-dose 1, 1 month post-dose 2

• Serotype-Specific Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Fold Rise (GMFR) From 1 Month After Dose 2 of 13vPnC to 1 Month After Dose 3 of 13vPnC

  1 month post-dose 2, 1 month post-dose 3

Other Outcomes (6)

• Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 1

  Within 14 days post-dose 1

• Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 2

  Within 14 days post-dose 2

• Percentage of Participants Reporting Pre-Specified Local Reactions: 13vPnC Dose 3

  Within 14 days post-dose 3

Study Arms (1)

1

EXPERIMENTAL

Biological: 13-valent pneumococcal conjugate vaccine; Procedure: Blood draw

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Three doses of 13vPnC given 6 months apart.

Also known as: 13vPnC

1

Blood draw PROCEDURE

Six blood draws pre-vaccination and 1 month post-vaccination, doses 1-3.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Pfizer Investigational Site

San Francisco, California, 94115, United States

Location

Pfizer Investigational Site

Aurora, Colorado, 80045, United States

Location

Pfizer Investigational Site

Washington D.C., District of Columbia, 20009, United States

Location

Pfizer Investigational Site

Lexington, Kentucky, 40536, United States

Location

Pfizer Investigational Site

Springfield, Massachusetts, 01199, United States

Location

Pfizer Investigational Site

St Louis, Missouri, 63110, United States

Location

Pfizer Investigational Site

New York, New York, 10011, United States

Location

Pfizer Investigational Site

New York, New York, 10016, United States

Location

Pfizer Investigational Site

New York, New York, 10029, United States

Location

Pfizer Investigational Site

New York, New York, 10032, United States

Location

Pfizer Investigational Site

New York, New York, 10065, United States

Location

Pfizer Investigational Site

Rochester, New York, 14642, United States

Location

Pfizer Investigational Site

Johnson City, Tennessee, 37604, United States

Location

Pfizer Investigational Site

Austin, Texas, 78705, United States

Location

Pfizer Investigational Site

Dallas, Texas, 75246, United States

Location

Related Publications (1)

• 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.

  PMID: 25395187 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

HIV Infections; Pneumococcal Infections; Acquired Immunodeficiency Syndrome

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Slow Virus Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2009
• First Posted: August 21, 2009
• Study Start: November 1, 2009
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: June 10, 2013
• Results First Posted: June 10, 2013

Record last verified: 2013-04

Locations

US (15)